Stem Cell Treatment for MS: Can’t We Move Any Faster?
There is some good news about stem cell therapy. A just-published study concludes that one form of human stem cell therapy is more effective at treating multiple sclerosis than the best of the MS medications being used currently.
The not-so-good news is that approval of this therapy in the U.S. still seems to be a long way off.
The treatment is known as high-dose immunosuppressive therapy and autologous hematopoietic cell transplant (HDIT/HCT). The procedure, more widely known as HSCT, aims to suppress active disease and to prevent further disability by removing disease-causing cells and resetting the immune system. During the procedure doctors collect a patient’s blood-forming stem cells, give the patient high-dose chemotherapy to deplete the immune system, and then return the patient’s own stem cells to rebuild the immune system.
Stem cell replacement is better than MS drugs
The five-year study, that was published in the February issue of Neurology, shows that HDIT/HCT can result in sustained remission of relapsing-remitting MS. Five years after receiving HDIT/HCT, 69% of the trial participants had no progression of disability, relapse of MS symptoms or new brain lesions. And some of the patients had some of their symptoms improve. This occurred without taking any MS medications after the stem cells were replaced.
“These extended findings suggest that one-time treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications for people with a certain type of MS,” said Anthony S. Fauci, MD, the Director of the National Institute of Allergy and Infectious Diseases.
More study needed
But, here’s the not-so-good news. In a press release Fauci continued: “These encouraging results support the development of a large, randomized trial to directly compare HDIT/HCT to standard of care for this often-debilitating disease.” So, Dr. Fauci, how many more years will that take? Granted, the study that was just completed involved only 24 volunteers, all of whom had aggressive, relapsing-remitting MS. We know the treatment carries some risks and that many participants in the study experienced some serious, but expected, side effects, such as infections. But, five years after receiving HDIT/HCT treatment, most trial participants remained in remission and their MS had stabilized. In addition, some participants showed improvements, such as recovery of mobility or other physical capabilities. It seems as if results such as that should shift research into high gear.
Is research moving fast enough?
Why, then, do investigators seem not to have greater urgency in making HDIT/HCT treatment available in the U.S.? “If these findings are confirmed in larger studies, HDIT/HCT may become a potential therapeutic option for patients with active relapsing-remitting MS, particularly those who do not respond to existing therapies,” said Daniel Rotrosen, MD, director of NIAID’s Division of Allergy, Immunology and Transplantation.
To me, that sounds like several more years of study before researchers will be ready to ask the U.S. Food and Drug Administration to approve this treatment. I’m not a doctor. I’m not a scientist. I’m just an MS patient who’s anxious to halt the progression of my disease and to walk better. Do I need to wait another five years or more while “a large, randomized trial” is conducted?
Just venting, I guess. But scientists have been studying stem cell treatments for years and it sure seems as if we’re still crawling when we should be cruising.
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[You’re invited to read more columns on my personal blog: www.themswire.com]
Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today, or its parent company, Bionews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.
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Comments
Tamara Sellman
Thanks for taking the time to lay this all out for readers. Good information here. Keep up the great work!
Tamara
Ed Tobias
Hi Tamara,
I'm glad you found the info useful.
Ed
Tom
Never will be a cure as the government want us with MS suffer and pay for these useless drugs.
Lynda Strecker
I so agree w/you! A friend of mine is friends w/a Sweedish Dr. who also has MS. She told my friend that when she attended some seminar,(this was @ 5 yrs. ago), the facilitator of the event wrote the following statement on the board:"CURES DO NOT = PROFITS". That says it all doesn't it? So sad.
Margaret
It is amazing how successful HSCT has been in Russia with lots of Australians having to go there for this treatment when we have Neurologists in Australia quite willing to do this.
Kay Rucker
Sadly, pharmaceutical companies make money on treatments, not cures. They will delay this as long as they can and pay for those delays out of a tiny portion of tha gazillions of dollar profits off those treatments.
