Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD).

Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular injection into the ischemic limb.

“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,” said principal investigator Bijan Modarai, who treated the first enrolled patient at Guy’s and St. Thomas’ Hospital, King’s Health Partners, in London, U.K. “Circulating nucleated cells are thought to stimulate vascular repair and regeneration and are of growing interest as a potential therapeutic option for these patients.”

The international, randomized, controlled, multicenter study will enroll up to 350 patients. Subjects with Rutherford class 4 or 5 CLI will be randomized to receive a series of three intramuscular injection treatments of TNCs or saline, six weeks apart. The primary endpoint is clinical benefit through 12-month follow-up, defined as freedom from reintervention, major amputation or death. Following the 12-month study period, all patients will be offered TNC treatment for both study and non-study limbs. Patients will be followed for a total of 24 months.

“Patients with PAD-associated CLI who are poor candidates for surgical or endovascular procedures require alternative treatment options that deliver improved long-term outcomes,” said Brad Shirley, business leader at Cook Regentec, in a news release. “We are excited that patients enrolled in our global CLI trial will begin to receive HemaTrate as treatment for this often-devastating condition.”