Signature Biologics received FDA approval of an Investigational New Drug Application (IND) to proceed with the study of Signature Cord Prime™ in patients with symptomatic knee osteoarthritis (OA).
Signature Cord Prime cryopreserved, human umbilical cord tissue allograft comprises micronized umbilical cord tissue. The product contains naturally occurring cellular growth factor, pro angiogenesis, anti-inflammatory cytokines and extracellular components.
FDA granted IND approval based on multicenter, retrospective clinical evidence from 135 knees treated with Signature Cord™ that demonstrated both safety and statistically significant reduction in pain and improvement in function.
"This represents a push for regenerative medicine as the first hUC [human umbilical cord] product of its kind to receive approval to be studied in osteoarthritis of the knee," said Dr. Neil Riordan Ph.D., CEO of Signature Biologics. "We are pleased that FDA has enabled us to proceed and we are grateful for the partnership."