Advanced BioHealing Initiates Celaderm(TM) Clinical Trial
"We are delighted to begin working with some of the world's leading investigators on the clinical development of this exciting new product," said David Eisenbud, MD, Executive Vice President and Chief Medical Officer of Advanced BioHealing. "We believe that our proprietary cryopreservation technology will enable the proven keratinocyte-based wound healing approach to become a therapeutic reality for thousands of patients."
The novel preservation technology was developed by Walid Kuri-Harcuch, PhD and colleagues at El Centro de Investigacion y de Estudios Avanzados del Instituto Politecnico Nacional (Cinvestav) in Mexico City, Mexico. It features a preservative that is non-toxic to wound beds and also allows for higher temperature storage than previous products. Initial clinical development of Celaderm in the U.S. was begun by Marcia Simon, PhD at the State University of New York at Stony Brook. Dr. Simon now consults to ABH on the development of this innovative treatment approach.
Kevin Rakin, CEO of Advanced BioHealing said, "There are at least seven well executed studies by Dr. Kuri-Harcuch and his clinical collaborators involving hundreds of patients that support the healing properties of early versions of Celaderm. These studies supplement more than 30 years' world experience using keratinocytes for healing indications. We are optimistic that this technology could result in a product that can be conveniently stored at the point of care and will be simpler and more practical than earlier bioengineered skin products."
Success in this pilot study would allow Celaderm, which is regulated as a medical device, to move directly to a pivotal trial of clinical efficacy and subsequent PMA submission. If approved for sale, Celaderm will complement ABH's current portfolio of marketed products: Dermagraft(R) (http://www.Dermagraft.com) which is approved for diabetic foot ulcers and TransCyte(R) for the treatment of burns.
About Advanced BioHealing, Inc.
Advanced BioHealing is an industry leader in the science of regenerative medicine. The Company is focused on the commercialization of cell-based and tissue-engineered products including two that have FDA approval for marketing: Dermagraft, for diabetic foot wounds and TransCyte, to treat burns. ABH is a privately held company with research & development offices in New York, NY and manufacturing operations in La Jolla, CA.
Advanced BioHealing, Inc.
http://www.AdvancedBioHealing.com
Advanced BioHealing iniþiazã Celaderm (TM) de studiu clinic - Advanced BioHealing Initiates Celaderm(TM) Clinical Trial - articole medicale engleza - startsanatate