Aldagen has reported that the FDA has cleared an investigational new drug (IND) application to conduct a clinical trial using Aldagen's Aldesort product to isolate a unique stem cell population for therapy for critical limb ischemia patients. It will be the first clinical trial involving this unique cell population for therapy for critical limb ischemia patients in the U.S.
Aldagen's clinical trial will involve 20 patients, all of which will have bone marrow extracted. Ten patients will receive multiple injections of the bone marrow directly into muscle in the ischemic leg and ten patients will receive multiple injections of stem cells isolated from the bone marrow using Aldesort. The patients will be monitored for up to six months with a primary endpoint at three months. Endpoints will include safety and the ability of therapy to reduce rest pain, increase exercise capacity, increase skin surface oxygen pressure and improve ulcer healing. The company is finalizing the clinical trial sites for the study.