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Clinical trial launches to see whether vitamin D helps treat multiple sclerosis |
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Thursday, 19 April 2012 16:45 |
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Contact: Arney Rosenblat
arney.rosenblat@nmss.org
212-476-0436
National Multiple Sclerosis Society
The investigator-initiated study, funded by the National MS Society, tests whether supplements added to standard treatment can reduce disease activity
New York – Doctors at several centers across the U.S. are recruiting people who have multiple sclerosis (MS) to determine the effectiveness of high-dose vitamin D supplements for reducing MS disease activity. The vitamins would be added to standard therapy with glatiramer acetate (Copaxone®, Teva Pharmaceutical Industries). The study, funded by the National Multiple Sclerosis Society, is being led by Ellen Mowry, MD, MCR, at Johns Hopkins University in Baltimore. Other cities with centers recruiting participants include Portland, St. Louis, and San Francisco, and additional centers are being established.
A number of genetic and environmental factors influence whether a person will get MS. These factors may also impact the severity of the disease. Mounting evidence has been pointing to a reduced level of vitamin D in the blood as a risk factor for developing MS. In lab mice, vitamin D can reduce the effects of EAE, an MS-like disease, and growing evidence suggests it is time to test whether vitamin D can provide benefits to people who have MS.
Investigators are seeking 172 clinical trial participants between the ages of 18 and 50, who have been diagnosed with the relapsing-remitting form of MS. More details on the enrollment criteria are available at: http://www.clinicaltrials.gov/ct2/show/NCT01490502.
Participants will begin standard Copaxone treatment daily and will be randomly assigned to take the current recommended daily allowance of vitamin D or a high dose. The primary goal of the study is to determine whether vitamin D can reduce the proportion of people who experience a relapse. Other outcomes being studied include relapse rates, quality of life, brain tissue volume, disability progression, and safety.
Read More from Eureka Alerts
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Last Updated on Thursday, 19 April 2012 17:09 |
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Treating Relapsing Multiple Sclerosis |
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Written by Stuart Schlossman
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Friday, 20 April 2012 14:58 |
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Treating Relapsing Multiple Sclerosis
Source: WebMD
By Peter Jaret
Reviewed By Neil Lava, MD
Living with multiple sclerosis means living with uncertainty. The course of the disease is very difficult for doctors to predict. Some people live with MS for years without suffering serious symptoms. Others may rapidly become disabled. Why the course of the disease varies so widely remains unclear. One thing is certain. Most people with MS experience periodic relapses, also called flare-ups or attacks. These can be mild or severe. They may show up in many different ways. Symptoms can include:
- ØMuscle weakness
- ØVisual disturbances
- ØBalance problems
- ØMemory loss
- ØLoss of bowel or bladder control
“Between 85% and 95% of MS patients begin with what we call remitting/relapsing MS,” says Anne Cross, MD, professor of neurology at Washington University School of Medicine. During that phase of the disease, the pattern of relapses varies widely among patients. Some people have frequent relapses. Others have very few. The average is typically one to two attacks a year, according to Cross.
Doctors can help MS patients live as active and normal a life as possible by treating acute relapses as soon as they occur. Yet there are instances when doctors may recommend not treating a relapse.
Long-term and Short-term Treatment Strategies
Doctors follow two basic strategies in treating multiple sclerosis. To slow the long-term progression of the disease and reduce the frequency of flares, doctors prescribe “disease-modifying” agents. The most commonly used drugs are interferon (Avonex and Rebif ), fingolimod (Gilenya), mitoxantrone (Novantrone), and natalizumab (Tysabri). Other MS drugs used to reduce the number of flares or disease exacerbation include interferon beta (Betaseron and Extavia) or drugs such as Copaxone (glatiramer acetate).
Research shows that these disease-modifying drugs can decrease the rate of relapses by about 30%. They also lessen the severity of relapses. Not all forms of MS respond to these drugs, however. And even when the drugs work, they do not offer a cure. Most people continue to experience periodic relapses.
