Adding Regenerative medicine to your practice.

[lobelsteve]

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Drusso must be out skiing this weekend
Not a good study, but great results. N=1

Vertebral intraosseous plasma rich in growth factor (PRGF-Endoret) infiltrations as a novel strategy for the treatment of degenerative lesions of endplate in lumbar pathology: description of technique and case presentation - Journal of Orthopaedic Su

Background Motivation and necessity to adopt minimally invasive therapies in the field of spinal regenerative medicine is increasing. Autologous platelet-rich plasma (PRP) therapy has recently been used as an effective technological and biological approach to tissue repair and has shown to...

josr-online.biomedcentral.com

 

[drusso]

Drusso must be out skiing this weekend
Not a good study, but great results. N=1

Vertebral intraosseous plasma rich in growth factor (PRGF-Endoret) infiltrations as a novel strategy for the treatment of degenerative lesions of endplate in lumbar pathology: description of technique and case presentation - Journal of Orthopaedic Su

Background Motivation and necessity to adopt minimally invasive therapies in the field of spinal regenerative medicine is increasing. Autologous platelet-rich plasma (PRP) therapy has recently been used as an effective technological and biological approach to tissue repair and has shown to...

josr-online.biomedcentral.com

Big Pow Day on the Mountain. Gotta get it when you can. I'll check it out Apres Ski...

 

[drusso]

Drusso must be out skiing this weekend
Not a good study, but great results. N=1

Vertebral intraosseous plasma rich in growth factor (PRGF-Endoret) infiltrations as a novel strategy for the treatment of degenerative lesions of endplate in lumbar pathology: description of technique and case presentation - Journal of Orthopaedic Su

Background Motivation and necessity to adopt minimally invasive therapies in the field of spinal regenerative medicine is increasing. Autologous platelet-rich plasma (PRP) therapy has recently been used as an effective technological and biological approach to tissue repair and has shown to...

josr-online.biomedcentral.com

@Ducttape

Clinical Efficacy of Intra-articular Mesenchymal Stromal Cells for the Treatment of Knee Osteoarthritis: A Double-Blinded Prospective Randomized Controlled Clinical Trial


Show all authors
Jaime R. Garza, MD, Richard E. Campbell, BS, Fotios P. Tjoumakaris, MD, ...
First Published February 28, 2020 Research Article Find in PubMed
https://doi.org/10.1177/0363546519899923

Abstract
Background:
Currently, there are limited nonoperative treatment options available for knee osteoarthritis (OA). Cell-based therapies have emerged as promising treatments for knee OA. Autologous stromal vascular fraction (SVF) has been identified as an efficient medium for intra-articular administration of progenitor cells and mesenchymal stem cells derived from adipose tissue.
Hypothesis:
Patients receiving intra-articular SVF would show significantly greater improvement than patients receiving placebo injections, and this improvement would be dose dependent.
Study Design:
Randomized controlled trial; Level of evidence, 1.
Methods:
This was a multisite prospective double-blinded randomized placebo-controlled clinical trial. Adult patients with symptomatic knee OA were eligible. Thirty-nine patients were randomized to high-dose SVF, low-dose SVF, or placebo (1:1:1). SVF was obtained via liposuction, processed to create the cellular implant, and injected during the same clinical visit. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores and magnetic resonance images were obtained preoperatively and at 6 and 12 months after injection. The Wilcoxon rank sum nonparametric test was utilized to assess statistical significance, and the Hodges-Lehmann location shift was used to assess superiority.
Results:
The median percentage change in WOMAC score at 6 months after injection for the high-dose, low-dose, and placebo groups was 83.9%, 51.5%, and 25.0%, respectively. The high- and low-dose groups had statistically significant changes in WOMAC scores when compared with the placebo group (high dose, P = .04; low dose, P = .02). The improvements were dose dependent. The median percentage change in WOMAC score from baseline to 1 year after injection for the high-dose, low-dose, and placebo groups was 89.5%, 68.2%, and 0%, respectively. The high- and low-dose groups displayed a greater percentage change at 12 months when compared with the placebo group (high dose, P = .006; low dose, P = .009). Magnetic resonance image review revealed no changes in cartilage thickness after treatment. No serious adverse events were reported.
Conclusion:
Intra-articular SVF injections can significantly decrease knee OA symptoms and pain for at least 12 months. The efficacy and safety demonstrated in this placebo-controlled trial support its implementation as a treatment option for symptomatic knee OA.
Registration:
NCT02726945 (ClinicalTrials.gov identifier)

 

[Ferrismonk]

Good article. Can't wait to read the rest. I wonder how they figured out the high-dose and low-dose SVF though. A saline wash, filter, and centrifuge doesn't lead to dose counts...

 

[drusso]

For @lobelsteve and @Ducttape ...

A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis - PubMed

Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections...

www.ncbi.nlm.nih.gov

Stem Cells Int. 2020 Jan 30;2020:5962354. doi: 10.1155/2020/5962354. eCollection 2020.
A Randomized Controlled Trial of the Treatment of Rotator Cuff Tears with Bone Marrow Concentrate and Platelet Products Compared to Exercise Therapy: A Midterm Analysis.
Centeno C1,2, Fausel Z1, Stemper I2, Azuike U1, Dodson E2.
Author information

