Cytori Therapeutics (NSDQ:CYTX) said today that the FDA approved an Investigational Device Exemption for a pilot trial of the company’s cell therapy in patients with thermal burn injury. The Relief trial is a part of Cytori’s ongoing R&D efforts under its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority.
The San Diego-based company plans to assess the safety and feasibility of intravenous delivery of its cell therapy as an adjunct to standard care in patients with thermal burn injuries covering between 20% and 50% of their body surface area. The Relief trial is slated to enroll up to 30 patients and will start when BARDA exercises a contract option to provide the necessary funds, according to Cytori.
“This announcement is yet another milestone achieved as BARDA and Cytori continue to move this technology forward through the development process, from preclinical to clinical implementation,” president & CEO Dr. Marc Hedrick said in prepared remarks. “Approval of Relief is a major step towards the ultimate goal of making this technology available to our citizens as a national countermeasure against burn injuries potentially including those complicated by radiation exposure.”
Participants in the Relief trial will have their burn wounds autografted with a meshed split thickness skin graft, Cytori said. Patients randomized to receive the company’s cell therapy will undergo a small volume fat harvest during their burn surgery, followed by intravenous delivery of Cytori’s cell therapy.
Cytori’s cell therapy is derived from human adipose tissue, or fat, and is also known as adipose-derived regenerative cells. Because the regenerative cells come from the patient’s body, treatment with these cells avoid cell rejection and do not require immunosuppressive drugs. Previous studies have shown that the cells can promote angiogenesis – the creation of new blood vessels from pre-existing vessels. Preclinical studies also demonstrated that the regenerative cells are associated with wound healing, promoting the expression of extracellular matrix components and remodeling enzymes.
CYTX shares soared more than 40% today, trading at $1.94 apiece in mid-afternoon activity.