INDIANAPOLIS, Ind.-- Chip Gagnier doesn’t mince words when it comes to the pain he’s experienced in his leg.
“I couldn’t sleep,” said Gagnier. “I was getting out of bed and trying to sleep on the floor and pain medication did not work. It just got to the point where I talked to my wife and we made the decision to have it taken off.”
Gagnier has Peripheral Artery Disease (PAD) and scleroderma, conditions that affect blood flow and put him at risk for an amputation. Gagnier got a call from a friend who knew about a study at IU Health that Gagnier was a candidate for. That study is headed up by Dr. Michael Murphy. It’s a clinical trial involving the injection of stem cells into areas where there is a lack of circulation.
“So we separate out those cells and they are in a syringe,” said Dr. Murphy. “We inject it right into the muscle of the leg, about one and a half to two inches deep with a 23-gauge needle, at about 35 to 40 sites.”
The cells were injected into his leg, beginning at the knee down to the foot itself.
This procedure has been studied for close to 12 years. In fact, it’s now in phase three. The official name is the mobile study. Twenty-three medical centers around the country are involved and Dr. Murphy is getting results.
“We found overall there was an improvement in preventing amputations,” said Dr. Murphy. “More interesting, when we looked at certain sub groups of our study population, that is those patients who did not have tissue loss and non diabetics, we found there was a significant improvement in preventing amputation.”
Gagnier was admitted to the hospital for the procedure seven years ago. His doctor marked the spots where the injections would go. Following the procedure, he stayed the night. The good news for him came several months after the stem cell transplant.
“We noticed they were starting to heal,” said Gagnier. “The pain was still there, but it looked like they were starting to heal. And they got better and better and the pain got less and less.”
Murphy said the implanted cells signal the muscles to grow new blood vessels.
“They secrete growth factors or signals that tell the skeletal muscle itself, the patient's own tissue, to grow new blood vessels. The cells produce signals that tell the host tissue how to respond and repair itself,” said Murphy.
Today, Gagnier is able to golf and do much of what he likes to do. He’s even communicated with the FDA, hoping the agency will approve it.
Although much of phase 3 of the mobile study is completed, the continued access program is in place to treat another 200 patients, who could be at risk for losing a limb.