Home › Osteoarthritis › NCT02844764
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
RecruitingPhase 2Healthy volunteers welcome
Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Hip
Who can join
Ages 18 to 90 · All sexes · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: 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 hip pain with the index side (left or right). Exclusion Criteria: 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 and 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: * Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than hip osteoarthritis * Corticosteroid injection at treatment site within 1 month * Consistent use of NSAIDs within 48 hours of procedure.
About the 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 hip. Follow-up will consist of a larger sample including 4,000 patients.
What is being tested
- [StroMed + platelet rich plasma (PRP)] (biological)
Sponsor: VivaTech International, Inc. · Participants: 4,000 · Started: 2015-07
Contact the study team
- Scott M Herkes, MBA · Phone: 855-984-8287
- Michael P Hutchinson, DVM · Phone: 412-503-3788
Official record on ClinicalTrials.gov — NCT02844764
Locations in the U.S.
| Pennsylvania | VivaTech International, Inc., Grove City |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.