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

Trial Summary

What is the purpose of this trial?

To demonstrate the efficacy of the combined use of platelet-rich plasma (PRP) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: PRP plus lipoaspirate, PRP plus bone marrow aspirate, and PRP plus both lipoaspirate and bone marrow aspirate.

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.

What data supports the effectiveness of the treatment PRP + Cell Therapy for Osteoarthritis?

Research shows that both platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC) can improve pain and function in knee osteoarthritis, suggesting that combining these therapies may be beneficial. ^{1 2 3 4 5}

Is PRP + Cell Therapy safe for humans?

Research on PRP and bone marrow aspirate concentrate (BMAC) therapies, which are used for conditions like knee osteoarthritis, suggests they are generally safe as they are derived from the patient's own tissues, reducing the risk of rejection or severe side effects. ^{1 6 7 8 9}

How is the PRP + Cell Therapy treatment for osteoarthritis different from other treatments?

PRP + Cell Therapy is unique because it uses the patient's own cells and blood components, like platelet-rich plasma (PRP) and bone marrow aspirate concentrate (BMAC), to potentially repair cartilage and reduce pain, unlike traditional drugs or surgery. ^{1 2 10 11 12}

Research Team

Stephen Rosenfeld, MD

Principal Investigator

Quorum Review IRB

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States 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. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intraarticular injection autologous platelet-rich plasma and bone marrow concentrate in a goat osteoarthritis model. [2019]

4. United States 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. [2023]

5. England pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

In vivo comparison of the bone regeneration capability of human bone marrow concentrates vs. platelet-rich plasma. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. [2020]

8. Romania 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Basic Science of Autologous Orthobiologics: Part 2. Mesenchymal Stem Cells. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

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

11. Italy 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. [2022]

12. United States 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. [2023]