is a cell therapy-based product proposed for use in patients with PAD secondary to blocked arteries in the legs. MultiGeneAngio is composed of a cell suspension of endothelial and smooth muscle cells. The cells are isolated from a short vein segment stripped from the patient's arm under local anesthesia. After isolation, endothelial and smooth muscle cells are expanded, characterized, and finally gene modified by the transfer of angiogenic genes into these cells.
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage using a standard diagnostic catheter, in order to expand and create new collateral arteries, thereby improving blood flow to the ischemic limb.
Two phase I/II clinical trials with MultiGeneAngio had been completed between February 2007 and August 2011. Twelve patients with intermittent claudication were initially treated in two leading medical centers in the USA. In a second trial, 23 patients with critical limb ischemia, a severe stage of PAD in which rest pain and non-healing wounds appear and the patient is at risk of limb amputation were treated in seven leading medical centers in Israel. Results demonstrated product safety and promising clinical efficacy.
For further details please see www.clinicaltrials.gov
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