Cook Regentec announces enrollment of first critical limb ischemia patient in international clinical trial to evaluate the HemaTrate Blood Filtration System.
Global Banking News-September 11, 2019-Cook Regentec announces enrollment of first critical limb ischemia patient in international clinical trial to evaluate the HemaTrate Blood Filtration System
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Indianapolis-based biotechnology company Cook Regentec disclosed on Wednesday that it has enrolled the first patient in an international clinical trial to evaluate the HemaTrate Blood Filtration System for the treatment of critical limb ischemia (CLI) due to peripheral arterial disease (PAD).
The first enrolled patient was treated at Guy's and St Thomas' Hospital, King's Health Partners, in London, UK, by Professor Bijan Modarai, the principal investigator of the study and a paid consultant of Cook Regentec.
Professor Modarai said: "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 said its HemaTrate system produces an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular injection into the ischemic limb.
The company added that the HemaTrate CLI (HT-CLI) trial is an international, randomised, controlled, multicentre study that will enroll up to 350 patients. Patients with Rutherford class 4 or 5 CLI will be randomised 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. After 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.
((Distributed via M2 Communications - http://www.m2.com))
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|Publication:||Global Banking News (GBN)|
|Date:||Sep 11, 2019|
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