Adding Regenerative medicine to your practice.

[Ducttape]

B.S.

some people say the same thing about PRP....

and just like PRP, we should use empirical data to answer the question.

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Members don't see this ad.

 

[Ducttape]

prelim search:

Lower Plasma Melatonin in the Intervertebral Disk Degeneration Patients Was Associated with Increased Proinflammatory Cytokines - PubMed

The plasma melatonin concentration was significantly decreased in the IDD cases and plasma melatonin could be used as a diagnostic biomarker for IDD. Lower plasma melatonin was associated with longer disease durations, elevated disease severity and higher inflammatory cytokines levels in IDD...

pubmed.ncbi.nlm.nih.gov

Conclusion: The plasma melatonin concentration was significantly decreased in the IDD cases and plasma melatonin could be used as a diagnostic biomarker for IDD. Lower plasma melatonin was associated with longer disease durations, elevated disease severity and higher inflammatory cytokines levels in IDD patients.

Melatonin Attenuates Intervertebral Disk Degeneration via Maintaining Cartilaginous Endplate Integrity in Rats - PubMed

These results indicate that Mel protects the integrity of the EPs and attenuates IVDD by binding to the Mel receptors in the EPs. It may alleviate the inflammatory response and matrix degradation of EPCs activated by NF-κB pathway.

pubmed.ncbi.nlm.nih.gov

Conclusion: These results indicate that Mel protects the integrity of the EPs and attenuates IVDD by binding to the Mel receptors in the EPs. It may alleviate the inflammatory response and matrix degradation of EPCs activated by NF-κB pathway.

needs human studies and prospective blinded research with reproducible protocols.....

 

[drusso]

some people say the same thing about PRP....

and just like PRP, we should use empirical data to answer the question.

Well, some insurances pay for PRP and Melatonin is cash.

 

[drusso]

LOL AAOS! You Guys Crack Me Up - More Steroids and Less PRP for Knees! - Regenexx

Regenexx offers non-surgical, regenerative orthopedic treatment options for pain related to osteoarthritis, joint injuries, overuse conditions, spine pain, and common sports injuries.

regenexx.com

J Clin Med

Predictors of Effectiveness of Platelet-Rich Plasma Therapy for Knee Osteoarthritis: A Retrospective Cohort Study​

Yo****omo Saita 1 2, Yohei Kobayashi 1 2, Hirofumi Nishio 1 2, Takanori Wakayama 1 2, Shin Fukusato 1 2, Sayuri Uchino 1 2, Yasumasa Momoi 1 2, Hiroshi Ikeda 2, Kazuo Kaneko 2
Affiliations expand

• PMID: 34640529
• PMCID: PMC8509123
• DOI: 10.3390/jcm10194514

Free PMC article

Abstract​

There has recently been growing interest worldwide in biological therapies such as platelet-rich plasma injection for the treatment of knee osteoarthritis. However, predicting the effectiveness of platelet-rich plasma therapy remains uncertain. Therefore, this retrospective cohort study was performed to assess a range of predictors for the effectiveness of platelet-rich plasma therapy in treating knee osteoarthritis. The study included 517 consecutive patients who underwent three injections of leucocyte-poor platelet-rich plasma therapy from 2016 to 2019 at a single institution. The treatment outcomes, including patient-oriented outcomes (visual analogue scale score and Knee Injury and Osteoarthritis Outcome Score), were analyzed and compared according to the severity of knee osteoarthritis based on Kellgren-Lawrence (KL) grading using standing plain radiographs. Fisher's exact test, univariate regression, and multivariate regression were used for data analysis. Patient-oriented outcomes were significantly improved 6 and 12 months after platelet-rich plasma therapy. The overall responder rate in patients who met the Outcome Measures in Rheumatology (OMERACT)-Osteoarthritis Research Society International (OARSI) responder criteria was 62.1%. The responder rate was significantly lower in patients with severe knee osteoarthritis (KL4, 50.9%) than in those with mild (KL2, 75.2%) and moderate (KL3, 66.5%) knee osteoarthritis. The multivariate logistic regression analysis revealed that deterioration of the knee osteoarthritis grade (increased KL grade) was a significant predictor of a worse clinical outcome (odds ratio, 0.58; 95% confidence interval, 0.45-0.75; p < 0.001). The relative risk for non-responders in severe (KL4) KOA was 2.1 (95% CI, 1.5-3.0) at 6 months and 2.3 (1.6-3.2) at 12 months compared with mild-to-moderate (KL2-3) KOA. The efficacy of platelet-rich plasma therapy was not affected by age, sex, body weight, or platelet count. This study revealed that the effectiveness of platelet-rich plasma therapy for the treatment of knee osteoarthritis is approximately 60% and that the effectiveness depends on the severity of knee osteoarthritis. This observation is useful not only for physicians but also for patients with knee osteoarthritis.
Keywords: knee osteoarthritis; platelet-rich plasma; predictor of effectiveness.

 

[Ducttape]

no offense, but garbage study.

1. retrospective
2. no control
3. not blinded
4. essentially comparing severe to not so severe and stating that the severe didnt do as well as the not so severe.


essentially: those who have more clinically significant severe osteoarthritis will have poorer outcomes with PRP than those with moderate or mild disease.


or, in other words: if you be really sick you gonna do worse than if you aint so sick.

 

[drusso]

Arch Orthop Trauma Surg. 2021 Oct 27. doi: 10.1007/s00402-021-04230-2. Online ahead of print.

Multiple platelet-rich plasma injections are superior to single PRP injections or saline in osteoarthritis of the knee: the 2-year results of a randomized, double-blind, placebo-controlled clinical trial

Alparslan Yurtbay 1, Ferhat Say 2, Hikmet Çinka 2, Ahmet Ersoy 2
Affiliations expand
PMID: 34705072 DOI: 10.1007/s00402-021-04230-2
Abstract
Introduction: The primary purposes of this study were to prove the efficacy of PRP injection therapy on knee pain and functions by comparing patients with mild to moderate OA with a placebo control group, and also to understand the effectiveness of multiple doses compared to a single dose. It was hypothesized that PRP would lead to more favorable results than the placebo at 1, 3, 6, 12 and 24 months after treatment.

Materials and methods: 237 patients diagnosed with OA were randomly separated into 4 groups, who were administered the following: single dose of PRP (n: 62), single dose of sodium saline (NS) (n: 59), three doses of PRP (n: 63), and three doses of NS (n: 53). Clinical evaluations were made pre-treatment and at 1, 3, 6, 12 and 24 months post-treatment, using the Knee Injury and Osteoarthritis Result Score (KOOS), Kujala Patellofemoral Score, knee joint range of motion (ROM), measurements of knee circumference (KC), and mechanical axis angle (MAA) and a Visual Analog Scale (VAS) for the evaluation of pain.

Results: The better score values in the groups were recorded at 3 and 6 months. Patients treated with PRP maintained better scores at 3, 6 and 12 months compared to the NS groups (p < 0.05). Multiple doses of PRP were seen to be more effective than single-dose PRP at 6 and 12 months (p < 0.05). At the end of 24 months, there was no significant score difference across all the groups. The most positive change in scores was found in stage 2 OA, and the most positive change in ROM was in stage 3 OA patients. In the PRP groups, KC decreased more at 1 and 6 months (p < 0.05). Compared to other age groups, patients aged 51-65 years scored better at 6 months (p < 0.05). A negative correlation was determined with MAA scores (r = - 0.508, p < 0.001).

Conclusion: In comparison to the placebo (NS), leukocyte-rich PRP treatment was determined to be effective in the treatment of OA. Multiple doses of PRP increase the treatment efficacy and duration. Of all the patients treated with PRP, the best results were obtained by patients aged 51-65 years, with lower MAA, and by K/L stage 2 OA patients.

Study design: Randomized controlled trial; Level of evidence, 1.

