Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder
Recruiting now · Phase 2
Conditions studied: Osteoarthritis
In brief
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.
Key facts
- Study ID
- NCT02844738
- Run by
- VivaTech International, Inc.
- People needed
- 4000
- Starts
- 2015-07-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2025-10-14
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients with indication of Osteoarthritis. Can be from degeneration or chronic injury.
- Patients range from 18-90 years of age.
- Patients must be able to comply with treatment plan, laboratory tests and periodic interviews.
- Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.
- Patients with adequate cardiac and respiratory function.
- Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT
- Patients must have adequate immune system function, with no known immunodeficiency disease.
- Greater than 6 months shoulder pain with the index side (left or right shoulder).
You may not qualify if…
- Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
- Presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke)..
- Diagnosis of a transient ischemic attack in the 6 months prior to screening.
- Patients infected with hepatitis B, C or HIV.
- Patients with Body Mass Index (BMI) > 40kg/m2
- Presence of active infection.
- 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.
- Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
- Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than shoulder osteoarthritis
- Corticosteroid injection at treatment site within 1 month
- Consistent use of NSAIDs within 48 hours of procedure.
Where it is running
- VivaTech International, Inc. — Grove City, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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