Clinical Research

Stem Cell Trial Update

Since the November 2011 announcement, there has been tremendous interest in the IRB approved stem cell trial for multiple sclerosis. Due to the overwhelming response, the IMSMP and MSRCNY hope to expand the study to include 40 participants instead of the initially approved 20. The first six participants have already been selected, but therapy will not be initiated until funding through grants and private donors has been obtained. There are certain inclusion and exclusion criteria that must be satisfied to be eligible for the trial.

Stem Cell Trial Questions

Here are some answers to common questions regarding our new stem cell trial. Our websites will have more information shortly on pages devoted to our stem cell work.

How did the trial get approved?

Stem Cell Trial Approved!

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.

Ocrelizumab Phase II Trial Results

The results of a small trial of a new medication called Ocrelizumab were recently published in the journal, The Lancet. Ocrelizumab is essentially the same as the currently available medication, Rituximab (although not FDA-approved for MS). Because of how it is made, however, Ocrelizumab may be better tolerated during the intravenous infusion. The effectivenss seems promising in this small study but there have also been significant safety concerns with this medication, including a death.

BG-12 Phase III Results presented at ECTRIMS

Phase III results for another emerging oral medication for MS were presented at ECTRIMS this weekend. The DEFINE trial evaluated the use of dimethyl fumarate (also known as BG-12) versus placebo in patients with MS. The study met the primary endpoint of a reduction in relapse rate as well as multiple MRI endpoints. The safety profile of this medication seems to be very good. Below is a link to an article with a nice summary of the results.

http://www.medicalnewstoday.com/articles/236427.php

Teriflunomide Phase III Results

The New England Journal of Medicine has published results of the phase III teriflunomide trial (this center was not involved in this trial). Teriflunomide is a new oral medication developed to treat MS. The phase III data, in 1088 relapsing-remitting MS patients, is encouraging in that this medication showed a significant reduction in relapse rate and MRI endpoints over placebo (sugar pill). Importantly, the saftey profile of this drug is also encouraging. This drug is not yet been approved by the FDA and is currently not available.

Journal Club: Monday August 22nd, 2011

Dr. Sadiq was the speaker at journal club this week. He presented the article: "Intravenous gammaglobulin suppresses inflammation through a novel Th2 pathway". The discussion focused on the mechanism of action of IVIg in autoimmune diseases. IVIg, which is a blood product of pooled immunoglobulins, is a treatment for various autoimmune diseases including MS, however it is not FDA approved for the treatment of MS.

PML Update: Phase II Trial Underway for Treatment of JC Virus Infection

Inhibikase Therapeautics has received FDA approval to begin a Phase II trial of a compound called IkT-001. This compound is intended to clear the body of JC virus, which is the virus that causes PML. PML is the serious brain infection which has been seen in patients on the MS medication called Tysabri. This study is primarily a safety and dosing study in a small number of patients who are receiving Tysabri.

Although the IMSMP is not participating in this small study at this time, we will be following the research closely and share information as it becomes available.

British Stem Cell Trial

A stem cell trial in the United Kingdom has just received funding to initiate a phase II trial. This study will treat relapsing-remitting patients with autologous, mesenchymal stem cells administered intravenously. This study is similar to the MSRCNY stem cell proposal, except that, in the MSRCNY planned trial, we will be using neural progenitor cells which are derived from mesenchymal stem cells and the cells would be administered intrathecally (directly into the spinal fluid).

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