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hmmm... ACS more effective than PRP?

why havent you discussed ACS? it is a regenerative product.
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Ducttape said:
hmmm... ACS more effective than PRP?

why havent you discussed ACS? it is a regenerative product.
Click to expand...

It's more or less just another version of PRP...

Randomized Controlled Trial

Am J Sports Med

. 2016 Apr;44(4):884-91.
doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial​

Patrick A Smith 1
Affiliations expand

Abstract​

Background: Platelet-rich plasma (PRP) injections have become an intriguing treatment option for osteoarthritis (OA), particularly OA of the knee. Despite the plethora of PRP-related citations, there is a paucity of high-level evidence that is comparable, cohort specific, dose controlled, injection protocol controlled, and double-blinded.
Purpose: To determine the safety and efficacy of leukocyte-poor PRP autologous conditioned plasma (ACP) for knee OA treatment through a feasibility trial regulated by the US Food and Drug Administration (FDA).
Study design: Randomized controlled trial; Level of evidence, 1.
Methods: In accordance with FDA protocol, patient selection was based on strict inclusion/exclusion criteria; 114 patients were screened, and 30 were ultimately included in the study. These patients were randomized to receive either ACP (n = 15) or saline placebo (n = 15) for a series of 3 weekly injections. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores served as the primary efficacy outcome measure. Patients were followed for 1 year.
Results: No adverse events were reported for ACP administration. Furthermore, the results demonstrated no statistically significant difference in baseline WOMAC scores between the 2 groups. However, in the ACP group, WOMAC scores at 1 week were significantly decreased compared with baseline scores, and the scores for this group remained significantly lower throughout the study duration. At the study conclusion (12 months), subjects in the ACP group had improved their overall WOMAC scores by 78% from their baseline score, compared with 7% for the placebo group.
Conclusion: ACP is safe and provides quantifiable benefits for pain relief and functional improvement with regard to knee OA. No adverse events were reported for ACP administration. After 1 year, WOMAC scores for the ACP subjects had improved by 78% from their baseline score, whereas scores for the placebo control group had improved by only 7%. Other joints affected with OA may also benefit from this treatment.
Keywords: FDA; WOMAC; autologous conditioned plasma; leukocyte-poor platelet-rich plasma; level 1; osteoarthritis; placebo; saline control.
 
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drusso said:
Little did they know how far ahead of the times they were.
Click to expand...
snake-oil-salesman-1024x514.jpg
 
Dr. Ice said:
Are you a hospital employed doc?
Click to expand...


Hospitals and health systems benefit from employing doctors in other ways. Physicians in hospital groups order their tests from hospital labs and radiology centers. In addition, hospitals are able to bill Medicare for the ambulatory care provided by their doctors at a much higher rate than what Medicare pays to private practices for the same services. The hospitals have been allowed to do this because their employed physicians are considered to be part of hospital outpatient departments (HOPDs). HOPDs, which also include emergency departments and same-day surgery units, charge not only professional fees but also facility fees.

Just how much of a difference this makes can be seen by comparing the Medicare-allowed fees for a medium-level office visit in the two types of care settings. In hospital-affiliated clinics that are considered part of HOPDs, the payment was $116 in 2018. In contrast, private practices received $81 for the same kind of visit.
 
drusso said:

Hospitals and health systems benefit from employing doctors in other ways. Physicians in hospital groups order their tests from hospital labs and radiology centers. In addition, hospitals are able to bill Medicare for the ambulatory care provided by their doctors at a much higher rate than what Medicare pays to private practices for the same services. The hospitals have been allowed to do this because their employed physicians are considered to be part of hospital outpatient departments (HOPDs). HOPDs, which also include emergency departments and same-day surgery units, charge not only professional fees but also facility fees.

Just how much of a difference this makes can be seen by comparing the Medicare-allowed fees for a medium-level office visit in the two types of care settings. In hospital-affiliated clinics that are considered part of HOPDs, the payment was $116 in 2018. In contrast, private practices received $81 for the same kind of visit.
Click to expand...
I wonder if there iS a fancy name fOr thiS.
 
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drusso said:
It's more or less just another version of PRP...

Randomized Controlled Trial

Am J Sports Med

. 2016 Apr;44(4):884-91.
doi: 10.1177/0363546515624678. Epub 2016 Feb 1.

