>Here’s evidence of private funds backing adult stem cell therapy.
Dr. James Willerson will lead a team investigating a special technique to isolate a special population of bone marrow stem cells. The stem cells will be used to attempt to increase the circulation in the legs of patients with “Critical Limb Ischemia,” or very low blood flow to the legs.
DURHAM, N.C., Dec. 15 /PRNewswire/ — Aldagen, Inc. today announced that the Texas Heart Institute at St. Luke’s Episcopal Hospital in Houston, Texas will be the first site for its clinical trial using Aldagen’s ALDESORT(R) product to isolate a unique stem cell population as therapy for critical limb ischemia (CLI) patients. The co-lead investigators at Texas Heart Institute on the study will be Dr. Emerson Perin and Dr. James Willerson.
“We are very excited to begin this study as it represents the first clinical study in the United States to use purified stem cells for the treatment of critical limb ischemia. We believe that these cells have the potential to offer CLI patients a new therapeutic option,” said Drs. Willerson and Perin. Dr. James Willerson is president-elect and medical director of the Texas Heart Institute at St. Luke’s and President of The University of Texas Health Sciences Center at Houston. Dr. Perin is director of New Cardiovascular Interventional Technology and director of the Stem Cell Center at the Texas Heart Institute at St. Luke’s.
About the Study
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 Aldagen’s ALDESORT product. 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 skin surface oxygen pressure and improve ulcer healing.
ALDESORT isolates a highly potent population of stem cells taken from the patient’s own bone marrow. These stem cells have the potential to build new blood vessels (angiogenesis) in ischemic legs which could ultimately lead to improved functionality for CLI patients.
About Critical Limb Ischemia
Critical limb ischemia is a severe form of peripheral vascular disease (PVD). It is estimated that between eight to 12 million Americans suffer from PVD, which is a disease of the blood vessels characterized by narrowing and hardening of the arteries that supply the legs and feet. This causes a decrease in blood flow that can injure nerves and other tissues. CLI can lead to gangrene or tissue death, often necessitating amputation of the affected limb. Currently, there are no suitable alternatives to either percutaneous or surgical revascularization in patients with CLI. Despite some success of limb salvage with leg bypass, the condition remains associated with a substantial rate of morbidity and mortality and the need for subsequent surgery and hospitalization for wound complications is as high as 50%. There is a pressing need for the development of techniques to improve the vascular supply to ischemic leg by less invasive means.