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- Stem Cell Trial
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Tisch MSRCNY welcomed almost 1,000 guests on Sunday, October 13, 2013 to the New York Hilton. We would like to thank our patients and supporters for making this a truly momentous event!
The title of Dr. Sadiq’s talk, “What Does This Study Mean For Me?” signified an opportunity to answer many questions about our recent FDA Approval to begin a Phase I Clinical Stem Cell Trial using autologous stem cells. First and foremost, if you would like to express interest in participation in this study, you must speak to your IMSMP neurologist.
Dr. Sadiq expressed that our annual patient symposium is in many ways a time of reflection. It is a chance to look at the previous year and ask ourselves “How far have we come? Why do we work? Are we making a difference? Can we end patient suffering? Can there be a future without MS?”
As he stated in the last newsletter, this approval is just the beginning and much work and continued research needs to be done. As part of his presentation, Dr. Sadiq introduced the proposed timeline for the Stem Cell Trial. We hope to obtain Institutional Review Board (IRB) approval and funding for the initial core study (approximately one million dollars) by mid-November. In the latter connection, Dr. Sadiq expressed his gratitude to all of our generous patients and benefactors for their continued support in helping us achieve this goal. Our first patient treatment is expected to commence in December of 2013 and initial safety data on patients to be reported by June 2014. A Phase II Efficacy study shall be planned by the end of 2014.
Many patients have asked about the inclusion/exclusion criteria for this study. As part of Dr. Sadiq’s talk, he presented the following bullet points. Please keep in mind that this is an overview and a thorough neurological exam and medical history must be documented by your IMSMP neurologist as well.
• Definite MS
• 18-70 age group
• Stable Disease preceding 12 months and EDSS score of at least 3.0
• Must agree to undergo all MRI and other testing for safety and efficacy determination
• Be able to easily come (on request) to the Tisch Center – multiple visits over study period
• Pregnancy or nursing
• Any significant other medical condition (systemic, cancer, infectious illness)
• Patient with substance abuse problems
• Any patient enrolled in any other clinical study
• Patients who cannot have MRI scans (e.g. metals)
• If cognition dysfunction is severe enough to invalidate an “informed consent”
A thorough evaluation process and protocol will be implemented following treatment targeting a primary outcome and secondary outcome. This will evaluate safety and tolerability of the stem cell injections both short term and long term.
Dr. Sadiq concluded with the story of Linda Cardinale. Already disabled and in great pain from her multiple sclerosis, Linda came to the IMSMP as a patient in 2002. Over the years, various treatments failed as the course of Linda’s disease grew worse. A strategy for repair and regeneration was needed, but not yet available and Linda passed away on October 7, 2013. Unfortunately, the story of the Cardinale’s battle with MS did not end with Linda. In 2011, Linda’s daughter was diagnosed and is currently a patient of Dr. Sadiq. This talk was not just about stem cells, but was really about working towards a future without MS.