Intra-articular Autologous Conditioned Plasma Injections Provide Safe and Efficacious Treatment for Knee Osteoarthritis: An FDA-Sanctioned, Randomized, Double-blind, Placebo-controlled Clinical Trial​

Patrick A Smith 1
Affiliations expand

Abstract​

Background: Platelet-rich plasma (PRP) injections have become an intriguing treatment option for osteoarthritis (OA), particularly OA of the knee. Despite the plethora of PRP-related citations, there is a paucity of high-level evidence that is comparable, cohort specific, dose controlled, injection protocol controlled, and double-blinded.
Purpose: To determine the safety and efficacy of leukocyte-poor PRP autologous conditioned plasma (ACP) for knee OA treatment through a feasibility trial regulated by the US Food and Drug Administration (FDA).
Study design: Randomized controlled trial; Level of evidence, 1.
Methods: In accordance with FDA protocol, patient selection was based on strict inclusion/exclusion criteria; 114 patients were screened, and 30 were ultimately included in the study. These patients were randomized to receive either ACP (n = 15) or saline placebo (n = 15) for a series of 3 weekly injections. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores served as the primary efficacy outcome measure. Patients were followed for 1 year.
Results: No adverse events were reported for ACP administration. Furthermore, the results demonstrated no statistically significant difference in baseline WOMAC scores between the 2 groups. However, in the ACP group, WOMAC scores at 1 week were significantly decreased compared with baseline scores, and the scores for this group remained significantly lower throughout the study duration. At the study conclusion (12 months), subjects in the ACP group had improved their overall WOMAC scores by 78% from their baseline score, compared with 7% for the placebo group.
Conclusion: ACP is safe and provides quantifiable benefits for pain relief and functional improvement with regard to knee OA. No adverse events were reported for ACP administration. After 1 year, WOMAC scores for the ACP subjects had improved by 78% from their baseline score, whereas scores for the placebo control group had improved by only 7%. Other joints affected with OA may also benefit from this treatment.
Keywords: FDA; WOMAC; autologous conditioned plasma; leukocyte-poor platelet-rich plasma; level 1; osteoarthritis; placebo; saline control.
Click to expand...
so...

this was a good study.

refreshing to see a study that was double blinded, randomized, placebo controlled.

and found clinically significant improvement 1 year out for the LP-PRP product.

these are the type of studies we should be looking at, not the other "stuff"/GIGO
 
Dr. Ice said:
Are you a hospital employed doc?
Click to expand...
nope, been in private practice for 20 years and have owned my practice for last 15yr. What does that have to do with me calling Prolotherapy junk, which it is?
 
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Cureus.
2021 Oct 11;13(10):e18668. doi: 10.7759/cureus.18668. eCollection 2021 Oct.

Efficacy of Local Autologous Platelet-Rich Plasma in the Treatment of Pressure Ulcer in Spinal Cord Injury Patients

Gurpreet Singh 1, Diganta Borah 1, Geetika Khanna 2, Sakshi Jain 3
Affiliations expand
PMID: 34790446 PMCID: PMC8583427 DOI: 10.7759/cureus.18668
Free PMC article

Abstract
Background: Pressure ulcer is one of the common complications occurring in spinal cord injury (SCI) patients. Platelet-rich plasma (PRP) has been found useful in the treatment of pressure ulcers in few studies. The purpose of this study was to evaluate the role of PRP in pressure ulcer healing in comparison to hydrogel dressing in SCI patients.

Methods: In this randomized interventional study, 52 patients of SCI having pressure ulcers of grade III/IV were randomized into two groups of 26 each. In group A patients, hydrogel dressing was done while freshly prepared PRP was used in patients of group B. Pressure ulcers were evaluated at baseline and after three weeks and six weeks in terms of ulcer surface area, volume, Pressure Ulcer Scale for Healing (PUSH) score, histopathology, and ulcer healing parameters. Data were collected and quantitative variables were compared using unpaired t-test or Mann-Whitney test between the two groups and qualitative variables were compared using the chi-square test or Fisher's exact test. A p-value of <0.05 was considered statistically significant.

Results: Baseline characteristics were comparable in both groups. There was a significant improvement in ulcers in terms of surface area, volume, and PUSH score in both the groups but it was comparable (p-value >0.05). There was a significant improvement in the PRP group as compared to the other group in terms of epithelization, granulation, and neovascularization at three and six-week follow-up.

Conclusions: This study suggests that PRP is a possible and better alternative to conventional dressing methods for the treatment of pressure ulcers.

Keywords: hydrogel dressing; platelet-rich plasma; pressure ulcer; spinal cord injury; ulcer healing.
 
drusso said:
Cureus.
2021 Oct 11;13(10):e18668. doi: 10.7759/cureus.18668. eCollection 2021 Oct.

Efficacy of Local Autologous Platelet-Rich Plasma in the Treatment of Pressure Ulcer in Spinal Cord Injury Patients

Gurpreet Singh 1, Diganta Borah 1, Geetika Khanna 2, Sakshi Jain 3
Affiliations expand
PMID: 34790446 PMCID: PMC8583427 DOI: 10.7759/cureus.18668
Free PMC article

Abstract
Background: Pressure ulcer is one of the common complications occurring in spinal cord injury (SCI) patients. Platelet-rich plasma (PRP) has been found useful in the treatment of pressure ulcers in few studies. The purpose of this study was to evaluate the role of PRP in pressure ulcer healing in comparison to hydrogel dressing in SCI patients.