Linguini
The Stem Cell Treatment (HSCT) referred to above has been studied for 50 years in cancer treatments. Dr. Burt at Northwestern has been studying HSCT (non-myeloablative) since 1996. His trial just finished phase 3. More research is not needed on HSCT. President Obama signed the 21st Century Cures Act in December making it much easier to bring procedures such as HSCT to patients, lets get it done!
Paul Brinkley
I wonder how quick they would be if it was happening to themselves
Gwen Hamer
HSCT is not strictly a stem cell treatment. The curative part is the "resetting" of the immune system using chemotherapy. The stem cells in HSCT are just used to hasten recovery from the chemo.
Mic
I am a little baffled. HSCT is being perfomed around the world. Recently in India http://hsctindia.com/. It's $30k. The world doesn't revolve around what happens in US only, rest of the world that have doctors also.
The more you wait the more permanent damage MS does to the body. I would not wait around for FDA to approve MS in US. The key is to get HSCT done asap (earlier the better chance of stopping this disease).
Good luck and god bless all of you.
Barbara
About 3 months ago I did a clinical study a STEMGENEX in San Diego. They harvested fat cells from my abdomen put them in a centrifuge, extracted the stem cells, activated them and put them back into my body intravenously. The doctors told me it could take 3 to 6 months to notice anything. I have noticed I am not as fatigued and I think I'm walking better. No chemo was involved.
Jennifer
Thank you SO much for providing this information! I've been wondering about the mesenchymal stem cell therapy, which does not involve chemo. It's hard to find information on it. I'd love to learn more about what STEMGENEX and other research facilities are discovering. Thank you, again.:)
Aaron
Barbara,
I contacted STEMGENEX as well. They told me that this was a 'trial' and I would have to shell out a few thousand dollars to participate. Is this the same company, or am I mistaken?
Sandy
I had the same procedure done over 2 years ago. I was all ready in a wheelchair when I went out to Santa Monica and I'm still in it. Nothing has gotten any better, in fact it has gone downhill in many ways. I have PPMS, don't know what type you have or how long you've had it. I was DX in 1998, and have been in the wheelchair for 7 years. I believe the chemo is the most important part of the procedure. Without destroying the crazy immune cells that are destroying the healthy cells, the new stem cells don't have a chance. They are under constant attack.
Tracy Thacker
you had the Adipose Stem cell done over 2 years age? Never any improvement?
Lisa
Did your neurologist agree with this? My neurologist at the Cleveland clinic discouraged that. I feel that it's my body not theirs. Did you have to pay for that? If so how much did it cost? Thank you, Lisa
Tracy Thacker
How are you doing now Ms. Barbara? I am sheduled to have this done for $10,650.00. Is it worh it? Will you please talk to me
Tracy Thacker
I was told they will inject it in my spinal area
bishan jain
Babrara,
I have recently (9th August 17 ) been diagnosed with MS. I lost 90% vision to one of my eye. After steroids treatment for 15 days have regained by 60/70%.
As per doctors MS is at a initial stage and investigation is on. Online information is very clear about no medical cure via drugs. It can just slow the patter but cant cure. I am worried regarding the same and had done a bit of research online. As you have had a clinical study at STEMGENEX i would like to have further more information about your expereince about it. Will going through this treatment help me for my future ?
Jacen
Your article expresses my feelings as well. I am completely frustrated at the pace the United States operates for chronic illness treatments. HSCT has been in practice for several years in other countries. I have been following several MS patients who have travelled abroad to receive this amazing life changing treatment.
Meanwhile we are told to be patient. As we wait... over the years our bodies transition from RRMS to SPMS... and we will no longer benefit from HSCT.
Meredith
I have been in touch with one of dr burt's patients. After more than two years she has thrown away her cane and she can play with her children. There have been many patients rejected by dr Burt whose circumstances were much different. I believe dr burts requirements are pretty strict. Young patients have a much better chance for success.
joan quilter
I was told by Northwestern that they'll take you if you have enhanced lesions. My daughter who now has SPMS (#9 on EDSS) has such lesions, but she's afraid to risk the procedure. Chemo can kill you, and some patients do die. She is now 39 and severely disabled, after being diagnosed in 1997. I think a patient must be aware of the risks involved with chemo.
