Tisch Center MS Stem Cell Trial: Interview with Dr. Saud Sadiq, Director and Lead Research Scientist (Part Two)

Dr. Sadiq and research staff at the Tisch Center

The Tisch MS Research Center of New York (click here) will soon begin its first-ever FDA approved Phase 2 regenerative stem cell study for multiple sclerosis. Last week, I published the first part of my interview with Dr. Saud Sadiq, the Director and Lead Research Scientist of The Center, which discussed  the Phase 1 study and its results (click here). As promised, here is the second part of our discussion, which focuses on the upcoming Phase 2 study, the Tisch Center's new stem cell laboratories, how stem cells might help repair damaged nervous system tissues, and some of the other multiple sclerosis research projects being conducted by Tisch Center researchers and scientists.
This interview has been lightly edited for readability, and I’ve added some “WK Notes,” which attempt to translate overly complicated medical jargon into plain English.

WK: The Tisch center is now preparing to embark on Phase 2 of your MS stem cell trial. When do you expect this next phase of the study to get started?

Dr. Sadiq: After the  Phase 1 study ended, we made a commitment at The Tisch Center that we needed to make our stem cell laboratories absolutely state-of-the-art. We’ve invested heavily in building a new stem cell lab, which is being completed now. Everything’s automated, it’s a next generation stem cell facility that will be functional and certified in about a month and a half. Then we will be prepared to start the Phase 2 study. We do still need some additional funding for Phase 2. We are applying to the National Multiple Sclerosis Society for a grant. Though they didn’t support Phase 1, given the impressive results of that trial we are hopeful that they will support us as we go forward. We also expect private contributions to help fund Phase 2, as these have always been the lifeblood of the foundation.

WK: How many patients will be involved in the Phase 2 study?

Dr. Sadiq: There will be 50 patients involved. It will be a double-blinded crossover study specifically designed to establish the effectiveness of the neural progenitor stem cells we've developed in our laboratories. So it has an entirely different aim than the Phase 1 sstudy, which was intended primarily to determine the safety and tolerability of our stem cell procedures. We are going to give Phase 2 study participants six treatments, one every two months. Therefore there will be more treatments given in greater frequency than in the Phase 1 study.

WK: So, with 50 patients, 25 will be getting actual stem cells, and 25 will be getting placebo treatments?

Dr. Sadiq: Yes, in the first year 25 subjects will get treatment and 25 will get placebo, and in the second year the ones who got placebo will get treatment and vice versa.

WK: What will the patient population look like for this Phase 2 trial?

Dr. Sadiq: The patients for this trial will have to meet much tighter inclusion criteria then the patients in Phase 1. They all must be diagnosed with SPMS or PPMS. They have to be ambulatory, so they’ll all have EDSS scores between 3 and 6.5. The FDA is requiring that we have an equal distribution of the EDSS scores. So there will be equal numbers of patients distributed between all the points along the EDSS scale. The other limitation is that all patients will need to have had the disease for 15 years or less.

WK: Will the study participants continue with their disease modifying drugs?

Dr. Sadiq: Yes, but they can’t have switched medications within six months from the start of the trial.

WK: Once they are in the trial they’ll have to remain on the same DMD for the duration of the study?

Dr. Sadiq: Yes.

WK: What will be the total duration of this trial?

Dr. Sadiq: There will be two years of study and placebo, and one year of follow-up. So a total of three years.

WK: Just to be clear, in the third year none of the patients will be receiving stem cells?

Dr. Sadiq: That’s correct, in the third year there will be no stem cells and no placebos. After the second year, all patients will have received six treatments. The patients who received stem cells in the first year will have placebo in the second year, and the patients who received placebo in the first year will receive stem cells in the second. The third year will be for observation of all patients.

WK: For all the folks out there with RRMS, if the Phase 2 trial proves successful then the stem cell protocol developed at Tisch could be applied to them as well, correct?