Registration: NCT04454164 (ClinicalTrials.gov identifier).

Keywords: Injections; Intra-articular; Knee; Osteoarthritis; Platelet-rich plasma.

JAMA. 2021 Oct 26;326(16):1595-1605. doi: 10.1001/jama.2021.16602.

Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial

Liam D A Paget 1 2 3, Gustaaf Reurink 1 2 3 4, Robert-Jan de Vos 5, Adam Weir 5 6 7, Maarten H Moen 4 8, Sita M A Bierma-Zeinstra 5 9, Sjoerd A S Stufkens 1 2 3, Gino M M J Kerkhoffs 1 2 3, Johannes L Tol 2 3 10, PRIMA Study Group
Collaborators, Affiliations expand
PMID: 34698782 DOI: 10.1001/jama.2021.16602
Abstract
Importance: Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis.

Objective: To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis.

Design, setting, and participants: A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020.

Interventions: Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52).

Main outcomes and measures: The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks.

Results: Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was -1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.

Conclusions and relevance: Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis.

Trial registration: Netherlands Trial Register: NTR7261.

LinkOut - more resources

 

[lobelsteve]

Arch Orthop Trauma Surg. 2021 Oct 27. doi: 10.1007/s00402-021-04230-2. Online ahead of print.

Multiple platelet-rich plasma injections are superior to single PRP injections or saline in osteoarthritis of the knee: the 2-year results of a randomized, double-blind, placebo-controlled clinical trial

Alparslan Yurtbay 1, Ferhat Say 2, Hikmet Çinka 2, Ahmet Ersoy 2
Affiliations expand
PMID: 34705072 DOI: 10.1007/s00402-021-04230-2
Abstract
Introduction: The primary purposes of this study were to prove the efficacy of PRP injection therapy on knee pain and functions by comparing patients with mild to moderate OA with a placebo control group, and also to understand the effectiveness of multiple doses compared to a single dose. It was hypothesized that PRP would lead to more favorable results than the placebo at 1, 3, 6, 12 and 24 months after treatment.

Materials and methods: 237 patients diagnosed with OA were randomly separated into 4 groups, who were administered the following: single dose of PRP (n: 62), single dose of sodium saline (NS) (n: 59), three doses of PRP (n: 63), and three doses of NS (n: 53). Clinical evaluations were made pre-treatment and at 1, 3, 6, 12 and 24 months post-treatment, using the Knee Injury and Osteoarthritis Result Score (KOOS), Kujala Patellofemoral Score, knee joint range of motion (ROM), measurements of knee circumference (KC), and mechanical axis angle (MAA) and a Visual Analog Scale (VAS) for the evaluation of pain.

Results: The better score values in the groups were recorded at 3 and 6 months. Patients treated with PRP maintained better scores at 3, 6 and 12 months compared to the NS groups (p < 0.05). Multiple doses of PRP were seen to be more effective than single-dose PRP at 6 and 12 months (p < 0.05). At the end of 24 months, there was no significant score difference across all the groups. The most positive change in scores was found in stage 2 OA, and the most positive change in ROM was in stage 3 OA patients. In the PRP groups, KC decreased more at 1 and 6 months (p < 0.05). Compared to other age groups, patients aged 51-65 years scored better at 6 months (p < 0.05). A negative correlation was determined with MAA scores (r = - 0.508, p < 0.001).

Conclusion: In comparison to the placebo (NS), leukocyte-rich PRP treatment was determined to be effective in the treatment of OA. Multiple doses of PRP increase the treatment efficacy and duration. Of all the patients treated with PRP, the best results were obtained by patients aged 51-65 years, with lower MAA, and by K/L stage 2 OA patients.

Study design: Randomized controlled trial; Level of evidence, 1.

Registration: NCT04454164 (ClinicalTrials.gov identifier).

Keywords: Injections; Intra-articular; Knee; Osteoarthritis; Platelet-rich plasma.

JAMA. 2021 Oct 26;326(16):1595-1605. doi: 10.1001/jama.2021.16602.

Effect of Platelet-Rich Plasma Injections vs Placebo on Ankle Symptoms and Function in Patients With Ankle Osteoarthritis: A Randomized Clinical Trial

Liam D A Paget 1 2 3, Gustaaf Reurink 1 2 3 4, Robert-Jan de Vos 5, Adam Weir 5 6 7, Maarten H Moen 4 8, Sita M A Bierma-Zeinstra 5 9, Sjoerd A S Stufkens 1 2 3, Gino M M J Kerkhoffs 1 2 3, Johannes L Tol 2 3 10, PRIMA Study Group
Collaborators, Affiliations expand
PMID: 34698782 DOI: 10.1001/jama.2021.16602
Abstract
Importance: Approximately 3.4% of adults have ankle (tibiotalar) osteoarthritis and, among younger patients, ankle osteoarthritis is more common than knee and hip osteoarthritis. Few effective nonsurgical interventions exist, but platelet-rich plasma (PRP) injections are widely used, with some evidence of efficacy in knee osteoarthritis.

Objective: To determine the effect of PRP injections on symptoms and function in patients with ankle osteoarthritis.

Design, setting, and participants: A multicenter, block-randomized, double-blinded, placebo-controlled clinical trial performed at 6 sites in the Netherlands that included 100 patients with pain greater than 40 on a visual analog scale (range, 0-100) and tibiotalar joint space narrowing. Enrollment began on August 24, 2018, and follow-up was completed on December 3, 2020.

Interventions: Patients were randomly assigned (1:1) to receive 2 ultrasonography-guided intra-articular injections of either PRP (n = 48) or placebo (saline; n = 52).

Main outcomes and measures: The primary outcome was the validated American Orthopaedic Foot and Ankle Society score (range, 0-100; higher scores indicate less pain and better function; minimal clinically important difference, 12 points) over 26 weeks.

Results: Among 100 randomized patients (mean age, 56 years; 45 [45%] women), no patients were lost to follow-up for the primary outcome. Compared with baseline values, the mean American Orthopaedic Foot and Ankle Society score improved by 10 points in the PRP group (from 63 to 73 points [95% CI, 6-14]; P < .001) and 11 points in the placebo group (from 64 to 75 points [95% CI, 7-15]; P < .001). The adjusted between-group difference over 26 weeks was -1 ([95% CI, -6 to 3]; P = .56). One serious adverse event was reported in the placebo group, which was unrelated to the intervention; there were 13 other adverse events in the PRP group and 8 in the placebo group.

Conclusions and relevance: Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks. The results of this study do not support the use of PRP injections for ankle osteoarthritis.

Trial registration: Netherlands Trial Register: NTR7261.

LinkOut - more resources

First article shows more money is better than less money.
Second article shows PRP does not work for OA ankle- fair and balanced or posted in error? Don't let Centeno see this.

 

[Ducttape]

thanks for posting.

both blinded, randomized study comparing to placebo.

decent looking study.

unfortunately,
knee study: "At the end of 24 months, there was no significant score difference across all the groups."

ankle study: "Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks."

 

[Nodolor]

First article shows more money is better than less money.
Second article shows PRP does not work for OA ankle- fair and balanced or posted in error? Don't let Centeno see this.

 

[drusso]

thanks for posting.

both blinded, randomized study comparing to placebo.

decent looking study.

unfortunately,
knee study: "At the end of 24 months, there was no significant score difference across all the groups."

ankle study: "Among patients with ankle osteoarthritis, intra-articular PRP injections, compared with placebo injections, did not significantly improve ankle symptoms and function over 26 weeks."

Do placebos last 24 months?

 

[Ducttape]

in this study, the injections didnt provide any benefit over placebo at 24 months.

so either placebo helped (and so did the injections), or the injections didnt (just like the placebo).

your choice.

 

[drusso]

in this study, the injections didnt provide any benefit over placebo at 24 months.

so either placebo helped (and so did the injections), or the injections didnt (just like the placebo).

your choice.

