Date: 2015-08-10
Type of information: Clinical trial autorization
phase: 2
Announcement: clinical trial authorization
Company: Hemostemix (Canada - Israel)
Product: ACP-01 (angiogenic cell precursors)
Action
mechanism: cell therapy
Disease: critical limb ischemia
Therapeutic area: Cardiovascular diseases
Country: USA
Trial details:
Latest
news: * On August 10, 2015, Hemostemix, a clinical-stage autologous cell-therapy company, announced that the FDA has cleared the Company\'s Investigational New Drug (IND) application to expand its trial for critical limb ischemia (CLI) to enroll patients at clinical sites across the United States. This is a key milestone in its international phase-2 double-blind, randomized, placebo-controlled clinical trial. The ongoing phase-2 clinical trial investigates the safety and efficacy of the company\'s lead product, ACP-01, which uses angiogenic progenitor cells to combat the life-threatening complications of CLI. These proprietary cells are grown from a patient\'s own blood and, once injected into his or her diseased tissue, are able to support the formation of new blood vessels. The trial has enrolled 20 of its target 100 participants to date.
