Using autologous cell therapy to treat shoulder osteoarthritis pain and inflammation

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Shoulder

This study is testing whether injections of a special type of cell therapy can help people with shoulder osteoarthritis feel less pain and inflammation.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4000 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: VivaTech International, Inc. (Industry-sponsored)
• Locations: 1 site (Grove City, Pennsylvania)
• Trial ID: NCT02844738 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the safety and effectiveness of autologous regenerative cell therapy for patients suffering from pain and inflammation due to osteoarthritis of the shoulder. A total of 50 patients will receive treatment involving injections of autologous Stromed and Platelet Rich Plasma (PRP) into the affected joints. Patient outcomes will be monitored through various assessments, including laboratory tests for inflammation markers, quality of life questionnaires, and follow-up MRIs over a period of six months. The study is designed to inform a larger follow-up involving 4,000 patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-90 with a diagnosis of shoulder osteoarthritis lasting more than six months.

Not a fit: Patients with recent cancer diagnoses, significant cardiovascular issues, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce pain and inflammation for patients with shoulder osteoarthritis, potentially improving their quality of life.

How similar studies have performed: While this approach is innovative, similar studies using autologous cell therapies have shown promising results in other joint conditions.

Eligibility criteria

Inclusion Criteria:

1. Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
2. Patients range from 18-90 years of age.
3. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
5. Patients with adequate cardiac and respiratory function.
6. Patients with adequate blood coagulation activity, PT(INR) \< 1.5, APTT
7. Patients must have adequate immune system function, with no known immunodeficiency disease.
8. Greater than 6 months shoulder pain with the index side (left or right shoulder).

Exclusion Criteria:

1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
2. Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.
4. Patients infected with hepatitis B, C or HIV.
5. Patients with Body Mass Index (BMI) \> 40kg/m2
6. Presence of active infection.
7. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
8. Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:

   1. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
   2. Corticosteroid injection at treatment site within 1 month
   3. Consistent use of NSAIDs within 48 hours of procedure.

Where this trial is running

Grove City, Pennsylvania

• VivaTech International, Inc. — Grove City, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Mark LoDico, MD — Advanced Regenerative Medicine
• Study coordinator: Scott M Herkes, MBA

Conditions Osteoarthritis