BUT, looking at their technique should we really expand their conclusion to include all "PRP"?

Why is "PRP" in quotes? See below.

The authors used the Arthrex ACP system... with a technique that was a 15cc blood draw and concentrates only 2-3x over baseline platelet counts at most. The authors did not evaluate their injectate.....what they injected was not put thru a hematology machine so we don't really have the data. So, if we assume an average of about 200 for a human platelet count and 2.5x concentration for the Arthrex ACP based on their data....the platelet count of the PRP injected was 500. The authors injected 2cc. Total platelet dose = 1000 (units left off intentionally). So, even with the 2 injections in this study, the patients got a total of 2000 (units) of PRP. The authors found that this dose was no better than placebo. I am not surprised....probably should not use that PRP system and protocol for ankle arthritis based on this study. BTW.....Most clinical researchers don't consider the product PRP unless it gets to 4x or 5x but that is a separate discussion.

GIGO

 

[Ducttape]

BUT, looking at their technique should we really expand their conclusion to include all "PRP"?

Why is "PRP" in quotes? See below.

The authors used the Arthrex ACP system... with a technique that was a 15cc blood draw and concentrates only 2-3x over baseline platelet counts at most. The authors did not evaluate their injectate.....what they injected was not put thru a hematology machine so we don't really have the data. So, if we assume an average of about 200 for a human platelet count and 2.5x concentration for the Arthrex ACP based on their data....the platelet count of the PRP injected was 500. The authors injected 2cc. Total platelet dose = 1000 (units left off intentionally). So, even with the 2 injections in this study, the patients got a total of 2000 (units) of PRP. The authors found that this dose was no better than placebo. I am not surprised....probably should not use that PRP system and protocol for ankle arthritis based on this study. BTW.....Most clinical researchers don't consider the product PRP unless it gets to 4x or 5x but that is a separate discussion.

GIGO

no, not all PRP.

this is a decent study - looking at one specific body part and one specific treatment algorithm and comparing it to a placebo. eliminates quite a few of the confounding factors.



you can make an argument about the system, but....
arguing that a specific system isnt good doesnt negate the negative results and allow you to say that PRP is effective.

i also find the argument kind of tenuous that you are arguing about a specific system in this case. this is not the argument that we have for other interventional treatments. noone posts arguments to specifically use neurotherm RF vs other companies, or, for conventional stim, only BS systems have scientific backing, or you have to use a 18 gauge Touhy for epidurals as opposed to a 25 gauge quinke needle or that depomedrol cant be used for epidurals and that studies only show benefit from celestone....

 

[drusso]

no, not all PRP.

this is a decent study - looking at one specific body part and one specific treatment algorithm and comparing it to a placebo. eliminates quite a few of the confounding factors.



you can make an argument about the system, but....
arguing that a specific system isnt good doesnt negate the negative results and allow you to say that PRP is effective.

i also find the argument kind of tenuous that you are arguing about a specific system in this case. this is not the argument that we have for other interventional treatments. noone posts arguments to specifically use neurotherm RF vs other companies, or, for conventional stim, only BS systems have scientific backing, or you have to use a 18 gauge Touhy for epidurals as opposed to a 25 gauge quinke needle or that depomedrol cant be used for epidurals and that studies only show benefit from celestone....

Uh...orthobiologics are a different kind of treatment paradigm altogether compared to devices or RFA. Your body is the orthobiological factory. So, host factors, processing techniques, etc are all extremely relevant.

Designing regen RCT is not like a cholesterol pill RCT. It's more like a surgical technique clinical trial.

 

[nvrsumr]

Is there a blinded article that shows difference in clinical outcome based on plt concentration of prp?

 

[Ducttape]

Uh...orthobiologics are a different kind of treatment paradigm altogether compared to devices or RFA. Your body is the orthobiological factory. So, host factors, processing techniques, etc are all extremely relevant.

Designing regen RCT is not like a cholesterol pill RCT. It's more like a surgical technique clinical trial.

um....

first statement - orthobiologics are different than devices. (devices in my mind does include the actual device and effects of the device.)

second statement - regen RCT is more like a surgical technique clinical trial.


at the very least, getting back to my statement, a somewhat comparative example to PRP concentration is to state that celestone is so different from depomedrol that we can invalidate any negative study using depomedrol, or dexamethasone is so superior to any other steroid that only dexamethasone studies are valid and we do not make that kind of distinction at all.

 

[lobelsteve]

PRP is faith based medicine.

 

[drusso]

PRP is faith based medicine.

 

[Nodolor]

As an atheist I probably have faith in the "almighty"

 

[drusso]

WaPo: https://www.washingtonpost.com/heal...3eb3f0-3b22-11ec-a493-51b0252dea0c_story.html


Could platelet-rich plasma injections help avoid knee surgery? More studies may give answers.

By Marlene Cimons
November 6, 2021 at 12:00 p.m. EDT



Douglas Jantz, 57, a retired middle school teacher from Houston, has been playing tennis since he was 9. He is serious about his game, so he was worried when his knees started to hurt. Eventually, he was diagnosed with osteoarthritis (OA).

“Tennis is my favorite sport, so I was very upset,” he says. “I was really afraid I would have to give it up.”

A cortisone shot and physical therapy didn’t help, and the pain grew worse. Having switched doctors when his insurance changed, his new physician suggested he consider something different: injections with platelet-rich plasma, or PRP, a therapy that uses certain cells, platelets and growth factors from a patient’s own blood to ease pain and mend injured tissues.

After suffering for two years, Jantz readily agreed. “I thought it was definitely worth a try,” he says. Jantz has had several PRP injections in each knee since 2018, and he says they helped. He’s playing tennis again, mostly pain free, and doing other things that he found difficult before. “Today, I feel very good,” he says.

PRP is among several therapies that are part of the growing practice of regenerative medicine, a field that relies on the body’s natural properties to heal itself. While these therapies have been in use for many years, mainstream medicine has been slow in adopting them, in part because studies have shown conflicting results.

Researchers say that these procedures suggest efficacy, and pose little risk, because the material comes from the patient’s own body. But they agree that more standardized studies are needed, especially when it comes to PRP.

There have been at least 80 studies using PRP in the knees with mixed results, depending on the severity of the arthritis and a lack of consistency in composition of the PRP — that is, which blood cells are separated out and used. For this reason, some medical organizations, such as the Arthritis Foundation and the American College of Rheumatology, recommend against it.

“All PRP is not the same,” says John Ferrell III, a regenerative sports medicine physician in the D.C. area who uses PRP in his practice and believes in its therapeutic benefits when administered by experienced clinicians. “Also, it seems to work best on mild to moderate OA,” he says.

Insurance companies and Medicare still regard the therapy as experimental and refuse to cover the costs.

Nevertheless, the market for regenerative medicine, including for knee osteoarthritis, has been growing with estimates that it will expand to $39 billion in 2024, up from $13.3 billion in 2019, according to Doctor.com, a company that provides marketing information to medical practices.

In addition to PRP, the knee therapies include the use of micro-fragmented adipose (fat) transfer and bone marrow aspirate. In recent years, clinicians who use them say all three are attractive — and less dangerous — alternatives to widely used steroid injections, which research now suggests not only fail to help patients but actually hasten cartilage loss.

“My goal as a knee surgeon is to save knees, so it’s very exciting to see these emerging technologies,” says Nicholas DiNubile, a Philadelphia-area orthopedic surgeon and vice president of the American Academy of Anti-Aging Medicine.

“Several years ago, we used to say, in terms of regenerative therapies, that the marketing was ahead of the science,” DiNubile says. “But today, the science is beginning to catch up. There is solid research that they are effective and safe. They don’t regrow cartilage, but they reboot the knee in a way that it behaves better.”

Prathap Jayaram, director of regenerative sports medicine and assistant professor in the department of physical medicine and rehabilitation and orthopedic surgery at the Baylor College of Medicine — and who treated Jantz — calls knee osteoarthritis one of the leading musculoskeletal disabilities of aging.

