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Tuesday, December 10, 2013
Have you heard anything about the cell transplants being done in the dominican Republic? Especially for IPF? A Fl Dr is heading this. His name is Zannos Grekos, MD, director of Cardioligy. With their positive work with heart cell transplants they are now doing lungs. I`m very interested.
Stem cell transplantation is a promising treatment for many diseases. However, it is in an early stage of development and it has not been subjected to clinical trials. For any new treatment, whether it be a new drug or stem cell transplantation, the U.S. FDA requires a series of safety and efficacy studies be performed starting with Phase 1 (safety), Phase 2 (dose determination), and Phase 3 (efficacy) studies.
The most powerful of the Phase 3 studies are the multi-center, randomized, double-blinded, controlled studies which are performed at a variety of locations. In these studies, patients either receive the experimental treatment or a placebo and neither the patient nor the physician know which one the patient is receiving. Until such studies are performed, stem cell transplantation cannot be recommended for routine (non-experimental) treatment.
I would be particularly cautious about treatments that are only offered in countries that do not require strict adherence to proof of safety and efficacy studies; in many cases, claims are made that have not been substantiated by well conducted clinical trials. Like patients with other untreatable and eventually fatal diseases, patients with idiopathic pulmonary fibrosis often grasp at any form of treatment that offers any hope. However, before spending considerable personal financial resources, it is prudent to be sure that the advertised new treatment actually works and even more importantly, to be sure that the treatment is not harmful.
James N Allen, Jr, MD
Clinical Professor of Pulmonary, Allergy, Critical Care & Sleep Medicine
College of Medicine
The Ohio State University