Regenerative medicine biotechnology company BioTime announced it has received approval from The Spanish Agency of Medicines and Medical Devices (AEMPS) to commence human clinical trials of Renevia. Renevia is a unique biomaterial used as a delivery matrix for autologous adipose derived cells to treat the loss of subcutaneous adipose tissue (lipoatrophies) that arises from trauma, surgical resection, and congenital defects and disease. Receipt of AEMPS approval comes on the heels of an earlier 2013 approval from the Balearic Island Ethics Committee Approval for the first phase of a multiphase clinical investigation of Renevia.
Renevia clinical studies will be conducted at The Stem Center in Palma de Mallorca Spain, which is an innovative pain therapy center, laboratory, and professional research facility located within the Clinical USP Palma Planas hospital. The Stem Center is owned and operated by the GID Group, Inc. of Louisville, Colo. Ramon Lull, M.D., Ph.D., medical director of The Stem Center and principal investigator for the Renevia studies, is a leading expert on adipose technology-based advanced regenerative therapies.
BioTime anticipates that the first clinical investigation, which will be a study in 10 volunteers demonstrating the safety of Renevia in humans, will be completed before the end of 2013. Subsequent clinical studies are also being planned that will document the efficacy of Renevia as a delivery matrix for autologous adipose cells to restore normal skin contours in patients who have lost subcutaneous adipose tissue to lipoatrophy.
Manufactured in the United States in compliance with cGMP requirements, Renevia has been tested pursuant to ISO 10993 standards for Class III implantable medical devices. Renevia has been shown to be biocompatible in these studies.
Renevia has been developed to provide plastic and reconstructive surgeons with a safe and effective delivery matrix for tissue engineering and regenerative medicine applications that utilize autologous adipose cells.
For more information, visit www.biotimeinc.com
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