Take Heart: Stem Cell Therapy Found to Be Promising September 17, 2006
Posted by TheraVitae in : VesCell in the News , trackbackLAKELAND — Businessman Jack Bodolay went to Thailand for help when Florida doctors couldn’t do anything more to boost his failing heart.
Jack Bodolay
“I can tell I’m feeling stronger inside,” stem-cell therapy recipient Jack Bodolay said about his health in August. The surgery used his own cells.
Stem cells from his blood were multiplied by the millions and put into his heart in an experimental procedure to improve the heart’s ability to pump blood.
The treatment at Bangkok Heart Hospital cost him between $30,000 and $35,000. Improvement wasn’t guaranteed.
Not getting it, however, would have meant giving in to his steadily worsening congestive heart failure, which the Lakeland man wasn’t willing to do.
“My thoughts were `I don’t have much time left and I’m going to do what I have to do,’ ” said Bodolay, who is 76.
His ejection fraction — the percentage of blood pumped from the heart each beat — was 20 percent or less when he left for Thailand, he said. Normal pumping ability is 50 percent to 75 percent; below 35 is low.
Four months later, he’s glad he had the procedure. His pumping percentage has increased slightly to 22 or 23, and Bodolay is optimistic that it is going up instead of down.
“I can tell I’m much stronger on the inside than I was,” he said. “If I can make the same progress in the next three months . . . I’ll be in good shape.”
In deciding to get that treatment, he was encouraged by the improved condition of singer Don Ho, well known for “Tiny Bubbles” and “The Hawaiian Wedding Song,” who had the same procedure late last year.
Although the procedure is experimental, it isn’t hocus pocus.
A growing number of researchers in the United States and abroad are studying whether cellular treatment, using a patient’s own stem cells, can provide better health for many patients.
Stem cells have the potential to develop into many types of cells.
Controversy about stem cells from embryos has dominated public discussion of stem-cell treatment, but use of adult stem cells avoids many of the ethical and moral disagreements inherent in embryonic stem cell use.
With an aging population and a growing number of heart-attack survivors with damaged hearts, doctors want additional treatments to offer their patients.
“I’m very excited about it,” said Dr. Kevin Browne Jr., a Lakeland cardiologist and director of Watson Clinic Center for Research.
“The future of this whole area may revolutionize our care of people with weak hearts. . . . That’s one of the most cutting edge approaches that’s happening, but it’s a little ways off.”
Before letting adult stem cells be used for the type of therapy Ho and Bodolay received, the Food and Drug Administration wants clinical trials to show they are effective and won’t cause life-threatening complications.
The delay frustrates some patients, but Browne said he understands the FDA’s caution.
Past trials used different methods of acquiring and multiplying adult stem cells, with varying results, he said, which makes comparisons difficult.
And Browne sees at least two areas of potential risk that need to be monitored closely:
Whether stem cells, if they induce growth of blood vessels and help scar tissue convert to heart muscle, also will cause more growth of cancer cells
Danger of heart-rhythm disturbances, which can be deadly, if imported stem cells don’t communicate with the heart.
Bodolay said he doesn’t expect government to provide the answer for heart disease, but he doesn’t want it getting in the way of research and treatment.
“They need to accelerate that,” he said.
His local cardiologist, Dr. Luis Carrillo, couldn’t be reached for comment. But Bodolay said Carrillo was very cooperative in providing information the doctors in Thailand needed before accepting him as a patient.
The heart doctors in Bangkok were concerned about whether his heart would be able to accept the stem cells, Bodolay said.
When Carrillo tested him, however, Bodolay said, he determined more than 50 percent of the heart surface was in good shape.
“Though that operation is not legal in this country, supplying the supporting information is not illegal, so Clark & Daughtrey (Medical Group) gave them records back to 1999,” he said.
There was a lot to review. Bodolay had a heart attack in 1977. In 1999, he said, he had a double bypass, valve repair and surgery to peel away scar tissue.
That bought him some time, but it didn’t end the weakness in his heart’s pumping mechanism.
“Congestive heart failure is a breakdown in the heart’s ability to squeeze out liquid,” he said.
Last fall, he was admitted to LRMC with extreme weakness. He had hallucinations. When they sent him home, Bodolay said, it was with the understanding he would get hospice care.
Which he did, but his heart and mind weren’t prepared for dying.
“You join a hospice to have a comfortable death,” he said. “That’s why I joined, but I fooled them.”
His daughter, Susan Barroso, found information on the Internet about the procedure.
He said Carrillo continues monitoring his heart, making his experience different than that of another Florida man whose doctor dropped him as a patient when he got stem-cell therapy.
Eager to make others aware of the procedure’s potential, he agreed earlier this month to talk about it at a Lakeland South Rotary Club meeting.
The VesCell stem-cell treatment he received is done at hospitals affiliated with TheraVitae, the biotechnology company that produces VesCell.
“While VesCell treatment may not cure heart disease, it can substantially improve the flow of blood in a large majority of the patients treated,” the company said. TheraVitae uses it on patients with coronary artery disease and congestive heart failure.
In November, TheraVitae presented favorable clinical data at an American Heart Association scientific session.
Bodolay and his wife, Norma, spent three weeks in Thailand.
One was spent on tests. Another was spent sending the blood to a lab in Israel, where the stem cells were multiplied, he said.
Receiving the cells involved two incisions, a small one on his right side and another, about six inches long, on the left side.
“The most difficult part of the whole thing was the trip back,” he said. “A 24hour day became a 36-hour day.”
