SpinalCyte enrols first patient in human dermal fibroblasts phase I human clinical trial


SpinalCyte, an engineering technology company focused on the regrowth of the spinal disc nucleus using human dermal fibroblasts, has announced the enrolment of its first patient in a study for the development of CybroCell, the first dermal fibroblast cell product for treatment of degenerative disc disease.

“This…marks the first time a human patient will receive dermal fibroblasts for treatment of degenerative disc disease,” says SpinalCyte chief executive officer Pete O’Heeron. “Our preclinical trials resulted in significant regrowth of the spinal disc nucleus, increases in disc height, and gene expression such as proteoglycan. This could be the beginning of a new wave of cell-based treatments for degenerative disc disease, in lieu of surgery.”

The clinical trial will enrol 18 patients between the ages of 18 and 85. Each patient will be administered CybroCell alone, in combination with platelet-rich plasma, or saline only. The measurable outcomes of the study will take 12 months. SpinalCyte aims to show that using its allogenic “pre-packaged” cell therapy product will lead to a reduction in pain, improved function, and regeneration of damaged discs.

“We are excited about the potential of this new technology to treat degenerative disc disease,” says Carlos Manuel Ruiz Macias, principal investigator of the SpinalCyte clinical trials. “We believe that regenerative cell therapy is the future of medicine, and the life-changing opportunities that lie ahead could have enormous impact on the millions around the world who deal with back pain and problems due to injury, age, or other factors.”