“It causes chronic pain, impaired mobility and functional impairment — being able to get up and go to the bathroom, go down the stairs, walk the dog, and imposes a significant financial burden,” he says. “It’s very common — nearly 80 percent of people older than 55 have X-ray evidence of it. Either you have it, or you know somebody who does.”
More than 32.5 million Americans suffer from osteoarthritis, according to the Centers for Disease Control and Prevention. The disease occurs when cartilage — the tissue that cushions the ends of the bones within the joints — breaks down and wears away, sometimes leaving bones that rub up against each other, often described as “bone on bone.” The knees are among the joints most commonly afflicted, causing stiffness, pain, making it difficult to walk, climb, get in and out of chairs and bathtubs — and, for active older adults, to play sports.

While it doesn’t regrow new cartilage, researchers say that the use of PRP might delay its loss, raising the prospect that patients might be able to avoid knee replacement surgery if they are treated early enough. Jayaram and his colleagues already have shown it works in mice.

“There really are no treatments for knee osteoarthritis,” he says. “We have therapies that manage symptoms, but no disease-modifying treatment. In preclinical work, we’ve been able to show that PRP can delay disease progression, laying the foundation for a pilot clinical study in patients.”

For moderate-to-severe cases, clinicians often turn to micro-fragmented adipose tissue transfer or bone marrow. Both involve using fat or marrow taken directly from the patient, then reintroduced after processing into the knees. These procedures are more invasive than PRP — which involves a simple blood draw from a patient’s arm — but can be done in an office setting using a local anesthetic.

“I’ve had patients, whose average age was 70, who could have been immediate candidates for total knee replacement, who did well,” after receiving fat injections, says William Murrell, an orthopedic regenerative sports medicine specialist in New York and lead author of a recently published study on the use of adipose tissue in elderly patients with knee osteoarthritis. “Also, the great benefit of using adipose tissue is that we see a significant amount of symptom amelioration for a good amount of time.”

These approaches are all autologous, meaning the patient is both donor and recipient — and not taken from anyone else, which enhances safety — and should not be confused with stem-cell therapies. Stem cells have become controversial in recent years because of false claims and misinformation over social media about unproven therapies, resulting in patient injuries when used by inexperienced practitioners or non-physicians. PRP is a blood product that doesn’t contain stem cells. And, while bone marrow concentrate and micro-fragmented adipose contain a small amount of stem cells, the two aren’t marketed as stem-cell treatments.

Bone marrow aspirate contains growth factors that decrease inflammation and promote healing, while micro-fragmented adipose tissue is marketed for cushioning and support. The Food and Drug Administration regulates them as human cells, tissues, and cellular and tissue-based products. Both are prepared for injection using kits cleared by the FDA, while PRP is processed using a centrifuge, also approved by the agency.

For human cells and tissues, the agency monitors for safety but does not give “approval” for specific uses because that would be regulating the practice of medicine, which it does not have the authority to do. While PRP isn’t “FDA approved” per se, the agency allows it to be legally offered “off-label” in clinics for numerous musculoskeletal conditions.

“You can use these products if they meet two criteria, minimal manipulation [meaning the product hasn’t been changed in a way that would turn it into a drug] and homologous use,” Ferrell says. Micro-fragmented adipose tissue and bone marrow aspirate treatments “are minimal manipulation and, as long as the physician is injecting ‘like into like,’ this is homologous use. So, injecting bone marrow into bone or fat into areas that contain fat for the purposes of cushioning, this is homologous use.”

Moreover, “fat grafting is a common medical procedure and has been considered mainstream since the 1990s in plastic surgery,” he adds. “Insurance companies are really the only ones that consider this experimental.”

Numerous studies suggest clinical improvement in knee osteoarthritis using PRP, micro-fragmented adipose tissue transfer and bone marrow aspirate.

Jayaram recently completed a pilot study of PRP injections for knee arthritis in 12 patients in their 50s and 60s, Jantz among them, using novel wearable microchip sensors to measure PRP’s therapeutic effects on function and movement.

Six weeks after treatment, they found significant improvement in pain and “timed up and go,” a test that measures how long it takes someone to rise from a chair, walk about 10 feet, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees.

“PRP is emerging as one of the promising candidates to treat OA that are currently being used in clinical practice,” he says.

Patients with more advanced osteoarthritis benefit more from fat or bone marrow treatments, clinicians say.

“Adipose tissue is a signaling device that sends messages to other cells in the area to turn off the inflammation,” Murrell says. “Adipose doesn’t regenerate cartilage, but it turns off the pathways that prompt the breakdown.”

The fat is taken from the abdomen, hips or gluteal region. “Then we do a mechanical separation — it sounds like using a cocktail shaker — that removes oils, red blood cells, but keeps the good fat that we do want,” Ferrell says. “We use about 12 ounces — about a soda can full.”

It usually requires a single shot, and relief — from the cushioning, lubrication and reduced inflammation — can last as long as three years, he says.

With bone marrow aspirate concentrate, the material is extracted from the back of the hip bone — equal to about half a soda can, Ferrell says — which is spun into a concentrated solution to eliminate certain cells, then injected into the knee.

“It’s a great anti-inflammatory, and continues to turn off inflammation,” Ferrell says. “It also creates more stabilization in the meniscus and supporting ligaments of the knee. Patients can notice an improvement in their symptoms within one week.”

The costs can range from $3,500 to $10,000 (the latter in expensive areas such as New York or San Francisco) for fat and bone marrow, considerably less for PRP, although insurance often does cover fees for office visits and diagnostics, such as ultrasound exams.

Many patients think it’s worth it “when you look at price of knee replacement at $50,000, which is covered, but there are deductibles and co-pays — which typically cost the patient $4,000 to $6,000 out of pocket — and a much more difficult and painful recovery,” Ferrell says. “We’re trying to redefine orthopedic medicine. We want to give people minimally invasive options before they need definitive invasive surgery.”

Meanwhile, Jantz, whose last PRP injection was nearly a year ago, is playing tennis and has resumed hiking and other past activities.

“Going down those hills used to be tough,” he says, remembering his earlier hikes. “I had to crab walk my way down, but now I’m not afraid to do them anymore. I’m also much better sitting, standing and walking, which used to be painful. Now I’m at the gym every day.”

 

[drusso]

Platelet-rich plasma: A regenerative approach to healing chronic wounds - Mayo Clinic News Network

By Madelyn Fell Platelet-rich plasma is the fraction of blood plasma that contains concentrations of platelets that are higher than baseline. Platelet-rich plasma attracts significant interest in the medical and research community since platelets possess various growth factors and cell parts...

regenerativemedicineblog.mayoclinic.org

 

[Doctodd]

WaPo: https://www.washingtonpost.com/heal...3eb3f0-3b22-11ec-a493-51b0252dea0c_story.html


Could platelet-rich plasma injections help avoid knee surgery? More studies may give answers.

By Marlene Cimons
November 6, 2021 at 12:00 p.m. EDT



Douglas Jantz, 57, a retired middle school teacher from Houston, has been playing tennis since he was 9. He is serious about his game, so he was worried when his knees started to hurt. Eventually, he was diagnosed with osteoarthritis (OA).

“Tennis is my favorite sport, so I was very upset,” he says. “I was really afraid I would have to give it up.”

A cortisone shot and physical therapy didn’t help, and the pain grew worse. Having switched doctors when his insurance changed, his new physician suggested he consider something different: injections with platelet-rich plasma, or PRP, a therapy that uses certain cells, platelets and growth factors from a patient’s own blood to ease pain and mend injured tissues.

After suffering for two years, Jantz readily agreed. “I thought it was definitely worth a try,” he says. Jantz has had several PRP injections in each knee since 2018, and he says they helped. He’s playing tennis again, mostly pain free, and doing other things that he found difficult before. “Today, I feel very good,” he says.

