Its been called the next big 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. They see it as a second chance, but are they putting their health, hopes, and bank accounts in danger?

One Florida cardiologist claims to do what no one else can.

"We're able to increase heart function in patients who suffered major heart attacks," Zannos Grekos, M.D., director of Regenocyte Therapeutic's cardiac and vascular service, told Ivanhoe.

Dr. Grekos is the man behind a stem cell therapy that has patients and their cells flying around the world. First, the patient's blood is sent to an Israeli lab. There, Dr. Grekos says 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," Dr. Grekos explained.

For $64,000, the patients meet up with their stem cells in the Dominican Republic or Bahams 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," Dr. Grekos said.

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

Barbara McKean and Howard Lindeman say the proof is in how they feel.

"It's a totally different life," McKean said.

Lindeman has coronary artery disease.

"I can't say 5 more years, 10 more years," he said. "What I know is it's given me a life."

Before treatment, Lindeman said he had "99.9% blockage everywhere." The recording engineer who toured the world with the rich and famous was out of options.

"We were in the Dominican Republic, and I was a little nervous because it was something new," Lindeman said.

Six months after surgery, tests from Dr. Grekos show his heart's pumping capacity went from 39 to 62 percent.

For McKean, her lungs were the problem. "I was on oxygen around the clock, 24/7," McKean said. "One pulmonologist told me that my life was pretty much finished."

She called on friends, family and fundraisers to pay for the procedure. A year later, she doesn't need oxygen.

"Keep in mind that the placebo effect is very powerful," Dr. Patterson said. "It can fool patients. It can fool other physicians, and it certainly doesn't surprise me at all that some people feel they've gotten better after they've invested an enormous amount of money, time and effort."

Derek van der Kooy, Ph.D., is a member of the International Society for Stem Cell Research (ISSCR). He urges people to get the facts first.

"Ask your normal health care provider whether this seems like a reasonable treatment," Dr. van der Kooy said. "Ask the companies that are providing these services in other countries, what's the evidence that his treatment works? What are the side effects?"

The ISSSCR warns patients to be on the look-out for these warning signs -- stem cells that treat multiple conditions, high cost and no clear studies or documents showing results.

"That is one of the things we do want to do when we collect all our data and have compiled it: We are going to pursue FDA trials," Dr. Grekos said.

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

A treatment ahead of it's time, or too good to be true? While doctors debate, some patients take their health into their own hands.

Dr. Grekos says the stem cell transplant is only done as a last resort after traditional bypass surgery or organ transplant are ruled out. The ISSCR issued a set of guidelines for patients to follow if they're undergoing experimental stem cell treatment. You can read the full list at www.isscr.org.

Content courtesy of Ivanhoe. For more information, click here.