Harry Crawford
Well it seems everyone is on the same page. The crooked FDA isn't gonna stop accepting kickbacks from big pharma. Therefore, those of us suffering will continue to suffer. This therapy has been used for many Years with success in other countries. The US had too many sorry politicians and people on the take in the FDA for this to be approved anytime soon. Look how long the FDA had been holding up Ocrevus due to the huge dent it's gonna make in much of the pharma business leaving many of the other drugs obsolete. Isn't it something how one organization can allow so much damage and despair with no repercussions. That's our wonderful government. Dr.Burt has been doing stem cell procedures for MS many years in the UK. One day this country might get a clue about the FDA and their lack of capabilities to do their job.
brian melton
I'm glad I got HSCT in Russia. It's not necessary for the government to decide my fate.
Scott
(Cure vs regiment)
"If,"when I was diagnosed with primary progressive multiple sclerosis five years ago, I had been told there was a drug that is about to lose its patent (Rituxan), that has shown promising results when given to patients early in their diagnosis of primary progressive multiple sclerosis and that I might could start a regiment of that medicine (made by biogen) until they could get a new patent on their slightly improved version (Ocrelizumab), that has apparently taken as many years to reinvent and bring to FDA, but I wasn't!
If I had been told five years ago when I was diagnosed with primary progressive multiple sclerosis, and still had some inflammation on my MRI, one of the criteria to be eligible for autologous hemopoietic stem cell transplant (AHSCT), that could have possibly halted and or even reverse my progression, but that I must have inflammation and walking to be eligible, but I wasn't!
If I had been told in early spring of last year when the trial for high-dose Biotin called MD 1003 had shown outstanding results for those 10 to 15% considered primary progressive multiple sclerosis more than anything other medicine currently offered that was a simple, safe, over-the-counter vitamin that needs no prescription might could help me, but I wasn't!
If I had "not" been told by the neurologist, "I will not write a prescription for Rituximab, but will write a prescription for Olcrizumab when it is available." But I was.
If I had been offered any of these options along with any others that may be out there early in the diagnosis of my disease five years ago, please hear me out, then I may agree that my well-being is in the interest of the neurologist and competitive pharmaceuticals and not just set aside until I was most profitable. But I wasn't!
I don't blame the pharmaceuticals. They have no choice. Just like myself they have families to feed and a business to run while keeping a eye on innovation and competition that could possibly put them out of business. Unlike neurologist who have taken an oath,"I will do no harm", I can't say that a large pharmaceutical company has the same obligation to that oath. Especially not personally knowing their customers, excuse me patients. It's sad but a cure could put them out of business, obviouslly! Undoubtedly they are fist obligated to shareholders and quarterly profits, obviously! As would be expected with any profitable business. Good business decisions and quarterly profits are required, or no business. This alone justifies keeping their fingers crossed that anything with the terms over the counter, once and done and or curable, such as AHSCT, could be devastating to their (God bless them),800 million dollar possibly 10 year investments. All this makes my head hurt and breaks my heart while knocking some of the wind out of my fight for survival.
If I had only known the truth from the start, I could've saved a lot of family finances and energy chasing down the truth. This is my motivation in writing anything about this at all. Other wise this is absolutely exhausting and robs me of much needed energy. We can say and do things that make us feel better about this, but the truth is an absolute. It is what it is.
Being so, it would only seem fair to me to let those following in my footsteps know what I know now so they can enjoy more time that they might have with their families and save time looking for options that are not obvious.