Dr. Sadiq: For patients with relapsing-remitting disease who experience a relapse that results in damage from which they don’t recover, stem cells could be introduced in an attempt to repair that damage. That would be the dream scenario, and it could render disability resulting from MS a thing of the past. But at this point were getting ahead of ourselves…

WK: As we move forward into a world in which stem cell treatments for MS become a standard of care, would you anticipate that patients will need continued and repeated stem cell treatments to maintain or advance whatever benefits they realize until a cure is finally found for multiple sclerosis?

Dr. Sadiq: Yes, that’s likely. I think the Phase 2 trial will really go a long way towards answering that question. It will be important to ascertain what happens to patients in the years after they receive their stem cells. Do they maintain their benefits, do they return to baseline, or do they fall somewhere in the middle? These will be significant findings. The design of this crossover trial will allow us to figure that out. My feeling going in is that patients will need stem cell treatments over the long-term, maybe not six a year after the initial treatment., but perhaps less frequently to maintain whatever improvement is seen.

WK: The neural progenitor cells developed by the Tisch Center – or any regenerative stem cells, for that matter – don’t directly address the disease process, correct? If so, does the disease remain active despite the use of these stem cells?

Dr. Sadiq: Yes, that’s right, the cells are not a cure for the disease. They hopefully secrete trophic factors that would stimulate the body’s own progenitor cells to activate and induce repair at sites of injury. (WK Note: trophic factors are elements which cause the body to maintain or start some action, in this case repairing damaged nerve cells and possibly affording some protection against attack from immune cells.)

WK: So, the stem cells may not necessarily repair injury all by themselves, but they may jumpstart natural repair mechanisms within the bodies of the patients in which they are implanted?

Dr. Sadiq: I think that’s the most likely mechanism. Whether they play some direct role is something we have to figure out, but I think it’s more likely that they’ll turn on a patient’s own progenitors and also create a trophic environment that acts as a shield from the immune system and allows the body to make repairs.

WK: I know that stem cells aren't the only focus of the Tisch Center's researchers and scientists. I’d like to touch on The Tisch Multiple Sclerosis Research Center of New York itself, and some of the other areas of research that are currently ongoing in The Center’s labs. Could you give us a peek inside and tell us about some of the other projects Tisch researchers are working on?

Dr. Sadiq: Well, at the Tisch Center our original goal was to identify the root cause of the disease. It may be some type of immune cell, or some unidentified infectious agent, or maybe some other environmental element. Once we can identify the cause of multiple sclerosis, we can then methodically work towards a cure. And finding a cure is our ultimate goal.

WK: So, the Tisch Center currently has researchers who spend their days searching for the root cause of multiple sclerosis?

Dr. Sadiq: Yes, absolutely. I try to focus on the real challenges that I see as a clinician treating patients every day. My focus is on trying to understand primary progressive MS, which is perhaps the most challenging form of MS as far as treatment is concerned. There are very few treatments that can alter the course of progressive MS. We’ve created an animal model in our lab to try to understand the mechanisms of progression and why remyelination does not take place at all in this form of the disease. In relapsing-remitting MS we see damage occur and then some repairs get made by the body, especially in early disease. This is something not seen in progressive MS. We need to understand the mechanisms of progression better. We are also focused on cognition dysfunction because that can really dehumanize the patients who suffer from severe cognitive deficits.

We are also hard at work identifying biomarkers that can indicate the activity and severity of the disease. We’ve published a lot of papers in this area. We are doing a lot of work on metabolic dysfunction in the central nervous system in MS, and hopefully, that will lead us to readily identify markers that can pinpoint progression and disease activity, which will, in turn, allow us to assess the effectiveness of treatments in individual patients. In conjunction to the Phase 2 stem cell study itself, one of our aims is to analyze the spinal fluid of all of the study participants for markers that may predict which patients are going to get better by Identifying which patients experience actual repair and remyelination. The goal of identifying biomarkers is to be able to tailor treatments to each individual patient, specific to them and the intricacies of their disease. MS is a very heterogeneous illness, meaning that it affects each patient differently. Through the use of biomarkers, we hope to be able to address these differences on a patient by patient basis.

