Mayo Clinic
Aaron Krych
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?
Osteoarthritis, Hip
Autologous Adipose Derived Mesenchymal Stromal Cells
PHASE1
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 |
Estimated Enrollment : | 24 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | ASCLEPIOS Autologous Stem CelL Expansion and Prospective Injection for Osteoarthritic Hip Symptoms |
Actual Study Start Date : | 2018-11-05 |
Estimated Primary Completion Date : | 2024-11 |
Estimated Study Completion Date : | 2024-12 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years to 65 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905