Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Hip (NCT02844764)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).
Location: VivaTech International, Inc. โ Grove City, Pennsylvania
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- 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:
- 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.
๐ Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
๐ All Participating Trial Locations (1 Sites)
- VivaTech International, Inc. โ Grove City, Pennsylvania
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.