The Tampa surgeon who performed the state's first heart transplant 30 years ago is again breaking new ground, but this time he's receiving some raised eyebrows. In fact, he's having to do the procedure overseas because it has not been approved by the U.S. Food and Drug Administration.
As the Tampa Tribune reports, Dr. Raghavendra Vijaynagar -- usually called "Dr. Vijay" -- has treated its first two patients with adult stem cells. His company, Advanced Innovative Medicine, grows the cells in an FDA-approved lab in Orlando but does the injection in the Bahamas, since the FDA regards stem cells as an unapproved drug.
Clinical trials on adult stem cell injections are still going on around the country, and the verdict is not in, said Dr. Charles Lambert, medical director of the Florida Hospital Pepin Heart Institute and Dr. Kiran Patel Research Institute in Tampa. He said two clinical studies conducted there "showed minimal benefits to the patients," the Tribune reported.
Dr. Vijay concedes the treatment is not a cure for damaged hearts, but says it can greatly improve the quality of life and help patients waiting for a heart transplant to live long enough to get one.