Cell Therapy for Shoulder 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, 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 cell therapy treatment to reduce pain and inflammation in people with shoulder osteoarthritis, a condition causing joint pain and stiffness. The study evaluates the safety and effectiveness of combining StroMed and PRP (platelet-rich plasma) injections. People with shoulder pain from osteoarthritis for over six months may be suitable for this trial. Participants receive injections directly into the affected joint to assess symptom improvement. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to potentially benefit from innovative therapy.

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, 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 has shown that both StroMed and platelet-rich plasma (PRP) are generally safe to use. StroMed involves a type of cell therapy using the patient's own cells, known as stromal vascular fraction (SVF) cells. This treatment is safe, well-tolerated, and used for conditions like osteoarthritis, helping to reduce inflammation and aid healing. Data from over 3,500 patients confirm its safety, with no major side effects reported.

PRP is also considered low-risk, with few major side effects. It uses a concentrate of platelets from the patient's own blood to promote healing. Some studies mention minor side effects, but these are rare. Overall, PRP is safe for osteoarthritis and other joint issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for shoulder osteoarthritis, such as NSAIDs, corticosteroid injections, and physical therapy, the combination of StroMed and PRP is unique because it harnesses the body's own healing potential. StroMed uses a mechanical process to create a cell concentrate that includes the extracellular matrix, without adding enzymes or drugs, which minimizes risk and maintains the natural state of the cells. Additionally, PRP involves injecting a concentration of the patient's own platelets directly into the joint, promoting tissue regeneration and reducing inflammation. Researchers are excited about these treatments because they offer a natural, minimally invasive alternative that could provide more sustainable relief and improved joint function.

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

Research has shown that platelet-rich plasma (PRP) injections effectively reduce pain and improve movement in shoulder problems. PRP has been particularly successful in treating conditions like frozen shoulder and partial tears in the rotator cuff. Studies have found that PRP provides significant long-term pain relief and better function compared to steroid treatments. In this trial, participants will receive a combination of StroMed's cell therapy and PRP. Although researchers have not extensively studied StroMed's cell therapy, combining it with PRP seems promising for easing pain and swelling in shoulder osteoarthritis. Early research suggests this combination might work better than traditional treatments. ^{4 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 shoulder pain from osteoarthritis lasting over 6 months. They must have good kidney, blood clotting, immune system function, and no immunodeficiency diseases. Excluded are those using strong painkillers or NSAIDs recently, with recent infections or cancer (except certain skin cancers), stroke history within six months, hepatitis B/C or HIV infection, very high BMI (>40kg/m2), unstable heart conditions, or steroid injections in the last month.

Inclusion Criteria

My heart and lungs are working well.

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

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

Exclusion Criteria

I haven't taken strong opioids for pain other than shoulder pain in the last 4 weeks.

Nothing affects my ability to evaluate my pain or mobility.

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

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 shoulder

6 months

Multiple visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, including laboratory tests, questionnaires, and MRI

6 months

Follow-up MRI and assessments at various endpoints

What Are the Treatments Tested in This Trial?

Interventions

• PRP
• StroMed

Trial Overview The study tests a combination of StroMed and platelet rich plasma (PRP) to treat shoulder pain and inflammation due to osteoarthritis. It's an open-label trial starting with 50 patients to assess safety and effectiveness before expanding to a larger group of 4,000 participants.

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 processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to affected joint.

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

Platelet-rich plasma (PRP) and growth factors are gaining popularity in orthopedic treatments for conditions involving low or absent tissue regeneration, such as cartilage and tendon injuries.

The review highlights the potential of PRP to enhance growth and regeneration in tissues like bone and muscle, suggesting its clinical feasibility for treating degenerative and traumatic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical administration of platelet-rich plasma and growth factors to the musculoskeletal system]. Leitner, L., Gruber, G., Lohberger, B., et al.[2020]

In a study involving 4 patients with supraspinatus muscle injuries, the combination of pulsed radiofrequency neuromodulation and platelet-rich plasma (PRP) treatment significantly improved shoulder function and reduced pain, as measured by the Constant-Murley shoulder score and visual analog scale.

The treatment showed no significant increase in postoperative pain or complications, highlighting its safety and effectiveness in managing shoulder joint injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: pulsed radiofrequency surgery combined with platelet-rich plasma injection in the treatment of supraspinatus injury. Jin, H., Gao, Y., Ji, Y., et al.[2022]

In a review of 14 prospective studies involving platelet-rich plasma (PRP) as an adjuvant treatment in arthroscopic rotator cuff repairs, the overall re-rupture rate was found to be 24%.

While the PRP group showed a decrease in re-rupture rates and improved functional outcomes, these differences were not statistically significant, indicating that more evidence is needed before PRP can be routinely recommended in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma in rotator cuff repair: systematic review and meta-analysis. Sánchez-Losilla, C., Ferré-Aniorte, A., Álvarez-Díaz, P., et al.[2023]

A study involving 60 patients with rotator cuff disease found that allogeneic platelet-rich plasma (PRP) injections are safe and do not lead to treatment-related adverse events.

