NCT03672825

REcycled CartiLage Auto/Allo IMplantation

RECLAIM: A Phase I Safety and Feasibility Trial of REcycled CartiLage Auto/Allo IMplantation for the Treatment and Repair of Focal Knee Cartilage Defects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cartilage Defect

Interventions

Type	Name	Description
DRUG	REcycled CartiLage Auto/Allo IMplantation	Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).

Timeline

• Start date: 2018-09-13
• Primary completion: 2024-05-09
• Completion: 2024-06-21
• First posted: 2018-09-17
• Last updated: 2024-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study