Researchers at Dartmouth-Hitchcock have found that injections of a patient’s own stem cells may help people suffering from peripheral artery disease (PAD), according to a study recently published in Molecular Therapy.
The study is the second stage of a three-stage clinical trial involving 550 patients at 80 different sites nationwide. The second stage included 72 patients suffering from critical limb ischemia, the most severe form of PAD, which often results in amputation. The researchers used a technique called ixmyelocel-T, where stem cells are removed from the patient’s hip and sent to a lab where they are separated and incubated for 2 weeks, allowing more stem cells to grow. The cells were then re-injected intramuscularly over 20 locations in one leg. Forty-eight participants received the ixmyelocel-T injections and 24 received a placebo.
The researchers found that after 6 months, approximately half of the patients who received the placebo died, required an amputation or experienced a worsening of their leg condition compared with only a quarter of the patients who received the stem cell injections.
“What was truly remarkable was that it was a relatively small number of patients, but that we saw clinically significant improvement in the stem cell-treated patients,” Richard J. Powell, MD, chief of vascular surgery at Dartmouth-Hitchcock and lead researcher, stated in a press release. “It’s compelling enough that there's no question that the pivotal trial needs to be done as quickly as possible.”
The third stage is currently under way. In this trial, half of the participants will receive stem cell injections and half will receive a placebo, and the researchers will measure incidents of amputation and death 1 year after treatment.
“We really want to see a therapy that’s effective out to a year,” Powell stated. “Nonetheless, the results so far are really promising.”