Abstract
Injectable regenerative therapies such as bone marrow concentrate (BMC) and platelet-rich plasma (PRP) may represent a safe alternative in the treatment of rotator cuff tears. This is a midterm review of a randomized, crossover trial comparing autologous BMC and platelet product injections versus exercise therapy in the treatment of partial and full-thickness supraspinatus tears. Patients enrolled into the study were between 18 and 65 years of age presenting to an outpatient orthopedic clinic with partial to full thickness, nonretracted supraspinatus tendon tears. Enrolled patients were randomized to either ultrasound-guided autologous BMC with PRP and platelet lysate (PL) percutaneous injection treatment or exercise therapy. Patients could cross over to BMC treatment after at least 3 months of exercise therapy. Patients completed the Disability of the Arm, Shoulder and Hand (DASH) scores as the primary outcome measure. Secondary outcomes included the numeric pain scale (NPS), a modified Single Assessment Numeric Evaluation (SANE), and a blinded MRI review. At this midterm review, results from 25 enrolled patients who have reached at least 12-month follow-up are presented. No serious adverse events were reported. Significant differences were seen in patient reported outcomes for the BMC treatment compared to exercise therapy at 3 and 6 months for pain, and for function and reported improvement (SANE) at 3 months (p < .05). Patients reported a mean 89% improvement at 24 months, with sustained functional gains and pain reduction. MRI review showed a size decrease of most tears post-BMC treatment. These findings suggest that ultrasound-guided BMC and platelet product injections are a safe and useful alternative to conservative exercise therapy of torn, nonretracted supraspinatus tendons. This trial is registered with NCT01788683.
Copyright © 2020 Christopher Centeno et al.

 

[Ducttape]

promising...

but not blinded, small sample size, looks like they are comparing data at 12 and 24 months who had injection with patients who only had 6 months conservative treatment - kind of incomplete. but promising.

why not wait until he has complete data? a naysayer might wonder if the midterm data is being posted because the long term data is not as encouraging...

other question - so is it the bone marrow or the platelets that are beneficial, or is the practice now to do both concurrently?

also, is this a true crossover study? one can only go from conservative treatment to BMC/PRP and not the other way around.

 

[Ducttape]

so I looked at the pubmed publication.

patients who got conservative therapy left the study at 6 months period of time, which I wonder whether that was the best move. you do not have a true comparison between injection therapy and conservative therapy at 12 and 24 months.

I would guess that the data would be favorable, but what if healing from the tear occurred during that 12-24 month time period, such that pain reduced significantly in conservative care patients at 24 months?

 

[drusso]

promising...

but not blinded, small sample size, looks like they are comparing data at 12 and 24 months who had injection with patients who only had 6 months conservative treatment - kind of incomplete. but promising.

why not wait until he has complete data? a naysayer might wonder if the midterm data is being posted because the long term data is not as encouraging...

other question - so is it the bone marrow or the platelets that are beneficial, or is the practice now to do both concurrently?

also, is this a true crossover study? one can only go from conservative treatment to BMC/PRP and not the other way around.

It's increasingly common to do both PRP and BMAC because the veterinary literature shows that MSC's like PRP...


Sci Rep. 2020 Apr 21;10(1):6771. doi: 10.1038/s41598-020-63496-5.
Platelet-rich plasma enhances the repair capacity of muscle-derived mesenchymal stem cells to large humeral bone defect in rabbits.
Yin N1, Wang Y1, Ding L1, Yuan J1, Du L1, Zhu Z1, Pan M1, Xue F2, Xiao H3.
Author information

Abstract
Mesenchymal stem cell-based therapy is a highly attractive strategy that promotes bone tissue regeneration. The aim of the present study was to evaluate the combination effect of muscle-derived mesenchymal stem cells (M-MSCs) and platelet-rich plasma (PRP) on bone repair capacity in rabbits with large humeral bone defect. Precise cylindrical bone defects of 10 mm diameter and 5 mm depth were established in rabbit humeral bones, which were unable to be repaired under natural conditions. The rabbits received treatment with M-MSCs/PRP gel, M-MSCs gel, or PRP gel, or no treatment. The bone tissue regeneration was evaluated at day 0-90 after surgery by HE morphological staining, Lane-Sandhu histopathological scoring, tetracycline detection, Gomori staining and micro-computed tomography. Beyond that, Transwell assay, CCK8 assay, Western blot analysis and ALP activity detection were performed in M-MSCs in vitro with or without PRP application to detect the molecular effects of PRP on M-MSCs. We found that the repair effect of M-MSCs group or PRP group was limited and the bone defects were not completely closed at post-operation 90 d. In contrast, M-MSCs/PRP group received obvious filling in the bone defects with a Lane-Sandhu evaluation score of 9. Tetracycline-labeled new bone area in M-MSCs/PRP group and new mineralized bone area were significantly larger than that in other groups. Micro-computed tomography result of M-MSCs/PRP group displayed complete recovery of humeral bone at post-operation 90 d. Further in vitro experiment revealed that PRP significantly induced migration, enhanced the growth, and promoted the expression of Cbfa-1 and Coll I in M-MSCs. In conclusion, PRP application significantly enhanced the regeneration capacity of M-MSCs in large bone defect via promoting the migration and proliferation of M-MSCs, and also inducing the osteogenic differentiation.

 

[lobelsteve]

And it add$ to the effect$ of the $hot.

$O$.

 

[drusso]

And it add$ to the effect$ of the $hot.

$O$.

Don't be bitter...Not everything that is "proven" works and not everything that "works" is proven...

Curr Pain Headache Rep. 2020 Apr 14;24(5):22. doi: 10.1007/s11916-020-00850-2.
Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post-2009 Trials.
Manchikanti L1, Sanapati J2, Pampati V2, Kaye AD2, Hirsch JA2.
Author information

