Cell Therapy for Shoulder 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, 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 shoulder. 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, 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 this treatment for shoulder osteoarthritis?

Research suggests that platelet-rich plasma (PRP) injections, which contain growth factors that help repair tissues, have shown promise in treating shoulder diseases and osteoarthritis by reducing pain and improving joint function. ^{1 2 3 4 5}

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

Research indicates that platelet-rich plasma (PRP) is generally safe for use in humans, as studies have shown it to be safe in procedures like rotator cuff repair and shoulder arthroplasty, with no significant safety concerns reported. ^{6 7 8 9 10}

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

PRP (Platelet-Rich Plasma) is unique because it uses a patient's own blood to create a solution rich in platelets, which are cells that release growth factors to help repair tissues. This treatment is different from others because it aims to promote natural healing and tissue repair, rather than just reducing symptoms like pain. ^{1 2 5 11 12}

Research Team

Mark LoDico, MD

Principal Investigator

Advanced Regenerative Medicine

Eligibility Criteria

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.

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 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

Treatment Details

Interventions

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

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.

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

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) 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 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]

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 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]

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 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 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]

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 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]

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]

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]

References

1. Korea (South) 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. [2022]

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

Case report: pulsed radiofrequency surgery combined with platelet-rich plasma injection in the treatment of supraspinatus injury. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[Clinical administration of platelet-rich plasma and growth factors to the musculoskeletal system]. [2020]

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

Injection of platelet-rich plasma in patients with primary and secondary knee osteoarthritis: a pilot study. [2022]

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

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

6. France pubmed.ncbi.nlm.nih.gov

Autologous platelet gel and platelet-poor plasma reduce pain with total shoulder arthroplasty. [2022]

7. Spain pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma in rotator cuff repair: systematic review and meta-analysis. [2023]

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

Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial. [2021]

9. Brazil pubmed.ncbi.nlm.nih.gov

ALLOGENEIC PLATELET-RICH PLASMA FOR ROTATOR CUFF REPAIR. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Autologous platelet rich plasma for arthroscopic rotator cuff repair. A pilot study. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Comparative Efficacy of Platelet Rich Plasma Injection, Corticosteroid Injection and Ultrasonic Therapy in the Treatment of Periarthritis Shoulder. [2020]

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

Platelet-Rich Plasma and Cartilage Repair. [2020]