WK: The Tisch Center is not affiliated with any hospital or academic institution, correct, so it’s an entirely independent research entity?

Dr. Sadiq: Yes we are completely independent. We run Tisch like an academic center in every regard. We have guest speakers and all of the activities that would be associated with typical University research centers, but we are not affiliated with any academic centers. We retain absolute independence in choosing our areas of research.

WK: If you don’t have any of these affiliations, how is all of the research we’ve discussed funded?

Dr. Sadiq: We rely entirely on grants and donations. We use almost all the funds raised directly for research. Fully 90% of all monies raised goes directly into research, which is really an extraordinarily high number compared to other organizations. We keep expenses very low, so only a small percentage of funds raised go towards administrative costs and other such overhead. All of our tax forms and documentation in this regard are available online.

WK: My understanding is that you are not currently receiving any funding at all from the National Multiple Sclerosis Society. Is this correct?

Dr. Sadiq: Yes, that's right, we’ve had some bad luck with the MS Society, but they promised to look into our Phase 2 study, and I’m putting in a grant application. Hopefully, this time they’ll get involved.

WK: Obviously, the Tisch family (click here) is involved, but where does the rest of the Center’s funding generally come from?

Dr. Sadiq: The Tisch family is a very big supporter, but so are our patients and their loved ones. We have a very loyal following of patients and their families and other supporters that really enable this to happen. They’ve been supporting us for close to two decades, even before we were formed as an independent center.

WK: How much is this Phase 2 trial going to cost?

Dr. Sadiq: The build-out of the laboratory cost $5 million, and that’s a done deal. The trial itself calls for another $4 million, and we are currently raising funds for the study itself.

WK: So funding is still needed for the Phase 2 trial?

Dr. Sadiq: Yes.

WK: Well, speaking strictly for myself as a patient who has been ravaged by this disease, I can’t think of any cause more important and worthy of donations.

Dr. Sadiq: That’s very kind. Maybe I should hire you as a fundraiser…

WK: You can pay me in stem cells… Even though I know I don’t qualify for the trial because of my  level of disability…

Dr. Sadiq: That’s true, but don’t ever lose hope. Every day researchers here at Tisch and others around the world are working hard towards solving the puzzle of MS. I’m personally obsessed with curing multiple sclerosis.



As a patient of Dr. Sadiq’s, I can attest to his obsession with curing the disease. The man works at least six out of every seven days and even has a bedroom behind his office at the clinic affiliated with the Tisch Center. The clinic is called The International Multiple Sclerosis Management Practice (click here).  I’m also acquainted with some of the researchers at the Tisch Center, who are so dedicated that they'll even put up with my incessant questions when I manage to corner one of them with my wheelchair.

For those interested in donating to the Tisch Center, you can learn about the various ways to contribute by (clicking here). If you’d like to encourage the National Multiple Sclerosis Society to get behind the first ever FDA approved Phase 2 MS stem cell trial with a nice big grant, here’s a webpage with contact info for all of the Society’s senior leadership (click here). Please be polite If you do reach out to the NMSS. As my grandmother always told me, you can catch more flies with honey than you can with vinegar…

An Interview with Dr. Saud Sadiq – FDA Approves Phase II MS Stem Cell Study Conducted by Tisch Research Center of New York

In some dramatic news regarding stem cell treatments for Multiple Sclerosis, the FDA has given its first ever approval for a Phase II Multiple Sclerosis regenerative stem cell trial to the Tisch MS Research Center of New York.