Abstract
PURPOSE OF REVIEW:
To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the literature and the enactment of the Affordable Care Act (ACA).
RECENT FINDINGS:
The analysis of vertebroplasty and kyphoplasty utilization patterns was carried out using specialty utilization data from the Centers for Medicare and Medicaid Services Database. Of note, over the period of time between 2009 and 2017, the number of people aged 65 or older showed a 3.2% rate of annual increase, and the number of Medicare beneficiaries increased by 27.6% with a 3.1% rate of annual increase. Concurrently, vertebroplasty utilization decreased 72.8% (annual decline of 15% per 100,000 Medicare beneficiaries), and balloon kyphoplasty utilization decreased 19% (annual decline of 2.6% per 100,000 Medicare beneficiaries). This translates to a 38.3% decrease in vertebroplasty and balloon kyphoplasty utilization (annual decline of 5.9% per 100,000 Medicare beneficiaries) from 2009 to 2017. By contrast, from 2004 to 2009, there was a total 188% increase in vertebroplasty and balloon kyphoplasty utilization (annual increase rate of 23.6% per 100,000 Medicare beneficiaries). The majority of vertebroplasty procedures were done by radiologists, and the majority of kyphoplasties were done by aggregate groups of spine surgeons. These results illustrate a significant decline in vertebral augmentation procedures in the fee-for-service Medicare population between 2004 and 2017, with dramatic decreases following the publication of two 2009 trials that failed to demonstrate benefit of vertebroplasty over sham and the enactment of the ACA.
KEYWORDS:
Kyphoplasty; Osteoporosis; Osteoporotic compression fracture; Vertebral augmentation; Vertebroplasty
PMID: 32291587 DOI: 10.1007/s11916-020-00850-2

 

[lobelsteve]

I'm almost done with kypho after todays mishap.
IVAS box taped shut from Stryker. Ran my finger under tape and cut it up pretty good. Workers comp for sure. Other than that the case went well. Also, we got superiority for stax over standard aug. SOS gives more money for it through October, hoping for new CPT that will increase office based reimbursement so I can get paid like a stem cell rock star. Only if I wasn't an employed lowly salaried physician.

 

[geauxg8rs]

I'm almost done with lypho after todays mishap.
IVAS box taped shut from Stryker. Ran my finger under tape and cut it up pretty good. Workers comp for sure. Other than that the case went well. Also, we got superiority for stax over standard aug. SOS gives more money for it through October, hoping for new CPT that will increase office based reimbursement so I can get paid like a stem cell rock star. Only if I wasn't an employed lowly salaried physician.

I am going to see if I can create a fingerprint of this for my next crime spree.

 

[lonelobo]

I'm almost done with lypho after todays mishap.
IVAS box taped shut from Stryker. Ran my finger under tape and cut it up pretty good. Workers comp for sure. Other than that the case went well. Also, we got superiority for stax over standard aug. SOS gives more money for it through October, hoping for new CPT that will increase office based reimbursement so I can get paid like a stem cell rock star. Only if I wasn't an employed lowly salaried physician.

Good thing it was on your amputated finger😉

 

[Ferrismonk]

I'm almost done with kypho after todays mishap.
IVAS box taped shut from Stryker. Ran my finger under tape and cut it up pretty good. Workers comp for sure. Other than that the case went well. Also, we got superiority for stax over standard aug. SOS gives more money for it through October, hoping for new CPT that will increase office based reimbursement so I can get paid like a stem cell rock star. Only if I wasn't an employed lowly salaried physician.

Looks like your platelets did a good job starting the healing process.

 

[drusso]

so I looked at the pubmed publication.

patients who got conservative therapy left the study at 6 months period of time, which I wonder whether that was the best move. you do not have a true comparison between injection therapy and conservative therapy at 12 and 24 months.

I would guess that the data would be favorable, but what if healing from the tear occurred during that 12-24 month time period, such that pain reduced significantly in conservative care patients at 24 months?

EULAR Issues Recommendations for Knee OA Platelet-Rich Plasma Injections
Jun 11, 2020
Katie Robinson

Relevant Topics
An expert consensus on the first clinical practice recommendations for platelet-rich plasma (PRP) injections in knee osteoarthritis was presented at the European Congress of Rheumatology annual meeting.

An expert consensus on the first clinical practice recommendations for platelet-rich plasma (PRP) injections in knee osteoarthritis was presented at the European Congress of Rheumatology (EULAR) annual meeting.

“There has been much debate regarding the use of intra-articular injections of platelet-rich plasma as symptomatic treatment for knee osteoarthritis,” said Florent Eymard, M.D., of the Henri Mondor Hospital in Créteil, France. “The heterogeneity of the preparation and injection protocols limits the extrapolation of data from randomized controlled trials and meta-analyses.”

The task force of 15 physicians settled on 25 recommendations, with strong agreement on only one recommendation that intra-articular PRP treatment for knee osteoarthritis may include one to three consecutive injections.

The main recommendations, with relative agreement, also include: Benefit in early, moderate and severe knee osteoarthritis: Intra-articular injections of PRP are an efficient treatment of early or moderate symptomatic knee osteoarthritis and may be useful in severe knee osteoarthritis (Kellgren-Lawrence grade IV).

When to use: PRP injections should be proposed as second-line therapy, after failure of non-pharmacological and pharmacological symptomatic treatment.

When to avoid: PRP injections should not be performed in osteoarthritis flare-up with significant effusion.
Treatment specifics: Leukocyte-poor PRP is preferred for knee osteoarthritis treatment. PRP should not be mixed with injectable anesthetic or corticosteroid.

However, there was no consensus on whether PRP injections should be performed under ultrasound or fluoroscopic guidance.

In a separate presentation at the EULAR meeting, Seyed Ahmad Raeissadat, M.D. of the Shahid Beheshti University of Medical Sciences in Tehran, Iran, referred to knee osteoarthritis as one of the most important leading causes of disability and relative dependence. While intra-articular injections are among the minimally invasive methods recommended for knee osteoarthritis management, a large array of products have been used.

Dr. Raeissadat and colleagues randomized 200 patients with mild to moderate knee osteoarthritis to intra articular injections of hyaluronic acid, PRP, plasma rich in growth factors (PRGF), and ozone. While ozone injections had rapid effects and better short-term results after two months, the therapeutic effects did not persist after six months. At the six-month follow up, PRP,PRGF and hyaluronic acid were superior to ozone.

“Only patients in PRP and PRGF groups improved symptoms persisted for 12 months,” Dr. Raeissadat said. “Therefore, these products could be the preferable choices for long-term management.”

