PRP + Cell Therapy for Osteoarthritis

Overseen By Michelle Murtha, MScN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dr. Grant M. Pagdin

Must not be taking: Antiplatelets, Cortisone, HA

Disqualifiers: BMI > 35, Cancer, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 104 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for osteoarthritis in major joints, such as knees or hips. It examines the effectiveness of combining platelet-rich plasma (PRP) with either fat cells (lipoaspirate), bone marrow cells, or both, in reducing symptoms. The trial includes three groups to determine which combination is most effective. Suitable participants have confirmed osteoarthritis through recent imaging and have not undergone recent joint surgery or specific injections. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be able to pause antiplatelet therapy before the procedure.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using platelet-rich plasma (PRP) with fat tissue are generally well-tolerated. One study found that PRP injections for osteoarthritis (OA) improved patient outcomes without major side effects. Another study confirmed that combining PRP with small pieces of fat tissue led to significant improvements, with no major safety differences compared to using PRP alone.

When PRP is combined with bone marrow extract, studies have found this mix is safe and can improve pain and movement for knee OA patients. Reports suggest that about 40 to 70 percent of those treated experience pain relief, indicating a positive safety profile.

For treatments that combine PRP, fat tissue, and bone marrow extract, research shows these methods also help with pain and function. Patients generally handle these treatments well, with many experiencing long-lasting relief.

Overall, these treatments are in a middle stage of testing, having shown some safety in earlier studies. However, more research is needed to confirm these results in larger groups. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for osteoarthritis because they combine platelet-rich plasma (PRP) with either lipoaspirate, bone marrow aspirate, or both. Unlike traditional treatments such as NSAIDs or corticosteroid injections, these therapies use the body's own cells to potentially promote healing and reduce inflammation. The PRP acts as a catalyst, enhancing the regenerative properties of the cells derived from fat or bone marrow. This approach not only targets symptoms but might also address the underlying joint damage, offering hope for longer-lasting relief.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

This trial will compare different combinations of platelet-rich plasma (PRP) with other therapies for osteoarthritis. Research has shown that using PRP with fat tissue (lipoaspirate), which participants in Group A may receive, can ease osteoarthritis symptoms, with significant improvements in knee pain lasting up to six months. Participants in Group B will receive PRP combined with bone marrow aspirate, which has provided pain relief for about six to twelve months, with a success rate of 60% to 70%. Group C will receive a combination of PRP with both fat tissue and bone marrow aspirate, potentially offering even better pain relief and joint function, especially when other treatments haven't worked. These combinations aim to improve joint healing and effectively reduce pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Stephen Rosenfeld, MD

Principal Investigator

Quorum Review IRB

Are You a Good Fit for This Trial?

This trial is for adults over 19 with Osteoarthritis in a major joint, confirmed by recent imaging. They must be able to consent and follow the study plan. Excluded are those with BMI >35, recent joint surgery or injections, certain medication restrictions, severe arthritis (Grade 4), low platelet or hemoglobin levels, active infection or cancer, pregnant women, and those with autoimmune diseases or allergies to specific medications.

Inclusion Criteria

I am 19 years old or older.

I have arthritis in a major joint with recent imaging showing Grades 1-3 severity.

Capable of providing written informed consent and willing and able to adhere to all protocol requirements

Exclusion Criteria

I currently have an infection with a fever or high white blood cell count.

I am not pregnant and willing to use birth control during the study.

You have an autoimmune disorder like rheumatoid arthritis or lupus.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of PRP with lipoaspirate and/or bone marrow aspirate into an arthritic joint

104 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Autologous cell therapy

Trial Overview The trial tests how effective PRP therapy combined with lipoaspirate and/or bone marrow aspirate is for Osteoarthritis. Participants will receive one of three treatment combinations: PRP plus lipoaspirate; PRP plus bone marrow aspirate; or PRP with both lipoaspirate and bone marrow aspirate.

How Is the Trial Designed?

Group I: Group A - PRP plus Lipoaspirate Active Control 1 Intervention

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate). Total Volume varies by joint.

Group II: Group B - PRP plus Bone Marrow Aspirate Active Control 1 Intervention

Equal proportions of PRP plus bone marrow aspirate. Total Volume varies by joint.

Group III: Group C - PRP plus Lipoaspirate plus Bone Marrow Aspirate Active Control 1 Intervention

Equal proportions of PRP plus micronized adipose tissue (lipoaspirate) plus bone marrow aspirate. Total Volume varies by joint.