Most previous attempts at using stem cells to repair MS damage have involved intravenously infusing a basic type of stem cell (called mesenchymal stem cells) back into the patient from which they were taken. The Tisch Center (click here) takes this approach several steps further, using proprietary methods to transform raw mesenchymal stem cells into a type of stem cell known as neural progenitors, which are specific to the central nervous system. The cells are then injected directly into the spinal fluid of trial subjects, where, in theory, they should be more effective than raw mesenchymal stem cells at effecting repairs and combating the disease. The Phase I results of the Tisch center’s trial thus far have been quite impressive, offering MS patients worldwide a glimpse into the future of MS treatments and some tangible reasons for hope.

A press release put out by the Tisch Center provides details on what has already been accomplished in the Phase I trial, and what is being planned for the upcoming Phase II study:

"Our unprecedented Phase I results have propelled us into the next phase of research," said Dr. Saud A. Sadiq, Chief Research Scientist at Tisch MSRCNY and the study's principal investigator. He added, "No treatment has shown reversal of established disability until now. The objective improvement experienced in bladder function, vision and walking speed in both secondary and primary progressive MS is remarkable. We now plan to establish efficacy of stem cells as a reparative therapy in Phase II."

The Phase II trial will be a double-blind, placebo-controlled, randomized trial with forty patients in a crossover design. Stem cells are taken from the patient’s bone marrow and manipulated to become brain-like neural cells, a process created and found only at Tisch MSRCNY.  All treatments and research will be conducted at the Tisch MS Research Center of New York and will expand to include an additional leading MS center.

The main obstacle in intiating the study is the need for critical funding. Once funding is obtained, patients will be recruited and the study is anticipated to commence in the summer of 2016.

I had the chance to talk with Dr. Sadiq (who just so happens to be my MS neurologist) about this ongoing and groundbreaking MS stem cell trial, as well as other stem cell related topics. The following interview has been lightly edited for clarity…

How long did it take the Tisch Center laboratories to develop the proprietary process to produce neural progenitor cells from raw mesenchymal stem cells?

Dr. Sadiq: It took about 2 ½ years of intensive lab work, and our lab is the only lab in the world currently using this process.

Is this type of stem cell treatment considered a cure, or can patients expect to require repeated treatments in order to maintain whatever benefits they achieve?

Dr. Sadiq: All of this is still in the experimental phases, so we really don’t know how long the treatments will need to be continued in order to maintain benefit. It’s likely there will be an initial induction period where we will do a number of frequent treatments to induce repair and then to maintain the benefits I think it will require less frequent treatments. But I anticipate that some treatments will need to be given for the duration of the illness, until we find the cure.

What was the treatment protocol during the Phase I trial, and what will the treatment protocol be during the Phase II trial?

Dr. Sadiq: In Phase I we did three treatments over the course of one year, which seemed necessary in order to get some benefit. We don’t know whether the Phase I patients will continue to show benefit or not without further treatment. In the Phase II trial, we are proposing six treatments over a year followed by no treatments over a year to see if benefits are sustained. There will be a control group as well, who will get no treatments the first year and then get six treatments the second year. I anticipate less frequent treatments will be needed to maintain benefit for the duration of the disease until we find a cure.

And would this hold true for any type of regenerative stem cell treatment, such as those being offered by some of the for-profit clinics at which many patients are seeking a single treatment or a single round of treatments over a relatively short period of time?

Dr. Sadiq: Most likely yes, it’s been shown that one treatment probably would be insufficient to even start regeneration. You’ll need multiple treatments…

Are the effects of the regenerative stem cell treatments cumulative?

Dr. Sadiq: You know, we don’t know that yet, in the Phase II trial we intend to collect data on this question…

How much more effective are the neural progenitor cells than the raw mesenchymal stem cells (MSCs) that have been used in other trials?

Dr. Sadiq: Well, as far as I’m aware, the way MSCs have been used in trials so far, there’s not been a single trial that has shown real substantial benefit with MSCs. There’s been some very mild improvements seen in the Cambridge trials, which used one dose given intravenously. It could be that they didn’t use fresh cells or they didn’t use the proper route of administration. Our trial administers the cells intrathecally, directly into the spinal canal. It could be that raw MSCs are in fact effective, but the trials I’ve seen didn’t use multiple dosing. So it’s very difficult to compare the two. But in our hands we found that neural progenitor cells given intrathecally are more effective than raw MSCs.

