RecruitingOsteoarthritis
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder
Eligible age
18–90 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: VivaTech International, Inc.
You may qualify if…
- ✓ 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).
You may not qualify if…
- ✕ 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:
Where it's recruiting
Pennsylvania
Grove City
Source: ClinicalTrials.gov · NCT02844738 · last updated 2025-10-14