REFERENCE
AB0862 (2020) Consensus Statement On Intra-Articular Injections Of Platelet-Rich Plasma For The Management Of Knee Osteoarthritis. Florent Eymard, M.D. 2020 EULAR E-Congress
AB0878 (2020) The Comparison Effects Of Intra-Articular Injection Of Platelet Rich Plasma, Plasma Rich In Growth Factor, Hyaluronic Acid, And Ozone In Knee Osteoarthritis; A One Year Randomized Clinical Trial. Seyed Ahmad Raeissadat, M.D. 2020 EULAR E-Congress

 

[drusso]

EULAR Issues Recommendations for Knee OA Platelet-Rich Plasma Injections
Jun 11, 2020
Katie Robinson

Relevant Topics
An expert consensus on the first clinical practice recommendations for platelet-rich plasma (PRP) injections in knee osteoarthritis was presented at the European Congress of Rheumatology annual meeting.

An expert consensus on the first clinical practice recommendations for platelet-rich plasma (PRP) injections in knee osteoarthritis was presented at the European Congress of Rheumatology (EULAR) annual meeting.

“There has been much debate regarding the use of intra-articular injections of platelet-rich plasma as symptomatic treatment for knee osteoarthritis,” said Florent Eymard, M.D., of the Henri Mondor Hospital in Créteil, France. “The heterogeneity of the preparation and injection protocols limits the extrapolation of data from randomized controlled trials and meta-analyses.”

The task force of 15 physicians settled on 25 recommendations, with strong agreement on only one recommendation that intra-articular PRP treatment for knee osteoarthritis may include one to three consecutive injections.

The main recommendations, with relative agreement, also include: Benefit in early, moderate and severe knee osteoarthritis: Intra-articular injections of PRP are an efficient treatment of early or moderate symptomatic knee osteoarthritis and may be useful in severe knee osteoarthritis (Kellgren-Lawrence grade IV).

When to use: PRP injections should be proposed as second-line therapy, after failure of non-pharmacological and pharmacological symptomatic treatment.

When to avoid: PRP injections should not be performed in osteoarthritis flare-up with significant effusion.
Treatment specifics: Leukocyte-poor PRP is preferred for knee osteoarthritis treatment. PRP should not be mixed with injectable anesthetic or corticosteroid.

However, there was no consensus on whether PRP injections should be performed under ultrasound or fluoroscopic guidance.

In a separate presentation at the EULAR meeting, Seyed Ahmad Raeissadat, M.D. of the Shahid Beheshti University of Medical Sciences in Tehran, Iran, referred to knee osteoarthritis as one of the most important leading causes of disability and relative dependence. While intra-articular injections are among the minimally invasive methods recommended for knee osteoarthritis management, a large array of products have been used.

Dr. Raeissadat and colleagues randomized 200 patients with mild to moderate knee osteoarthritis to intra articular injections of hyaluronic acid, PRP, plasma rich in growth factors (PRGF), and ozone. While ozone injections had rapid effects and better short-term results after two months, the therapeutic effects did not persist after six months. At the six-month follow up, PRP,PRGF and hyaluronic acid were superior to ozone.

“Only patients in PRP and PRGF groups improved symptoms persisted for 12 months,” Dr. Raeissadat said. “Therefore, these products could be the preferable choices for long-term management.”

REFERENCE
AB0862 (2020) Consensus Statement On Intra-Articular Injections Of Platelet-Rich Plasma For The Management Of Knee Osteoarthritis. Florent Eymard, M.D. 2020 EULAR E-Congress
AB0878 (2020) The Comparison Effects Of Intra-Articular Injection Of Platelet Rich Plasma, Plasma Rich In Growth Factor, Hyaluronic Acid, And Ozone In Knee Osteoarthritis; A One Year Randomized Clinical Trial. Seyed Ahmad Raeissadat, M.D. 2020 EULAR E-Congress

J Orthop Surg Res

. 2020 Jul 10;15(1):257.
doi: 10.1186/s13018-020-01753-z.
Intra-articular Platelet-Rich Plasma vs Corticosteroids in the Treatment of Moderate Knee Osteoarthritis: A Single-Center Prospective Randomized Controlled Study With a 1-year Follow Up
Andrejs Elksniņš-Finogejevs 1 2, Luis Vidal 3, Andrejs Peredistijs 4
Affiliations expand

• PMID: 32650801
• DOI: 10.1186/s13018-020-01753-z

Abstract
Background: Osteoarthritis is the most prevalent type of arthritis, which significantly impacts the patient's mobility and quality of life. Pharmacological treatments for osteoarthritis, such as corticosteroids, produce an immediate reduction of the patient's pain as well as an improvement in the patient's mobility and quality of life, but with a limited long-term efficacy. In this context, platelet-rich plasma (PRP) infiltrations represent a therapeutic tool due to its trophic properties and its ability to control inflammatory processes, especially in musculoskeletal applications. The aim of this study is to evaluate and compare the clinical benefits of PRP when injected intra-articularly vs a commonly used corticosteroid (CS, triamcinolone acetonide, Kenalog®) in patients affected by mild to moderate symptomatic knee osteoarthritis.
Methods: Forty patients affected by symptomatic radiologically confirmed knee osteoarthritis (Kellgren-Lawrence grades II-III) were enrolled in this randomized study. Patients randomized in the PRP group (n = 20) received an intra-articular injection of PRP (8 mL) while patients randomized in the CS group (n = 20) received an intra-articular injection of triamcinolone acetonide (1 mL of 40 mg/mL) plus lidocaine (5 mL of 2%). The pain and function of the target knee were evaluated by the VAS, IKDC, and KSS scales at the baseline (V1), 1 week (V2), 5 weeks (V3), 15 weeks (V4), 30 weeks (V5), and 1 year (V6) after treatment.
Results: No serious adverse effects were observed during the follow-up period. A mild synovitis was registered in 15 patients (75%) in the PRP group within the first week after treatment which resolved spontaneously. Both treatments were effective in relieving pain and improving the knee function in the very short-term follow-up visit (1 week). A high improvement of the subjective scores was observed for both groups up to 5 weeks, with no significative differences between the groups for the VAS, IKDC, or KSS. After 15 weeks of follow-up, the PRP group showed significative improvements in all scores when compared to the CS group. Overall, the patients who received PRP treatment had better outcomes in a longer follow-up visit (up to 1 year) than those who received CS.
Conclusions: A single PRP or CS intra-articular injection is safe and improves the short-term scores of pain and the knee function in patients affected by mild to moderate symptomatic knee OA (with no significant differences between the groups). PRP demonstrated a statistically significant improvement over CS in a 1-year follow-up. This study was registered at ISRCTN with the ID ISRCTN46024618.
Keywords: Corticosteroid; Knee; Osteoarthritis; Platelet-rich plasma.

