BioTime seeks EU support for stem cell delivery gel
BioTime is looking to have its drug delivery system Renevia approved in Europe before it tackles FDA regulation in the U.S. The company expects to begin human trials by the end of March if the recently submitted Clinical Investigation Protocol (CIP) is successful.
Renevia is a type of hydrogel that resembles the network of molecules outside the human cell membrane, known as the extracellular matrix, according to the company. Injected as a liquid and combined with the stem cells, the hydrogel forms a tissuelike scaffold that anchors the new cells onto existing ones, allowing for more effective tissue regeneration.
In the CIP submitted to European regulatory authorities, Renevia's stated purpose is to restore subcutaneous tissue. BioTime expects the treatment to be used for injuries, cancer surgery and congenital defects, as well as restoration after plastic surgery. Hydrogels like Renevia are already used for academic research in regenerative medicine areas such as wounds, ischemic stroke, brain cancer, vocal fold scarring and heart attacks.