Cell Therapy for Hip Osteoarthritis

Overseen By Michael P Hutchinson, DVM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VivaTech International, Inc.

Must not be taking: Strong opioids, Corticosteroids, NSAIDs

Disqualifiers: Cancer, Cardiovascular, Stroke, Hepatitis, 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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy to determine if it can safely reduce pain and swelling in individuals with hip osteoarthritis. Participants receive injections of their own cells, combined with platelet-rich plasma (PRP therapy), directly into the affected hip joint. The study is open to those who have experienced hip pain for more than six months due to osteoarthritis, whether from wear and tear or a long-term injury. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

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

Research shows that the treatments under study for hip osteoarthritis—StroMed and Platelet-Rich Plasma (PRP)—are generally safe. StroMed uses cells from the patient's own body and has been safely used in many individuals with joint issues like osteoarthritis, with no major safety concerns reported. PRP involves injecting a concentration of the patient's own platelets and is also considered safe. Studies indicate that PRP is a low-risk procedure and usually does not cause serious side effects. Since it uses the patient's own blood, the risk of immune reactions or disease transmission is very low. Overall, both treatments have been well-tolerated in past studies, with no significant safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for hip osteoarthritis, which often include pain relievers, anti-inflammatory medications, or surgery, the combination of StroMed and Platelet Rich Plasma (PRP) offers a unique approach. This treatment harnesses the body’s own healing power by using a cell concentrate that retains the natural extracellular matrix, without any added enzymes or drugs. Researchers are excited because StroMed and PRP aim to stimulate the body's repair processes directly, potentially offering a safer and more natural alternative with minimal risk and no artificial additives.

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

Studies have shown that Stromal Vascular Fraction (SVF) cell therapy, such as StroMed, can reduce pain and improve movement in people with hip osteoarthritis. Specifically, three months after treatment, about 86% of patients reported at least 50% improvement. Additionally, PRP (Platelet-Rich Plasma) therapy has significantly eased pain and improved function, with 70% of patients experiencing positive results within three months. Both treatments use the body's own cells to reduce swelling and support healing. In this trial, participants will receive a combination of StroMed and PRP therapy, which could effectively manage hip osteoarthritis pain and improve joint function. ^{2 6 7 8 9}

Who Is on the Research Team?

Mark LoDico, MD

Principal Investigator

Advanced Regenerative Medicine

Are You a Good Fit for This Trial?

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.

Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• PRP
• StroMed

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• Osteoarthritis
• Tendonitis
• Ligament sprains
• Hair loss
• Skin rejuvenation

Approved in European Union as Platelet-Rich Plasma for:

• Osteoarthritis
• Tendonitis
• Ligament sprains
• Orthopedic conditions

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+

Published Research Related to This Trial

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 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]

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]

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 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]

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-&#954;B Pathway and Mitochondrial Apoptosis in Human Synovial Fibroblast Cells. Xie, L., Lin, W., Zhu, L., et al.[2023]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371981/

Platelet-Rich Plasma for Knee and Hip Osteoarthritis Pain A recent retrospective analysis of 431 patients found PRP therapy resulted in statistically significant improvements in WOMAC and VAS pain ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11488654/

Efficacy of Platelet-Rich Plasma Intra-articular Injections in Hip ... Another study reported significant improvement in pain and function at one and three months, with 70% of patients showing favorable outcomes, ...

3. sportsmed.org sportsmed.org/membership/sports-medicine-update/spring-2024/platelet-rich-plasma-for-osteoarthritis-in-2024

Platelet-Rich Plasma for Osteoarthritis in 2024 – More Hype A recent meta-analysis demonstrated that exogenously activated PRP is more effective in improving pain and function than non-activated PRP in patients with ...

4. academic.oup.com academic.oup.com/jhps/advance-article/doi/10.1093/jhps/hnaf008/8058728

Effectiveness of platelet-rich plasma in pain management of ... The study finds that PRP treatment is at least as effective as HA treatment in reducing hip pain for OA secondary to DDH.

5. cureus.com cureus.com/articles/304833-efficacy-and-safety-of-platelet-rich-plasma-prp-intra-articular-injections-in-hip-osteoarthritis-a-systematic-review-of-randomized-clinical-trials

Efficacy and Safety of Platelet-Rich Plasma (PRP) Intra ... In conclusion, PRP injections appear to be a safe and effective treatment option for managing hip OA, with favorable outcomes compared to ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39569300/

Efficacy and Safety of Platelet-Rich Plasma (PRP) Intra ... In conclusion, PRP injections appear to be a safe and effective treatment option for managing hip OA, with favorable outcomes compared to ...

7. hopkinsmedicine.org hopkinsmedicine.org/health/treatment-tests-and-therapies/plateletrich-plasma-prp-treatment

Platelet-Rich Plasma (PRP) Injections A PRP injection is a low-risk procedure and does not usually cause major side effects. The procedure involves a blood draw, so you should make sure you are ...

8. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1204144/full

Efficacy and safety of platelet-rich plasma injections for the ... PRP injection therapy can safely and effectively improve functional activity in patients with OA and produce positive analgesic effects in patients with KOA, ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2786501

Effect of Intra-articular Platelet-Rich Plasma vs Placebo ... This randomized trial assesses the effect of injections of platelet-rich plasma vs saline placebo on 12-month changes in knee pain scores and medial.