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New York research centre to conduct stem cell clinical trial for multiple sclerosis

Aug. 14, 2013 – The Tisch MS Research Center of New York announced it has received Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) to commence a phase one trial using autologous neural stem cells in the treatment of multiple sclerosis (MS). MS is a chronic human autoimmune disease of the central nervous system that leads to myelin damage and neurodegeneration. The disease affects approximately 2.1 million people worldwide.


August 14, 2013
By MT staff

Aug. 14, 2013 – The Tisch MS Research Center of New York announced it
has received Investigational New Drug (IND) approval from the Food and
Drug Administration (FDA) to commence a phase one trial using autologous
neural stem cells in the treatment of multiple sclerosis (MS). MS is a
chronic human autoimmune disease of the central nervous system that
leads to myelin damage and neurodegeneration. The disease affects
approximately 2.1 million people worldwide.

 "To my knowledge, this is the first FDA-approved stem cell trial in the United States to investigate direct injection of stem cells into the cerebrospinal fluid of MS patients, and represents an exciting advance in MS research and treatment," said Dr. Saud A. Sadiq, senior research scientist at Tisch MS Research Center of New York, based in New York City, and the study’s principal investigator.

The groundbreaking study will investigate a regenerative strategy using stem cells harvested from the patient’s own bone marrow. These stem cells will be injected intrathecally (into the cerebrospinal fluid surrounding the spinal cord) in 20 participants who meet the inclusion criteria for the trial. This will be an open label safety and tolerability study. All study activities will be conducted at the Tisch MS Research Center and affiliated International Multiple Sclerosis Management Practice.

The clinical application of autologous neural progenitors in MS is the culmination of a decade of stem cell research conducted by a dedicated team of scientists headed by Dr. Sadiq and by Dr. Violaine Harris, research scientist at Tisch MS Research Center.

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Preclinical testing found the injection of these cells may decrease brain inflammation and promote myelin repair and/or neuroprotection.

"This study exemplifies the Tisch MS Research Center’s dedication to translational research and provides a hope that established disability may be reversed in MS," Dr. Sadiq noted.

Participants will undergo a single bone marrow collection procedure, from which mesenchymal stem cell-derived neural progenitor cells (MSC-NPs) will be isolated, expanded and tested prior to injection. Participants will receive three rounds of injections at three month intervals. Safety and efficacy parameters will be evaluated in all participants through regular follow-up visits.

For more information on this study visit, www.tischms.org


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