Methods: In this randomized interventional study, 52 patients of SCI having pressure ulcers of grade III/IV were randomized into two groups of 26 each. In group A patients, hydrogel dressing was done while freshly prepared PRP was used in patients of group B. Pressure ulcers were evaluated at baseline and after three weeks and six weeks in terms of ulcer surface area, volume, Pressure Ulcer Scale for Healing (PUSH) score, histopathology, and ulcer healing parameters. Data were collected and quantitative variables were compared using unpaired t-test or Mann-Whitney test between the two groups and qualitative variables were compared using the chi-square test or Fisher's exact test. A p-value of <0.05 was considered statistically significant.

Results: Baseline characteristics were comparable in both groups. There was a significant improvement in ulcers in terms of surface area, volume, and PUSH score in both the groups but it was comparable (p-value >0.05). There was a significant improvement in the PRP group as compared to the other group in terms of epithelization, granulation, and neovascularization at three and six-week follow-up.

Conclusions: This study suggests that PRP is a possible and better alternative to conventional dressing methods for the treatment of pressure ulcers.

Keywords: hydrogel dressing; platelet-rich plasma; pressure ulcer; spinal cord injury; ulcer healing.
Click to expand...
The limited info above makes it appear that primary endpoints were volume and surface area and both improved. Th secondary endpoints of granulation, epithelization, neovasc were better in PRP. Is this clinically meaningful? I wouldn’t biopsy healing wounds.

This looks like a bait and switch conclusion.
 
lobelsteve said:
The limited info above makes it appear that primary endpoints were volume and surface area and both improved. Th secondary endpoints of granulation, epithelization, neovasc were better in PRP. Is this clinically meaningful? I wouldn’t biopsy healing wounds.

This looks like a bait and switch conclusion.
Click to expand...

Just another example of "Big Platelet" putting their thumbs on the scale. Nothing but shills for the Heme.
 
not a blinded study. only the pathologist was blinded.

they play with stats too much. there were 24 patients in 1 group, 26 in the other. 1 data point will throw off the results tremendously. for example, in necrosis grading, hydrogel was 0.0002 and PRP was <0.0001, but the difference was because there were 23 out of 24 patients that were grade 0 in hydrogel vs 25 out of 26 in PRP. they declare a difference when their numbers are too small.



take home message - both hydrogel and PRP work for sacral ulcers. both work statistically significant amount. the perceived difference between the two is likely to be a statistical anomaly as opposed to true difference.
 
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Excellent analysis of KOL's, Big Pharma, Big Platelet, COI, shilling for the Gene, and shilling for the Heme...

regenexx.com

Why Bad PRP Studies Matter: The Katz PRP JAMA Editorial - Regenexx

Dr. Centeno reviews the Katz JAMA editorial on PRP.
regenexx.com regenexx.com

Biosplice is a company developing a gene therapy to treat knee arthritis. So the guy who wrote this editorial about the three bad PRP studies is a university scientist who is taking grant money from a company developing a drug to treat knee arthritis. As I always say, you just can’t make this stuff up. This editorial is a direct example of the drug development stakeholder problem PRP now faces.
 
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Sci Rep. 2021 Dec 8;11(1):23603. doi: 10.1038/s41598-021-03081-6.

Two or four injections of platelet-rich plasma for osteoarthritic knee did not change synovial biomarkers but similarly improved clinical outcomes

Srihatach Ngarmukos 1 2, Chotetawan Tanavalee 1 3, Chavarin Amarase 1 2, Suphattra Phakham 4, Warayapa Mingsiritham 1 2, Rangsima Reantragoon 1 5, Nitigorn Leearamwat 5, Thidarat Kongkaew 5, Kittipan Tharakhet 6, Sittisak Honsawek 1 4, Sinsuda Dechsupa 4, Aree Tanavalee 7 8
Affiliations expand
PMID: 34880370 DOI: 10.1038/s41598-021-03081-6
Abstract
We compared two and four intra-articular injections of platelet-rich plasma (PRP) in terms of changes of synovial cytokines and clinical outcomes. One hundred twenty-five patients having knee osteoarthritis (OA) underwent PRP injections at a 6-week interval. Before each PRP injection, synovial fluid aspiration was collected for investigation. Patients were divided into two or four intra-articular PRP injections (group A and B, respectively). Changes in synovial biomarkers were compared with the baseline levels of both groups, and clinical outcomes were evaluated until one year. Ninety-four patients who had completed synovial fluid collection were included for final evaluation, 51 in group A and 43 in group B. There were no differences in mean age, gender, body mass index (BMI), and radiographic OA grading. The average platelet count and white blood cell count in PRP were 430,000/µL and 200/ µL, respectively. There were no changes of synovial inflammatory cytokines (IL-1β, IL-6, IA-17A, and TNF-alpha), anti-inflammatory cytokines (IL-4, IL-10, IL-13, and IL-1RA), and growth factors (TGF-B1, VEGF, PDGF-AA, and PDGF-BB) between baseline levels and six weeks in group A, and 18 weeks in group B. Both groups had significantly improved clinical outcomes from six weeks including visual analog scale (VAS), patient-reported outcome measures [PROMs; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Short Form-12 (SF-12)], with a significant delayed improvement of performance-based measures [PBMs; time up and go (TUG), 5-time sit to stand test (5 × SST), and 3-min walk test (3-min WT)]. In conclusion, two- or four-PRP intra-articular injection at a 6-week interval for knee OA demonstrated no changes of synovial cytokines and growth factors but similarly improved clinical outcomes from 6 weeks until 1 year.