PRP is among several therapies that are part of the growing practice of regenerative medicine, a field that relies on the body’s natural properties to heal itself. While these therapies have been in use for many years, mainstream medicine has been slow in adopting them, in part because studies have shown conflicting results.

Researchers say that these procedures suggest efficacy, and pose little risk, because the material comes from the patient’s own body. But they agree that more standardized studies are needed, especially when it comes to PRP.

There have been at least 80 studies using PRP in the knees with mixed results, depending on the severity of the arthritis and a lack of consistency in composition of the PRP — that is, which blood cells are separated out and used. For this reason, some medical organizations, such as the Arthritis Foundation and the American College of Rheumatology, recommend against it.

“All PRP is not the same,” says John Ferrell III, a regenerative sports medicine physician in the D.C. area who uses PRP in his practice and believes in its therapeutic benefits when administered by experienced clinicians. “Also, it seems to work best on mild to moderate OA,” he says.

Insurance companies and Medicare still regard the therapy as experimental and refuse to cover the costs.

Nevertheless, the market for regenerative medicine, including for knee osteoarthritis, has been growing with estimates that it will expand to $39 billion in 2024, up from $13.3 billion in 2019, according to Doctor.com, a company that provides marketing information to medical practices.

In addition to PRP, the knee therapies include the use of micro-fragmented adipose (fat) transfer and bone marrow aspirate. In recent years, clinicians who use them say all three are attractive — and less dangerous — alternatives to widely used steroid injections, which research now suggests not only fail to help patients but actually hasten cartilage loss.

“My goal as a knee surgeon is to save knees, so it’s very exciting to see these emerging technologies,” says Nicholas DiNubile, a Philadelphia-area orthopedic surgeon and vice president of the American Academy of Anti-Aging Medicine.

“Several years ago, we used to say, in terms of regenerative therapies, that the marketing was ahead of the science,” DiNubile says. “But today, the science is beginning to catch up. There is solid research that they are effective and safe. They don’t regrow cartilage, but they reboot the knee in a way that it behaves better.”

Prathap Jayaram, director of regenerative sports medicine and assistant professor in the department of physical medicine and rehabilitation and orthopedic surgery at the Baylor College of Medicine — and who treated Jantz — calls knee osteoarthritis one of the leading musculoskeletal disabilities of aging.

“It causes chronic pain, impaired mobility and functional impairment — being able to get up and go to the bathroom, go down the stairs, walk the dog, and imposes a significant financial burden,” he says. “It’s very common — nearly 80 percent of people older than 55 have X-ray evidence of it. Either you have it, or you know somebody who does.”
More than 32.5 million Americans suffer from osteoarthritis, according to the Centers for Disease Control and Prevention. The disease occurs when cartilage — the tissue that cushions the ends of the bones within the joints — breaks down and wears away, sometimes leaving bones that rub up against each other, often described as “bone on bone.” The knees are among the joints most commonly afflicted, causing stiffness, pain, making it difficult to walk, climb, get in and out of chairs and bathtubs — and, for active older adults, to play sports.

While it doesn’t regrow new cartilage, researchers say that the use of PRP might delay its loss, raising the prospect that patients might be able to avoid knee replacement surgery if they are treated early enough. Jayaram and his colleagues already have shown it works in mice.

“There really are no treatments for knee osteoarthritis,” he says. “We have therapies that manage symptoms, but no disease-modifying treatment. In preclinical work, we’ve been able to show that PRP can delay disease progression, laying the foundation for a pilot clinical study in patients.”

For moderate-to-severe cases, clinicians often turn to micro-fragmented adipose tissue transfer or bone marrow. Both involve using fat or marrow taken directly from the patient, then reintroduced after processing into the knees. These procedures are more invasive than PRP — which involves a simple blood draw from a patient’s arm — but can be done in an office setting using a local anesthetic.

“I’ve had patients, whose average age was 70, who could have been immediate candidates for total knee replacement, who did well,” after receiving fat injections, says William Murrell, an orthopedic regenerative sports medicine specialist in New York and lead author of a recently published study on the use of adipose tissue in elderly patients with knee osteoarthritis. “Also, the great benefit of using adipose tissue is that we see a significant amount of symptom amelioration for a good amount of time.”

These approaches are all autologous, meaning the patient is both donor and recipient — and not taken from anyone else, which enhances safety — and should not be confused with stem-cell therapies. Stem cells have become controversial in recent years because of false claims and misinformation over social media about unproven therapies, resulting in patient injuries when used by inexperienced practitioners or non-physicians. PRP is a blood product that doesn’t contain stem cells. And, while bone marrow concentrate and micro-fragmented adipose contain a small amount of stem cells, the two aren’t marketed as stem-cell treatments.

Bone marrow aspirate contains growth factors that decrease inflammation and promote healing, while micro-fragmented adipose tissue is marketed for cushioning and support. The Food and Drug Administration regulates them as human cells, tissues, and cellular and tissue-based products. Both are prepared for injection using kits cleared by the FDA, while PRP is processed using a centrifuge, also approved by the agency.

For human cells and tissues, the agency monitors for safety but does not give “approval” for specific uses because that would be regulating the practice of medicine, which it does not have the authority to do. While PRP isn’t “FDA approved” per se, the agency allows it to be legally offered “off-label” in clinics for numerous musculoskeletal conditions.

“You can use these products if they meet two criteria, minimal manipulation [meaning the product hasn’t been changed in a way that would turn it into a drug] and homologous use,” Ferrell says. Micro-fragmented adipose tissue and bone marrow aspirate treatments “are minimal manipulation and, as long as the physician is injecting ‘like into like,’ this is homologous use. So, injecting bone marrow into bone or fat into areas that contain fat for the purposes of cushioning, this is homologous use.”

Moreover, “fat grafting is a common medical procedure and has been considered mainstream since the 1990s in plastic surgery,” he adds. “Insurance companies are really the only ones that consider this experimental.”

Numerous studies suggest clinical improvement in knee osteoarthritis using PRP, micro-fragmented adipose tissue transfer and bone marrow aspirate.

Jayaram recently completed a pilot study of PRP injections for knee arthritis in 12 patients in their 50s and 60s, Jantz among them, using novel wearable microchip sensors to measure PRP’s therapeutic effects on function and movement.

Six weeks after treatment, they found significant improvement in pain and “timed up and go,” a test that measures how long it takes someone to rise from a chair, walk about 10 feet, turn around 180 degrees, walk back to the chair and sit down while turning 180 degrees.

“PRP is emerging as one of the promising candidates to treat OA that are currently being used in clinical practice,” he says.

Patients with more advanced osteoarthritis benefit more from fat or bone marrow treatments, clinicians say.

“Adipose tissue is a signaling device that sends messages to other cells in the area to turn off the inflammation,” Murrell says. “Adipose doesn’t regenerate cartilage, but it turns off the pathways that prompt the breakdown.”

The fat is taken from the abdomen, hips or gluteal region. “Then we do a mechanical separation — it sounds like using a cocktail shaker — that removes oils, red blood cells, but keeps the good fat that we do want,” Ferrell says. “We use about 12 ounces — about a soda can full.”

It usually requires a single shot, and relief — from the cushioning, lubrication and reduced inflammation — can last as long as three years, he says.

With bone marrow aspirate concentrate, the material is extracted from the back of the hip bone — equal to about half a soda can, Ferrell says — which is spun into a concentrated solution to eliminate certain cells, then injected into the knee.

“It’s a great anti-inflammatory, and continues to turn off inflammation,” Ferrell says. “It also creates more stabilization in the meniscus and supporting ligaments of the knee. Patients can notice an improvement in their symptoms within one week.”

The costs can range from $3,500 to $10,000 (the latter in expensive areas such as New York or San Francisco) for fat and bone marrow, considerably less for PRP, although insurance often does cover fees for office visits and diagnostics, such as ultrasound exams.

