MSRCNY RECEIVES APPROVAL FOR GROUNDBREAKING
STEM CELL TRIAL IN MULTIPLE SCLEROSIS

Landmark Study Targets Repair and Regeneration for MS Patients

New York, NY- November 21, 2011- The Multiple Sclerosis Research Center of New York (MSRCNY) and the International Cellular Medicine Society (ICMS) jointly announced today the ICMS Institutional Review Board’s (IRB) approval of the first study to use autologous brain-like or neural stem cells for multiple sclerosis.

“We are entering a whole new world of possibilities for our patients” said Dr. Saud A. Sadiq, Neurologist and Director of the MSRCNY. “This initial stem cell treatment strategy opens up new avenues of treatment options focused on repair and regeneration that didn’t exist before.” Dr. Sadiq added, “We are delighted that the ICMS has approved our study and feel both the MSRCNY and the ICMS share the basic ideology of advancing safe and effective treatment in addressing patient needs.”

The landmark study investigates a regenerative strategy using mesenchymal stem cell-derived neural progenitor cells harvested from the patient’s own bone marrow. These stem cells will be injected into the cerebral spinal fluid surrounding the spinal cord in 20 participants with a confirmed diagnosis of progressive MS. This will be an open label safety and tolerability study where all participants will be enrolled through the Multiple Sclerosis Research Center of New York (MSRCNY). All study activities will be conducted at the MSRCNY and affiliated International Multiple Sclerosis Management Practice (IMSMP).

Participants in the three year study will undergo a single bone marrow collection procedure, from which the neural progenitor cells will be isolated, expanded and tested prior to injection. Participants will undergo three rounds of injections at three month intervals. Safety and efficacy parameters will be evaluated in all participants through scheduled follow-up visits.

MS is a chronic human autoimmune disease of the central nervous system (CNS) that leads to myelin damage and neurodegeneration. Stem cell transplantation has long been regarded as a viable treatment option for patients with neurodegenerative disorders. The clinical application of autologous neural progenitors in MS is the culmination of almost a decade of basic research conducted at the MSRCNY, which has found that the injection of these cells may decrease inflammation in the CNS and promote myelin repair and/or neuroprotection.

The ICMS IRB reviewed the treatment protocols, informed consents and the inclusion/exclusion criteria for the study at its November meeting. The IRB, comprised of medical doctors, researchers and non-scientific community members evaluated the therapeutic approach, the scientific foundation and the medical justification for the use of these cells in the treatment of MS. According to David Audley, Executive Director and CEO of the ICMS, “The main purpose of the IRB is to evaluate the safety of the therapy. After reviewing the study and all the supporting materials, we were convinced that the therapy was not going to put patients at undue risk, and that the treatment itself is the practice of medicine.”

For additional information, please contact:

Pamela Levin, RN
Multiple Sclerosis Research Center of New York
work: 646.557.3858
plevin@imsmp.org
www.msrcny.org
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ABOUT THE MSRCNY www.msrcny.org
Founded in 2006 by Dr. Saud A. Sadiq, The Multiple Sclerosis Research Center of New York (MSRCNY) is a non-profit research organization solely focused on discovering the cause and cure for multiple sclerosis. MSRCNY helps people with MS by conducting cutting-edge, translational, patient based research to ensure unparalleled care for patients. The close relationship of the research center and the clinical practice (IMSMP) helps to test new treatments for MS and easily moves research discoveries into application to treat symptoms of MS and halt or reverse damage caused by the disease. Patients benefit from the research laboratory by investigation into the cause of MS, disease mechanisms and a devotion to the latest technology to improve MS treatment and care.

ABOUT THE IMSMP www.imsmp.org
The International Multiple Sclerosis Management Practice (IMSMP) is the leader in MS healthcare. It has established a comprehensive level of care for individualized attention to patients’ needs and well-being. As the clinical arm of the MSRCNY, the goal of IMSMP is to take bench research and apply it safely to the bedside with extraordinary service and compassion. As an international MS center, patients throughout the United States and from more than 40 countries on 5 continents rely on and visit the IMSMP for care.

ABOUT THE ICMS
The ICMS is a physician guided international 501(c)(3) nonprofit organization dedicated to patient safety and the protection of the practice of medicine and physician education through the production of global standards for the practice of cell based medicine. The society maintains two websites, www.cellmedicinesociety.org, focused on adult stem cell education and awareness for physicians and researchers and www.stemcellwatch.com, a portal for patient education and information about therapies provided at stem cells clinics around the world.