Aldagen Adds Three Clinical Sites to its Critical Limb Ischemia Study

clinical-stage regenerative therapies, today announced the addition of three new sites for its

clinical trial of ALD-301 for the treatment of critical limb ischemia. The three additional sites are

Duke University Medical Center (Durham, NC), Indiana University (Indianapolis, IN) and Saint

Joseph’s Research Institute (Atlanta, GA). These sites join Texas Heart Institute at St. Luke’s

Episcopal Hospital in Houston, Texas, which was the original site on the study.

Dr. Rob Mitchell will be the principal investigator at Duke University Medical Center. Dr. Michael

Murphy and Dr. Keith March are the co-lead investigators at Indiana University. Dr. Nicolas

Chronos is the principal investigator at Saint Joseph’s Research Institute. The co-lead

investigators at Texas Heart Institute on the study are Dr. Emerson Perin and Dr. James

Willerson.

Aldagen’s clinical trial will involve 20 patients, all of which will have their own 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 ALD-301. 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.

“We are very excited to have such prestigious institutions join this study, which is the first clinical

study in the United States to use purified stem cells for the treatment of critical limb ischemia.

Tom Amick, Chairman and Chief Executive Officer of Aldagen.

For more information on the study, visit www.aldagen.com.

ALD-301 is a potent population of stem and progenitor cells isolated from patient’s bone marrow

using Aldagen’s proprietary technology. ALD-301 is administered via intramuscular injections

into the lower half of the leg of CLI patients. ALD-301 contains a mix of all of the stem and

progenitor cell types needed for CLI therapy including endothelial, mesenchymal and neural

progenitors. In preclinical testing, ALD-301 has been shown to repair ischemic damage and to

significantly out-perform the unfractionated adult bone marrow preparation that is currently

being used in clinical trials to treat severe peripheral vascular disease.

Critical limb ischemia (CLI) is the severe form of peripheral vascular disease (PVD). It is

estimated between 8 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. Critical limb

ischemia can lead to gangrene or tissue death, often necessitating amputation of the effected

limb. It is estimated that over 100,000 individuals lose a limb each year in the United States

because of CLI. 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. 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.

ALDAGEN is a biotechnology company advancing a pipeline of clinical-stage regenerative

therapies. The Company has three product candidates in clinical development for chronic heart

failure, critical limb ischemia and pediatric metabolic disorders and malignancies. ALDAGEN’s

therapeutics are produced by a proprietary technology platform that selects potent, adult stem

and progenitor cells for therapeutic use. The platform yields a broad range of therapeutic cells

that can be used rapidly, without culture or expansion. To learn more about ALDAGEN, please

visit www.aldagen.com.