BioWorld International Correspondent
BORNHEIM, Germany Co.don AG started a Phase III trial to investigate the long-term benefit of its chondrotransplant DISC for the treatment of herniated discs.
Teltow, Germany-based Co.don focuses on tissue engineering.
Chondrotransplant DISC is a chondrocyte graft for transplantation, which is derived from the patient’s own autologuous cells.
Physicians dissect a small piece of the patient’s intervertebral cartilage tissue by microsurgery, then Co.don isolates chondrocytes from the sample and cultivates them. A few weeks later surgeons re-transfer them to the patient. Co.don said it expects the graft to develop into new cartilage tissue, thus curing the herniated discs.
Previous studies have shown that intervertebral cartilage was regenerated three months after transplantation of chondrotransplant DISC, Co.don said.
Phase I and Phase II trials of the products were performed at the Bergmannstrost Hospital in Halle, Germany.
The current Phase III study aims to prove safety and efficacy over five years after transplantation.
Co.don plans to include 100 patients in six hospitals in Germany and France. Fifteen patients have been recruited, Co.don spokesman Laszlo Kiss told BioWorld International.