Adult stem cell therapy is currently in numerous clinical trials in the United States and Internationally. A sample of ongoing trials can be seen at
www.clinicaltrials.gov if you search for the words "stem cell". In clinical trials the objective is to determine safety (in Phase I), efficacy in an unblinded manner (Phase II) and efficacy in a blinded manner (Phase III). Numerous stem cell clinical trials are in Phase II, meaning that although safety has been established there is a question of efficacy. Patients with terminal
diseases sometimes make the informed decision not to wait until efficacy trials are completed and to go to stem cell clinics that offer similar procedures being
performed in clinical trials, but without the risk of offering the patient a placebo. The additional benefit to patients of making this choice is that they are offered treatment rapidly, whereas getting into a clinical trial could mean months on a waiting list.
The stem cell clinic Cellmedicine has been offering this choice to patients. Unlike other stem cell clinics, Cellmedicine has made it a priority to publish its protocols, scientific rationale, and outcomes in the peer reviewed literature. This means that all the scientists and doctors in the world can learn about the work being performed at Cellmedicine and offer comments/suggestions on it.
Today Cellmedicine announced publication of a paper in the peer reviewed journal, International Archives of Medicine, of a patient with terminal heart failure who underwent profound recovery after receiving adult stem cell therapy. The publication is freely available at
http://www.intarchmed.com/content/pdf/1755-7682-3-5.pdf.
The patient discussed in the report was administered adult stem cells in November 2007, when his heart had an ejection fraction of 25-30%. The ejection fraction is a quantitative measurement of the heart’s pumping activity. On June 2008, August, and Oct 2009, this marker of function increased to 40%. The patient reported a major improvement in quality of life. Additionally, proteins in the blood associated with heart failure were decreased.
Given that the report was based on only one patient, doctors at the clinic are excited but still caution in their statements.
"Stem cell therapy is a new science, and although the results discussed in the paper are promising, only the conduct of double-blinded, placebo controlled trials will allow definitive conclusions to be drawn," said Dr. Paz Rodriguez, Medical Director of the Cellmedicine Panama clinic and coauthor of the study.
In the publication, Cellmedicine provides detailed rationale for how the stem cell therapy may be affecting the process of heart failure. Data from other studies was described which states that stem cells can:
a) Directly differentiate into new heart cells
b) Stimulate the body’s ability to generate new heart muscle by activating dormant stem cells that already exist in the heart
c) Cause formation of new blood vessels that accelerate the healing process.
Heart failure is only one of the conditions that Cellmedicine treats.
"To date our group has published results on multiple sclerosis, non-ischemic heart failure, and Duchenne Muscular Dystrophy patients in collaboration with major
American Universities including University of California San Diego, Indiana University, and University of Utah. By publishing our data in a scientific forum, we welcome discussion and interaction, which will lead to advanced patient care not only in Panama City but internationally," concluded Dr. Paz Rodriguez.