Many patients think it’s worth it “when you look at price of knee replacement at $50,000, which is covered, but there are deductibles and co-pays — which typically cost the patient $4,000 to $6,000 out of pocket — and a much more difficult and painful recovery,” Ferrell says. “We’re trying to redefine orthopedic medicine. We want to give people minimally invasive options before they need definitive invasive surgery.”

Meanwhile, Jantz, whose last PRP injection was nearly a year ago, is playing tennis and has resumed hiking and other past activities.

“Going down those hills used to be tough,” he says, remembering his earlier hikes. “I had to crab walk my way down, but now I’m not afraid to do them anymore. I’m also much better sitting, standing and walking, which used to be painful. Now I’m at the gym every day.”

Oh no a WAPO story! I….can’t….click….on….it.

 

[drusso]

Review

Int J Impot Res. 2021 Nov 6.
doi: 10.1038/s41443-021-00482-z. Online ahead of print.

The potential of platelet-rich plasma injections and stem cell therapy for penile rejuvenation​

Joseph M Israeli 1, Soum D Lokeshwar 2, Iakov V Efimenko 1, Thomas A Masterson 1, Ranjith Ramasamy 3
Affiliations expand

• PMID: 34743193
• DOI: 10.1038/s41443-021-00482-z

Abstract​

Penile concerns include erectile dysfunction (ED) and Peyronie disease (PD). Restorative therapies including Stem Cell Therapy (SCT) and Platelet Rich Plasma (PRP) injections are proposed to treat these concerns. SCT encompasses the harvesting and injection of mesenchymal stem cells or stromal vascular fractions from various tissue sources. PRP is derived autologously from a patient's plasma and is then injected into the penile tissue. These therapies repair damaged penile tissue and promote both new cellular and vascular growth, as demonstrated in basic science studies. Human trials on SCT and PRP for both ED and PD and have yielded promising results with few side effects. While encouraging, small cohort size and lack of blinding or placebo control limit these studies' external validity. Recently, the first double-blinded randomized controlled trial on PRP for ED was published, providing significant evidence of efficacy. With the rapid commercial availability of SCT and PRP for ED and PD, it is imperative to perform more randomized and placebo-controlled trials with standardized procedures and preparations to evaluate efficacy and safety. This narrative review will summarize the available literature on these penile restorative therapies to date.
© 2021. The Author(s), under exclusive licence to Springer Nature Limited.

 

[drusso]

whats a "Seninar"?

lobel does hit upon an important point - the fact that these procedures are essentially wild wild west means that everyone is going to do them, and they will not be effective - since they will be done incorrectly. it will put a black mark on these procedures, and will perpetuate the Medicare notion that they are not effective and should not be covered.

Rev Bras Ortop (Sao Paulo)

2021 Apr 19;56(5):634-640.
doi: 10.1055/s-0041-1724075. eCollection 2021 Oct.

Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Chondral Injuries In Young Patients​

Marcus Vinicius Danieli 1 2, João Paulo Fernandes Guerreiro 1 2, Telvio Ataide Vimercati 1, Pedro Henrique Favaro Mendes 2, Paulo Raphael Tsutomu Katayama Miyazaki 2, Daniele Cristina Cataneo 3
Affiliations expand

• PMID: 34733436
• PMCID: PMC8558929
• DOI: 10.1055/s-0041-1724075

Free PMC article

Abstract​

Objective The present study aimed to compare the clinical and functional outcomes of hyaluronic acid (HA) or platelet-rich plasma (PRP) applications to treat young patients with knee chondral lesions with no arthrosis. Methods Prospective clinical and functional evaluation of 30 young adult patients with knee chondral lesions submitted to conservative treatment with HA or PRP for a minimum follow-up time of 12 months. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) and visual analog scale (VAS) were used for the evaluation. Results According to the WOMAC score, the PRP group showed significant improvement in all evaluated points, whereas the HA group presented no score improvement. In the VAS, the PRP group showed improvement in all evaluated points, and the HA group presented improvement at 6 and 12 months. Compared to the HA group, the PRP group presented better WOMAC scores at all evaluated points and better VAS scores up to 6 months after treatment. Conclusion Platelet-rich plasma application resulted in better clinical and functional outcomes at both the WOMAC and VAS scores when applied to knees from young patients with chondral lesions, but no arthrosis. These outcomes were sustained for up to 12 months. Level of evidence Randomized clinical trial (Type 2B).
Keywords: cartilage, articular; hyaluronic acid; knee; platelet-rich plasma; viscosupplementation.

 

[Ferrismonk]

I've got an actual question about "Adding Regenerative Medicine to your Practice". Weird huh?

In my last job I brought in Regenerative Medicine treatments including PRP and BMAC via Arthrex. I used Arthrex based on my larger company recommendation. While clinically I had excellent results with every PRP I did (didn't get any BMAC takers), I ran into a lot of difficulty incorporating the different philosophy of Regenerative Medicine into my traditional pain clinic.

A big part of that was how patients normally find a pain clinic (referrals from other healthcare providers), the expectation that insurance will cover treatments at the pain clinic, the patient population that goes to a pain clinic (not usually athletes or healthy people with mild/moderate OA and/or tendon/ligament issues), and patient expectations of "You fix me even though I don't want to help myself" vs "I want to get healthier and more functional". I also ran into difficulty marketing Regenerative Medicine separately from our other services because the clinic focus was not geared towards RegenMed and there was some confusion getting all the staff to understand the treatment differences. Practically it was also difficult in the office visits. There simply isn't enough time to discuss traditional treatments AND regenerative medicine treatments during a normal 15min office visit. Especially since you also need to discuss NSAIDs, Steroids, anti-inflammatory diet changes, smoking cessation, etc during the OV if you're doing it right.

Most RegenMed docs I know either have created a separate RegenMed office where the whole system is cash-based (makes it easier to spend more time with patient and treatment goal is already established) or have just added simple single-spin PRP like Arthrex ACP for joints in addition to their normal practice.

In my new job I carved out an exception in my contract during negotiation where I can establish my own RegenMed clinic (albeit outside a certain distance from my office) if I so choose. There is no current RegenMed at my current employer. The only people who do RegenMed in my area are a semi-quack family doc, an ortho group who does PRP peripheral joints, and an integrative medicine doc who does Prolo only.

My dilemma is that my current employer now would like to bring in RegenMed and would like me to start it up. My problem is that I know the problems with my prior attempt to incorporate RegenMed into a "normal" pain clinic and that most of the partners I work with are not RegenMed minded. To them PRP is just a different medicine you inject instead of steroids that may pay better. The benefit would be I could already bring patients in an established location with Fluro/Ultrasound ready as well as their insurance company would pay for office visits.

If you were in a similar situation, what would you do? For those who have also incorporated RegenMed into their practice, did you experience the same issues I did? What do you think about creating a subsidiary of the pain group, with a RegenMed type name, but share the same clinic?

 

[Ducttape]

i am not in that situation, but i would suggest you keep them separate in all aspects - administrators, cost center, location.

you do not want poor quality chronic pain patients to fill up your regen medicine clinic slots that you should keep open for younger healthy people with musculoskeletal issues that can improve with PRP.

 

[Dr. Ice]

It’s challenging. I mix it in with my regular clinic patients. I still don’t offer it as first line treatment, so I have established patients who have expressed interest through word of mouth from others, or bring it up to me. I usually discuss it briefly with patients as an option if they inquire about “what if this doesn’t work.” The visits regarding regen do wind up taking quite a bit more time and I wind up then becoming behind, but I haven’t found a great way to stream line better. The schedulers would not be able to filter regen specific patients to me, and we are already dealing with major staffing issues as it is.

Fortunately, my surgical partners have really taken to PRP ( a little too much, unfortunately) but that helps in that they will refer for it, if they don’t think their superior anatomical skills are capable of doing the procedures blind themselves.