 

[drusso]

ORIGINAL PAPER
Subchondral bone or intra-articular injection of bone marrow concentrate mesenchymal stem cells in bilateral knee osteoarthritis: what better postpone knee arthroplasty at fifteen years? A randomized study

Philippe Hernigou1 & Charlie Bouthors2 & Claire Bastard1 &
Charles Henri Flouzat Lachaniette1 & Helene Rouard3 & Arnaud Dubory1

Received: 12 April 2020 /Accepted: 26 June 2020
# SICOT aisbl 2020

Abstract

Purpose There is an increasing number of reports on the treatment of knee osteoarthritis (OA) using mesenchymal stem cells
(MSCs). However, it is not known what would better drive osteoarthritis stabilization to postpone total knee arthroplasty (TKA):
targeting the synovial fluid by injection or targeting on the subchondral bone with MSCs implantation.
Methods A prospective randomized controlled clinical trial was carried out between 2000 and 2005 in 120 knees of 60 patients
with painful bilateral knee osteoarthritis with a similar osteoarthritis grade. During the same anaesthesia, a bone marrow
concentrate of 40 mL containing an average 5727 MSCs/mL (range 2740 to 7540) was divided in two equal parts: after
randomization, one part (20 mL) was delivered to the subchondral bone of femur and tibia of one knee (subchondral group)
and the other part was injected in the joint for the contralateral knee (intra-articular group). MSCs were counted as CFU-F (colony
fibroblastic unit forming). Clinical outcomes of the patient (Knee Society score) were obtained along with radiological imaging
outcomes (including MRIs) at two year follow-up. Subsequent revision surgeries were identified until the most recent follow-up
(average of 15 years, range 13 to 18 years).

Results At two-year follow-up, clinical and imaging (MRI) improvement was higher on the side that received cells in the
subchondral bone. At the most recent follow-up (15 years), among the 60 knees treated with subchondral cell therapy, the yearly
arthroplasty incidence was 1.3% per knee-year; for the 60 knees with intra-articular cell therapy, the yearly arthroplasty incidence
was higher (p = 0.01) with an incidence of 4.6% per knee-year. For the side with subchondral cell therapy, 12 (20%) of 60 knees
underwent TKA, while 42 (70%) of 60 knees underwent TKA on the side with intra-articular cell therapy. Among the 18 patients
who had no subsequent surgery on both sides, all preferred the knee with subchondral cell therapy.

Conclusions Implantation of MSCs in the subchondral bone of an osteoarthritic knee is more effective to postpone TKA than
injection of the same intra-articular dose in the contralateral knee with the same grade of osteoarthritis.

@Ducttape

 

[Ducttape]

interesting, would never think to inject the bone itself.

would suggest that any intraarticular injection, including PRP, would not be preferred.

issues that I could not confirm - was it blinded? was is powered enough? any reason why no placebo control...

 

[drusso]

interesting, would never think to inject the bone itself.

would suggest that any intraarticular injection, including PRP, would not be preferred.

issues that I could not confirm - was it blinded? was is powered enough? any reason why no placebo control...

How many placebos last 15 years??

 

[Crybaby]

For all of you doing a lot of regen.....

My MIL is looking at getting it done by a sports med physician

They were looking at doing PRP into facets, SI joint, and hip joint and platelet poor plasma into paraspinal muscles and ligaments

Is it common to do so much at once? When reading about PRP, I always felt it's evidence seemed best with tendinopathies rather than OA...

I don't know much about the clinic she is getting it done at except she has had some epidurals and SI joints and things aren't ever explained well and she get's enough sedation to not remember anything. She has had another pain doc in the past that was great, she could tell me exactly what was done afterwards and she did great with cervical RF. I feel like they are looking at her thinking $$$$$$ but maybe I am too jaded.

 

[drusso]

For all of you doing a lot of regen.....

My MIL is looking at getting it done by a sports med physician

They were looking at doing PRP into facets, SI joint, and hip joint and platelet poor plasma into paraspinal muscles and ligaments

Is it common to do so much at once? When reading about PRP, I always felt it's evidence seemed best with tendinopathies rather than OA...

I don't know much about the clinic she is getting it done at except she has had some epidurals and SI joints and things aren't ever explained well and she get's enough sedation to not remember anything. She has had another pain doc in the past that was great, she could tell me exactly what was done afterwards and she did great with cervical RF. I feel like they are looking at her thinking $$$$$$ but maybe I am too jaded.

Do you know what the facility fee is?

 

[lobelsteve]

For all of you doing a lot of regen.....

My MIL is looking at getting it done by a sports med physician

They were looking at doing PRP into facets, SI joint, and hip joint and platelet poor plasma into paraspinal muscles and ligaments

Is it common to do so much at once? When reading about PRP, I always felt it's evidence seemed best with tendinopathies rather than OA...

