BioTime recently announced that the company has submitted Clinical Investigation Protocol (CIP) to European authorities in order to begin studies for its Renevia stem cell delivery platform.
Based in Alameda, CA, BioTime is focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime also develops and markets products for the stem cell and regenerative medicine industries, including its PureStem cell lines, HyStem hydrogels, culture media, and differentiation kits.
The Principal Investigator for the studies will be Ramon Llull, MD, and the planned 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 in Q2 of this year upon approval of the CIP.
William P. Tew, PhD, Chief Commercialization Officer of BioTime, said, “This is an important step forward in our commercialization efforts and brings us closer to delivering this much-needed matrix technology for the emerging field of regenerative medicine. The technology forms a foundation for the delivery of cell-based therapeutic products in both the adult and embryonic stem cell marketplace. Current preclinical studies at leading medical institutions have shown that HyStem hydrogels are compatible with a wide variety of tissue types including brain, bone, skin, nerve, cartilage, and heart.”
For more information, visit www.biotimeinc.com
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