It does make it a lot easier when patients come in clearly telling me they want PRP but that is not a big percentage of people.

 

[drusso]

I've got an actual question about "Adding Regenerative Medicine to your Practice". Weird huh?

In my last job I brought in Regenerative Medicine treatments including PRP and BMAC via Arthrex. I used Arthrex based on my larger company recommendation. While clinically I had excellent results with every PRP I did (didn't get any BMAC takers), I ran into a lot of difficulty incorporating the different philosophy of Regenerative Medicine into my traditional pain clinic.

A big part of that was how patients normally find a pain clinic (referrals from other healthcare providers), the expectation that insurance will cover treatments at the pain clinic, the patient population that goes to a pain clinic (not usually athletes or healthy people with mild/moderate OA and/or tendon/ligament issues), and patient expectations of "You fix me even though I don't want to help myself" vs "I want to get healthier and more functional". I also ran into difficulty marketing Regenerative Medicine separately from our other services because the clinic focus was not geared towards RegenMed and there was some confusion getting all the staff to understand the treatment differences. Practically it was also difficult in the office visits. There simply isn't enough time to discuss traditional treatments AND regenerative medicine treatments during a normal 15min office visit. Especially since you also need to discuss NSAIDs, Steroids, anti-inflammatory diet changes, smoking cessation, etc during the OV if you're doing it right.

Most RegenMed docs I know either have created a separate RegenMed office where the whole system is cash-based (makes it easier to spend more time with patient and treatment goal is already established) or have just added simple single-spin PRP like Arthrex ACP for joints in addition to their normal practice.

In my new job I carved out an exception in my contract during negotiation where I can establish my own RegenMed clinic (albeit outside a certain distance from my office) if I so choose. There is no current RegenMed at my current employer. The only people who do RegenMed in my area are a semi-quack family doc, an ortho group who does PRP peripheral joints, and an integrative medicine doc who does Prolo only.

My dilemma is that my current employer now would like to bring in RegenMed and would like me to start it up. My problem is that I know the problems with my prior attempt to incorporate RegenMed into a "normal" pain clinic and that most of the partners I work with are not RegenMed minded. To them PRP is just a different medicine you inject instead of steroids that may pay better. The benefit would be I could already bring patients in an established location with Fluro/Ultrasound ready as well as their insurance company would pay for office visits.

If you were in a similar situation, what would you do? For those who have also incorporated RegenMed into their practice, did you experience the same issues I did? What do you think about creating a subsidiary of the pain group, with a RegenMed type name, but share the same clinic?

You're absolutely right. It's very hard to have the two service lines run in parallel. I regenerate on Tuesdays and Thursdays and degenerate on Monday, Wednesdays, and Fridays. For a lot of patients, a visit to Regen Clinic is like shopping at Bergdorf's---nice stuff but they can't afford it. They really need to go down to the JC Penny's or Sears Pain Clinic.

And almost everything is insurance-driven in health care so a lot of my conversations go like this, "Well, you'd be a good candidate to try one of these new regenerative procedures and some data show it would probably reduce your pain, cause less tissue damage, and improve your function. But, you have Medicare and the Government won't pay for it. Your health care insurance is like Government cheese--you only get so much and not necessarily the best but it's better than nothing. And, you're poor and you can't afford it. So, instead, you get to be injected with corticosteroids until your arms and legs fall off or until some orthopedic surgeon offers you a joint replacement."

Add to the mess the whole SOS arbitrage schemes with employed pain docs and surgeons driving up the cost of everything and it really is the definition of insanity. At that point, the Government will have no qualms about paying 10-20X for joint replacement, hospital stay, rehab, etc.

 

[cowboydoc]

You're absolutely right. It's very hard to have the two service lines run in parallel. I regenerate on Tuesdays and Thursdays and degenerate on Monday, Wednesdays, and Fridays. For a lot of patients, a visit to Regen Clinic is like shopping at Bergdorf's---nice stuff but they can't afford it. They really need to go down to the JC Penny's or Sears Pain Clinic.

And almost everything is insurance-driven in health care so a lot of my conversations go like this, "Well, you'd be a good candidate to try one of these new regenerative procedures and some data show it would probably reduce your pain, cause less tissue damage, and improve your function. But, you have Medicare and the Government won't pay for it. Your health care insurance is like Government cheese--you only get so much and not necessarily the best but it's better than nothing. And, you're poor and you can't afford it. So, instead, you get to be injected with corticosteroids until your arms and legs fall off or until some orthopedic surgeon offers you a joint replacement."

Add to the mess the whole SOS arbitrage schemes with employed pain docs and surgeons driving up the cost of everything and it really is the definition of insanity. At that point, the Government will have no qualms about paying 10-20X for joint replacement, hospital stay, rehab, etc.

Have you considered bringing your daughter in and paying her to recite Ayn Rand in your waiting room?

 

[nvrsumr]

I have a separate website for regen med so patients who want that call ahead. Was a lot easier a few years back when google ads let you advertise more specifically for stem cell. Also did airline magazine ads which were high yield and had a number of patients fly into town.

Patients are pretty savvy about this now and have lots of questions regarding process and are cost conscious so u need an employee who can answer theses questions without bothering you.

I wouldn’t spend a ton of money. My experience is that it went from high paying cash procedure with only a few docs performing locally to a volume and cost based procedure with docs all over town offering.

The prep can eat up alot of time for your staff and there are a number of higher paying procedures that you already perform. Regen Med patients can be needy and annoying(think aesthetics).

For me breaks up the day and is something a little different but not a big money maker. I mainly do PRP now and spin without a fancy kit which has helped the margins

 

[HyperSonic]

drusso, I really don't think you should be convincing people with data or studies. I wish people like lobesteve don't believe it so that it will never be covered by insurance because there isn't enough "data" to support it..

all I care is my PRP patients keep referring their friends and family members, paying cash out of pocket for this stuff, because it works, period.

I'm just glad I can offer PRP/stem cells injection therapy to my patients and when I need it myself, someone can give it to me.

Do you do any of these injections for spine? What kinds?

 

[Dr. Ice]

Do you do any of these injections for spine? What kinds?

Epidural lysate PRP, intra articular facet PRP, SIJ PRP, have done a few intradiscal PRP

 

[HyperSonic]

fwiw, it might help if you stopped posting infomercials from regenexx. imo, it isn't becoming of your status as a thought leader.

what’s wrong with Regenexx?

 

[drusso]

what’s wrong with Regenexx?

Yeah, what's wrong with Regenexx?

 

[nvrsumr]

Is that the group that was founded by personal injury docs and then brought those ethics to their regen med empire?

 

[Ducttape]

please remember the context of that statement which was posted July 2019, 2 1/2 years ago.

it was in response to the advertisement by Regenexx that was posted by drusso.

 

[drusso]

please remember the context of that statement which was posted July 2019, 2 1/2 years ago.

it was in response to the advertisement by Regenexx that was posted by drusso.

You are a loyal soldier for Labatria in the Galactic "PRP Wars..."

The PRP Wars and the Planet Academia - Regenexx

Regenexx offers non-surgical, regenerative orthopedic treatment options for pain related to osteoarthritis, joint injuries, overuse conditions, spine pain, and common sports injuries.

regenexx.com

"While I may have watched far too many Star Trek episodes, hopefully, this parody helps you understand why you continue to see dueling media pieces on PRP. In the real world, these media pieces happen because PRP does threaten the “economy” of lab scientists. Hence, now you know, that few of these stories have anything to do with actual science or the scientific method, but instead represent two sides of US universities who are “warring” with each other.

The upshot? The positive randomized controlled trials on PRP continue to be published at a furious pace. In the real world, that’s fantastic for medical doctors looking for new ways to help their patients that are less destructive than surgery. However, far far away on the planet academia and in the media, the wars continue. I mostly just ignore the drama and try to focus my energy on helping patients."

