Actively Recruiting
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder
Led by VivaTech International, Inc. · Updated on 2025-10-14
4000
Participants Needed
1
Research Sites
578 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with osteoarthritis of the shoulder caused by degeneration or chronic injury
- Age between 18 and 90 years
- Ability to follow the treatment plan, laboratory tests, and periodic interviews
- Adequate kidney function with creatinine ≤ 1.5 mg/dl
- Adequate heart and lung function
- Adequate blood clotting activity with PT(INR) < 1.5 and APTT within normal limits
- Adequate immune system with no known immunodeficiency
- Shoulder pain on the affected side lasting more than 6 months
You will not qualify if you...
- History of cancer within 5 years before screening, except resolved skin basal cell or squamous cell cancer
- Presence of serious or unstable heart, brain, or stroke-related conditions
- Transient ischemic attack diagnosed within 6 months before screening
- Infection with hepatitis B, hepatitis C, or HIV
- Body Mass Index over 40 kg/m2
- Active infection at the time of screening
- Any illness, psychiatric disorder, or substance dependence considered unsuitable by the investigator
- Treatments that may affect pain or mobility evaluation, including:
- Strong opioid use for non-shoulder pain within 4 weeks
- Corticosteroid injection at the shoulder treatment site within 1 month
- Regular use of NSAIDs within 48 hours of the procedure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
VivaTech International, Inc.
Grove City, Pennsylvania, United States, 16127
Actively Recruiting
Research Team
S
Scott M Herkes, MBA
CONTACT
M
Michael P Hutchinson, DVM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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