Actively Recruiting
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
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 knee. 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 Knee
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of osteoarthritis grade 2 or higher due to degeneration or chronic injury
- Age between 18 and 90 years
- Ability to comply with treatment, laboratory tests, and periodic interviews
- Adequate kidney function with creatinine level ≤ 1.5 mg/dl
- Adequate heart and lung function
- Adequate blood clotting with PT(INR) < 1.5 and normal APTT
- Adequate immune system function with no known immunodeficiency
- Knee pain on the affected side lasting more than 6 months
You will not qualify if you...
- Diagnosis of cancer within 5 years prior to screening except certain skin cancers resolved by excision
- Significant acute or unstable heart or brain blood vessel conditions
- Transient ischemic attack within 6 months prior to screening
- Infection with hepatitis B, hepatitis C, or HIV
- Body mass index (BMI) over 40 kg/m2
- Presence of active infections
- Any illness, psychiatric disorder, or substance dependence that makes participation unsuitable
- Conditions affecting pain or mobility evaluation such as knee instability, severe knee deformity, gout or pseudogout
- Treatment with strong opioids for other pain within 4 weeks prior
- Corticosteroid injection in treatment area within 1 month prior
- Consistent use of NSAIDs within 48 hours before 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
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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