Aldagen, Inc. has 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. We believe that ALD-301 has the potential to offer CLI patients a new therapeutic option,” said Tom Amick, Chairman and Chief Executive Officer of Aldagen.