How much funding is needed for the Phase II trial?

Dr. Sadiq: For the Phase II trial alone we need about $3 million, but for the actual support that we need to build out and expand the labs I’m looking to get $10 million. We need expanded lab facilities and an animal testing facility in place to properly conduct the Phase II trials.

And how much money have you already raised?

Dr. Sadiq: Planning for Phase II we just started, so we haven’t raised anything yet. We have talked to the National Multiple Sclerosis Society, we’ve talked to the National Institutes of Health. We are submitting a grant proposal to the NIH, and the MS Society Is in consultation with me currently to try to arrange funding. We’ll will have to apply for funding grant from the NMSS. We do have a pledge of about $3 million from one donor.

Wow, you have a pledge of $3 million from one donor?

Dr. Sadiq: Yes.

Is the Phase II trial on hold until all of the funding is in place?

Dr. Sadiq: The trial is not on hold, we are really just starting to think about implementation. We just received FDA approval, and we are going to get another MS center involved, I’m in talks with another MS center here in New York, and then after they’re on board we will get things going. So even if we got all the funding right now, we wouldn’t be able to start the trial until late summer 2016. Right now were planning on starting the trial in July or August 2016.

Assuming everything goes as planned, and there aren’t any unforeseen problems, how long do you think it would be until the type of treatment you are trialing would reach common clinical practice?

Dr. Sadiq: It will probably be by the end of the decade, by 2020 I hope if everything goes well.

Do you think there’s any difference in effectiveness between bone marrow derived and adipose (fat cell) derived stem cells?

Dr. Sadiq: Well, we’re not sure. We started working with bone marrow derived cells from the beginning, but adipose derived may turn out to be better because adipose tissues contain a greater number of MSCs, so you may be able to get a better harvest. But because the FDA oversees every project from start to finish, and our trials began using bone marrow derived cells, if we started using adipose cells now we have to go back to the drawing board with the FDA. So in order to continue our ongoing trial protocols, since we started with bone marrow derived cells, we will continue using bone marrow derived cells.

Do you have any thoughts on the clinics that are currently doing mini liposuctions and then re-injecting the cells intravenously the same day or the day after?

Dr. Sadiq: These clinics are just using the stromal fraction, and nobody really knows what that achieves. This process is really not a stem cell therapy, since the stromal fraction only includes a small number of MSCs. It seems like these clinics just want to make money, there’s no evidence that this method would be effective, at least when dealing with neurodegeneration.

What other avenues of research are being pursued in the Tisch MS center’s labs that you consider most promising?

Dr. Sadiq: My goal in life is to find the cause of MS, and that’s really where I concentrate my efforts. I think we have a number of discoveries that are coming together now and I hope that one day soon we will be able to declare that we’ve found the cause of MS.

We do a lot of work with biomarkers as well. In this Phase II trial we are going to look at all the biomarkers that are associated with clinical response, to be able to identify a marker that will be able to predict which patients have the best chance of responding and seeing benefit, and through what mechanisms they are getting better. This is very important work but it’s not the work that drives me to come into the clinic every day at 4 AM.

What does drive you to come to work every day at four in the morning?

Dr. Sadiq: That’s to find the cure to this damned disease.



I can personally attest to Dr. Sadiq’s obsession with finding the cause of and cure for MS. Through the years, Dr. Sadiq and I have developed quite a strong bond, and I know from experience that he can be found hard at work in his clinic and laboratory nearly round the clock, very often at least six days a week. I’ve spoken to Dr. Sadiq via telephone at all hours of the day and night, and have even had office visits with him on the day after Christmas. He once showed up at my bedside at 3 AM when I was hospitalized and suffering miserably from MS related symptoms, to simply be there with me and literally hold my hand. Not your typical doctor, to be sure.

