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In the trial, Renevia is being tested as a delivery matrix for the patient’s own fat-derived cells and injected into portions of the patient’s face where there is facial lipoatrophy in order to promote facial tissue reconstruction. The first treatment marks the beginning of enrollment for this pivotal trial and follows the previous successful safety trial of Renevia, the completion of which was announced in 2014. The procedure was performed at The Stem Center in
“The current options for patients with facial lipoatrophy do not provide a natural long lasting result, so I am excited to be leading this important clinical trial to bring Renevia to this community,” said
“The first subject treated in our Renevia pivotal trial is a significant clinical milestone for an important
About Facial Lipoatrophy and HIV-related Facial Lipoatrophy
Facial lipoatrophy is the loss of facial fat tissue, which is a key component for an overall youthful facial appearance. Facial lipoatrophy is an unfortunate, but inevitable, condition that typically develops as we age but is dramatically accelerated in those HIV-infected individuals being treated with antiretroviral therapy (ART). Indeed the loss of facial fat can be nearly complete in these individuals on ART.
In HIV-infected patients on antiretroviral therapy (ART) facial lipoatrophy is common and particularly devastating. The resulting facial wasting ages the individual’s appearance prematurely and, along with a thinning of the skin, allows musculature and vasculature to be easily seen, resulting in what is commonly known as “the face of AIDS.” Treatment of the condition has been determined to be medically advisable to improve the individual’s self-esteem and quality of life.
Because ART has greatly increased long term survival in HIV-positive patients the incidence of associated lipoatrophy has risen dramatically. According to statistics published by AVERT (www.avert.org), worldwide there were 34 million people living with HIV/AIDS in 2011. According to the
HyStem® Technology and Renevia™
BioTime’s HyStem® hydrogels, including Renevia, are a family of unique and proprietary biomaterials that are designed to function as adhesion matrices for the stable attachment and survival of cells. The failure rate in many applications of cell grafts without such a matrix is high because of difficulties in achieving cell attachment and survival. The achievement of high success rates for cell grafts would create opportunities to develop cell therapies for many high unmet medical needs. A unique feature of the proprietary technology is that it allows the mixture of cells with the matrix in a liquid form such that the cells and matrix can be injected easily and safely through a small gauge syringe, and then the matrix can polymerize around the cells to create a three-dimensional tissue within the body. The matrix is then resorbed by the body over a few months. HyStem hydrogels are currently sold worldwide by
Asterias Biotherapeutics, Inc. is developing pluripotent stem-cell based therapies in neurology and oncology, including AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based cancer vaccine. Asterias Series A common stock is traded on the NYSEMKT under the symbol AST. BioTime Asia, Ltd., a Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division.
- Cell Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders. OpRegen® is currently in a Phase I/IIa clinical trial for the treatment of the dry-form of age-related macular degeneration. ESI BIOis the research and product marketing division of BioTime, providing stem cell researchers with products and technologies to enable them to translate their work into the clinic, including PureStem® progenitors and HyStem® hydrogels.
- LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery® database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database.
- LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on developing mobile health (mHealth) products.
- OncoCyte Corporation is developing products and technologies to diagnose and treat cancer, including PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing therapies to treat orthopedic disorders, diseases and injuries.
- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of cardiovascular and related ischemic disorders, as well as products for research using cell reprogramming technology.
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for
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Judith Segall, 510-521-3390 ext. 301
EVC Group, Inc.
Gregory Gin, 862-236-0673
Jim Dawson, 646-445-4800
Doug Sherk, 415-652-9100