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WHO International Clinical Trials Registry Platform

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Umbilical cord stem cells treat heart failure?

Cord blood stem cells show promise treating heart failure....

A heart failure treatment using umbilical cord-derived stem cells may lead to notable improvements in heart muscle function and quality of life.
"We are encouraged by our findings because they could pave the way to a non-invasive, promising new therapy for a group of patients who face grim odds."

Fernando Figueroa MD, Professor of Medicine, Universidad de los Andes, Chile.

The work appears in Circulation Research Journal Report.

In this trial, 30 patients, ages 18 to 75, with stable heart failure receiving optimal drug therapy underwent intravenous infusions with either umbilical cord-derived stem cells or placebo. The umbilical cords were obtained from full-term human placentas of healthy donors by caesarean section after informed consent.

Compared to placebo - stem cell therapy one year following treatment:

• shows sustained, "significant" improvement in heart ability to pump blood
• showed greater improvement in functional status and quality of life
• had no adverse effects — or development of alloantibodies (a common immune complication in patients receiving organ transplants or blood transfusions)

Researchers had previously assessed bone marrow-derived stem cells as potential for treatment, but never evaluated intravenous umbilical cord-derived stem cells. Cord blood stem cells are particularly appealing as they are easily accessible, widely available, unlikely to cause immune complications, and free of the ethical concerns of embryonic stem cells.
"Standard drug-based regimens can be suboptimal in controlling heart failure, and patients often have to progress to more invasive therapies such as mechanical ventricular assist devices and heart transplantation."

Jorge Bartolucci MD, Cells for Cells, Professor, Universidad de los Andes, and lead study author.

Heart failure, marked as the heart's inability to pump blood efficiently, affects some 37 million people worldwide. Despite medical advances, half of patients diagnosed with heart failure die within five years, according to Dr. Figueroa. If affirmed by larger studies, these findings could provide a promising new treatment option for a condition that currently has few.

Rationale: Umbilical cord-derived mesenchymal stem cells (UC-MSC) are easily accessible and expanded in vitro, possess distinct properties, and improve myocardial remodeling and function in experimental models of cardiovascular disease. While bone marrow-derived mesenchymal stem cells (BM-MSCs) have been previously assessed for their therapeutic potential in individuals with heart failure and reduced ejection fraction (HFrEF), no clinical trial has evaluated UC-MSCs in these patients.

Objective: Evaluate the safety and efficacy of the infusion of UC-MSC in patients with chronic stable HFrEF.

Other co-authors included Fernando J. Verdugo, MD, Paz L. González, BSc, Ricardo E. Larrea, MD, Ema Abarzua, MD, Carlos Goset, MD, Pamela Rojo, MD, Ivan Palma, MD, Ruben Lamich, MD, Pablo A. Pedreros, MD, Gloria Valdivia, PhD, Valentina M. Lopez, BSc, Carolina Nazzal, PhD, Francisca Alcayaga, PhD, Jimena Cuenca, PhD, Matthew J. Brobeck, BSc, Amit N. Patel, M.D. and Maroun Khoury, Ph.D. Author disclosures are on the manuscript.

Keywords: Multipotent Stem Cells, controlled clinical trials, clinical trial, stem cell, mesenchymal stem cell,heart failure cardiomyopathy, transplantation

The study was funded by a grant from CORFO, the Chilean Economic Development Agency.

Cells for Cells S.A. is a Chilean biotechnology company engaged in research, development and commercialization of innovative cell therapies based on adult stem cells. Cells for Cells is a spin off of the University of the Andes, Chile, and was founded in 2010. Statements and conclusions of study authors published in American Heart Association scientific journals are solely those of the study authors and do not necessarily reflect the association's policy or position. The association makes no representation or guarantee as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations and health insurance providers are available at http://www.heart.org/corporatefunding.

Circulation Research is published on behalf of the American Heart Association, Inc., by Wolters Kluwer. This is an open access article under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0/), which permits use, distribution, and reproduction in any medium, provided that the original work is properly cited. About the American Heart Association
The American Heart Association is devoted to saving people from heart disease and stroke - the two leading causes of death in the world. We team with millions of volunteers to fund innovative research, fight for stronger public health policies and provide lifesaving tools and information to prevent and treat these diseases. The Dallas-based association is the nation's oldest and largest voluntary organization dedicated to fighting heart disease and stroke.

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Umbilical cord bood procedures from the New York Blood Center
Image Credit: the Wall Street Journal.

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