RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Knee Cartilage Defects
Overview
- Phase
- Phase 1
- Intervention
- REcycled CartiLage Auto/Allo IMplantation
- Conditions
- Cartilage Defect
- Sponsor
- Mayo Clinic
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Nature, incidence and severity of adverse events (AEs)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is an FDA phase I study to evaluate the safety of allogeneic culture-expanded adipose-derived mesenchymal stem cells (AMSCs) combined with autologous cartilage cells to treat focal knee cartilage defects in one stage surgery.
Detailed Description
This phase I study will enroll 25 subjects with unilateral, symptomatic ICRS Grade III or IV cartilage lesions of the knee will be candidates for this study. Baseline data will include physical examination of the knee, clinical assessment of knee pain and function using validated patient reported outcome measures (PROMs), radiographs, and MRI. Tissue from qualified donors will be used to establish allogeneic MSC banks (using current Good Manufacturing Practices (cGMPs) based on standard operating procedures), which will be tested and released for clinical use. Patients will undergo surgical debridement of their cartilage defect with harvest of the articular cartilage surrounding the defect rim. Following rapid digestion into chondrocytes and their pericellular matrix, autologous chondrons will be mixed in a 1:4 ratio with allogeneic AMSCs obtained from AMSC banks and suspended in fibrin glue for application to the debrided osteochondral defect. All patients will be clinically evaluated at 1-2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 18 moths, and 24 months post-RECLAIM for adverse events (AEs). Following completion of their respective RECLAIM treatment, each subject will be followed-up for study endpoints using a predetermined protocol, including clinical evaluation, radiography, and MRI.
Investigators
Aaron Krych
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
RECLAIM
Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).
Intervention: REcycled CartiLage Auto/Allo IMplantation
Outcomes
Primary Outcomes
Nature, incidence and severity of adverse events (AEs)
Time Frame: 2 years
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.