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.
 
drusso said:
Sci Rep. 2021 Dec 8;11(1):23603. doi: 10.1038/s41598-021-03081-6.

Two or four injections of platelet-rich plasma for osteoarthritic knee did not change synovial biomarkers but similarly improved clinical outcomes

Srihatach Ngarmukos 1 2, Chotetawan Tanavalee 1 3, Chavarin Amarase 1 2, Suphattra Phakham 4, Warayapa Mingsiritham 1 2, Rangsima Reantragoon 1 5, Nitigorn Leearamwat 5, Thidarat Kongkaew 5, Kittipan Tharakhet 6, Sittisak Honsawek 1 4, Sinsuda Dechsupa 4, Aree Tanavalee 7 8
Affiliations expand
PMID: 34880370 DOI: 10.1038/s41598-021-03081-6
Abstract
We compared two and four intra-articular injections of platelet-rich plasma (PRP) in terms of changes of synovial cytokines and clinical outcomes. One hundred twenty-five patients having knee osteoarthritis (OA) underwent PRP injections at a 6-week interval. Before each PRP injection, synovial fluid aspiration was collected for investigation. Patients were divided into two or four intra-articular PRP injections (group A and B, respectively). Changes in synovial biomarkers were compared with the baseline levels of both groups, and clinical outcomes were evaluated until one year. Ninety-four patients who had completed synovial fluid collection were included for final evaluation, 51 in group A and 43 in group B. There were no differences in mean age, gender, body mass index (BMI), and radiographic OA grading. The average platelet count and white blood cell count in PRP were 430,000/µL and 200/ µL, respectively. There were no changes of synovial inflammatory cytokines (IL-1β, IL-6, IA-17A, and TNF-alpha), anti-inflammatory cytokines (IL-4, IL-10, IL-13, and IL-1RA), and growth factors (TGF-B1, VEGF, PDGF-AA, and PDGF-BB) between baseline levels and six weeks in group A, and 18 weeks in group B. Both groups had significantly improved clinical outcomes from six weeks including visual analog scale (VAS), patient-reported outcome measures [PROMs; Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index and Short Form-12 (SF-12)], with a significant delayed improvement of performance-based measures [PBMs; time up and go (TUG), 5-time sit to stand test (5 × SST), and 3-min walk test (3-min WT)]. In conclusion, two- or four-PRP intra-articular injection at a 6-week interval for knee OA demonstrated no changes of synovial cytokines and growth factors but similarly improved clinical outcomes from 6 weeks until 1 year.


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.
Click to expand...
your first study is meh. no control, just comparing 2 vs 4 injections. in addition, no change in biomarkers.

one cannot make any determination on that study. one cannot conclude that there was an benefit over not doing any injection at all as there was no control.


your second study was much better. there were NS controls. there were distinct groups and there was validity in PRP helping at 3, 6 and 12 months.

unfortunately, no long term benefit noted in the study. no difference at the end of 24 months.


i guess the take home message might be to sign someone up and repeat frequent PRP injections as long term chronic therapy...
 
November 23/30, 2021

Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee OsteoarthritisThe RESTORE Randomized Clinical Trial​

Kim L. Bennell, PhD1; Kade L. Paterson, PhD1; Ben R. Metcalf, BSc1; et alVicky Duong, DPT2; Jillian Eyles, PhD2; Jessica Kasza, PhD3; Yuanyuan Wang, PhD3; Flavia Cicuttini, PhD3,4; Rachelle Buchbinder, PhD5; Andrew Forbes, PhD3; Anthony Harris, MSc6; Shirley P. Yu, MPH2; David Connell, MMed7; James Linklater, MBBS8; Bing Hui Wang, PhD9,10; Win Min Oo, PhD2,11; David J. Hunter, PhD2
Author Affiliations
JAMA. 2021;326(20):2021-2030. doi:10.1001/jama.2021.19415
 
lobelsteve said:
November 23/30, 2021

Effect of Intra-articular Platelet-Rich Plasma vs Placebo Injection on Pain and Medial Tibial Cartilage Volume in Patients With Knee OsteoarthritisThe RESTORE Randomized Clinical Trial​