I don't know much about the clinic she is getting it done at except she has had some epidurals and SI joints and things aren't ever explained well and she get's enough sedation to not remember anything. She has had another pain doc in the past that was great, she could tell me exactly what was done afterwards and she did great with cervical RF. I feel like they are looking at her thinking $$$$$$ but maybe I am too jaded.

Send her back to the old pain doc. Or just ask her to email.

Sounds like a big money grab for russo’s magic beans. I moved to Roswell.

 

[drusso]

For all of you doing a lot of regen.....

My MIL is looking at getting it done by a sports med physician

They were looking at doing PRP into facets, SI joint, and hip joint and platelet poor plasma into paraspinal muscles and ligaments

Is it common to do so much at once? When reading about PRP, I always felt it's evidence seemed best with tendinopathies rather than OA...

I don't know much about the clinic she is getting it done at except she has had some epidurals and SI joints and things aren't ever explained well and she get's enough sedation to not remember anything. She has had another pain doc in the past that was great, she could tell me exactly what was done afterwards and she did great with cervical RF. I feel like they are looking at her thinking $$$$$$ but maybe I am too jaded.

Sounds like treating the kinetic chain. Yes, you can treat multiple areas at once and there is good evidence for PRP for mild to mod OA. It sounds like she doesn't have any better options.

Clin Rheumatol

. 2020 Jun 12.
doi: 10.1007/s10067-020-05185-2. Online ahead of print.
The effects of platelet-rich plasma injection in knee and hip osteoarthritis: a meta-analysis of randomized controlled trials
Yujie Dong 1, Butian Zhang 2, Qi Yang 3, Jiajing Zhu 2, Xiaojie Sun 4
Affiliations expand

• PMID: 32533337
• DOI: 10.1007/s10067-020-05185-2

Abstract
Objective: We conducted this updated meta-analysis to evaluate the effects of PRP in patients with knee or hip OA.
Method: PubMed, Embase, and Web of Science were searched to identify randomized controlled trials (RCTs) that compared the efficacy of PRP with other intra-articular injections. The outcomes of interest included Western Ontario and McMaster (WOMAC), Knee Injury and Osteoarthritis Outcome Score (KOOS), Visual Analog Scale (VAS), Harris Hip Score (HHS), and International Knee Documentation Committee (IKDC).
Results: Twenty-four RCTs with 21 at knee OA and three at hip OA were included in this meta-analysis. The PRP injections significantly improved the WOMAC score, VAS score, IKDC score, and HHS score as compared with comparators. The WOMAC pain, stiffness, and physical function scores were also significantly better in the PRP group than in the control group. Most of the evaluated parameters that favored PRP were observed in knee OA but not in hip OA, at short-term (at 1, 2, 3, 6, 12 months) but not long-term follow-up (at 18 months), in RCTs with low risk of bias.
Conclusions: Intra-articular PRP injection provided better effects than other injections for OA patients, especially in knee OA patients, in terms of pain reduction and function improvement at short-term follow-up.Key Points• This updated meta-analysis, based on great sample size and high-quality studies, evaluates the effects of PRP in patients with knee or hip OA.• Intra-articular PRP injection provided better effects than other injections for OA patients.• Most of the evaluated parameters that favored PRP were observed in knee OA at short term (at 1, 2, 3, 6, 12 months).
Keywords: Hip osteoarthritis; Knee osteoarthritis; Platelet-rich plasma.

doi: 10.1097/PHM.0000000000001389.
Effectiveness of Ultrasound-Guided Platelet-Rich Plasma Injections in Relieving Sacroiliac Joint Dysfunction
Patrick Wallace 1, Laurie Bezjian Wallace, Sarah Tamura, Kirk Prochnio, Kyle Morgan, Douglas Hemler
Affiliations expand

• PMID: 31972616
• DOI: 10.1097/PHM.0000000000001389

Abstract
Objective: The aim of the study was to investigate the efficacy of ultrasound-guided platelet-rich plasma in reducing sacroiliac joint disability and pain.
Design: Prospective nonrandomized interventional study analyzing 50 patients with low back pain secondary to sacroiliac joint dysfunction. Platelet-rich plasma was injected into the sacroiliac joint under ultrasound guidance. Oswestry Disability Index and Numeric Rating Scale were measured at baseline, 2 wks, 4 wks, 3 mos, and 6 mos after injection.
Results: The mean reduction in Oswestry Disability Index and Numeric Rating Scale scores were significantly reduced at 6 mos after injection compared with baseline values (mean = -9.79%, 95% CI = -6.06 to -13.52) and (mean = -1.94, 95% CI = -1.14 to -2.78), respectively. All timeframes showed significant mean reduction compared with baseline, but overall improvement tapers off after 4 wks with no statistically significant reduction from 4 wks to 3 mos or 3 to 6 mos.
Conclusions: Ultrasound-guided platelet-rich plasma injections in the sacroiliac joint are effective at reducing disability and pain with most improvement seen within 4 wks after injection and with sustained reduction at 6 mos.

 

[Crybaby]

Do you know what the facility fee is?

She told me 1000

 

[Crybaby]

Send her back to the old pain doc. Or just ask her to email.

Sounds like a big money grab for russo’s magic beans. I moved to Roswell.

I am trying to get her back to you, they live an hour south of the city now.
I would like her to try a lumbar RF, she is coming up here this weekend, so maybe I will see if my husband to run the c-arm.....

 

[drusso]

She told me 1000

I hate seeing patients get ripped off by facility fees...

 

[lobelsteve]

V is 3, she can do it better than K.

 

[Agast]

I think a meaningful study comparing PRP to corticosteroid should blind the recipients to which one they’re getting. That means drawing blood from both groups and using opaque syringes so they can’t see what’s in it.

 

[drusso]

I think a meaningful study comparing PRP to corticosteroid should blind the recipients to which one they’re getting. That means drawing blood from both groups and using opaque syringes so they can’t see what’s in it.

