The treatment is based on the use of purified adult stem cells drawn from bone marrow.
The Food and Drug Administration approved the launch of the Phase II trial earlier this year. The stem cells are prepared for use by Aldagen’s proprietary technology known as Aldesort.
The stem cells will be used to combat a leg and feet ailment known as critical limb ischemia, a form of peripheral vascular disease that affects millions of Americans. It often leads to the need for amputation.
Between 8 -12 million people suffer from critical limb ischemia.
In pre-clinical animal trials, the purified, or fractionated, stem cells were more active in restoring blood flow to damaged tissue than untreated bone marrow, Aldagen reported earlier this year.
Patients will be tested at St. Luke’s Episcopal Hospital in Houston. Doctors Emerson Perin and James Willerson will lead the study. Willerson is medical director at the Heart Institute. Perin is director of new cardiovascular interventional technology and director of the Stem Cell Center at the Heart Institute.
“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,” the doctors said in a statement.
“We believe that these cells have the potential to offer CLI patients a new therapeutic option.”
All 20 patients will have bone marrow extracted, but only 10 will receive the treated stem cells from their own bodies. The Aldesort technology isolates the stem cells, which have the potential to build new blood vessels.
Aldagen, which changed its name from Stemco, has received FDA approval for two other trials. One involves a potential treatment for advanced heart failure. The other involves cord blood transplantation.