As Dr. Sadiq makes clear, funding is of the utmost importance in order to get this trial up and running in as timely a fashion as possible. There is a tremendous amount of work to be done, and all donations, no matter how small, will make a difference.

As a long-suffering MS patient myself, I know that friends and family are often eager for ways to help fight the disease. While there are many worthy MS charities, in my opinion the biggest bang for the MS donation buck can be had by donating to the Tisch MS Research Center of New York. Donations to the Tisch Center will directly serve to hasten the completion of these stem cell trials and hopefully bring this exciting technology to MS patients worldwide. Please pass the word along, and (click here) to donate.

A big thank you to all who participate in and contribute to this project, and to all the Wheelchair Kamikaze readers that have made their voices heard at the NMSS in regard to funding the Tisch Center’s efforts. It appears that the MS Society may finally be ready to listen, and hopefully the NMSS will this time come through with funding for this vital research.

I’ll keep you posted…

National MS Society FAIL: UPDATE – The NMSS Responds

First, I’d like to thank all who helped contribute to the online dialogue (some might even call it a brouhaha) spurred by my last post on this blog (click here), which detailed the American National Multiple Sclerosis Society’s repeated refusals to fund the only current ongoing FDA approved stem cell trial being done on MS patients in the nation, at The Tisch Multiple Sclerosis Research Center of New York. Your response has been a personal inspiration to me, and your comments and sharing of the article on social media have definitely been noticed by the powers that be.

Several readers have forwarded me statements they received from the NMSS in regards to phone calls or emails they sent to the Society in response to that Wheelchair Kamikaze post. The body of each example of the Society’s feedback includes identical text, apparently written by the Society’s communications department. Nothing wrong with that, per se, as any large organization needs to fashion a coordinated response to any issue of concern, but I do feel it necessary to make some points about the reply sent out by the NMSS. Here’s the heart of the text sent by the Society to those who inquired about the organization’s repeated lack of funding for the Tisch Center’s ongoing stem cell research efforts:

“Regarding stem cell research, the Society is currently funding 15 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin.  We have supported 70 stem cell studies over the past 10 years.  We have also convened international meetings on the potential of stem cells to drive new, effective MS treatments.

The Society’s research funding decisions are determined with advice from internationally renowned scientific experts who review the more than 500 research proposals received each year.  These volunteers bring a broad range of knowledge in different MS specialties, including stem cell research and clinical trials expertise. They help us determine each proposal’s scientific merit and relevance to MS, assess the originality of the proposed project, and evaluate the experience and scientific track record of the applicants. 

The decision to not fund the Tisch MS Center stem cell clinical trial was based on the advice of a review committee comprised of experts with experience in stem cell research and clinical trials as well as perspective from individuals living with MS.  The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns. We are pleased to receive proposals from Dr. Sadiq and to work with him. In fact, the Society has collaborated with his research team on an innovative pilot project to understand one of the biological pathways in MS. 

There is exciting progress being made through innovative research related to the potential of many types of stem cells for both slowing MS disease activity and for repairing damage to the nervous system. With the urgent need for more effective treatment for MS, especially progressive forms of the disease, we believe that the potential of all types of cell therapies must be explored.  

Additional information about Society funded stem cell studies and stem cells research underway internationally can be found on our website http://www.nationalmssociety.org/Research/Research-We-Fund/Restoring-What-s-Been-Lost/Repairing-Damaged-Tissues/Stem-Cells-in-MS”

Although my own professional expertise on any of the matters outlined above is infinitesimally small compared to that of the internationally renowned scientific experts who decide which research efforts the NMSS will fund, I’ll take the liberty of commenting from my position of expertise as a patient being forced to slowly watch himself disappear courtesy a horrendous brain and body eating disease. I've also been a patient at the MS clinic that works hand-in-hand with the Tisch Center since 2004, and being the pain in the ass that I am I’ve become quite familiar to and with many of the doctors and researchers involved.

