ALDAGEN is 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
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