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The Tisch MS Research Center of New Yorkis pleased to announce that it has successfully completed the initial steps towards accreditation to serve as a facility for the processing of human stem cells in clinical trials from the International Cellular Medicine Society. Along with soon-to-be-filed applications for additional certifications, this accreditation is an important step towards actually beginning the administration of neural progenitor stem cells to MS patients.
Our stem cell trial is the culmination of a decade of work by Tisch MS scientists and only a few more preliminary steps remain before patients can be initiated and clinical work can be underway. By far the most important of these is obtaining funds to finance the study. Per patient costs are estimated conservatively at approximately $30,000, and grant applications have been made to a variety of philanthropic and commercial sources. Because this is a Phase I trial simply to establish the safety, tolerability, and efficacy of neural progenitor cell treatments, participation in the trial cannot be billed as ordinary medical treatment, nor will individual donations to research (although much appreciated and encouraged) allow any potential trial subjects to speed up their enrollment.
Additionally, we advise patients to bear in mind that our protocol was initially approved by an Institutional Review Board (IRB) for only 20 trial subjects; although we have every intention to expand the scope of the trial in the relatively near future to 40, 60, etc. patients, hundreds of current IMSMP patients have communicated an interest in participating to the stem cell research team, and it will simply not be possible to accommodate all qualified candidates for some time.
Lastly, we should note that Tisch MS is a research laboratory, not a commercial pharmaceutical lab, and as such does not have the capacity to churn out stem cell treatments at commercial production speeds. We certainly understand and sympathize with patients who would like to begin treatments without further delay, and ask that they bear with us as we proceed with work on the clinical trial as quickly as it is actually possible to do so. As mentioned above, the stage at which this trial currently sits represents fully 10 years of work, and in just the last few months, significant progress has been made in obtaining IRB approval, lab accreditation and required certifications, identification of interested and qualified patients, and identification of promising sources of funds. As the final steps of the process get underway, we hope that patients can share in our excitement at beginning this important work.