I’ll start my comments on the statement put out by the NMSS with a short, general critique of the Society : Too Much Pharma!

Now, I know that this criticism may sound simplistic, hyperbolic, and even a bit trite at this point, but the influence of Big Pharma on all aspects of medical research has been terribly corrosive, and not because the pharmaceutical companies are staffed by evil ogres intent on hiding cures from a nettlesome population of sick people. No, I honestly believe that the vast majority of pharmaceutical company employees are good people doing their jobs to the best of their abilities, and therein lies the crux of the problem.

The job of pharmaceutical company executives, who helm what are almost all publicly traded enterprises, is to make as much money as possible to keep their companies’ stock prices on an ever increasing upward trajectory. This creates a confounding conflict of interest; treating chronic diseases in perpetuity with hyper expensive drugs has become a very successful business model; curing them, on the other hand, kills that business model. Combine this dynamic with the fact that we’ve handed almost all of our mid and late stage medical research over to the pharmaceutical companies, and you have a research model that is dysfunctional to its core, and one which leads many to suspect that the pharmaceutical companies would use a variety of tactics to delay or suppress any potential treatments – like, say, stem cells – that might damage their core business model.

The NMSS has consistently stated that less than 5% of their donations come from Pharma. I’m not sure if this figure includes all of the advertising dollars the pharmaceutical companies spend on NMSS publications and events, but even if it does, it’s too much. I am always astounded by the massive amount of advertising contained in the NMSS’s primary publication, the slick quarterly magazine Momentum, which serves as the face of the organization that serves as the face of multiple sclerosis for most of the general population of America. It’s hardly a stretch to say that every other page contains a Madison Avenue type advertisement for one MS drug or another, the total effect of which makes it easy to perceive the NMSS as a mere extension of the pharmaceutical companies.

If indeed Pharma monies make up less than 5% of the Society’s yearly take, my best advice to them would be to divest themselves completely of these monies. The shortfall would in large part, I’m sure, be quickly made up by donations from people who have long held back from giving because of their perception of the NMSS being locked in Big Pharma’s embrace. The Society could continue educating patients about MS disease modifying drugs, and do so without even the slightest hint of being under the sway of the companies who manufacture them.

In contrast, the International Multiple Sclerosis Management Practice (IMSMP), the MS clinic associated with The Tisch Center, doesn’t even allow pharmaceutical company representatives through the front door. The doctors who work there are not allowed to take any pharmaceutical company largess, and the clinic is one of the few medical facilities I’ve ever visited that doesn’t have the name of one pharmaceutical product or another emblazoned on every pen, sticky note, and wall decoration in the place. You’ll find none of these things at the IMSMP, precisely because the physician who runs the facility, Dr. Saud Sadiq, is fiercely independent and refuses to let the influence of Big Pharma, no matter how subtle, cloud the judgments of the staff who works there.

It is true, as the statement put out by the NMSS asserts, that the society has funded research into stem cell therapy in the past, and is currently funding 15 stem cell trials in the US. The problem is, as best I can tell, all of those studies are early-stage studies being conducted in test tubes or on animals, and even if successful the benefits of these trials will not reach MS patients for at least a decade or more.

The study being conducted by the Tisch Center is a human trial, using living, breathing MS patients to test a technologically advanced stem cell therapy which, if successful, could revolutionize the treatment of multiple sclerosis in a relatively few number of years, not decades. The Tisch Center spent over 10 years doing test tube and animal research before getting their FDA approval, so that work has already been successfully completed. Again, this trial is the only FDA approved stem cell study currently being conducted on MS patients. The only other such trial that I know of was completed by the Cleveland Clinic last year.