Kim L. Bennell, PhD1; Kade L. Paterson, PhD1; Ben R. Metcalf, BSc1; et alVicky Duong, DPT2; Jillian Eyles, PhD2; Jessica Kasza, PhD3; Yuanyuan Wang, PhD3; Flavia Cicuttini, PhD3,4; Rachelle Buchbinder, PhD5; Andrew Forbes, PhD3; Anthony Harris, MSc6; Shirley P. Yu, MPH2; David Connell, MMed7; James Linklater, MBBS8; Bing Hui Wang, PhD9,10; Win Min Oo, PhD2,11; David J. Hunter, PhD2
Author Affiliations
JAMA. 2021;326(20):2021-2030. doi:10.1001/jama.2021.19415
Click to expand...

Check the methods. Doesn’t even qualify as PRP.
 
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DOctorJay said:
Check the methods. Doesn’t even qualify as PRP.
Click to expand...
Interventions: Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants).

I don’t have full text. Here is from abstract.
 
lobelsteve said:
Interventions: Interventions involved 3 intra-articular injections at weekly intervals of either leukocyte-poor PRP using a commercially available product (n = 144 participants) or saline placebo (n = 144 participants).

I don’t have full text. Here is from abstract.
Click to expand...

Weak sauce PRP. It was a false flag regen study. One of the authors has COI's. PRP used that barely 2X. GIGO.

regenexx.com

More Fake PRP Studies - Regenexx

Dr. Centeno reviews the Bennell et al JAMA study on knee arthritis and PRP.
regenexx.com regenexx.com

regenexx.com

A Study, a Professor, PRP and COIs Galore - Regenexx

Dr. Centeno reviews research conflicts of interest for David Hunter, Ph.D. from the University of Sydney.
regenexx.com regenexx.com
 
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Although the optimal PRP preparation protocol is not yet established, preparations in RCTs reporting symptom benefits in knee OA have generally used a single slower-speed centrifugation cycle for 5 minutes and injected fresh leukocyte-poor PRP at weekly intervals for 3 weeks.16 Thus, fresh PRP samples were prepared at each weekly visit using a commercial product (Regen Lab SA) with single centrifugation at 1500g for 5 minutes. This protocol yields a platelet concentration factor of 1.6 to 5 times more than whole blood values, with approximately 80% platelet recovery, and is leukocyte poor.17 Details of the PRP characteristics according to recommended standards13,18 are available in eTable 2 in Supplement 2.
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This study has several limitations. First, PRP preparations are heterogeneous and lack standardization. Results from this trial may not be generalizable to other PRP preparations. However, a commercially available PRP product was used in this trial with a preparation and schedule that appears more efficacious for OA.
Click to expand...
eAppendix 1. Platelet-Rich Plasma Growth Factor and Cytokine Analysis Methods PRP samples were treated with a hypotonic 0.5 % Triton-X-100 solution (vol/vol, dilution in distilled water) at a 9 to 1 ratio (PRP to 0.5% Triton-X-100, vol/vol) and incubated for 15 min at room temperature, in order to maximize cell and platelet membrane breakage and growth factor release. PRP was then aliquot and stored at - 80°C until quantification (at least overnight). Before the assay, the samples were thawed and vortexed, then centrifuged at maximum speed for 5 minutes at 4o C. The clear lysates were aliquot for each cytokines and growth factor assays. Cytokines and growth factors, IL-1β, IL-1ra, IL-6, MMP9, TGFβ1 and PDGF-BB were analysed using Luminex multiplex kits purchased from R&D System. Assays were performed according to the protocols provided by the manufacturer. Clear lysates from PRP samples were diluted in the assay process according to manufacturer’s recommendation (PDGF-BB and MMP9: 1 in 50 dilutions. IL-1β, IL-1ra and IL-6: 1 in 2 dilutions, TGFβ1: 1 in 14.98 dilutions. All dilutions were performed with assay buffer provided by the assay kits. Luminex assays were performed with Luminex 200 and data analysis with BioPlex manager V6.2. All samples were analysed in duplicate and the results provided as the mean of two data points.
Click to expand...

so for my edification, what exactly about their PRP process or results make you feel it does not qualify as PRP?

its starting to sound as if only PRP used in studies that show benefit are really PRP, or whenever an injection or study does not show benefit, then the PRP is done wrong.

which implies that PRP is so tricky that most physicians should not be allowed to use it.


in addition, i am not doubting your reference to COI, but if you do so, you need to post what those COIs are so that we can all understand the conflict of interest. just saying "he has a COI!" does not justify your statement.
 
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Ducttape said:
what exactly about their PRP process or results make you feel it does not qualify as PRP?
Click to expand...
I don't have the full text so don't know if they analyzed their PRP, but a prior analysis of that system from RegenLab yielded a product with platelet concentration not much different from whole blood, so even calling it platelet-rich is inaccurate. Yes, that analysis may have bias, but I remember looking at RegenLab years ago and thinking there's no way it can be a high yield.
 
