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NBC News revealed treatment to save limbs
José A. Acosta, Ernesto L. Mola, Ricardo S. Rodríguez, Boris E. Acevedo, Marianela G. Siverio and Luis H. Martínez.
Havaba, January 18, 2006 . NBC News has recently published an extensive article on a significant contribution of the Centre for Genetic Engineering and Biotec hnology (CIGB), Havana , Cuba , to the national pharmaceutical industry. The paper is primarily focused on the success of the product CITOPROT-P® for end-stage diabetic foot ulcer.
The results obtained in clinical trials are described with special emphasis on a patient that works at CIGB. The article said that "three injections a week for three weeks stopped the gangrene from spreading and reversed most of the damage in his foot". According to the paper "We tested 41 critical patients. Everyone had between a 90 and 100% probability of amputation. We successfully regenerated the scar tissue in 85% of the cases", said the scientist behind CITOPROT-P®, Jorge Berlanga, MD, PhD. The Director of Clinical Trials and Regulations at CIGB said that Berlanga's contribution may be considered a significant discovery. "Even if the average drops to 50% success, we'll still be saving countless lives," said Pedro López, MD, PhD. "What the Cubans have now done is very clever. Rather than just dumping it into the wound, they've injected it into the healthy margins of the wound, thereby allowing it to kick-start the wound healing before it's destroyed", explained Kelman Cohen, Emeritus Professor of Plastic and Reconstructive Surgery at Virginia Commonwealth University, in Richmond, Virginia.
CITOPROT-P® is the result of more than 10 years of research at the CIGB and two well-designed clinical trials performed in Cuba . After preclinical results showing that CITOPROT-P® contributes to restoration of granulation tissues, which are the soldier joint materials of tissues toward open traumas, the CIGB and the National Institute of Angiology and Vascular Surgery performed the first clinical trial with CITOPROT-P® in 29 diabetic patients (type-II) with micro and/or macro angiopathy. As a first result, 55% of patients were saved from amputations. A second clinical trial was conducted with 41 patients and the results were even better: more than 80% patients were saved from amputations.
CITOPROT-P® is supported by a PCT patent application for use of a pharmaceutical composition containing epidermal growth factor (EGF) in a parenteral formulation, which is administered by mean of infiltration for preventing diabetic foot amputations. This product has been offered for out-license as an orphan designation for diabetic lower-limb amputation prevention, in North America , Europe , Japan and Australia .
For information: http://gndp.cigb.edu.cu or http://www.cigb.edu.cu
Contact: ernesto.lopez@cigb.edu.cu
Phone: (53-7) 271 2397.
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