Sunday, 18 August 2013

FDA approves groundbreaking stem cell trial for Multiple Sclerosis

The US Food and Drug Administration (FDA) has recently approved a new stem cell clinical trial for the treatment of MS (multiple sclerosis). Purpose of the trial is assess the safety and efficacy of autologous neural stem cells for the treatment of MS.

Currently, more than 400,000 people in the US alone have been diagnosed with MS, and 200 people are diagnosed with the disease each and every week.

During the trial, the investigators will use mesenchymal stem cell-derived neural progenitor cells (MSC-NPs), which will be harvested from the bone marrow of 20 MS patients who meet the criteria for the trial.

The stem cells will then be injected into the cerebrospinal fluid that surrounds the spinal cords of the patients.

The researchers say that the main objective of the clinical trial is to determine the safety of the treatment, while the secondary objective is to measure the effectiveness. The injections will be repeated at 3-month intervals, with their safety and efficacy frequently monitored through follow-up visits. After the final injection, patients will be monitored for up to 27 months.

Preclinical testing of this treatment showed that after injecting the stem cells, brain inflammation was reduced in seven MS patients, myelin was repaired (an insulating layer that forms around nerves), and protection of the neuronal structure and function of the brain was improved.

The clinical trial will begin enrolling patients once ethical approval has been granted and funding secured.

"This study provides a hope that established disability may be reversed in MS. 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 Sadiq, senior research scientist at Tisch MS Research Center of New York.
Similar trials but with larger number of patients (phase 2) are currently under way in the UK. In 2011, UK scientists received £1 million from the MS Society and the UK Stem Cell Foundation (UKCSF) towards research investigating whether stem cells can slow, stop or reverse brain and spinal cord damage in MS patients.

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