The NMSS writes that their decision whether to fund a project depends on “each proposal’s scientific merit and relevance to MS”, assessment “of the originality of the proposed project”, and evaluation “of the experience and scientific track record of the applicants”. I spoke to one of my friends who works at the NMSS's headquarters in Denver, but due to confidentiality agreements between the Society and grant applicants they could not divulge whatever issues the NMSS may have had with the research being done by the Tisch Center. I can say that the research proved safe enough and showed enough potential coming out of the laboratory to be only the second MS stem cell trial to win FDA approval, and the Tisch center applied for NMSS grants on three separate occasions, each application addressing the issues the Society had with the last. I'm not sure what "individuals living with MS" the NMSS consulted with, but from where I sit (since I can barely stand) the research is most certainly relevant to MS.

Furthermore, the Tisch trial is using proprietary methods to transform raw stem cells into a type of stem cell specific to the central nervous system, a technique far more sophisticated than any previously used in human stem cell trials, and far more refined than the stem cell treatments being offered, at substantial cost, to patients by most offshore clinics. I’d say that accomplishment should tick the “originality” box on the list of NMSS requirements.

As for the “experience and scientific track record of the applicants”, if I were to list the research published by scientists at The Tisch Center in only the last five years, this post might just break the Internet. Okay, maybe that’s an exaggeration, but you can check out just some of the research being done by the Center on their website (click here).

The Society’s response to inquiries about their repeated rejections of the Tisch Center’s research proposals further states that “The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns.” This is quite true. What is also quite true is that Dr. Sadiq submitted not one, not two, but three proposals to the NMSS, attempting each time to address their concerns, to no avail.

The first proposal was submitted before the trial received FDA approval, and one of the primary stated reasons for the NMSS’s rejection of that proposal was the fact that the trial wasn’t FDA approved. After the trial received FDA approval, another proposal was made, which was again rejected. Undaunted, and in need of funding to continue this vital research, the Tisch Center submitted a third proposal, which the researchers involved believed addressed the concerns expressed by the Society's most recent rejection. The third proposal was again rejected.

I’m not privy to the precise concerns expressed by the Society that were used to back up their rejection of the third and final grant proposal submitted by the Tisch Center. However, I do know that the trial did win an extremely rare FDA approval, is using state-of-the-art technology and techniques, is testing methodology that if successful will expand the boundaries of the science, and is being conducted by world-class researchers at a world-class facility in the heart of the biggest city in the nation.

Any safety concerns that the NMSS's experts may have had should have been alleviated by the FDA approval, and unless those experts included soothsayers and seers I'm not entirely sure how they could determine the odds of success for a trial the likes of which has never before been attempted. I may be admittedly biased, but I find it hard to imagine that the Society’s concerns were so dire that three rounds of proposals couldn’t result in a solution. Especially since, even as you read this, hundreds if not thousands of MS patients are flocking to medical tourism sites offering unproven stem cell treatments at facilities of widely varying quality at a cost of many tens of thousands of dollars out-of-pocket.

The NMSS further states that it is funding one pilot project currently underway at the Tisch Center, and this is true. The trial in question was funded back in 2011 to the tune of $44,000, which may seem like a substantial amount of money to the average Joe, but in the world of medical research is fairly negligible (keep in mind that the NMSS receives approximately $100 million worth of donations every year). I spoke with the head of fundraising at the Tisch Center, who told me that the NMSS may have funded another Tisch Center study back in 2005, but she’d have to dig through her files to confirm that. I told her not to bother.

So, there you have it, the National Multiple Sclerosis Society’s response to inquiries as to why they refused to fund a trial that, in my humble opinion, has at least as much potential to change the lives of MS patients as any currently ongoing study, and my reaction to that response. Perhaps I’m partial since I am a patient of Dr. Sadiq’s, but my passion on the subject comes more from the desperation I feel as a human being whose body is being consumed by a relentlessly vicious disease, and not from my allegiance to any medical professional or facility. I promise.

I would urge those who feel similar passion to have their voices heard. The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here).

I would also ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, as to a person the NMSS staffers I know personally are truly good people who are fully dedicated to the cause. It’s just the institution they work for that may be misguided…