SpinalCyte, LLC Receives Institutional Review Board Approval for Phase I Clinical Trial

December 13, 2016

HOUSTON–(BUSINESS WIRE)–SpinalCyte, LLC, a Texas-based tissue engineering technology company focused on regrowth of the spinal disc nucleus using human dermal fibroblasts, announced today it has received Institutional Review Board approval to begin clinical trials with its dermal fibroblast cell product, CybroCell, in the treatment of degenerative disc disease. SpinalCyte is now approved to begin randomized, placebo-controlled, double-blind Phase I clinical trials.

The clinical trials will enroll 18 patients between the ages of 18 and 85 who will either be administered CybroCell alone, in combination with platelet-rich plasma (PRP) or saline only. The primary endpoint of the study will measure outcome at 12 months. Multiple preclinical trials involving rabbits demonstrated the ability of CybroCell to regenerate the nucleus of the spinal disc in an animal model of degenerative disc disease.

“Initiating this clinical trial is an important step toward commercializing our first cell therapy product,” said Pete O’Heeron, CEO of SpinalCyte. “The opportunity to relieve the pain associated with degenerative disc disease presents an enormous benefit to the effected patient population and an equally large business opportunity for SpinalCyte.”

“Lower back pain due to degenerative disc disease can be a chronic and debilitating problem for our patients,” said Carlos Manuel Ruiz Macias, M.D., principle investigator of the SpinalCyte clinical trials. “SpinalCyte’s new cell therapy is a promising option for patients who could benefit from disc regeneration.”