Cell Therapy for Hip Osteoarthritis

Recruiting in Palo Alto (17 mi)

Overseen by Mark LoDico, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: VivaTech International, Inc.

Must not be taking: Strong opioids, Corticosteroids, NSAIDs

Disqualifiers: Cancer, Cardiovascular, Stroke, Hepatitis, others

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the hip. Follow-up will consist of a larger sample including 4,000 patients.

Will I have to stop taking my current medications?

The trial requires that you stop using strong opioid drugs for other pain at least 4 weeks before joining, avoid corticosteroid injections at the treatment site for 1 month, and not use NSAIDs (non-steroidal anti-inflammatory drugs) consistently within 48 hours of the procedure.

What data supports the effectiveness of the treatment for hip osteoarthritis?

Research suggests that platelet-rich plasma (PRP) may help reduce pain and improve cartilage repair in osteoarthritis, including hip osteoarthritis. Studies have shown that PRP can be as effective as hyaluronic acid, another treatment option, in providing short-term relief for hip osteoarthritis. ^{1 2 3 4 5}

Is platelet-rich plasma (PRP) therapy safe for humans?

Research suggests that platelet-rich plasma (PRP) therapy is generally considered a minimally invasive and safe treatment option for conditions like osteoarthritis, with no major safety concerns reported in the studies. ^{1 2 6 7 8}

How is the PRP treatment for hip osteoarthritis different from other treatments?

PRP (Platelet-Rich Plasma) treatment for hip osteoarthritis is unique because it uses a patient's own blood to create a concentrated plasma that is injected into the joint, potentially aiding in pain relief and cartilage repair. This approach is different from standard treatments as it targets the subchondral bone through intraosseous infiltrations, which may enhance its effectiveness for severe cases. ^{1 4 5 7 9}

Research Team

Mark LoDico, MD

Principal Investigator

Advanced Regenerative Medicine

Eligibility Criteria

This trial is for adults aged 18-90 with hip pain from osteoarthritis lasting over 6 months, who have good heart, lung, kidney function and blood coagulation. They must not be dependent on alcohol or drugs, have had certain cancers in the last 5 years, recent steroid injections at the site, or use strong opioids or NSAIDs shortly before treatment.

Inclusion Criteria

Patients must be able to comply with treatment plan, laboratory tests, and periodic interviews

I have osteoarthritis from wear and tear or a long-term injury.

My kidney function is good, with creatinine levels at or below 1.5 mg/dl.

Exclusion Criteria

I haven't had cancer in the last 5 years, except for skin cancer that was removed.

I have serious heart or stroke issues.

I am infected with hepatitis B, C, or HIV.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive autologous Stromed and Platelet Rich Plasma (PRP) injections for Osteoarthritis of the hip

6 months

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including laboratory tests, HOOS questionnaires, and follow-up MRIs

6 months

Follow-up visits at 0, 2, and 6 months

Extension

Follow-up will consist of a larger sample including 4,000 patients

Treatment Details

Interventions

• PRP (Platelet Rich Plasma)
• StroMed (Regenerative Medicine)

Trial Overview The study tests a cell therapy combining StroMed and PRP to treat hip osteoarthritis pain and inflammation. It's an open-label trial starting with 50 patients to assess safety and effectiveness before expanding to follow up with a larger group of 4,000 patients.

Participant Groups

Group I: StroMed + Platelet Rich plasma [PRP] Experimental Treatment 1 Intervention

Because no enzymes or drugs are added with this mechanical process, the resulting (StroMed) cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Additional treatments with Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product by direct injection to affected joints.

PRP is already approved in Canada for the following indications:

Approved in Canada as Platelet-Rich Plasma for:

• Osteoarthritis
• Tendonitis
• Ligament sprains
• Musculoskeletal conditions

Who Is Running the Clinical Trial?

VivaTech International, Inc.

Lead Sponsor

Trials

3

Recruited

12,000+

Findings from Research

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]

In a phase III clinical trial involving 74 patients with hip osteoarthritis, platelet-rich plasma (PRP) injections significantly improved hip function and reduced pain compared to hyaluronic acid, with a notable difference in hip function scores after one year (PRP: 70.9 vs. hyaluronic acid: 60.2).

No adverse events were reported in either treatment group, and the study found that higher platelet concentrations in PRP were associated with better clinical outcomes, particularly in patients with early-stage osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. Villanova-López, MM., Núñez-Núñez, M., Fernández-Prieto, D., et al.[2021]

A systematic review of six studies involving 408 patients found that both platelet-rich plasma (PRP) and hyaluronic acid (HA) injections provide similar short-term clinical benefits for treating hip osteoarthritis, with no significant differences in pain and function scores after treatment.

