Unique Stem Cell Therapy for MS Patients



Release date: 10/20/2013. Update below





?Last week, the ? FDA has approved a brand new path involving the employment of stem cells as an Investigational New Drug (IND).







This clinical study is being used to analyze the protection and efficiency of autologous mesenchymal stem cells, neural derived antecedent cells, in treating progressive MS in patients.



The neural antecedent cells are the cells which become neurons and alternative system cells. The oligodendrocytes have been shown to inspire neural repair as well as the regeneration of neurons, as experimented with mice in 2012. Mesenchymal stem cells are derived from adult bone marrow, which may be differentiated into alternative varieties of cells, such as neural antecedent cells. The mesenchymal stem cells are obtained from human, or animal, bone marrow.



Researcher at the Tisch MS center, conjointly referred to as the Disseminated Sclerosis Center of New York, Saud Sadiq, MD, and Violaine Harris, PHD, have recruited nearly twenty patients with progressive MS. These patients have been chosen from an existing list compiled by the International Multiple Sclerosis Management practice located in Manhattan. These patients are within the outlined path, however the enrollment has not been transfer as yet.



Each patient participating in the path will have their bone marrow from the MSC-NPs isolated, dilated, and tested before the injections during this trail period. Over the six month trial period that has been sketched out, each patient will be given up to three rounds of injections of the stem directly injected into the cerebrospinal fluid. Each participant in the study will have a follow ups until the end of the trial 27 months after the final injection.



Despite the fact that there are similar studies being done in the United Kingdom, Dr. Saud A. Sadiq suggests the United States is the primary country to participate in this path due to the amount of injections of stem cells directly into the cerebrospinal fluid of MS patients.



The trail’s main objective is to work out the protection of autologous MSC-NPs in MS patients who meet the criteria after the baseline screening. Another objective of the trial is to look at trends in effectiveness over the course of the three year study.



This path does not involve the simultaneous administration of high-dose chemotherapeutical medication in order to lower the patient’s immune system before stem cell transplantation. This is in contrast to the ongoing High-Dose Immunological Disorder and Autologous Transplantation for Multiple Sclerosis Study conducted by the National Institute of Health. This trial conjointly involves multiple intrathecal, instead of endovenous, injections of stem cells to directly target regenerative mechanisms within the central nervous system.



Researchers at Tisch MS center are excited to move forward with this run which represents ten years of somatic cell analysis. The analysis has been delayed for about three years due to regulatory problems, though the study was initially approved by the International Cellular Drugs Society (ICMS), which is an Institutional Review Board (IRB), in November 2011.



NEWS ITEM

Stem Cell Trial Update:February 27, 2014



Tisch MS Research Center of New York continues to be in active deliberation with an Institutional Review Board regarding approval of our stem cell clinical trial. We expect to have all outstanding concerns addressed in the near future and will begin study activities at that time. Please note that IRB approval and FDA approval are separate regulatory matters, and our IRB negotiations do not in any way affect our prior FDA approval. Tisch MS Research Center of New York is committed to full compliance with all laws and regulations concerning the practice of clinical research. As soon as IRB approval is obtained, notice will be posted in this space.