SpinalCyte’s IRB Approval for Phase I Clinical Trial

By Julie A. Vetalice

SpinalCyte received Institutional Review Board approval to commence randomized, placebo-controlled, double-blind Phase I clinical trials with CybroCell dermal fibroblast cell product in the treatment of degenerative disc disease.

Trials will enroll 18 patients receiving CybroCell alone, in combination with platelet-rich plasma or saline only. The primary endpoint will measure outcomes at 12 months.

Multiple preclinical trials have demonstrated CybroCell's ability to regenerate the disc nucleus in an animal model of degenerative disc disease.

Sources: SpinalCyte, LLC; ORTHOWORLD Inc.

Product Labels: Knee Replacement

Tags: Trial/Study