11 Jan 2013, BioSpectrum Bureau , BioSpectrum
Singapore: US-based BioTime submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia stem cell delivery platform.
Dr Ramon Llull will be the prinicipal investigator of the study and the trials will be conducted at the Stem Center, Palma de Mallorca, Spain. BioTime is currently completing the production of clinical materials according to current good manufacturing practice regulations. The initiation of human clinical studies is expected durig the second quarter of this year upon approval by the CIP.
Renevia, a member of the company's HyStem family of hydrogels, is a proprietary formulation that mimics the human extracellular matrix, a web of molecules surrounding cells that is essential to cellular function.
Reneviais is designed to act as a liquid injectable matrix, capable of safely polymerizing in the body into a three-dimensional tissue-like scaffold in combination with transplanted cells. Anchoring the transplanted cells in such a biocompatible matrix generally increases the percentage of viable cell engraftment.
HyStem hydrogels are currently being used by researchers at a number of leading medical schools in laboratory studies to investigate a broad array of stem cell therapies, including wound healing, treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.