Adult Stem Cells Successfully Treat Pulmonary Hypertension

Wall Street Journal, November 26, 2008

Physicians announce their successful results for the first patient to be treated with autologous adult stem cells in a clinical study of pulmonary hypertension.

Led by Dr. Leonel Fernandez Liriano, professor of medicine at the Pontifical Catholic University School of Medicine in the Dominican Republic, the international medical team announced their 9-month follow-up results for the clinical trial, in which autologous (in which the donor and recipient are the same person) adult stem cells were extracted from each patients' own blood and differentiated into new blood vessels.

According to Dr. Zannos Grekos, assistant clinical professor of cardiology at Nova Southeastern University and a member of the international team that developed the stem cell treatment protocol, "It goes against traditional theory that we should try to fix the existing pulmonary vasculature, but we are generating new blood vessels with impressive results."

The clinical study represents a collaborative effort involving researchers from the Tel Aviv based company TheraVitae, and physicians from the Florida based adult stem cell company Regenocyte Therapeutic, which also includes physicians from Regenocyte's Dominican Republic division. Patient baseline and follow-up testing are being conducted in part by the Mayo Clinic.

Karl Wagner, the 46-year-old patient who was the first to be treated, was previously described as having been in a rapid decline prior to receiving the adult stem cell therapy in February of 2008. According to Mr. Wagner, after having first been diagnosed with pulmonary hypertension, "I was being managed by medication but still had violent chest pains, heart palpitations, extreme fatigue, and severe shortness of breath. I could barely do anything with my daughters and was on oxygen almost all the time. Doctors at the Mayo Clinic gave me a three year prognosis."

After being treated with the adult stem cell therapy, Mr. Wagner's pulmonary artery pressure improved from 41 mm Hg, which is classified as severe pulmonary hypertension, to 24 mm Hg, which is classified as normal. The other patients who participated in the clinical trial are showing the same pattern of improvement.

According to Dr. Hector Jose Rosario, professor of cardiology and director of cardiovascular therapy for Regenocyte's Dominican division, "This is the first time medical science has successfully reversed the disease process in pulmonary hypertension, a previously untreatable condition with a very grim prognosis." As Dr. Grekos adds, "Using advanced engineered stem cell technology and innovative delivery methods, we've been able to harness the regenerative power of stem cells and literally replace the damaged blood vessels in the lungs of the pulmonary hypertension patients."

According to Mr. Wagner, whose oxygen saturation levels are now consistently high, so that he no longer needs to be supplemented with oxygen nor is he a candidate for a lung transplant any longer, "I feel great and have a normal life again. I take my girls to school every morning and work all day. My quality of life is ten-fold what it used to be. I also am off almost all of my medications and the doctors at Mayo Clinic have given me a new prognosis."

The autologous adult stem cell therapy used in the study is based upon several years of Regenocyte's clinical experience in the treatment of cardiac and vascular disease. As Dr. Athina Kyritsis, chair of Regenocyte's Scientific Advisory Board, explains, "In treating diseases like cardiomyopathy and peripheral vascular disease, we've had consistent success in generating viable heart tissue and growing new vessels. With the increased circulation, healing of wounds, and improvement in ejection fractions, it seemed a natural progression to approach pulmonary hypertension in the same manner. I believe we have only begun to discover what adult stem cells can accomplish in altering the course of diseases now thought to be untreatable."

The clinical trial was conducted with support from the nonprofit Alliance for the Advancement of Adult Stem Cell Therapy and Research.