A research group led by Associate Professor Daisuke Sakai (Orthopedic Surgery, Department of Surgery) of Tokai University School of Medicine has developed a new treatment method for repairing and regenerating damaged intervertebral discs with regenerative medicine. From May 2019, we will start the first clinical trial in Japan for patients with low back pain caused by lumbar disc degenerative disc at the hospital attached to the Faculty of Medicine.
Degeneration of the intervertebral disc causes various diseases related to the spine and is a major cause of low back pain.The clinical trial will be started this time by administering the cell therapy product "IDCT-001" made from the intervertebral disc-derived cells of an adult donor to the injured intervertebral disc of the patient to promote repair and regeneration. For "IDCT-001", a joint clinical trial plan was accepted at 6 medical institutions with Associate Professor Sakai as the clinical trial coordinating doctor after being examined for quality and safety by the Pharmaceuticals and Medical Devices Organization.In addition, it was approved by the clinical trial management committee of the hospital attached to the Faculty of Medicine on March 2019, 3, and it was decided to start clinical trials (Phase I, Phase II clinical trials and continuous observation studies) to confirm safety for patients. ..
Associate Professor Sakai said, "For disc disorders, surgery such as discectomy and spinal fusion is currently being performed in addition to symptomatic treatment for pain, but none of these are curative treatments. As a result, cell therapy that biologically repairs and regenerates the intervertebral disc by administration of "IDCT-001" is expected to improve the back pain from the results of histological repair and recovery of the intervertebral disc height. I want to work harder to get rid of the pain and lead a new life. "
A press briefing will be held on April 2019, 4.Mr. Flag Flanagan, CEO of American Discgenics Co., Ltd., who is the developer (trial client) of cell therapy products used in clinical trials, including Associate Professor Sakai, and ID Pharma Co., Ltd., Senior Managing Executive Officer, who is the domestic administrator of clinical trials. Mr. Ryutaro Shimazaki and others took the stage and explained the outline of the clinical trial.
