Doctors hope clinical trials using a new stem cell therapy will help patients with critical limb ischemia lead better lives.
The Phase 3 trial, called REVIVE, is taking place around the country, including locally through the Michigan CardioVascular Institute.
Critical limb ischemia is a form of peripheral arterial disease that occurs when arteries supplying blood to the legs become blocked. This can cause pain or numbness in the feet, open sores or ulcers and eventually gangrene of the legs or feet.
The condition affects about 1 to 1.5 million Americans overall. A good number of them can be helped with procedures to bypass the arteries, but about 25 to 30 percent of patients cannot have that kind of treatment, according to Dr. Safwan Kassas, director of the Cardiovascular Cell Therapy and Regenerative Medicine Program at Michigan CardioVascular Institute.
Out of this 25-30 percent, today, there is no treatment, he said. The FDA has not approved any treatment for them. Theyre really in a very dismal spot.
Statistics show within first year of developing critical limb ischemia, 25 percent of people will die, 25 percent will have amputation and 50 percent will be alive without amputation, Kassas said. He said in the second year, the chances of amputation or death increase.
That created the challenge for the scientific community and medical community that something needed to be done, he said. Thats where stem cell treatment today is leading the way for treatments.
The hope is that the stem cells will safely regenerate blood vessels and supply blood to the foot to avoid amputation.
The trials involve a product called ixmyelocel-T that was developed by Ann Arbor-based Aastrom Biosciences, Inc.
The company takes a 50 milliliter sample of a patients bone marrow and increases the amount of certain beneficial cells. Aastrom said it selectively expands mesenchymal cells, monocytes and alternatively activated macrophages up to several hundred times more than the number found in the patients bone marrow.
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Clinical trial seeks patients with critical limb ischemia