Do you really think people believe in it THAT much? Have you ever had a PRP injection? It's pretty hard to not know you got one. It hurts.

 

[Ducttape]

She told me 1000

darn. that neutralizes the PRP...

Do you really think people believe in it THAT much? Have you ever had a PRP injection? It's pretty hard to not know you got one. It hurts.

Influence of blinding on treatment effect size estimate in randomized controlled trials of oral health interventions - PMC

Recent methodologic evidence suggests that lack of blinding in randomized trials can result in under- or overestimation of the treatment effect size. The objective of this study is to quantify the extent of bias associated with blinding in ...

www.ncbi.nlm.nih.gov

Conclusions

We found significant differences in treatment effect size estimates between oral health trials based on lack of patient and assessor blinding. Treatment effect size estimates were 0.19 and 0.14 larger in trials with lack of blinding of both patients and assessors and blinding of patients, assessors, and care-providers concurrently.

Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies - PubMed

National Institute for Health Research Health Technology Assessment programme.

pubmed.ncbi.nlm.nih.gov

Conclusions: Bias associated with specific reported study design characteristics leads to exaggeration of beneficial intervention effect estimates and increases in between-trial heterogeneity. For each of the three characteristics assessed, these effects were greatest for subjectively assessed outcomes. Assessments of the risk of bias in RCTs should account for these findings.

 

[oreosandsake]

I’ve heard positive anecdotes from my patients about PRP they had elsewhere but nothing miraculous. So far no one has reported improvement with stem cells.

"stem cells" need to be defined much better. Amniotic tissue products are NOT stem cells. chiropractors injecting, or hiring poorly trained NPs to injection xyz without eval and imaging guidance is just a greedy money grab.

outcomes are more dependent on accurate diagnosis than the magical injectate. doesn't matter if it's normal saline, triamcinolone, or "stem cells"

 

[PMR2008]

@oreosandsake @drusso Are there any studies comparing stems cells vs PRP. I tend to consider and use stem cell injections using the emcyte kits if PRP injections fail. Would you ever consider Stem Cells as first line regenerative injections? Maybe it is just me but I have not had to use Stem Cells in my clinic other than a handful of times in 8 years.

 

[drusso]

@oreosandsake @drusso Are there any studies comparing stems cells vs PRP. I tend to consider and use stem cell injections using the emcyte kits if PRP injections fail. Would you ever consider Stem Cells as first line regenerative injections? Maybe it is just me but I have not had to use Stem Cells in my clinic other than a handful of times in 8 years.

I've used steadily less BMAC: PRP... probably 5:1. BMAC is still a winner in moderate+ OA in larger appendicular joints in my experience.

 

[Crybaby]

@drusso
What do you use to spin down your prp- kit or send to lab?

 

[Doctodd]

@drusso
What do you use to spin down your prp- kit or send to lab?

spin in office....in office lab equipment

 

[drusso]

AAOS Login

 

[BobBarker]

Did my first amnion injection Friday.

 

[drusso]

Did my first amnion injection Friday.

Why?

 

[BobBarker]

Organogenesis: ReNu

I think it is certainly anti inflammatory but open to learning more

 

[drusso]

Organogenesis: ReNu

I think it is certainly anti inflammatory but open to learning more

Yeah, maybe. As long as you didn’t call it a “stem cell” injection. Eye surgeons love amniotic tissues for corneal healing, but in ortho/MSK/pain I just haven’t seen an indication where I wouldn’t use PRP instead. Keep us posted how the patient does...

 

[beebermd]

this is a great conversation. I am a doc who recently incorporated USG amniotic stem cell joint cell injecitons into my regenerative practice. It was very frustrating to find evidence that it was benificial or not. It seemed every study out there or information i obtained was obviously tainted with conflicts of interest. and because of snake oil salsemen promoting stem cell IV push could cure your copd, aids, etc. Any serious conversations were impossible to have because of its scam like connotation and associated bias.
then there was the legailty. per FDA, if any allograft had living cells, it was a biologic and subject to certain regulations, which none of the stem cell companies were meeting. if you look at the brochures for any umbilical stem cell companay, none of them list living stem cells as part of thier allograft. They list cytokines, growthfactors, etc. but they know the FDA would shut them down if they stated that they had living stem cells. they will give you info that shows at harvest they have living cells, but many studies show that these are not viable after the freeze/thaw cycle. So at best, we are either on the wrong side of the law and they have stem cells, or they do not and we are lying to our patients. FDA gave all stem cell companies a time frame to comply or get shut down. that grace period is over this november. the ReNu product above.......from the looks of the product, to the instructions, to the product pamphelt are almost identical to any umbilical stem cell company product. in fact, i would wager money that stem cell companies will be remarketing thier product like this to avoid the looming FDA crack down in november.
What i have been telling my patients is that these umbilical allografts have cytokines, growth factors and cellular matrix components, that may promote healing. Throwing the word "stem cell" in there is ethically ambigious and something that honestly is not really needed IMO. anecdotal evidence for me has been very positive. Pt selection and management of expectations are of extreme importance. more objective studies are obviously needed

 