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Ducttape said:
so for my edification, what exactly about their PRP process or results make you feel it does not qualify as PRP?

its starting to sound as if only PRP used in studies that show benefit are really PRP, or whenever an injection or study does not show benefit, then the PRP is done wrong.

which implies that PRP is so tricky that most physicians should not be allowed to use it.


in addition, i am not doubting your reference to COI, but if you do so, you need to post what those COIs are so that we can all understand the conflict of interest. just saying "he has a COI!" does not justify your statement.
Click to expand...

The COI is ideological. Some people get paid if things DON'T work--regen, opioids, procedures, etc. Because it generates other revenue, career enhancement, speaker fees, tenure, travel boondoggles, etc.

There is an ongoing ideological war between Big Platelet and Big Nihilism. There are bets on both sides of the money-pay line. At the end of the day, you can only pay people to DO things or NOT TO DO things (and thus do OTHER things). There's a lot of money to be made in NOT DOING PRP and doing something else instead...
 
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drusso said:
The COI is ideological. Some people get paid if things DON'T work--regen, opioids, procedures, etc. Because it generates other revenue, career enhancement, speaker fees, tenure, etc.

There is an ongoing ideological war between Big Platelet and Big Nihilism. There are bets on both sides of the money-pay line.
Click to expand...
The war is in your mind.

PRP is not always PRP. Makes it harder to study and compromises results. Meta-analysis is futile.
 
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Ducttape said:
so for my edification, what exactly about their PRP process or results make you feel it does not qualify as PRP?

its starting to sound as if only PRP used in studies that show benefit are really PRP, or whenever an injection or study does not show benefit, then the PRP is done wrong.

which implies that PRP is so tricky that most physicians should not be allowed to use it.


in addition, i am not doubting your reference to COI, but if you do so, you need to post what those COIs are so that we can all understand the conflict of interest. just saying "he has a COI!" does not justify your statement.
Click to expand...

The COI is ideological. Some people get paid if things DON'T work--regen, opioids, procedures, etc. Because it generates other revenue, career enhancement, speaker fees, tenure, etc.

There is an ongoing ideological war between Big Platelet and Big Nihilism. There are bets on both sides of the money-pay line.
lobelsteve said:
The war is in your mind.

PRP is not always PRP. Makes it harder to study and compromises results. Meta-analysis is futile.
Click to expand...

There's a lot of money to do be made doing nothing...we've seen this over and over and over again in Pain and MSK medicine.

The JAMA authors had a great study design, good power, good methodology, but ultimately they used bad Juju. The sad thing is that:

1) There was no depth of content expertise in the JAMA editorial board or its reviewers to detect the problem; unless it is retracted this will go into the meta-analytic meat grinder as a "negative study." The stooges at Evicore, ODG, AHRQ, UpToDate, etc will be completely ignorant of the limitations and flaws of this "high-quality level I study." This happened with Kypho and Kallmes...it's deja vu all over again...

2) None of the key investigators picked up the telephone to talk to experts in orthobiologics about their prep methods.

Literally, a 15-minute telephone call could have cleared this up and prevented a huge waste of time, money, and resources.

J Bone Joint Surg Am
2017 May 17;99(10):809-819.
doi: 10.2106/JBJS.16.00793.

Minimum Information for Studies Evaluating Biologics in Orthopaedics (MIBO): Platelet-Rich Plasma and Mesenchymal Stem Cells​

Iain R Murray 1, Andrew G Geeslin, Ewan B Goudie, Frank A Petrigliano, Robert F LaPrade
Affiliations expand

Abstract​

Background: A comprehensive approach to the evaluation of biologic therapies for musculoskeletal conditions is required to guide appropriate future use. Clinical studies evaluating platelet-rich plasma (PRP) and mesenchymal stem cells (MSCs) are limited by inadequate reporting of scientific details critical to outcome. We developed minimum reporting requirements for clinical studies evaluating PRP and MSCs using Delphi consensus methods.
Methods: The need for consensus on the minimum reporting requirements for studies evaluating biologics was identified at the American Academy of Orthopaedic Surgeons/Orthopaedic Research Society (AAOS/ORS) Biologic Treatments for Orthopaedic Injuries Symposium in 2015 and the American Orthopaedic Society for Sports Medicine (AOSSM) Biologic Treatments for Sports Injuries II Think Tank in 2015. A working group facilitated the development of 2 expert consensus statements for PRP and MSCs using Delphi techniques. Exhaustive lists of items that could be reported on by clinical studies evaluating PRP or MSCs were generated by searching the published literature and protocols. PRP and MSC expert groups, each made up of 24 invited speakers at the AAOS and AOSSM symposia, were surveyed on 3 occasions to establish consensus on the inclusion of each item within minimum reporting guidelines. In addition to rating their agreement, the experts were encouraged to propose further items or modifications. Predefined criteria were used to refine item lists after each survey. Final lists were compiled into checklist statements by the working group.
Results: For PRP, the working group identified 93 experimental information items from the literature. Twenty-three experts (96%) completed 3 rounds of surveys. After 3 rounds, 58 items generated consensus with >75% agreement and <5% disagreement. These items were compiled into a 23-statement checklist. For MSCs, 103 items were identified from the published literature. Twenty-three experts (96%) completed 3 rounds of surveys. After 3 rounds, the 61 items for which consensus was reached were compiled into a 25-statement checklist.
Conclusions: This study has established expert consensus on the minimum reporting requirements for clinical studies evaluating PRP and MSCs.
Clinical relevance: These checklists provide specifications for the minimum information that should be reported by clinical studies evaluating PRP or MSCs.
 
