Arteriocyte Begins Trial for Compartment Syndrome Treatment Technology
Arteriocyte, a medical device company with offices in Cleveland, Ohio, and Hopkinton, Mass., has received approval from the U.S. Food and Drug Administration (FDA) to begin a Phase I clinical trial for its product Magellan MAR01 technology for the treatment of compartment syndrome. The technology has already received FDA 510 (k) clearance.
Compartment syndrome is the compression of nerves, blood vessels and muscle inside an enclosed muscle compartment in the body. This can lead to tissue death and amputation if the pressure is not released because the compression prevents blood from flowing through the affected area. The syndrome can occur after severe physical trauma or inflammation. Ateriocyte’s Magellan technology has been developed in partnership with the United States Army Institute of Surgical Research (ISR) and San Antonio Military Medical Center at Fort Sam, Houston, Texas, and Ohio State University as part of Arteriocyte's Cellular Therapies for Battlefield Wounds Program.
The Magellan system produces autologous platelet rich plasma from a patient’s blood and bone marrow that can be applied to a surgical site as surgeons deem necessary. Arteriocyte has partnered with the U.S. military to develop the system for clinical use across three trauma platforms: extremity trauma, burn wounds and infection prevention. The company already actively is enrolling patients in a separate clinical trial for MAR01 treatment in critical limb ischemia (CLI) under an FDA approved Investigational Device Exemption. CLI is a severe blockage of blood with the patient experiencing extreme pain as well as possible ulcers or sores.
The U.S. military has a vested interest in he Magellan clinical trial.
"Compartment syndrome and the associated complications are a major challenge in combat casualty care, resulting in elevated rates of amputations,” said retired Army Col. John Kragh, M.D., orthopedic surgeon and researcher at ISR, and Arteriocyte's program officer. “This treatment represents an important potential tool to improve success of limb salvage for these patients."
Enrollment in the compartment syndrome clinical trial is expected to begin immediately following final approval by the Army's Human Research Protections Office. The study will be performed at the Ohio State University Wexner Medical Center, led by Jason Calhoun, M.D., chair, Department of Orthopedics, and Frank J. Kloenne, chair of Orthopedic Surgery.
Arteriocyte produces stem cell related medical devices. The Magellan technology was built upon the foundation laid by Medtronic Inc.’s blood component therapies, according to company website.