BioLife Solutions’ HypoThermosol, a pre-formulated, cGMP, serum-free, protein-free cell and tissue storage/shipping medium, is currently incorporated into on-going US and European clinical trials of ICX-RHY-013, a proprietary cell-based therapy developed by Intercytex Ltd. In both clinical trials, HypoThermosol is the vehicle solution containing the therapeutic cells administered to the patients, and is also the placebo solution in a control arm of the studies.
Mike Rice, BioLife Solutions President and CEO, commented on the use of HypoThermosol in these clinical trials by stating, “We are quite pleased to support Intercytex in their very important work to develop improved treatments for burn injuries and recessive dystrophic epidermolysis bullosa (RDEB), an extremely debilitating skin and internal tissue disorder affecting children and adults.
The US phase 1/2 clinical trial (NCT01564407), titled A Clinical Study of Allogeneic Human Dermal Fibroblasts for Remodeling Scar Contractures, is being conducted at the University of Pittsburgh Medical Center and is funded by the United States Department of Defense. The primary objective of this study is to evaluate the safety of ICX-RHY-013 in the treatment of stable, restrictive scars in subjects who have suffered a burn injury.
Also, data from a phase 2, double-blind, randomized, vehicle-controlled European clinical trial (EudraCT Number: 2010-023121-38), titled A prospective placebo controlled phase II study to evaluate the use of allogeneic fibroblasts for the treatment of skin erosions in recessive dystrophic epidermolysis bulllosa, appears on page 28 in the online directory of abstracts presented at the 2013 International Investigative Dermatology meeting, held in Edinburgh, Scotland in May of this year.
Source: BioLife Solutions, Inc.