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lobelsteve said:
The war is in your mind.

PRP is not always PRP. Makes it harder to study and compromises results. Meta-analysis is futile.
Click to expand...
if you tested the PRP, you would know if it was PRP by definition.
 
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Is there evidence that PRP is better than whole blood for regenerative procedures?
 
You identify the problems with PRP and orthobilogics and why it is unlikely to become standard of care, unless something drastic changes.


The "right" way of using it seems to vary between providers with significant criticism amongst the researchers and those reviewing the studies, and there is no standardization of either the method of injection or the injectate itself.

This makes impossible for other non-invested physicians to be able to definitively state that the treatment is likely to be successful.
 
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Ducttape said:
You identify the problems with PRP and orthobilogics and why it is unlikely to become standard of care, unless something drastic changes.


The "right" way of using it seems to vary between providers with significant criticism amongst the researchers and those reviewing the studies, and there is no standardization of either the method of injection or the injectate itself.

This makes impossible for other non-invested physicians to be able to definitively state that the treatment is likely to be successful.
Click to expand...
plus you have to parse through the literature (as you frequently do) and pick out the occasional COI's
 
Ducttape said:
You identify the problems with PRP and orthobilogics and why it is unlikely to become standard of care, unless something drastic changes.


The "right" way of using it seems to vary between providers with significant criticism amongst the researchers and those reviewing the studies, and there is no standardization of either the method of injection or the injectate itself.

This makes impossible for other non-invested physicians to be able to definitively state that the treatment is likely to be successful.
Click to expand...

It's not a procedure for everyone and will probably remain scarce for the foreseeable future.
 
BMC Musculoskelet Disord

. 2022 Jan 3;23(1):23.
doi: 10.1186/s12891-021-04910-5.

Bone marrow aspirate concentrate versus platelet-rich plasma for treating knee osteoarthritis: a one-year non-randomized retrospective comparative study​

Abed El-Hakim El-Kadiry 1 2, Carlos Lumbao 3, Natasha Salame 2, Moutih Rafei 4 5 6 7, Riam Shammaa 8 9
Affiliations expand
Free article

Abstract​

Background: Knee osteoarthritis (OA) is a debilitating condition affecting human body biomechanics and quality of life. Current standard care for knee OA leads to trivial improvement and entails multiple adverse effects or complications. Recently, investigational cell therapies injected intra-articularly, such as bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP), have shown safety and therapeutic potency providing patients with pain relief. In the current retrospective comparative study, we investigated the differences in pain and functional improvements in patients with symptomatic knee OA receiving intra-articular injections of BMAC vs PRP.
Methods: Pain and functionality scores were measured at baseline and at different time points post-injection over 12 months, using 3 self-administered, clinically validated questionnaires: the visual analogue scale (VAS) for assessing pain intensity, the knee injury and osteoarthritis outcome score (KOOS) for evaluating functionality and knee-related quality of life, and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) for evaluating physical function. The repeated-measures general linear model with Sidak test for pairwise comparisons was used to investigate the influence of the treatment on the score evolution within groups (between baseline and each time point) and between groups (overall).
Results: The BMAC group (n = 26 knees) significantly improved in VAS, KOOS, and WOMAC scores between baseline and 12 months (57.4, 75.88, and 73.95% mean score improvement, respectively). In contrast, the PRP group (n = 13 knees) witnessed nonsignificant improvement in all scores. BMAC, in comparison to PRP, induced significant improvement in outcomes by 29.38% on the VAS scale, 53.89% on the KOOS scale, and 51.71% on the WOMAC scale (P < .002, P < .01, P < .011, respectively).
Conclusions: Intra-articular autologous BMAC injections are safe, effective in treating pain, and ameliorate functionality in patients with symptomatic knee OA to a greater extent than PRP injections. Intra-articular autologous BMAC therapy is safe and provides more relief to patients with symptomatic knee osteoarthritis compared to PRP therapy.
Keywords: Bone marrow aspirate concentrate; Knee; Knee injury and osteoarthritis outcome score; Mesenchymal stromal cells; Osteoarthritis; Platelet-rich plasma; Visual analogue scale; Western Ontario and McMaster universities arthritis index.
© 2021. The Author(s).


