ALDAGEN iis sponsoring a clinical trial testing ALD-301 for therapy for critical limb ischemia patients. It is the first clinical trial involving a novel stem cell therapy for critical limb ischemia patients in the United States. ALD-301 has the potential to build new blood vessels (angiogenesis) in ischemic legs which could ultimately lead to improved functional improvement in critical limb ischemia patients.

Enrollment in this study is currently ongoing. The clinical trial will enroll 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 ALD-301. The patients are 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.

For more information about the clinical trial, please visit ClinicalTrials.gov at
http://www.clinicaltrials.gov/ct/show/NCT00392509?order=1 or contact ALDAGEN at 1.877.484.2571

Site Locations and Contact Information:

Alabama:

Principal Investigator: Farrell Mendelsohn, MD
Cardiology, P.C.
801 Princeton Avenue, S.W. Suite 707 Birmingham, AL 35211

Study Nurse: Susan Deramus, RN, CCRC
Phone: (205) 780-4330 X338
E-mail: sderamus@cardiologypc.com

Indiana:

Principal Investigator: Michael Murphy, MD
Indiana University, Department of Surgery; Vascular Section
1801 N. Senate Blvd. MPC-2 D3500 Indianapolis, IN 46202

Study Nurse: Janet Klein, RN, MSN
Phone: (317) 962-0287
E-mail: jswklein@iupui.edu

North Carolina:

Principal Investigator: Robert Mitchell, MD
Duke University Medical Center
Erwin Road, Durham NC, 27710

Study Coordinator: Kim McIntosh
Phone: (919) 681-5072
E-mail: kim.mcintosh@duke.edu

Texas:

Principal Investigator: Emerson C. Perin, MD, PhD
Texas Heart Institute, Stem Cell Center
St Luke's Episcopal Hospital, Houston, Texas, 77030

Study Nurse: Sandi Shaw, RN
Phone: (832) 355-9802
E-mail: sshaw@heart.thi.tmc.edu

Georgia:

Principal Investigator: Nicolas Chronos, MD
Saint Joseph's Research Institute, Chief Medical and Scientific Officer
5673 Peachtree Dunwoody Rd Suite 675 Atlanta, GA 30342

Study Coordinator: Nichelle Jackson, RN
Phone: (404) 843-6089
E-mail: nljackson@sjha.org