By David Fitzpatrick and Drew Griffin CNN Special Investigations Unit

SANTIAGO, Dominican Republic (CNN) -- This Caribbean city already known for cigars, furniture, chocolate and coffee may become a magnet for Americans seeking controversial stem cell therapy for life-threatening illnesses if a Florida cardiologist has his way.

Dr. Zannos Grekos, a Florida cardiologist, says he's had success with stem-cell therapy in the Dominican Republic.

The Food and Drug Administration has not approved this stem cell therapy in the United States because no clinical trials to prove its effectiveness have been done. But Dr. Zannos Grekos says his company, Regenocyte Therapeutic, has successfully used adult stem cells to treat patients with heart and lung disease.

Grekos said he and his associates draw blood from a patient in Florida and then send it to a laboratory in Israel that produces what his company calls "regenocytes." The company defines regenocyte as "a stem cell that has been activated to become a target organ."

"These procedures work," he told CNN, standing inside a hospital room at the Clinica Union Medica del Norte in Santiago. "And it's substantiated by objective data that we are collecting."

But Grekos' procedures have not been reviewed by other researchers, and leading scientists involved in U.S. stem cell research efforts say Grekos is simply wrong. Dr. Irving Weissman, president-elect of the International Society for Stem Cell Research, told CNN, "There is no such cell. There is nothing called a 'regenocyte.' "

"As a stem cell scientist who works in the field of regenerative stem cells, I am disappointed and shocked that somebody would prey on a family that has an untreatable disease with the promise of a therapy that has no scientific or medical basis," Weissman said.

Grekos has a busy practice in Bonita Springs, Florida, outside Naples, and runs a company that promotes and administers stem cell therapies in Santiago, a noisy, crowded industrial city in the central Dominican Republic.

He told CNN that in the past 18 months, about 100 patients have received adult stem cell therapy at a Dominican hospital. Most of them have been patients with severe heart disease, while the rest have suffered from chronic lung illnesses, he said.

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