James Criniti has already lost part of one legdue to peripheral vascular disease (severe blockages of arteries in the leg). He has run out of options and without a new therapy, he will most likely lose his other leg.
Criniti decided to participate in a national research study, called REVIVE, to see if cells from his own bone marrow can help save his leg.
“When I lost my left leg two years ago, they told me I’d lose the other within three months to a year,” Criniti said. “I’m hoping these guys can help me keep my right leg.”
A hematologist/oncologist harvested a small amount of bone marrow from Criniti’s hip and sent it to a laboratory. Using a special production process, the lab expanded the number of cells that are believed to play a role in tissue remodeling and other functions. After this process is complete, the product, Ixmyelocel-T, was shipped back to the doctor for use in treating the patient. By participating in the study, Criniti either received 20 injections of Ixmyelocel-T or a placebo into the muscles of the thigh, calf and foot. All treatments are administered in an outpatient setting and do not require hospitalization.
The research coordinator will check on Criniti via telephone in two weeks. He’ll then come in for exams in the office as Dr. Patrick Stone monitors the progress of Criniti’s leg.
Because Ixmyelocel-T is made from the patient’s own cells, there is almost no risk of rejection. Critical limb ischemia (CLI) is a severe type of peripheral arterial disease (PAD) that causes markedly reduced blood flow to the legs, feet and hands. There are one million people in the U.S. who have CLI and five million who have PAD.
Patients with CLI often experience wounds that will not heal, infection, pain or extensive skin and tissue loss. CLI causes 160,000 amputations each year.
In the U.S. there are currently no drugs approved by the Food and Drug Administration to treat CLI. Patients are typically treated with wound management and revascularization, which is a surgical procedure to restore blood flow.
Some patients have many conditions that prevent them from having surgery. These patients are considered to be “no option.”