The analysis included patients with a mean age of around 60 years and a follow-up period of approximately 12 months, indicating that both treatments are effective options for managing symptoms of hip OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma Versus Hyaluronic Acid for Hip Osteoarthritis Yields Similarly Beneficial Short-Term Clinical Outcomes: A Systematic Review and Meta-analysis of Level I and II Randomized Controlled Trials. Belk, JW., Houck, DA., Littlefield, CP., et al.[2022]

In a study of 40 patients with severe hip osteoarthritis, a combination of intraosseous and intra-articular injections of Platelet-Rich Plasma (PRP) led to significant pain reduction and improved hip joint functionality over 12 months.

The treatment resulted in a clinically meaningful improvement in pain for 40% of patients at both 2 and 12 months, with no severe adverse effects reported, indicating a safe and effective intervention for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraosseous infiltrations of Platelet-Rich Plasma for severe hip osteoarthritis: A pilot study. Fiz, N., Delgado, D., Garate, A., et al.[2022]

Platelet-rich plasma (PRP) is generally considered a safe treatment option for knee and hip osteoarthritis (OA) and may provide short-term symptomatic relief, particularly in younger patients with less severe disease, based on evidence from 18 randomized controlled trials (RCTs).

However, the studies reviewed showed low to moderate quality and significant variability in PRP protocols, making it difficult to draw definitive conclusions about its effectiveness or impact on OA structural changes, highlighting the need for further high-quality research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma for the Management of Hip and Knee Osteoarthritis. Bennell, KL., Hunter, DJ., Paterson, KL.[2022]

In a study of 60 patients undergoing hip replacement surgeries, the use of platelet-rich plasma (PRP) did not significantly reduce postoperative bleeding complications, as measured by hemoglobin drop and transfusion requirements.

The findings suggest that PRP does not provide clinical benefits in terms of reducing analgesic needs or shortening hospital stays after hip arthroplasty, indicating a need for further research with larger sample sizes to explore its potential utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical efficacy of using autologous platelet rich plasma in hip arthroplasty: A retrospective comparative study. Safdar, A., Shaaban, H., Tibayan, R., et al.[2020]

Platelet-rich plasma (PRP) therapy has shown potential in protecting human synovial fibroblast cells from injury caused by synovial fluid from osteoarthritis patients, particularly at dilution ratios of 1:5 and 1:10.

PRP appears to work by reducing mitochondrial apoptosis and inflammation associated with the NF-κB pathway, suggesting a mechanism through which it may alleviate osteoarthritis-related cellular damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PRP from Personal Blood Relieves Joint Fluid-Inducing Synovial Injury through NF-κB Pathway and Mitochondrial Apoptosis in Human Synovial Fibroblast Cells. Xie, L., Lin, W., Zhu, L., et al.[2023]

In a study involving 62 participants with knee osteoarthritis, neither platelet-rich plasma (PRP) nor plasma showed significant improvement in pain or function compared to a saline placebo over 24 weeks.

The PRP group experienced a higher rate of mild adverse events, with 65% reporting increased pain, indicating that while PRP is a minimally invasive treatment, it may not be safer or more effective than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. Dório, M., Pereira, RMR., Luz, AGB., 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

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

2. Spain pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, controlled trial, phase III, to evaluate the use of platelet-rich plasma versus hyaluronic acid in hip coxarthrosis. [2021]

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

Platelet-Rich Plasma Versus Hyaluronic Acid for Hip Osteoarthritis Yields Similarly Beneficial Short-Term Clinical Outcomes: A Systematic Review and Meta-analysis of Level I and II Randomized Controlled Trials. [2022]

4. India pubmed.ncbi.nlm.nih.gov

Intraosseous infiltrations of Platelet-Rich Plasma for severe hip osteoarthritis: A pilot study. [2022]

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

Platelet-Rich Plasma for the Management of Hip and Knee Osteoarthritis. [2022]

6. India pubmed.ncbi.nlm.nih.gov

The clinical efficacy of using autologous platelet rich plasma in hip arthroplasty: A retrospective comparative study. [2020]

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

PRP from Personal Blood Relieves Joint Fluid-Inducing Synovial Injury through NF-κB Pathway and Mitochondrial Apoptosis in Human Synovial Fibroblast Cells. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. [2022]

9. 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]