Trial stem-cell treatment, Hospice patient seeks cardiac therapy overseas August 22, 2006

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An enthusiastic square-dancer, Shelton Strickland first noticed his heart straining when he was on the dance floor, unable to catch his breath.
“I started getting worse and worse,” he said, ending up in Cape Canaveral Hospital in Cocoa Beach with a diagnosis of congestive heart failure earlier this year.

The 74-year-old Merritt Island resident said he never realized his heart condition, which afflicts roughly 5 million other Americans, might be critical, until “I overheard one of my doctors talking to another doctor who said I was on a slippery slope.”

And his family put him in hospice — non-curative care for patients whose life expectancy is not expected to exceed six months.

That’s when Strickland said he first read about an experimental procedure offered by an Israeli-Thai company, TheraVitae, in which doctors use adult stem cells taken from patients’ own blood, to treat and strengthen their failing hearts.

“It is expensive,” he said, referring to the $34,500 price tag, which included lodging in Bangkok, Thailand, for 14 days, and no insurance coverage. “But my kids told me: ‘Go for it.’ ”

So he did.

In late April, Strickland flew with his wife, Carolyn, to Thailand, for the adult stem-cell operation, which involved injecting millions of these early-developmental cells directly into his heart — a last-resort option fewer than 200 patients worldwide have sought, estimates suggest, among them Hawaiian singer Don Ho.

The company’s brochure says the treatment has the “potential to build new blood vessels and heart muscle,” as the adult stem cells contribute to new blood vessel development and help to generate new tissue in the heart.

Several local cardiologists declined to comment, however, awaiting better understanding of the mechanism by which the treatment appears to work, and whether its benefits will last.

One who did comment, Dr. Norberto Schechtmann, chairman of the cardiology department at Holmes Regional Medical Center in Melbourne, described adult stem-cell therapy for the heart as “still early,” although there are “some promising responses.”

Ho, for example, is reported to be well enough after a December operation to be back on the entertainment circuit.

But Schechtmann cautioned, “there are a lot of things we don’t know, such as how best to deliver these cells, how much to deliver and whether there are toxic effects,” as several teams of heart doctors around the world, including in Cuba, South America and Europe, begin testing this approach.

Doctors in the United States at the University of Pittsburgh and the Texas Heart Institute, among others, also are conducting early stem-cell therapies to heal the heart, according to the National Institutes of Health clinical trials site.

“I would like to see randomized trials,” comparing it with other established treatments for the heart, Schechtmann said. “Not immediately, but in the next three to five years, hopefully, we will see some significant discoveries.”

Don Margolis, one of TheraVitae’s founders, said the company has almost completed a clinical study, involving 24 patients, in which investigators are looking at ejection fractions — a measure of how well the heart pumps — and patients’ stamina, as determined in a six-mile walk, to assess the therapy’s success.

Because the last patient to enroll has not been followed out six months, he said, no data has been published yet.

“But overall, our success rate is 70 to 80 percent, as measured by how the patients themselves feel” after treatment, he said. “At least half feel markedly better; another 25 percent feel somewhat better or no worse; and 25 percent have little benefit.”

Little to lose

Before going to Thailand, Strickland said, he got the names from the company of five or six other heart patients in the United States who had undergone the stem-cell procedure, including one patient who was one year out from the operation.

He also got a second opinion from another heart doctor in Brevard County, as well.

“He said, ‘If it was worth anything, we would be doing it here,’ ” Strickland recalled.

Undeterred, the soft-spoken retiree ultimately decided he had little to lose, as his heart continued to weaken, allowing fluid to back up and accumulate in his lungs and other tissues of the body.

On May 1, after a series of tests to check his kidney function and the status of his heart, Strickland said, doctors in Thailand drew about a half-pint of blood from his arm and flew the blood sample to Israel for expansion of his stem cells, using a proprietary process.

A week later, the expanded stem cells were directly injected into his heart.

“They cut a 1.5-inch incision between the ribs, and collapsed my lung, separating it from the heart,” he said. “Then they injected the stem cells into 30 different locations — into the heart muscle, the veins and the arteries.”

Afterward, Strickland said, he stayed in the hospital four days, before being discharged back to his hotel, where he rested for the next few weeks.

According to Margolis, an average of 20,000 stem cells are extracted from each heart patient and “expanded up to 20 million,” prior to reinfusion, either through a catheter — similar to an angioplasty procedure — or directly into the heart muscle through a surgical operation.

“Generally, those with severe coronary artery blockage get stem cells through a catheter,” he said, “while those in heart failure, like Mr. Strickland, get a direct injection into the heart.”

Pump improvement

Now, roughly three months after his operation, Strickland appears to fall into the group of heart patients who feel “somewhat better and no worse” than before their surgery.

Although his heart is pumping far more efficiently than it did, he said — a doubling in his ejection fraction from less than 10 percent to between 20 percent and 25 percent — he already has been hospitalized once since his return, because of fluid buildup around his heart again.

And his stamina has never really returned.

“I can change the oil in my car and put up storm shutters, but that’s about it,” he said. “My stamina is a little low, even with the improvement in my ejection fraction.”

But he no longer is in hospice care or on daily oxygen, and he has been told it will be “a while” — at least a year — before the stem cells start to repair his heart tissue, he said.

So, rather than be discouraged, Strickland takes the long view, sending back his test results to his doctors overseas every three months, sharing his experience with others and following the advice of his heart doctor in Cocoa Beach.

“He said: ‘Just stay active and do what you feel you can do,’ ” Strickland said. “There is no other option.”