[drusso]

this is a great conversation. I am a doc who recently incorporated USG amniotic stem cell joint cell injecitons into my regenerative practice. It was very frustrating to find evidence that it was benificial or not. It seemed every study out there or information i obtained was obviously tainted with conflicts of interest. and because of snake oil salsemen promoting stem cell IV push could cure your copd, aids, etc. Any serious conversations were impossible to have because of its scam like connotation and associated bias.
then there was the legailty. per FDA, if any allograft had living cells, it was a biologic and subject to certain regulations, which none of the stem cell companies were meeting. if you look at the brochures for any umbilical stem cell companay, none of them list living stem cells as part of thier allograft. They list cytokines, growthfactors, etc. but they know the FDA would shut them down if they stated that they had living stem cells. they will give you info that shows at harvest they have living cells, but many studies show that these are not viable after the freeze/thaw cycle. So at best, we are either on the wrong side of the law and they have stem cells, or they do not and we are lying to our patients. FDA gave all stem cell companies a time frame to comply or get shut down. that grace period is over this november. the ReNu product above.......from the looks of the product, to the instructions, to the product pamphelt are almost identical to any umbilical stem cell company product. in fact, i would wager money that stem cell companies will be remarketing thier product like this to avoid the looming FDA crack down in november.
What i have been telling my patients is that these umbilical allografts have cytokines, growth factors and cellular matrix components, that may promote healing. Throwing the word "stem cell" in there is ethically ambigious and something that honestly is not really needed IMO. anecdotal evidence for me has been very positive. Pt selection and management of expectations are of extreme importance. more objective studies are obviously needed

Do you think that the concentration of cytokines and growth factors is higher in amnion or PRP? Why not just offer PRP? Hint: there is a science-based answer to use one over the other...

 

[Doctodd]

My Univ of Miami PhD buddy's company hit a home run recently. I might get doxed by Centeno for this....

Kimera® Labs Files First FDA Investigational New Drug (IND) Application Using XoGlo® for Treatment of ARDS Secondary to COVID-19

/PRNewswire/ -- Kimera® Labs Inc, a privately held clinical stage biotechnology company, announces the filing of an extended FDA Investigational New Drug (IND)...

www.prnewswire.com

 

[SommeRiver]

Zero live stem cells in amniotic tissue. Tell your pts they're buying growth factors (which may help) instead.

I'd just use PRP though.

 

[beebermd]

Zero live stem cells in amniotic tissue. Tell your pts they're buying growth factors (which may help) instead.

I'd just use PRP though.

thats exactly the point, i really feel there is no reason to be shady. there are plenty of cytokines and other growth factors that may promote an healing environment. maybe calling it stem cells justifies the price. i dunno. i was never trained in PRP, but am planning on it. honestly the evidence for PRP has exploded over the last year or so. there was a time not so long ago that even it had it skeptics (and still does to a certain effect) im hoping the science for amniotic allografts follows suit

 

[drusso]

Neural Regen Res

. 2021 Feb;16(2):362-366.
doi: 10.4103/1673-5374.290903.
Combined administration of platelet rich plasma and autologous bone marrow aspirate concentrate for spinal cord injury: a descriptive case series
Joseph A Shehadi 1, Steven M Elzein 2, Paul Beery 3, M Chance Spalding 3, Michelle Pershing 4
Affiliations collapse
Affiliations

• 1Section of Neurosurgery at OhioHealth Grant Medical Center, Cedar Stem Cell Institute, Columbus, OH, USA.
• 2The Ohio State University College of Medicine, Columbus, OH, USA.
• 3Division of Trauma and Acute Care Surgery, OhioHealth Grant Medical Center, Columbus, OH, USA.
• 4OhioHealth Research Institute, Columbus, OH, USA.

• PMID: 32859799
• DOI: 10.4103/1673-5374.290903

Free article
Abstract
Administration of platelet rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) has shown some promise in the treatment of neurological conditions; however, there is limited information on combined administration. As such, the purpose of this study was to assess safety and functional outcomes for patients administered combined autologous PRP and BMAC for spinal cord injury (SCI). This retrospective case series included seven patients who received combined treatment of autologous PRP and BMAC via intravenous and intrathecal administration as salvage therapy for SCI. Patients were reviewed for adverse reactions and clinical outcomes using the Oswestry Disability Index (ODI) for up to 1 year, as permitted by availability of follow-up data. Injury levels ranged from C3 through T11, and elapsed time between injury and salvage therapy ranged from 2.4 months to 6.2 years. Post-procedure complications were mild and rare, consisting only of self-limited headache and subjective memory impairment in one patient. Four patients experienced severe disability prior to PRP combined with BMAC injection, as evidenced by high (> 48/100) Oswestry Disability Index scores. Longitudinal Oswestry Disability Index scores for two patients with incomplete SCI at C6 and C7, both of whom had cervical spine injuries, demonstrated a decrease of 28-40% following salvage therapy, representing an improvement from severe to minimal disability. In conclusion, intrathecal/intravenous co-administration of PRP and BMAC resulted in no significant complications and may have had some clinical benefits. Larger clinical studies are needed to further test this method of treatment for patients with SCI who otherwise have limited meaningful treatment options. This study was reviewed and approved by the OhioHealth Institutional Review Board (IRB No. 1204946) on May 16, 2018.
Keywords: Oswestry Disability Index; bone marrow aspirate concentrate; cell-based therapy; neural regeneration; platelet rich plasma; spinal cord injury; stem cells.
Conflict of interest statement
None

 

[NJPAIN]

Do you think that the concentration of cytokines and growth factors is higher in amnion or PRP? Why not just offer PRP? Hint: there is a science-based answer to use one over the other...

Don't make me beg. Give me the science-based answer.

 

[drusso]

Don't make me beg. Give me the science-based answer.

PRP has a broader profile of cytokines and growth factors. Amnio products do have one growth factor that is unique to it (I forget the name).

My reasoning is that since we don't know for certain which growth factor is the most important for tendinopathies or arthritis, go with a broad spectrum concoction.

I believe that someday we will tailor specific regen products to specific diagnoses and gene sequencing studies--kind of like we do antibiotics based upon sensitivities--but until then everyone gets Vanco&Clinda...

 

[Ducttape]

the only point that can be gleaned from that study is that it seems to safe.

 

[onewithpain]

The VA is paying for PRP in the knee for mild to moderate OA, and for tennis elbow. It is Tricare and they all seem to be active military. They only pay $140 which doesn't pay for a PRP kit. I use 10cc syringes and spin slow to get rid of the RBCs and then spin fast to settle the platelets. It works well and I can see another patient during each spin.