Regenocyte Therapeutic Reports Successful Treatment of Cardiomyopathy with Stem Cells

Stem Cells Therapy Successfully Reverses Effects of Fabry Disease; Cardiomyopathy Patient Removed from Heart Transplant List

BONITA SPRINGS, Fla.--(BUSINESS WIRE)--Feb 11, 2009 - An international team of physicians and scientists have discovered a way to treat cardiomyopathy (heart disease) with adult stem cells, including a rare metabolic condition otherwise requiring heart transplant.

Florida based Regenocyte Therapeutic is using stem cells extracted from patients' blood to repair damaged heart muscle, regenerate tissue, and create new vessels to improve circulation. According to the organization's director of Cardiology and Vascular Disease, Zannos G. Grekos, M.D., by applying specific growth factors to the patient's stem cells (in a lab) the team creates a new cell population which is educated to target the area of damage or deficiency when placed into the patient's heart and blood vessels. “We've now treated close to 100 patients with their own stem cells and seen an average 22 point increase in ejection fraction (EF) with a significant improvement in heart failure classification - typically from a Class IV to a Class II status in less than 180 days," Grekos states.

The cardiomyopathy treatment study, the first six months of which was published December 2008 in Anti-Aging Medical News, follows patients through one year post-treatment with autologous adult stem cells, also called Angiogenic Cardio-Regenerative Progenitor cells (ACP's). Regenocyte's chief medical advisor Athina Kyritsis, M.D. announced that, “Across the board, no adverse effects from treatment were reported by patients and function plus quality of life measurably improved.” Grekos and his team measured patients' heart function by cardiac nuclear scans, PET scans, and echocardiographs.

An invasive cardiologist in Florida, Grekos is also an associate clinical professor of Cardiology for Nova Southeastern University.

Case Study: Cardiomyopathy from Fabry Disease

Robert Pleva of Fort Myers, Florida, age 60, suffers from Fabry disease, a rare and untreatable enzyme deficiency that leads to multiple organ failure. His heart had been damaged by an attack in 1999. In addition to cardiomyopathy, Pleva had chronic high blood pressure, pulmonary hypertension (a severe lung condition) and mitral valve issues. He was living on kidney dialysis, awaiting a heart transplant with the hope that a new heart would make him strong enough to qualify for a kidney transplant.

Robert Pleva was treated with adult stem cell therapy in June 2008. Regenocyte announced that Pleva's ejection fraction has increased from 28 percent before stem cell treatment to 44 percent as of January 2009, six months after stem cell treatment. “This was a case where the patient's only option for survival was heart transplant and that is no longer the case,” said Dr. Grekos. “We couldn't be more pleased with this outcome. He's off the heart transplant list and continuing to improve. Bob's dialysis time has been reduced by 10 percent, so we are looking at treating his kidney function as a next step.”

Pleva says the improvement in his health since adult stem cell therapy has been dramatic. “I feel so good and have so much energy,” he explains. “The best part about it is being able to do things I haven't done in a long time.”

An electrician with the Lee County, Florida School Board for the past 26 years, Pleva describes concern prior to treatment that his debilitating symptoms would soon end his career. He is now back to working full time along with riding motorcycles, remodeling his house and working in his yard. “The treatment has put me back on track,” he says.

Pleva's wife Roxanne, who he cites as his “rock”, says in addition to his increased energy, one of the biggest changes is in the reduction in the amount of her husband's medication. “His blood pressure has come way down, so he's been taken off many of his prescriptions,” she explains. “We're just taking it one step at a time¦and I'm getting my husband back.”

Regenocyte Therapeutic is the first stem cell clinic in the United States to move beyond research and successfully treat end-stage diseases with adult stem cells. In addition to cardiac and vascular conditions, they have used adult stem cell therapy to help patients with severe pulmonary disease, early senile dementia and macular degeneration.

Paul Schwartz, Chief Operations Officer says the company's progressive technology and stringent protocols contribute to the high level of efficacy. “The patients' safety comes first,” he explains. “We adhere strictly to ISSCR (International Society for Stem Cell Research) and WHO (World Health Organization) guidelines, and only use FDA approved biologic factors. We believe we've found the right combination of biotechnology and medical expertise to advance adult stem cell therapy as the treatment that changes the future of medicine, particularly in dealing with diseases considered to be untreatable.”

To obtain more information about adult stem cell therapy, physicians and educational opportunities visit www.regenocyte.com or call Patient Services at 1-866-216-5710.

Patient interviews are available upon request. Images are available upon request.

Contact: Regenocyte Therapeutic
Beth S. Kalvin, Director of Communications & Education
239-495-2252 x306
bkalvin@regenocyte.com

Posted: February 2009

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