NCT02844764 Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip
| NCT ID | NCT02844764 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | VivaTech International, Inc. |
| Condition | Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2015-07 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 4,000 participants in total. It began in 2015-07 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Mark LoDico, MD
PRINCIPAL INVESTIGATOR
Advanced Regenerative Medicine
Frequently Asked Questions
Who can join the NCT02844764 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02844764 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT02844764 currently recruiting?
Yes, NCT02844764 is actively recruiting participants. Contact the research team at scott.herkes@gmail.com for enrollment information.
Where is the NCT02844764 trial being conducted?
This trial is being conducted at Grove City, United States.
Who is sponsoring the NCT02844764 clinical trial?
NCT02844764 is sponsored by VivaTech International, Inc.. The principal investigator is Mark LoDico, MD at Advanced Regenerative Medicine. The trial plans to enroll 4,000 participants.