Limb-saving trial shows promise

Tom Fisher, an avid rose gardener with an amputated leg, made himself a to-do list for March.

Below "major pruning" and "spray with fungicides," he penciled two mission statements:

1. Promote the growing of God's most beautiful floral creation. Grow nothing but blue ribbon roses.

2. Keep myself alive and well.

Fisher, 84, uses a cane to get around his Hanahan home and rose garden.

In July 2007, his right leg was amputated below the knee after poor circulation led to ulcers and gangrene, complications of diabetes. A long rehabilitation followed as he learned to walk with a prosthetic.

Then his left foot developed the same telltale black sores. His doctors told him to hold on. Science was going to catch up with him.

In November 2007, Roper Hospital began a randomized trial for a stem-cell therapy to treat critical limb ischemia, a severe obstruction of the arteries. The disease, which chokes extremities of oxygen-rich blood, can be related to smoking, diabetes or hypertension. The treatment takes a patient's own bone marrow stem cells and injects them into the affected limb, where they build new blood vessels.

Normally, stem cells travel from the rich bone core to circulate through the body, going where they are needed to mend broken bones or heal a wound.

Fisher was among the first patients to participate in the trial. A year and five months later, the ulcer and infection on his toes were healed, and circulation in his ankle was 94 percent normal. "That was astounding," said Dr. Jeb Hallett, medical director at the Roper St. Francis Heart and Vascular Center. "The results have been amazing."

Of the nine area patients participating, seven still have their limbs, Hallett said.

Hallett and Dr. George Geils Jr., who leads the Roper St. Francis Blood and Marrow Transplant Program, are co-principal investigators of the trial that includes eight U.S. medical centers. The Charleston researchers recently were approved for nine more Medicare patients to participate.

The procedure costs less than conventional limb-saving measures, such as bypass surgery or angioplasty with stents, Hallett said. "That's why Medicare is so interested in this," he said. "The cost of saving a limb could be reduced."

The U.S. Food and Drug Administration study is sponsored by Harvest Technologies, the Plymouth, Mass.-based manufacturer of the machine used to condense the stem cells from bone marrow.

Stem cells are primitive cells that, when coaxed in certain directions, can generate blood vessels and some tissues in the body, Geils said.

In the trial, patients either received stem cells from their bone marrow, a more robust source, or from their own blood. All patients had bone marrow and blood drawn, so neither the patient nor the doctor knows which the patient received.

"I still don't know," Fisher said. "But tests are showing great improvement in my leg. I'm wearing shoes now."

Committed to his health, he subscribes to newsletters from several medical universities and boasts that he is down to his high school football weight of 145 pounds.

The former Navy submarine officer has a Spanish dictionary on his desk. He studies to keep his mind keen, he said. He punctuates his sentences by tapping his cane on the floor.

Between 2003-05, South Carolina had the third highest rate of leg amputations in the U.S. For every 1,000 Medicare enrollees, 1.56 people in the state lost a leg, according to the Dartmouth Atlas, a nonprofit that analyzes health care data. Blacks are on average more than four times likely to undergo amputation than whites.

Hallett said research has yet to show how long the effects of the stem-cell transplants last. Results from the trial are expected as early as 2012, he said.

Harvest Technologies also is sponsoring studies in India and Europe. An update released April 1 from the ongoing Indian study showed 87.5 percent of the first 30 patients were able to keep their legs. European studies are reporting a limb salvage rate of 70 percent, Hallett said.

Without treatment, eight out of 10 patients would face amputation, he said. "If seven out of 10 keep their leg, that's great."