When acute attacks occur, doctors can suppress the underlying autoimmune damage, which is at the heart of MS, with the use of corticosteroids. Studies have shown that corticosteroid treatments significantly reduce the severity and shorten the duration of relapses for most patients. A typical dose is between 500 and 1,000 milligrams of intravenous methylprednisolone, which is gradually reduced over several weeks.
“But there is no clear-cut best way to administer corticosteroids, so doctors usually go on the basis of their own clinical experience with the disease,” says Ben W. Thrower, MD, medical director of the Andrew C. Carlos Multiple Sclerosis Institute at the Shepherd Center in Atlanta.
To Treat or Not to Treat
Even when they are untreated, however, acute relapses of MS typically resolve on their own over a matter of days or weeks. For that reason, and because corticosteroids are powerful drugs with some unwanted side effects, doctors may recommend using them only for relapses that significantly affect a patient’s function. Adverse side effects of corticosteroids can include fluid retention, weight gain, elevated blood pressure, and mood swings.
“If a patient comes in with a little bit of numbness in one foot, I may recommend just waiting it out,” Thrower tells WebMD. “But if a patient comes in with significant problems walking, for example, I’ll recommend corticosteroids.”
One of the most common forms that MS relapses take is optic neuritis, cause by temporary inflammation of the optic nerve. Symptoms include blurred vision and eye pain. Like so many other features of the disease, the severity of optic neuritis varies widely among patients. “If a patient has only mild vision problems, we may decide to watch and wait without treating the relapse,” says Cross. “But if vision is significantly affected or there’s pain, then we’ll usually recommend treatment.”
In addition to immune-suppressing corticosteroids, which suppress the underlying disease process in MS, a variety of drugs can be used to treat specific symptoms of relapses. These include antidepressants to treat depression, erectile dysfunction drugs to ease sexual problems associated with MS, and a new drug called dalfampridine (Ampyra), which has been shown to help improve walking in some patients.
Quality of Life
Can treating relapses quickly and aggressively reduce nerve damage and slow the long-term progression of the disease? Doctors don’t have a complete answer yet. In theory, it makes sense that if you limit damage from inflammation, the disease will progress more slowly. Some researchers have even tried using periodic treatments with corticosteroids in hopes of delaying the progression of MS. But so far, there’s little evidence that the approach offers any benefit.
“In general, I believe that steroids hasten recovery and may reduce the risk of future relapses for a time,” neurologist Elliot Frohman, MD, an MS researcher at the University of Texas Southwestern Medical Center, wrote in an email to WebMD.
But one recent study, called the Optic Neuritis Treatment Trial, found that treating relapses may have little if any effect on the long-term course of MS. Researchers looked at acute relapses that caused optic neuritis. Some patients were given oral prednisone. Others received no treatment at all. Patients in the high-dose prednisone group recovered more quickly from optic neuritis. But a year later, researchers found no difference between the treated and untreated groups in terms of disease progression.
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Last Updated on Friday, 20 April 2012 15:11 |
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What is Multiple Sclerosis? |
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Written by Stuart Schlossman
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What is Multiple Sclerosis?
Multiple Sclerosis (MS) is a chronic neurological disorder that affects the central nervous system, (CNS) comprised of the brain and spinal cord. In the CNS, nerve fibers or axons are surrounded by a layer of insulation called myelin. Myelin allows nerve signals to travel properly,
In MS, the myelin is destroyed (demyelination) on the brain and spinal cord. The scarring, located at multiple sites in the CNS, disrupts transmission of messages that communicate a desired action from the brain, through the spinal cord, to various parts of the body. The inflammation produced by MS damages the axons themselves and can cause permanent loss of function. In the process, the cells that produce myelin can also be damaged. This limits the ability of the brain to repair damaged myelin.