bmcmusculoskeletdisord.biomedcentral.com

Bone marrow aspirate concentrate versus platelet-rich plasma for treating knee osteoarthritis: a one-year non-randomized retrospective comparative study - BMC Musculoskeletal Disorders

Background Knee osteoarthritis (OA) is a debilitating condition affecting human body biomechanics and quality of life. Current standard care for knee OA leads to trivial improvement and entails multiple adverse effects or complications. Recently, investigational cell therapies injected...
bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com

"Intra-articular autologous BMAC therapy safely and effectively reduced pain and improved functionality in patients with symptomatic knee OA to a greater extent than PRP therapy."
 
shall we discuss the bad news or the worse news first in this "study"?


okay, bad news first.
1. poor study.
Retrospective.
small group size.
nonrandomized
unequal size groups
no control.
unequal number of injections.

worse news.
" In contrast, the PRP group (n = 13 knees) witnessed nonsignificant improvement in all scores." - ie maybe PRP doesnt work...
 
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Ducttape said:
You identify the problems with PRP and orthobilogics and why it is unlikely to become standard of care, unless something drastic changes.


The "right" way of using it seems to vary between providers with significant criticism amongst the researchers and those reviewing the studies, and there is no standardization of either the method of injection or the injectate itself.

This makes impossible for other non-invested physicians to be able to definitively state that the treatment is likely to be successful.
Click to expand...

just to be fair, the "right way" of doing an epidural for a patient with lumbar stenosis seems to be all over the place as well.

forums.studentdoctor.net

which level do you inject for stenosis

I’m worried about your reading comprehension as no where did I mention a lateral foraminotomy, only a laminectomy. So you have things backwards , not I. And as NJPain stated, there is no good data demonstrating that MILD is equal to a surgical posterior laminectomy, only data that MILD is...
forums.studentdoctor.net forums.studentdoctor.net

there is also no standardization of injectate or approach. what you are describing is not unique to a sub-specialty of medicine
 
Ducttape said:
shall we discuss the bad news or the worse news first in this "study"?


okay, bad news first.
1. poor study.
Retrospective.
small group size.
nonrandomized
unequal size groups
no control.
unequal number of injections.

worse news.
" In contrast, the PRP group (n = 13 knees) witnessed nonsignificant improvement in all scores." - ie maybe PRP doesnt work...
Click to expand...

Despite all those problems, they still found an effect on BMAC. It seems like a robust intervention against methodological threats.
 
PRP is dramatically effective for many pts and many diagnoses.

Rotator cuffs, tennis elbow, hip and knee OA, SIJ pain. I use it frequently for those Dx and I've hit far more homeruns with PRP than anything else.

If you're routinely using corticosteroids for those Dx and not offering PRP you're doing your pts a disservice.

Old pts on fixed income and they cannot afford it, I understand that.

I'm $650 for 5-6cc of PRP and that's total cost. I'll spread that PRP into multiple sites and the cost doesn't change.

It's satisfying to me.

I just did an oral maxillofacial surgeon's infraspinatus tear with advanced AC OA. He got 1cc into the AC joint and 3cc at the infraspinatus tendon and told me I "cured" him. $650.

One anecdote in a sea of others.
 
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MitchLevi said:
PRP is dramatically effective for many pts and many diagnoses.

Rotator cuffs, tennis elbow, hip and knee OA, SIJ pain. I use it frequently for those Dx and I've hit far more homeruns with PRP than anything else.

If you're routinely using corticosteroids for those Dx and not offering PRP you're doing your pts a disservice.

Old pts on fixed income and they cannot afford it, I understand that.

I'm $650 for 5-6cc of PRP and that's total cost. I'll spread that PRP into multiple sites and the cost doesn't change.

It's satisfying to me.

I just did an oral maxillofacial surgeon's infraspinatus tear with advanced AC OA. He got 1cc into the AC joint and 3cc at the infraspinatus tendon and told me I "cured" him. $650.

One anecdote in a sea of others.
Click to expand...
Anecdotes is not anecdata.
For every non responder, you should pay them $650 for the experiment on them.
 
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lobelsteve said:
Anecdotes is not anecdata.
For every non responder, you should pay them $650 for the experiment on them.
Click to expand...
*are

Anecdotes ARE not anecdata.

I make no money on PRP, and I hope you reimburse your pts their co-pays every time you inject corticosteroids into them without benefit.
 
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MitchLevi said:
*are

Anecdotes ARE not anecdata.

I make no money on PRP, and I hope you reimburse your pts their co-pays every time you inject corticosteroids into them without benefit.
Click to expand...

Co-pays and high deductible health plans basically leave patients functionally "cash pay" anyway.
 
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