18.3.6 - One-Stage Cartilage Recycling Facilitated by Adipose MSCs Safe and Clinically Effective (RECLAIM)
- D. Saris (Rochester, US)
- D. Saris (Rochester, US)
- A. Dietz (Rochester, US)
- M. Hevesi (Rochester, US)
- K. González-Carta (Rochester, US)
- A. Krych (Rochester, US)
Abstract
Purpose
Working towards safe and reliable one stage cell-based cartilage repair requires FDA monitored IND validation of MSC facilitated cartilage repair. This study evaluates the reproducibility and novel allogeneic cell source and allows comparison to a European cohort.The purpose of this study was to assess the safety and initial clinical outcomes following REcycled CartiLage Auto/Allo IMplantation for the Treatment of Focal Knee Cartilage Defects (RECLAIM).
Methods and Materials
This was a single-arm interventional FDA IND study conducted on 25 patients with age ranging between 21 and 40 years old. Following the RECLAIM procedure, patients were queried for adverse events, clinical outcomes were evaluated using patient reported outcomes that included the KOOS (Knee injury and Osteoarthritis Outcome Score), visual analog scale for pain. Repeated measure analysis ANOVA was used to test statistical significance p<.5. Results for all treated patients with a minimum of 12 months follow up or earlier safety issue are reported.
Results
Among 13 participants who completed the 12-month follow-up there were no treatment related adverse event. Complications and adverse events were as predicted from previous studies. Participants experienced clinically relevant and statistically significant improvements in mean VAS pain and all KOOS subscales scores at 3, 6 and 12 months. (Figure1).
Conclusion
RECLAIM is a feasible one-stage cartilage regeneration option, demonstrating good safety profile and encouraging clinical outcomes in this phase 1 trial. Also, improvements in pain, function, and quality of life were achieved in this small cohort of patients with symptomatic cartilage defects of the knee. Overall, these results provide external validation and confirm comparability, safety and initial effectiveness of IMPACT and RECLAIM procedure.