Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
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 knee. Follow-up will consist of a larger sample including 4,000 patients.
Key facts
- Study ID
- NCT02844751
- 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, grade 2 or more. 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 knee pain on the index side (left or right knee).
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 and 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:
- Knee instability.
- A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery.
- Gout or pseudo gout
- Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee 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
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.