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?
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Nature, incidence and severity of adverse events (AEs)
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
Time frame: For a period of 2 years following last injection
Change in Visual Analog Scale (VAS) for pain in the target hip following completion of treatment cycles
100 mm Visual Analog Scale. Range: 0 to 100 mm. Lower is better, higher is worse.
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Tegner activity scale in the target hip following completion of treatment cycles
Tegner activity scale (Level 0 to Level 10). Higher is better, lower is worse.
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in modified Harris Hip Score (mHHS) in the target hip following completion of treatment cycles
modified Harris Hip Score (mHHS). Score 0 to 100. Higher is better, lower is worse.
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in Hip disability and osteoarthritis Outcome Score (HOS) in the target hip following completion of treatment cycles
Hip disability and osteoarthritis Outcome Score (HOS). Score 0 to 100. Higher is better, lower is worse.
Time frame: Baseline, 6 weeks, 6 months, 12 months post-treatment cycle
Change in radiographic joint morphology
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Evaluation of joint morphology on hip X-rays, including standing antero-posterior, lateral, and false profile
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage thickness
Cartilage thickness on MRI
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage volume
Cartilage volume on MRI
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in cartilage morphology
Cartilage morphology on MRI
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in subchondral bone morphology
Subchondral bone morphology (i.e. edema) on MRI
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change periarticular soft-tissues
Evaluate periarticular tissues on MRI (i.e. visible synovitis)
Time frame: Baseline, 6 months, and 12 months post-treatment cycle
Change in synovial fluid biomarkers within the target hip
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.
Time frame: Baseline at the time of AMSC injection, At time of second injection (1 month status post first injection) in 2-injection group