Even though the doctors have taken and oath 'I will do no harm, I can see a little bit of harm (i.e. Me) could easily be justified for funding of future research. It is obvious through the sunshine act and dollars for docs, that my neurologist made nearly a half million dollars in kickbacks from pharmaceuticals. This has to have a influence in her divulging information that may effect a bottom line somewhere. Such as the only reason I can't have Rituxan, is the same reason the clinical trials were stopped and called "flawed". Then restarted with Olcrilzumab under strict criteria with a very small subset of patients. Ones that are younger and early in their diagnoses. Ones that are most likely to show success which in itself could be considered flawed because of the cherry picking. How does that help those like me that just missed these new rules of criteria, steered toward a better outcome using 99% the same medicine under a different name. Would it of really made that much of a difference if they had been prescribing Rituxan four or five years ago for primary progressive multiple sclerosis if Ocrilzumab is worthy of the first FDA approval. The neurologist told me and I quote,"it was a business decision based on quarterly profits". How could she ever say that? Is that not doing me and any others like me harm?By keeping me from medicine that has been used off script, shown to be save and effective, and has been FDA approved for more than a 15 years. Yet for everyone with MS, and especially primary progressive's we have no alternatives and at every new symptom we are at a point of no return. Again I quote the urologist "NIH is controlled by pharmaceuticals," How can she say something so profound if it was not true? But she did. I have all these quotes on audio.
Now, in this lies a conflict of interest. Leaving the future of cures in the hands of a business who's investors stand to lose billions because their business is regimental medicines. That leads to doctors who have a financial incentive to keep you in the slot of a customer, and not patient until you become more profitable. In other words It's is not as if there wont be enough people diagnosed with MS in the future to justify keeping all current on a slippery slope, unless the purpose is two fold, hide the similarities between Rituxan and Ocrevous for the purpose of patent while at the same time maximizing customer a base. The new and improved and very expensive Ocrevous is going to be used in all forms of MS not just progressives. The numbers are impressive! This could be a incentive to know who everyone is. In either case this is possibly, though a very weak helping hand,( Rituxan )that is being withheld from people who are on a very slippery slope during the meantime the reasons for this regardless, are sad.
Please feel free to agree to disagree. Seeing this in a different light may be good medicine for us, otherwise I will assume you agree their hands are tied along with our feet, legs, bladders, bowels, arms, and of course also our hands by this terribly progressive chronic disease that is the equivalent of a slow moving stroke. That has been given the hideous name that some may have learned to love, but I have come to love to hate, - Regimental multiple sclerosis.
Gary W.
I could not agree with you more Scott I also have PPMS and I am in a clinical trial at the NIH with no positive results to show from it, the fact that the FDA is jacking around with the approval of Ocrilzumab gets a bit frustrating, I have read some great things from improving mobility to even remyeliating the damaged nerves and they put it off until the end of march because they want to look at the how it is made process!! good luck and hopefully in a month we can get the new drug.
Susan Schroder
I was SPMS, with an EDSS of 4.5 when I had HSCT in Puebla Mexico at Clinica Ruiz. Five months later a new EDSS evaluation was 2.
Now at 7+ months, I am still in recovery phase, but doing quite well. I went to Mexico with my rollator, but now I don't even use a walking stick. I didn't expect such a dramatic response, and would have been pleased to simply halt progression of MS.
This was so worth having done! I'm very happy, but I wish our country would get a move on and at least equal what is being done around the world.
George
Would so love to talk to you, Ms. Schroeder, about your experience. We are in the same boat. Please email me if you feel comfortable doing that.
Amanda
They started studying it in Chicago more than 20 years ago, it is ridiculous that is still has not been approved! Boy they keep on approving those high priced drugs that don't work and can kill you! I have been studying this and waiting for 17 years for approval in the states. I can't wait any longer, I am heading to Moscow in February to receive the treatment that I need!
Brenda L
I have applied to Mexico to get accepted in their program. Waiting now to hear back. We're tired of being bent over too.
Ed Tobias
Please let me know how this goes for you.
Good luck.
Ed
Susan a
Brenda please share with me re: How you applied in Mexico.
Biki
Already done hsct in India.
Results are impressive
Karan
Could you please tell the name of the institute in India and Dr ?
Mike Vogel
I am 64. 14 years ago I had an episode of optic neuritis that left me with about 60% vision and loss of depth perception in my left eye. I don’t have MS. ANy thought on stem cell therapy for me?
Helena Botelho
I was diagnosed with MS. I did lots of research & did stem cell transplant. I never had those nasty medicines. I'm doing better. Still taking lots of vitamins.