BioTime Files Protocol To Start Human Clinical Trials Of Renevia In Europe

Posted: Published on January 12th, 2013

This post was added by Dr. Richardson

By RTT News, January 10, 2013, 09:17:00 AM EDT

(RTTNews.com) - BioTime Inc. ( BTX ) announced it has submitted a Clinical Investigation Protocol to European regulatory authorities for approval to initiate studies for Renevia stem cell delivery platform.

BioTime is currently completing the production of clinical materials according to current Good Manufacturing Practice regulations. The initiation of human clinical studies is expected in the second quarter of current year upon approval of the Clinical Investigation Protocol.

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. Renevia is designed to be a liquid injectable matrix capable of safely polymerizing in the body into a three-dimensional tissue-like scaffold in combination with transplanted cells.

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BioTime Files Protocol To Start Human Clinical Trials Of Renevia In Europe

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