Clinical Trial: Autologous Culture Expanded Adipose Derived MSCs for Treatment of Painful Hip OA
Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms
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 Summary: 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.
Sponsor: Mayo Clinic
Current Primary Outcome:
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
Original Primary Outcome:
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
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Mayo Clinic
Dates:
Date Received: July 10, 2018
Date Started: November 05, 2018
Date Completion: February 01, 2024
Last Updated: December 07, 2023
Last Verified: December 01, 2023
