Clinical trial at Holy Name Medical Center aims to save limbs and lives

BY Michael Hill, Correspondent |

Seventy-six-year-old Robert Masterson is only the second person in the United States to get stem cell injections in a clinical trial that could save his life.

“I thought it was a good idea. Let’s try it. They have to test it on somebody,” Masterson said.

The National Institutes of Health says Masterson and nearly 7 million other Americans suffer from chronic non-healing wounds. Some from diseases like diabetes. They face countless surgeries to improve their circulation. Masterson has had three to remove the blockage in a leg.

“I call it roto-rooter, and it didn’t work,” Masterson said.

Typically, and even worse, limbs are amputated, starting with the toes. Masterson had wounds on two toes that would not heal so doctors removed both. The NIH says half of all amputees die within five years.

“My sister and my father both lost their limbs because of poor circulation,” Masterson said.

Last September, the Food and Drug Administration fast tracked what’s called the Pluristem clinical study, stem cells from the placenta of a live, healthy birth and shipped frozen in a canister of liquid nitrogen.

Holy Name pharmacists wear special gloves to remove and then thaw them. No one at Holy Name knows whether the vials contain the active stem cells or placebos in the double-blind study. In the meantime, nurses roll Masterson to a room for his procedure.

Masterson had 30 injections all with the intent of preventing the amputation of his limbs.

“There are various trials underway now, largely conducted by the surgical community, looking at ways to preserve surgery and major bypass in patients who have wounds that won’t heal. And, I’ve always said that sort of like trying to preserve the rotary phone. It doesn’t make any sense trying to preserve something that hasn’t changed in 50 or 100 years. And that actually even the things that we do, in general which are very sophisticated ways of opening blood vessels and restoring blood flow, should not be the way we are thinking. We should be thinking to the future of therapies whereby we provide biological solutions, stem cells, genetic therapies, personalized medicine, that really recruit the body’s own healing capacity,” said Dr. John Rundback, Interventional Institute director at Holy Name Medical Center.

Rundback hopes the stem cell injections will grow new blood vessels for Masterson.

“We won’t know the results of these trials for several years. But, you know, these are the first steps in what we hope will be really tremendous advances in treating very difficult patients who suffer quite a bit,” Rundback said.

Holy Name is one of six hospitals in the country in this clinical trial that will eventually enroll 246 patients. Two thirds of the patients will get the active stem cells. Placebos for the other third. While doctors here say they understand the ethical concerns of such approaches, they’re already devising other clinical trials, including using stem cells to restore muscles after hip surgery.

“I think it is fascinating to take the miracle of childbirth into therapeutic options,” said Dr. Ravit Barkama, assistant vice president of clinical development at Holy Name Medical Center.

“This really is on the cutting edge, or perhaps should I say non-cutting edge, of medicine, and this is very new. This is the future of medicine once we perfect these therapies,” said Rundback.