CartiONE Clinical Trial Results

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.

INSTRUCT Clinical Trial

Key outcome conclusions:

  • Clinically and statistically improvement over time of all patient-reported outcome scores
  • Evidence of hyaline cartilage formation in most patients
  • Continuous lesion filling with good integration
  • Quick rehabilitation overall
  • Good safety profile with similar or lower failure rate compared to other cartilage treatments
Instruct study/ CartiONE Cell mix. Histology Results at 12 Months

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.

Clinical Scores at baseline 3, 6, 12, 18 and 24 months
MRI Results at Post-op, 12 and 24 Months

MRI images of a patient that illustrate continuous defect filling, gradual implant resorption, and cartilage regeneration.