The INSTRUCT Clinical Trial was a prospective, multi-center, open-label, single-arm pilot study in 40 patients with knee cartilage defects. This trial evaluated the safety and efficacy of the cell mix (now CartiONE) combined with INSTRUCT, a co-polymer scaffold developed by CellCoTec, in treating patients with full-thickness cartilage lesions over 2 years. The patient-reported scores, including those on pain and quality of life, improved statistically significant over time. Also, MRI results demonstrated a good fill of the lesion, and stable integration of the repair tissue with the surrounding original tissue.
Key outcome conclusions:
Sections contain predominantly hyaline cartilaginous tissue as indicated by the presence of abundant cartilage-specific proteins (collagen type II and proteoglycans) and only a slight amount of residual scaffold material.
MRI images of a patient that illustrate continuous defect filling, gradual implant resorption, and cartilage regeneration.