Date: 2013-01-10
Type of information:
phase:
Announcement: submission of a clinical investigation protocol
Company: BioTime (USA)
Product: Renevia™stem cell delivery platform
Action mechanism: Renevia® is a matrix technology for regenerative medicine. This proprietary formulation mimics the human extracellular matrix. It 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.
Disease: restoration of subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects
Therapeutic area: Regenerative medicine
Country: Spain
Trial details:
Latest
news: * On January 10, 2013, BioTime, a biotechnology company that develops and markets products in the field of regenerative medicine, has announced that it has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia™stem cell delivery platform. 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. The Stem Center is operated by the GID Group, Inc., of Louisville, Colorado. 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.
In the clinical application described in this CIP, Renevia™ will be used as a delivery matrix for autologous adipose cells in order to restore subcutaneous tissue lost as a result of injury, oncologic resection, or congenital defects. BioTime’s plan is to bring Renevia™ to the medical market first in the European Union, where the regulatory pathway will allow for faster approval. Once the use of Renevia™ is established in Europe, BioTime plans to address an even larger potential market in the United States.