While PRP injections did not show immediate superiority over corticosteroid injections in pain relief, they resulted in significantly better long-term outcomes in terms of overall function and external rotation at 6 months, indicating a gradual improvement in shoulder function compared to the quicker but less sustained response from corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial. Jo, CH., Lee, SY., Yoon, KS., et al.[2021]

Autologous platelet-rich plasma (PRP) injections significantly improve pain relief and functional outcomes in patients with common shoulder diseases compared to placebo and corticosteroid injections, based on an analysis of 17 randomized controlled trials.

PRP injections also enhance quality of life (QoL) for patients, with the most effective results seen when PRP is prepared using specific techniques, such as double centrifugation and high platelet concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can platelet-rich plasma injections provide better pain relief and functional outcomes in persons with common shoulder diseases: a meta-analysis of randomized controlled trials. Barman, A., Mishra, A., Maiti, R., et al.[2022]

In a study of 40 patients undergoing total shoulder arthroplasty, the use of autologous platelet gel (APG) and activated platelet-poor plasma (PPP) significantly reduced postoperative pain and the need for pain medication compared to a control group.

Patients treated with APG and PPP showed a greater improvement in internal rotation of the shoulder after surgery, suggesting that these treatments may enhance recovery outcomes in shoulder arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. Zavadil, DP., Satterlee, CC., Costigan, JM., et al.[2022]

In a study of 17 patients with full-thickness rotator cuff tears, allogeneic platelet-rich plasma (PRP) was found to be safe, with no adverse events reported during a minimum follow-up of 2 years.

The efficacy of allogeneic PRP was comparable to autologous PRP, as there were no significant differences in clinical outcomes or retear rates between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ALLOGENEIC PLATELET-RICH PLASMA FOR ROTATOR CUFF REPAIR. Jo, CH., Shin, JS., Lee, SY., et al.[2022]

In a study of 195 patients with periarthritis shoulder, a single injection of Platelet Rich Plasma (PRP) significantly improved shoulder range of motion and reduced pain compared to corticosteroid injections and ultrasonic therapy at 12 weeks.

PRP treatment was found to be more effective than ultrasonic therapy at 6 weeks as well, with no major adverse effects reported, highlighting its safety and efficacy as a treatment option for periarthritis shoulder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder. Kothari, SY., Srikumar, V., Singh, N.[2020]

In a study of 14 patients undergoing arthroscopic rotator cuff repair, the use of autologous platelet rich plasma (PRP) was found to be safe and resulted in significant improvements in pain and function over a 24-month follow-up period.

Patients experienced a notable decrease in pain scores and increases in functional scores (UCLA and Constant scores) at multiple follow-up points, indicating that the benefits of PRP application are stable over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. Randelli, PS., Arrigoni, P., Cabitza, P., et al.[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]

Platelet-rich plasma (PRP) therapy shows promise as a treatment for osteoarthritis (OA) by modulating inflammation and promoting healing through the release of growth factors and anti-inflammatory substances.

Current research indicates that PRP can be an effective non-operative management option for OA, but more randomized controlled trials with long-term follow-up are needed to confirm its efficacy and optimize treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Plasma and Cartilage Repair. Kennedy, MI., Whitney, K., Evans, T., et al.[2020]

In a preliminary study of 14 patients with knee osteoarthritis, intraarticular platelet-rich plasma (PRP) injections showed significant improvements in pain and function, with no reported adverse events, indicating a favorable safety profile.

Patients experienced almost linear improvements in their Knee Injury and Osteoarthritis Outcome Scores over 12 months, suggesting that PRP may effectively relieve symptoms of osteoarthritis and warrant further investigation in larger clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. Sampson, S., Reed, M., Silvers, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10652151/

Current Status and Advancements in Platelet-Rich Plasma ... It has been proven that PRP injections are an effective treatment in improving pain and function in patients with subacromial impingement (SAI) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2666639125001403

Platelet rich plasma for treatment in the shoulder and elbow PRP has been shown to be most effective in the management of adhesive capsulitis and lateral epicondylitis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10155124/

The role of platelet-rich plasma in shoulder pathologies In a level 1 study by Kwong et al., P-PRP had superior functional outcomes over CS in the short term (3 months) in 99 patients with partial rotator cuff tears.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X24002273

One year results of intraarticular platelet rich plasma in ... Both PRP & Steroid showed improvement in treating frozen shoulder. However, PRP resulted in significant long-term pain relief and functional improvement in ...

5. worksafebc.com worksafebc.com/resources/health-care-providers/guides/efficacy-effectiveness-orthobiologics-treatment-shoulder-osteoarthritis?lang=en&direct

“Efficacy and/or Effectiveness of some Orthobiologics as ... Platelet-rich plasma and shoulder osteoarthritis (shoulder OA): o Of the of fifteen(30,41,42,45,49,52,53,83,86,89,91,97,101,104,115) studies ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10333515/

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 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424001329

Adverse events related to platelet-rich plasma therapy and ... Although there have been recent reports of adverse events (AEs) possibly related to PRP treatment, the safety profile of PRP treatment remains unclear.

8. 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 ...

9. 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 Activated PRP causes the platelets to degranulate, and nearly 100% of the growth factors are released within 1 hour of activation. A recent meta-analysis ...