 

[Nodolor]

So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

 

[Ducttape]

and you continue to spout stories from one of the primary PRP evangelicals.



what if Centeno is one of the false prophets?

because there is no evidence that PRP is curing people...

 

[lobelsteve]

So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

Check clears: in the mix.
No money: no magic goo.

 

[drusso]

and you continue to spout stories from one of the primary PRP evangelicals.



what if Centeno is one of the false prophets?

because there is no evidence that PRP is curing people...

Have you ever seen Chris's shoes?

 

[drusso]

and you continue to spout stories from one of the primary PRP evangelicals.



what if Centeno is one of the false prophets?

because there is no evidence that PRP is curing people...

More imaginary evidence that PRP/BMAC "doesn't work..."

 

[Doctodd]

So Harvard and Mayo and other universities are going to discontinue their Regen med programs?

 

[Nodolor]

More imaginary evidence that PRP/BMAC "doesn't work..."

You are all about Centano, can you answer the question from above?

So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

 

[drusso]

You are all about Centano, can you answer the question from above?

So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

Email him and ask. I don't do sugar water injections. He does.

 

[Nodolor]

you are all things Centano, can you answer the question from above?
So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

Email him and ask.

Just figured you would know, his website seems to show similar indications for procedures are for Prolotherapy/PRP/Stem Cell........but I am sure there are no financial considerations on choosing which one is done.

 

[callmeanesthesia]

You are all about Centano, can you answer the question from above?

So how does Centeno decide which patient gets Stem cell injections vs injections of sugar water?

The key is the proper diagnostic workup beforehand - most importantly the wallet biopsy.

 

[Ducttape]

you keep reporting studies that do not necessarily back your contentions.

lets break this down, again.

Conclusions: Bone marrow aspirate concentrate, Leukocyte rich Platelet Rich Plasma, and Hyaluronic acid injections are safe therapeutic options for knee OA and provide positive clinical outcomes after 12 months in comparison with findings preceding the intervention. BMAC could be better in terms of clinical improvements in the treatment of knee OA than PRP and HA up to 12 months. PRP provides better outcomes than HA during the observation period, but these results are not statistically significant. More randomized controlled trials and high quality comparative studies are needed for direct correlative conclusions.

doing a study and then stating that people better than before the study is insufficient to state that the injections made improvements. the authors admit it was not fully randomized. this study was primarily for comparing the 3 forms of "regenerative" therapies.


second, PRP is not statistically significant from hyaluronidase at 12 months. but better than 12 months ago. maybe.

if one assumes that the results of the study are to be believed, then one must conclude also that hyaluronidase works...

interestingly, 111 people got BMAC.
30 ppl got HA.
34 ppl got PRP
no good explanation for the huge difference in numbers.

please note a comment from the authors of the study:

Efficacy of BMAC therapy for the knee OA was investigated in few different studies, comparing both results between the pre-intervention period and after the observation period, or comparing this therapy with placebo or physical therapy. Results from these studies are controversial; some investigators proved the efficacy of BMAC therapy, whereas others found no differences between this therapy and placebo. We found somewhat better clinical results of BMAC therapy after 12 months in comparison with both competing regenerative therapeutic options and with the pre-intervention period

 

[drusso]

Just figured you would know, his website seems to show similar indications for procedures are for Prolotherapy/PRP/Stem Cell........but I am sure there are no financial considerations on choosing which one is done.

BTW, the literature for dextrose injections is mixed...

Randomized Controlled Trial

Iran J Allergy Asthma Immunol. 2020 Jun 23;19(3):243-252.
doi: 10.18502/ijaai.v19i3.3452.

Effect of Dextrose Prolotherapy, Platelet Rich Plasma and Autologous Conditioned Serum on Knee Osteoarthritis: A Randomized Clinical Trial​

Alireza Pishgahi 1, Rozita Abolhasan 2, Seyed Kazem Shakouri 3, Mohammad Sadegh Soltani-Zangbar 4, Shahla Dareshiri 5, Sepideh Ranjbar Kiyakalayeh 6, Amirghasem Khoeilar 7, Majid Zamani 8, Farhad Motavalli Khiavi 9, Behzad Pourabbas Kheiraddin 10, Amir Mehdizadeh 11, Mehdi Yousefi 12
Affiliations expand

• PMID: 32615658
• DOI: 10.18502/ijaai.v19i3.3452

Free article

Abstract​

Knee osteoarthritis (OA) is one of the common degenerative articular disorders that are related to decreased quality of life. Currently, novel biologic therapeutic approaches are introduced in the literature for OA management. In this study, the clinical efficiency of Dextrose prolotherapy, platelet-rich plasma (PRP) and autologous conditioned serum (ACS) injection on the level of pain and function in Knee OA were compared. A randomized clinical trial was directed on 92 knee OA patients. Patients were randomly divided into three groups: 30 were received dextrose prolotherapy once in a week for three weeks, 30 received autologous PRP for two times with seven days interval, and in the remaining 32 patients 2ml of ACS were injected two times every seven days. Study participants were measured through the Western Ontario and McMaster Universities (WOMAC) score, the visual analogue scale (VAS), at baseline, 1 and 6 months post-intervention. Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group. Dextrose prolotherapy showed no substantial changes in pain and function of the affected knee in treated patients. Treatment of Knee OA with ACS and PRP injections are associated with pain reduction and knee function improvement. Not only, ACS therapy is more effective than that of PRP, but also due to its less variability in processing and less reported side effects, it could be considered as a safe and effective non-surgical alternative for OA management.


Ann Fam Med.
May-Jun 2013;11(3):229-37.
doi: 10.1370/afm.1504.

Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial​

David Rabago 1, Jeffrey J Patterson, Marlon Mundt, Richard Kijowski, Jessica Grettie, Neil A Segal, Aleksandra Zgierska
Affiliations expand

Abstract​

Purpose: Knee osteoarthritis is a common, debilitating chronic disease. Prolotherapy is an injection therapy for chronic musculoskeletal pain. We conducted a 3-arm, blinded (injector, assessor, injection group participants), randomized controlled trial to assess the efficacy of prolotherapy for knee osteoarthritis.
Methods: Ninety adults with at least 3 months of painful knee osteoarthritis were randomized to blinded injection (dextrose prolotherapy or saline) or at-home exercise. Extra- and intra-articular injections were done at 1, 5, and 9 weeks with as-needed additional treatments at weeks 13 and 17. Exercise participants received an exercise manual and in-person instruction. Outcome measures included a composite score on the Western Ontario McMaster University Osteoarthritis Index (WOMAC; 100 points); knee pain scale (KPS; individual knee), post-procedure opioid medication use, and participant satisfaction. Intention-to-treat analysis using analysis of variance was used.
Results: No baseline differences existed between groups. All groups reported improved composite WOMAC scores compared with baseline status (P <.01) at 52 weeks. Adjusted for sex, age, and body mass index, WOMAC scores for patients receiving dextrose prolotherapy improved more (P <.05) at 52 weeks than did scores for patients receiving saline and exercise (score change: 15.3 ± 3.5 vs 7.6 ± 3.4, and 8.2 ± 3.3 points, respectively) and exceeded the WOMAC-based minimal clinically important difference. Individual knee pain scores also improved more in the prolotherapy group (P = .05). Use of prescribed postprocedure opioid medication resulted in rapid diminution of injection-related pain. Satisfaction with prolotherapy was high. There were no adverse events.
Conclusions: Prolotherapy resulted in clinically meaningful sustained improvement of pain, function, and stiffness scores for knee osteoarthritis compared with blinded saline injections and at-home exercises.
Trial registration: ClinicalTrials.gov NCT00085722.
Keywords: dextrose; knee; osteoarthritis; prolotherapy; randomized controlled trial.

 

[Nodolor]

20 years ago when I was in Med School seemed a lot of sketchy docs were doing Prolo