Cook Regentec’s HemaTrate CLI Clinical Trial Enrolls First Patient
September 11, 2019—Cook Regentec announced the enrollment of the first patient in an international clinical trial evaluating the company's HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) caused by peripheral artery disease. To treat CLI, the HemaTrate system produces an autologous, peripheral blood–derived total nucleated cell (TNC) concentrate for intramuscular injection into the ischemic limb.
According to the company, the HemaTrate CLI trial is an international, randomized, controlled, multicenter study that will enroll up to 350 patients. Patients with Rutherford class 4 or 5 CLI will be randomized to undergo a series of three intramuscular injection treatments of TNCs or saline, 6 weeks apart. The primary endpoint is clinical benefit through 12-month follow-up, defined as freedom from reintervention, major amputation, or death. After the 12-month study period, all patients will be offered TNC treatment for both study and nonstudy limbs. Patients will be followed for a total of 24 months.
Professor Bijan Modarai, PhD, FRCS, who is Principal Investigator of the HemaTrate CLI trial, treated the first enrolled patient at Guy’s and St. Thomas’ Hospital, King’s Health Partners in London, United Kingdom. In the company's announcement, Prof. Modarai commented, “Critical limb ischemia is the final stage of peripheral arterial disease and is associated with major morbidity and mortality despite current medical and surgical treatment. Circulating nucleated cells are thought to stimulate vascular repair and regeneration and are of growing interest as a potential therapeutic option for these patients.”
Cook Regentec is based in Indianapolis, Indiana and was founded in 2015 to develop next-generation technologies for the preparation and delivery of biologic and therapeutic agents. Originating from Cook Medical, the company is an incubator/accelerator for innovation and entrepreneurial activity.