It has been called the next frontier in medicine. But stem cell treatment is still in its infancy. Some patients say they don't have time to wait for the studies. So they're ready to risk it all on a controversial transplant. But they may be putting their health, hopes and bank accounts in danger.

Florida cardiologist Dr. Zannos Grekos is the man behind a stem cell therapy that has patients and their cells flying around the world. He claims he can do what no one else can.

"We're able to increase heart function in patients who suffered major heart attacks," said Grekos, the director of Cardiac and Vascular Service at Regenocyte Therapeutic in Bonita Springs, Fla.

First, the patient's blood is sent to an Israeli lab. There, Grekos said scientists extract, grow and activate stem cells that target specific organs.

"We grow them in a special culture medium that includes growth factors that tell the stem cell what to become," said Grekos.

For $64,000, the patients meet up with their stem cells in the Dominican Republic and have a transplant that's not approved in the United States.

"That tends to be the case with the U.S. and the FDA. Many things lag behind," Grekos said.

"This is not even off-label, and unfortunately, it's not even experimental. These patients are being charged an enormous amount of money for a therapy that's unproven," said Dr. Cam Patterson, director of cardiology at the University of North Carolina in Chapel Hill, North Carolina.

Howard Lindeman said the proof is in how he feels. He has coronary artery disease.

"There's 99.9 percent blockage everywhere," he said.

The recording engineer who toured the world with the rich and famous was out of options. Six months after surgery, tests from Grekos show Lindeman's heart's pumping capacity went from 39 percent to 62 percent.

"Keep in mind that the placebo effect is very powerful," Patterson said.

The International Society of Stem Cell Researchers warns patients to look out for companies offering stem cells that treat multiple conditions, high costs and no clear studies or documents showing results.

"When we collect all our data and have compiled it, we are going to pursue FDA trials," Grekos said.

"It's a scam. I don't see any other way to characterize this," Patterson said.

Grekos said the stem cell transplant is only done as a last resort after traditional bypass surgery or organ transplant are ruled out. The International Society of Stem Cell Researchers issued a set of guidelines for patients to follow if they're undergoing experimental stem cell treatment.

You can read the full list at ISSCR.org.

BACKGROUND: Although doctors have been collecting stem cells from bone marrow for more than 50 years, the International Society for Stem Cell Research (ISSCR) said the range of diseases for which there are proven stem cells treatments is still "extremely small."

Many of the conditions for which stem cell treatments have proven effective and safe affect the blood and immune system and are treated with cells from bone marrow. Stem cells from umbilical cord blood are also being used experimentally as an alternative to bone marrow.

The worth of stem cells lies in the fact that they are the foundation for every organ and tissue in the body. Like a blank microchip, they can be "programmed" to perform particular tasks. Under proper conditions, they differentiate into specialized cells to carry out specific functions. Stem cells can also "self-renew," which means they can divide to produce more stem cells.

TAKING A RISK ON STEM CELLS: The Food and Drug Administration approved a stem cell clinical trial for the first time in January. The trial will involve a procedure to repair spinal cord damage through an injection of cells that experts hope will differentiate into cells that protect spinal cord nerves. Some think the first FDA-approval of a stem cell trial brings in a new age of stem cell research. How can you know if a stem cell trial is reputable? The ISSCR recommends patients watch out for the following warning signs:

Claims based on patient testimonials. Unless there has been carefully evaluated clinical research, experts say it is very difficult to know what is a true effect of treatment and what is a "placebo effect."

Multiple disease treated with the same cells, unless the diseases are related, such as all being diseases of the blood.

The source of cells is not clearly documented.

How the treatment will be done is not clearly documented. Patients should be able to request a protocol that outlines treatment in detail.

High or hidden costs. It is not customary for someone to pay to be in a clinical trial.

Claims that there is no risk. There is always risk involved with treatment, and these should be available from earlier clinical research.

Additional Resources:

Greg Finley
Regenocyte Therapeutic
gfinley@regenocyte.com

Clinton Colmenares
UNC Health Care
Chapel Hill, NC
(919) 966-8757