Safety and Feasibility of Autologous Culture Expanded Adipose Derived Mesenchymal Stromal Cells in the Treatment of Painful Knee Osteoarthritis
Overview
- Phase
- Phase 1
- Intervention
- Autologous Adipose-Derived Mesenchymal Stromal Cells
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Jacob L. Sellon, M.D.
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Number of subjects experiencing adverse events.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The study seeks to determine the safety and feasibility of using adipose-derived mesenchymal stromal cells to treat symptoms of mild to severe knee osteoarthritis.
Detailed Description
Interventions to alter the natural course of osteoarthritis (OA) in the knee are elusive and joint replacement remains the definitive management for refractory, end-stage disease. The Mayo Clinic has a large, ongoing experience using autologous adipose derived mesenchymal stromal cells (AMSCs) for the treatment of a variety of other diseases under INDs. Thus far, the treatments have been well tolerated. These data along with the investigators' pre-clinical animal studies and published experiences using related approaches lead the investigators to believe that this approach provides a reasonable safety profile to treat patients with refractory painful knee OA. The purpose of the current study is to investigate the safety and feasibility of single and multiple injections of autologous, culture expanded AMSCs in subjects with painful, refractory knee OA. Subjects with unilaterally symptomatic mild to severe knee OA will be enrolled based on satisfaction of inclusion and exclusion criteria.
Investigators
Jacob L. Sellon, M.D.
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
S50
Subjects in the S50 cohort will receive one injection of 50 million AMSCs.
Intervention: Autologous Adipose-Derived Mesenchymal Stromal Cells
S100
Subjects in the S100 cohort will receive one injection of 100 million AMSCs.
Intervention: Autologous Adipose-Derived Mesenchymal Stromal Cells
M50
Subjects in the M50 cohort will receive three injections of 50 million AMSCs at one-month intervals.
Intervention: Autologous Adipose-Derived Mesenchymal Stromal Cells
M100
Subjects in the M100 cohort will receive three injections of 100 million AMSCs at one-month intervals.
Intervention: Autologous Adipose-Derived Mesenchymal Stromal Cells
Outcomes
Primary Outcomes
Number of subjects experiencing adverse events.
Time Frame: 2 years post final injection
Assess the local and systemic safety of single and multiple injections of human, autologous, culture expanded AMSCs in the treatment of symptomatic knee OA.