Autologous cell therapy is already approved in United States, European Union for the following indications:

Approved in United States as Autologous cell therapy for:

• Not FDA-approved for osteoarthritis; used off-label for various conditions including osteoarthritis, tendonopathies, and musculoskeletal injuries

Approved in European Union as Autologous cell therapy for:

• Not centrally approved for osteoarthritis; individual countries may have varying regulations and approvals for autologous cell therapies

Who Is Running the Clinical Trial?

Dr. Grant M. Pagdin

Lead Sponsor

Trials

1

Recruited

240+

Published Research Related to This Trial

Intraarticular injections of autologous platelet-rich plasma (PRP) and bone marrow concentrate (BMC) significantly reduced inflammatory cytokines and delayed cartilage degeneration in a goat model of osteoarthritis, indicating their therapeutic efficacy.

The BMC treatment provided greater cartilage protection and less loss of extracellular matrix compared to PRP, suggesting that BMC may be a more effective option for treating osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraarticular injection autologous platelet-rich plasma and bone marrow concentrate in a goat osteoarthritis model. Wang, Z., Zhai, C., Fei, H., et al.[2019]

In a randomized controlled trial involving 90 participants with knee osteoarthritis, both autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) showed significant improvements in pain and function over 24 months, with no significant differences between the two treatments.

Both PRP and BMC led to sustained improvements in patient-reported outcomes, plateauing at 3 months and maintained through 24 months, indicating that neither treatment was superior to the other for managing knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 2 Years: A Prospective Randomized Trial. Anz, AW., Plummer, HA., Cohen, A., et al.[2022]

PTP-001, a novel placental tissue particulate, contains significantly higher levels of key growth factors compared to both leukocyte-rich and leukocyte-poor platelet-rich plasma (PRP), suggesting a potentially more effective treatment for knee osteoarthritis.

Both PTP-001 and PRP can reduce inflammation in cell cultures, but PTP-001 shows more consistent results and greater efficacy in reducing harmful gene expressions related to cartilage degradation, indicating its superior therapeutic potential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composition and Bioactivity of a Placental Tissue Particulate (PTP-001) Indicate Greater Potential than Platelet-Rich Plasma for the Treatment of Osteoarthritis. Flannery, CR., Buddin, KE., Begum, L., et al.[2023]

In a case study of 3 females with knee osteoarthritis, the combination of a single bone marrow aspiration concentrate (BMAC) injection followed by a platelet-rich plasma (PRP) injection led to improvements in pain and functionality scores for all patients.

These results suggest that using BMAC and PRP together may enhance pain relief and functional status, potentially improving the quality of life for individuals suffering from knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone marrow aspiration concentrate and platelet-rich plasma in the treatment of knee osteoarthritis: A report of three cases. Subaşı, V., Ekiz, T.[2019]

Autologous platelet-rich plasma (PRP) shows promise in reducing pain from osteoarthritis and may aid in cartilage repair, highlighting its potential therapeutic benefits.

PRP is derived from the patient's own blood and contains a variety of growth factors, but the commercial versions available can vary significantly in composition, which may affect their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial commentary: autologous platelet-rich plasma. Lubowitz, JH.[2018]

The systematic review analyzed 16 articles on injectable ortho-biological treatments for severe knee osteoarthritis (OA), including platelet-rich plasma (PRP) and mesenchymal cells, but found no consistent beneficial effects across studies.

Due to the variability in treatment protocols, follow-up periods, and small sample sizes, the study concluded that there is insufficient evidence to recommend routine use of these injectable treatments for severe knee OA, highlighting the need for larger, randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of biologic agents for treating severe knee osteoarthritis: is there a chance for a good outcome? A systematic review of clinical evidence. Anzillotti, G., Conte, P., Di Matteo, B., et al.[2022]

A randomized controlled trial involving 90 participants with knee osteoarthritis found that both autologous platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMC) injections significantly improved pain and function for up to 12 months, with no significant differences in outcomes between the two treatments.

While PRP has a strong clinical evidence base for treating knee osteoarthritis, BMC showed similar effectiveness in this study, indicating that both treatments can be viable options, but neither was superior to the other.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis at 1 Year: A Prospective, Randomized Trial. Anz, AW., Hubbard, R., Rendos, NK., et al.[2022]

Bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) both significantly enhance initial bone regeneration when combined with β-tricalcium phosphate (β-TCP) in an immunodeficient mouse model, with new bone formation observed at 7.6% and 7.2% respectively, compared to only 2.7% in the control group.

