BioTime, Inc., a biotechnology company that develops and markets products in the field of regenerative medicine, has submitted a Clinical Investigation Protocol (CIP) to European regulatory authorities for approval to initiate studies for its Renevia stem cell delivery platform. The human clinical studies is expected to start in Q2 of this year upon approval of the CIP.

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 Centre 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.

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. Anchoring the transplanted cells in such a biocompatible matrix generally increases the percentage of viable cell engraftment. HyStem hydrogels are currently being used by researchers at a number of leading medical schools in laboratory studies to investigate a broad array of stem cell therapies, including wound healing, treatment of ischemic stroke, brain cancer, vocal fold scarring, and cardiac infarct.

“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,” stated William P Tew, PhD, chief commercialization officer of BioTime, Inc. “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.”

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. Restoration of the normal skin contour is an important quality-of-life issue, not only in elective cosmetic procedures, but also in reconstructive surgeries needed to repair deformities and traumatic injuries to the face and upper extremities. 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.

Evaluation of Renevia in ISO 10993 biocompatibility studies has been successfully completed as prescribed by the International Organisation for Standardisation for permanent implantable medical devices. This testing is required by the United States Food and Drug Administration and European Union regulatory authorities prior to the initiation of clinical studies in humans. The results of these preclinical studies successfully demonstrated the safety and biocompatibility of Renevia.