Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA
- Conditions
- Osteoarthritis, Hip
- Interventions
- Registration Number
- NCT03608579
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Will injection(s) of autologous culture-expanded AMSCs be safe and efficacious for treatment of painful Hip OA, and if so, which dosing regimen is most effective?
- Detailed Description
This phase I study will enroll 24 subjects with mild to moderate osteoarthritis of the hip. Subjects will receive either a single dose of 30 million autologous culture-expanded adipose-derived mesenchymal stromal cells (AMSCs), or two doses of AMSCs (with one month interval between doses) via ultrasound guided intra-articular hip injection. Patients will be followed for 24 months past their last injection to determine the local and systemic safety of single and two-dose injections of AMSCs in the treatment of symptomatic hip OA.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Two Injections Autologous Adipose Derived Mesenchymal Stromal Cells Two-dose administration (2 x ultrasound guided injections) of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip with one month interval between doses Single Injection Autologous Adipose Derived Mesenchymal Stromal Cells Single administration of Autologous Adipose Derived Mesenchymal Stromal Cells into the hip by single ultrasound guided injection
- Primary Outcome Measures
Name Time Method Nature, incidence and severity of adverse events (AEs) For a period of 2 years following last injection Defined as any untoward or undesirable medical occurrence in the form of signs, symptoms, abnormal findings, or diseases that emerge or worsen relative to baseline (i.e., if present upon study entry) during the study regardless of causal relationship.
Methods i. Spontaneous subject reports ii. Subject interview by study personnel iii. Clinical examination during face-to-face clinic follow-ups
- Secondary Outcome Measures
Name Time Method Change in cartilage thickness Baseline, 6 months, and 12 months post-treatment cycle Cartilage thickness on MRI
Change in radiographic joint morphology Baseline, 6 months, and 12 months post-treatment cycle Evaluation of joint morphology on hip X-rays, including standing antero-posterior, lateral, and false profile
Change in synovial fluid biomarkers within the target hip Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group Synovial fluid from attempted aspiration at the time of injection (and re-injection for the two injection cohort) will be analyzed for cells, cytokines, growth factors, and other similar biomarkers.
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles Baseline, 6 weeks, 6 months, 12 months post-treatment cycle 100 mm Visual Analog Scale. Range: 0 to 100 mm. Lower is better, higher is worse.
Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles Baseline, 6 weeks, 6 months, 12 months post-treatment cycle modified Harris Hip Score (mHHS). Score 0 to 100. Higher is better, lower is worse.
Change in cartilage volume Baseline, 6 months, and 12 months post-treatment cycle Cartilage volume on MRI
Change in cartilage morphology Baseline, 6 months, and 12 months post-treatment cycle Cartilage morphology on MRI
Change periarticular soft-tissues Baseline, 6 months, and 12 months post-treatment cycle Evaluate periarticular tissues on MRI (i.e. visible synovitis)
Change in Tegner activity scale in the target hip following completion of treatment cycles Baseline, 6 weeks, 6 months, 12 months post-treatment cycle Tegner activity scale (Level 0 to Level 10). Higher is better, lower is worse.
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles Baseline, 6 weeks, 6 months, 12 months post-treatment cycle Hip disability and osteoarthritis Outcome Score (HOS). Score 0 to 100. Higher is better, lower is worse.
Change in subchondral bone morphology Baseline, 6 months, and 12 months post-treatment cycle Subchondral bone morphology (i.e. edema) on MRI
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States