The study found that while both BMAC and PRP increased the number of bone cells and showed similar efficacy in promoting bone growth, the differences in effectiveness between the two treatments were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. platelet-rich plasma. Zhong, W., Sumita, Y., Ohba, S., et al.[2022]

Bone marrow concentrate (BMC) has a significantly higher concentration of the anti-inflammatory interleukin 1 receptor antagonist (IL-1Ra) compared to other preparations, making it a potentially more effective treatment for osteoarthritis and post-surgical healing.

Leukocyte-rich PRP (LR-PRP) shows higher concentrations of growth factors like platelet-derived growth factor (PDGF) and matrix metalloproteinases (MMPs), suggesting it may be optimal for enhancing vascularity and healing in injured tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Ziegler, CG., Van Sloun, R., Gonzalez, S., et al.[2020]

In a study involving 21 male rabbits with knee lesions, both platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) treatments showed improved articular surface remodeling compared to a control group, indicating their potential effectiveness in treating knee injuries.

The use of regenerative therapies like PRP and BMAC after surgery can enhance joint outcomes and reduce degeneration, suggesting they should be considered as valuable adjunct treatments in orthopedic practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing PRP and bone marrow aspirate effects on cartilage defects associated with partial meniscectomy: a confocal microscopy study on animal model. Lăzărescu, AE., Văduva, AO., Hogea, GB., et al.[2021]

Autologous biological preparations, known as orthobiologics, are increasingly used in orthopedic procedures and surgeries, utilizing the patient's own tissues to create treatments like platelet-rich plasma (PRP) and bone marrow concentrate (BMC).

The article highlights the physiological variability in the preparation of BMC and adipose tissue concentrate (ATC), which can affect the delivery of mesenchymal stem cells and their effectiveness in supporting tissue repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic Science of Autologous Orthobiologics: Part 2. Mesenchymal Stem Cells. Everts, PA., Panero, AJ.[2022]

A systematic review of 27 Level I studies involving 2,396 patients found that platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) injections significantly improved knee osteoarthritis symptoms compared to hyaluronic acid (HA) injections, as measured by patient-reported outcome scores.

There were no significant differences in outcomes between PRP and BMAC, suggesting both treatments are equally effective for improving knee OA symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients With Knee Osteoarthritis Who Receive Platelet-Rich Plasma or Bone Marrow Aspirate Concentrate Injections Have Better Outcomes Than Patients Who Receive Hyaluronic Acid: Systematic Review and Meta-analysis. Belk, JW., Lim, JJ., Keeter, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35289231/

Bone Marrow Aspirate Concentrate Is Equivalent to Platelet ... The purpose of this study was to compare the efficacy of BMC and PRP on pain and function in patients with knee osteoarthritis up to 24 months after injection.

2. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/analyzing-the-performance-of-platelet-rich-plasma-and-bone-marrow-aspirate-concentrate-injections-for-the-treatment-of-knee-osteoarthritis/mqc-20578651

Analyzing the performance of platelet-rich plasma and ... Many of our patients with knee OA report from 6 to 12 months of pain relief after treatment with PRP. We usually see a 60% to 70% chance of success.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806324000938

Meta-Analysis Platelet-Rich Plasma, Bone Marrow Aspirate ... At a minimum 6-month follow-up, PRP demonstrated significantly improved pain and function for patients with knee osteoarthritis compared to placebo.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03984461

The Combined Use of PRP with Lipoaspirate And/or Bone ... The purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10960965/

A Comprehensive Review of Platelet-Rich Plasma and Bone ... This comprehensive review provides an in-depth analysis of platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) as potential treatments for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7336820/

Patient-Reported Outcomes After Platelet-Rich Plasma ... The objective of this study was to compare platelet-rich plasma (PRP), bone marrow aspirate concentrate (BMAC), and adipose-derived mesenchymal stem cell (MSC) ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0749806323002207

Patients With Knee Osteoarthritis Who Receive Platelet ... The most important findings from this systematic review were consistently better results with PRP and BMAC compared with HA injections for patients with knee ...

8. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-021-04910-5

Bone marrow aspirate concentrate versus platelet-rich ... In clinical studies, PRP injections in symptomatic patients with knee OA have demonstrated safety and better pain and mobility outcomes up to 12 ...

9. mayoclinic.org mayoclinic.org/medical-professionals/physical-medicine-rehabilitation/news/case-study-use-of-platelet-rich-plasma-and-bone-marrow-aspirate-concentrate-injections-to-treat-knee-osteoarthritis/mcc-20422665

Case study: Use of platelet-rich plasma and bone marrow ... Current scientific literature indicates that between 40 and 70 percent of individuals who receive this treatment find some level of pain relief.