ICL 107 State of the Art Approach to Chondral Injury-Gomoll Handout

Gomoll Handout

Pdf Summary

This presentation by Dr. Andreas H. Gomoll at the Cartilage Repair Center of Brigham and Women's Hospital discusses the current state and future directions of cartilage repair technologies, highlighting regulatory challenges and clinical realities.<br /><br />Historically, many cartilage repair studies in the US have stalled or been cancelled due to difficulties with FDA approval processes and patient recruitment. Devices like DeNovo ET and CAIS had trials canceled in Phase 3, while companies like Tigenix withdrew from US studies after FDA feedback.<br /><br />Currently, limited cartilage repair products are available on the US market, including Carticel (autologous chondrocyte implant), osteochondral allografts, and products like Biocartilage and DeNovo NT. Ongoing clinical trials include Novocart 3D, Neocart, and Cartistem, utilizing various techniques such as stem cells and hydrogel scaffolds. New studies are anticipated soon for products like DeNovo ET and Agili-C.<br /><br />A central problem is regulatory requirements that mandate highly selective patient populations—single defects, normal alignment, minimal co-morbidities—yet most real-world patients have multiple lesions, alignment issues, and meniscal or ligamentous injuries, excluding the majority from trials. For example, data show only 5-12% of cartilage repair patients meet strict trial criteria, limiting enrollment. In contrast, Europe has progressed with randomized controlled trials (RCTs) such as the ACI SUMMIT trial due to differences in insurance coverage and trial access.<br /><br />The presentation argues for adapting trial designs, including non-inferiority trials, loosening inclusion criteria to reflect typical patient populations, and using alternative data strategies like propensity matching or single-arm studies with historical controls. This would improve feasibility while maintaining safety and efficacy evaluation.<br /><br />In conclusion, the US market is constrained to decades-old technology due to regulatory hurdles, delaying access to promising new treatments. Regulatory flexibility, balanced with patient safety, is needed to advance cartilage repair and better serve patients with cartilage injuries.

Keywords

Cartilage repair

FDA approval

Clinical trials

Regulatory challenges

Autologous chondrocyte implant

Stem cell therapy

Hydrogel scaffolds

Patient selection criteria

Randomized controlled trials

Non-inferiority trials