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- Enrollment completed in first safety study of Renevia™ for dermatological applications -
- Two weeks following administration, Renevia™ appears safe and well tolerated with no serious unexpected adverse events observed to date -
The ten healthy volunteers each received one subcutaneous injection of Renevia™ without cells. The primary objective of the trial is to determine the safety, tolerability, and acceptance of Renevia™ without cells as determined by monitoring subjects for any post-treatment reactions. Examinations of the subjects after they received Renevia™ injections have shown that Renevia™ was well-tolerated by all subjects with no serious adverse events or subject withdrawals. A final check of the enrolled subjects for adverse events will be made four weeks after the injection.
The Renevia™ safety study was initiated on
Subsequent clinical studies are planned to document the efficacy of Renevia™ as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to lipoatrophy, beginning with HIV related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin. Lipoatrophy is often a consequence of the normal aging process where the loss of fat in the cheeks or the back of the hands contributes to an aged appearance, but lipoatrophy can also be associated with trauma, surgery, and diseases, and is frequently suffered by HIV patients being treated with anti-viral drugs. According to published estimates, at least several hundred thousand patients in
Renevia™ is manufactured in the US in compliance with cGMP requirements and has been tested pursuant to ISO 10993 standards for implantable medical devices and shown to be biocompatible without adverse effects in animal studies.
Renevia™ is a member of BioTime’s HyStem® family of hydrogels. These unique biomaterials are designed as matrices and scaffolds for tissue engineering and regenerative medicine applications. HyStem® hydrogels are distributed and sold worldwide by
OncoCyte Corporationis developing products and technologies to diagnose and treat cancer. ES Cell International Pte Ltd., a Singaporeprivate limited company, develops hES products for research use. BioTime Asia, Limited, a Hong Kongcompany, may offer and sell products for research use for BioTime’s ESI BIO Division. OrthoCyte Corporationis developing therapies to treat orthopedic disorders, diseases and injuries. ReCyte Therapeutics, Inc.is developing therapies to treat a variety of blood and lymphatic vascular disorders, as well as products for research using iPS and other cell reprogramming technology. Cell Cure Neurosciences Ltd.is an Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological degenerative diseases. Its lead product is OpRegen® for the treatment of macular degeneration. 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.. Asterias Biotherapeutics, Inc.is a new subsidiary that recently acquired the stem cell assets of Geron Corporation, including patents and other intellectual property, biological materials, reagents and equipment for the development of new therapeutic products for regenerative medicine.
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