U.S. Researchers Still Question Stem Cell Therapy, But Can't Deny Effectiveness

By Jennifer Booth Reed, News-Press, May 20, 2007

Some U.S. researchers warn that much remains unknown, still, local patients are going overseas to put their hopes and spend their money on stem cell treatment.

Currently, adult stem cells are being used in numerous clinical trials worldwide to establish their effectiveness in treating patients with cardiovascular diseases. 67 trials are acknowledged by the National Heart, Lung, and Blood Institute for investigating how to regenerate damaged heart tissue. But a biotechnology firm is saying that they have already accomplished just that.

The company TheraVitae operates in Thailand and Israel, with pre and post treatment care performed by Dr. Zannos Grekos, a Bonita Springs cardiologist.

Stem cell researchers said that before putting their confidence in procedures like the ones Southwest Floridians are seeking, they want to discern much more about stem cells. The cardiovascular experts contacted for this report did not want to discuss TheraVitae directly.

"There are little niches here and there doing various types of treatments without much science," said Dr. Carl Pepine at the University of Florida. UF is part of the Cardiovascular Cell Therapy Research, a five-member consortium conducting research with the backing of the National Heart, Lung and Blood Institute.

Treating those diagnosed with heart failure and those who have had heart attacks using stem cells is the focus of Pepine's research.

"Nobody knows what the proper dose is," Pepine said. "How many cells should you give?"

How soon a patient should receive cells following a heart attack will also be investigated by Pepine's study.

Sonia Skarlatos says that researchers are trying to determine which variety of stem cell is really responsible for tissue regeneration. Sonia is the acting director for the division of cardiovascular diseases at the National Heart, Lung and Blood Institute.

"We are still not sure what is the right cell, what is the right delivery and what is the right dose," Skarlatos said.

Skarlatos says that it is tough to draw conclusions from the small-scale studies that have been conducted all over the world. Various doses of cells and different types have been used on patients who all have varying degrees of heart functionality.

"It makes it very hard to compare all the trials," Skarlatos said.

But the one thing that Skarlatos does agree with is that stem cell treatment is safe. And that is good news for patients wanting to at least give the cells a shot at healing their ailments.

Part of the explanation that patients see progress could be due to the development of new vessels that stem cells encourage says Dr. Johnny Huard, the director of stem cell research at the Children's Hospital of Pittsburgh. Huard said that too much vascular growth could also be a problem.

Huard is also curious to find out if other parts of the body could also be affected by stem cells injected into the heart.

"One thing is very important: You may inject cells in the heart, but are they migrating?" he said.

50-year-old Neim flew to Bangkok last November for stem cell treatment to heal his deteriorating heart.

He has gotten used to people and their questions about the treatment.

"(My cardiologist) just kept hoping for improvement. Finally, he broke the news. He gave me my time — five years," Malo said.

Neim co-owns a 6,000 square foot restaurant with his brother, and he couldn't walk around it without stopping at least once to catch his breath. His viper sports car was not being driven. Even tying his shoes was impossible because he couldn’t bend down due to his weakness. It was all because half of Neim's heart tissue was dead.

"I felt myself going downhill. I was so tired out," he said.

Since he would be leaving behind two daughters and his wife, he started to make arrangements, and began to get his finances in order.

As fortune would have it, Neim came to know of the stem cell treatment in Bangkok from a customer at his restaurant. Before he knew it, he had been accepted as a patient after he did his research and sent his medical records to Thailand.

Neim sent $34,000 in advance for the procedure by electronic check.

"I had nothing to lose — nothing but the money," Malo said.

Grekos, who is an acquaintance, accompanied him on the trip.

He leans over to tie his shoe with a grin now, six months following the procedure. Frequent breaks are a thing of the past, and he can now manage his Watermark Grille more effectively. His Viper doesn't get the best gas mileage, but he'd rather be driving it around like he does now instead of having it sitting in the garage cold.

Before he left for Bangkok, his ejection fraction (a measure of how forcefully blood pumps) was 26. Normally it should be 55 to 65, and Neim has made it all the way back to 40 so far. He says that the proof is undeniable and in the numbers.

"I've got life again — I'm excited," Malo said.

It is too early to tell if he will need another injection of cells, or if he will continue to improve without further treatment. Those questions are still unanswered sine the procedure is so new.

Regardless, Neim thinks he has found a new lease on life.

"I'm just the luckiest man in the world," he said.

More than 2,00 cardiac patients have received stem cells worldwide, with many procedures being performed in Brazil or Germany. But Grekos says that Thailand is more open to medical tourism than the other nations.

"As our experience grows, our need for knowledge grows," Grekos said.

Grekos hopes that the United States plays host to FDA approved trials using methods that are the same as those used in Bangkok. Some researchers feel that the protocols are difficult to get set, but many of Grekos' patients feel that the FDA is being lazy about this matter. Either way, some individuals argue that before a patient pays $40,000 for the treatment, they should wait for the FDA clinical trials to validate the procedure. But few have the time to wait.

"The worst thing that could happen is you start a trial and you have a side effect, or, God forbid, a patient dies," Huard said. "You're not only going to slow down your work, you're going to slow down the entire field."