The San Diego-based company said the current healthcare system is ill-prepared to care for large numbers of patients that require simultaneous treatment and that patients with severe burns commonly suffer with prolonged pain and aggressive scarring. The company touts its autologous cell therapies as a cost-effective way to improve the quality and rate of wound healing, while reducing scarring.
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.
The study, published in the International Journal of Radiation Biology, evaluated local and intravenous administration of the cell therapy to burns that were compromised by exposure to marrow-damaging total body irradiation. Two weeks after treatment, the treated wounds had 3.5 times greater re-epitheliazation and a 67% increase in blood vessel density on average. The treated wounds also saw a 30% increase in collagen deposition. The therapy was well tolerated and no serious side effects were observed over the course of the study.
“These preclinical data support the clinical rationale for the investigational use of topical or intravenous administration of Cytori cell therapy in burn patients,” Dr. John Fraser, Cytori’s chief scientist, said in prepared remarks. “We are leveraging this data in a forthcoming U.S. FDA investigational device exemption (IDE) application for the RELIEF Phase I clinical trial to assess the safety and feasibility of the intravenously administered Cytori Cell Therapy as a novel thermal burn countermeasure.”