This is similar to a frayed electrical cord. The insulation assures that the electricity running along the wire reaches its destination without short-circuiting. In MS, the transmission along the nerve fibers “short-circuits,” becoming faulty or absent. This can cause problems with vision, coordination, sensation in the limbs, and other symptoms.
The course of the disease varies greatly from person to person. It is impossible to predict the severity or progression in any given individual. To better develop appropriate management plans, MS is divided into four classifications:
Relapsing-Remitting - clearly defined attacks lasting from days to weeks, with full recovery or with some remaining neurological symptoms and deficits upon recovery. Periods between relapses are stable and absent of disease progression. This is by far the most common form of the disease.
Secondary-Progressive – begins initially with a relapsing-remitting course that becomes consistently progressive and includes occasional relapses and minor remission. Deficits are accumulated without recovery between attacks.
Primary-Progressive – progression of level of disability from the onset without any distinct relapses of remissions. Temporary, minor improvements may be experienced.
Progressive-Relapsing – clear progression in disability level from the onset, but also clear acute relapses that may or may not include memory.
(Last reviewed 7/2009) - Source: MSF
Read more on Diagnosing MS, found here
Register to receive a weekly MS e-Journal by clicking here
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Last Updated on Sunday, 08 April 2012 10:52 |
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Multiple Sclerosis Researchers Find Cognitive Performance Declines as Outdoor Temperature Rises |
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Wednesday, 14 March 2012 09:37 |
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WEST ORANGE, NJ, Mar 13, 2012 (MARKETWIRE via COMTEX) -- Kessler Foundation scientists have shown for the first time that outdoor temperature significantly affects cognitive functioning in multiple sclerosis (MS). While it is recognized that disease activity increases during warmer months, this is the first study to document that cognition also fluctuates. During warmer outdoor temperatures, patients with MS performed worse on tasks involving processing speed and memory. An estimated 50 to 65% of people with MS experience problems with thinking, learning and remembering that can be disabling.
"Warmer outdoor temperature is associated with worse cognitive status in MS," was published online ahead of print by Neurology. An accompanying editorial, "MS and heat: The smoke and the fire," discusses the study's contributions to understanding MS. According to the results, cognitive performance may be a more sensitive indicator of subclinical disease activity than traditional assessments.
In the study, which spanned the calendar year, 40 individuals with MS and 40 people without MS underwent cognitive assessment of memory and processing speed. People with MS scored 70 percent higher on cooler days; no association was found for individuals without MS. Funding was provided by the National MS Society and the NIH.
According to Victoria M. Leavitt, Ph.D., research scientist, and the study's principal investigator, these findings have implications for patients, clinicians and researchers. "This information is relevant to making life decisions and choosing therapies and evaluating their effects," said Dr. Leavitt. "Outdoor temperatures may be an important consideration when designing and conducting clinical trials, many of which span six months." For example, taking baseline measurements during warmer months could inflate positive findings. The study's co-investigators are James F. Sumowski, Ph.D., Research Scientist, Nancy Chiaravalloti, Ph.D., Director of Neuropsychology & Neuroscience Research, and John DeLuca, Ph.D., VP for Research.
Kessler Foundation is nationally and internationally known for cognitive rehabilitation research in MS and traumatic brain injury. Its neuroscience research supports the theory of cognitive reserve, ie, people with MS who lead intellectually enriching lives are less likely to experience cognitive decline. A recent publication documented changes in brain activity on fMRI associated with effective memory retraining in people with MS.
About Kessler Foundation Kessler Foundation, the largest public charity in the field of disability, conducts rehabilitation research in mobility and cognition that advances the care of people with multiple sclerosis, brain injury, stroke and spinal cord injury. Kessler Foundation Program Center fosters new approaches to the persistently high rates of unemployment among people disabled by injury or disease. Find us at KesslerFoundation.org and on Facebook, Twitter, and YouTube.
Carolann Murphy, PA
973.324.8382
CMurphy@KesslerFoundation.org
Lauren Scrivo
973.324.8384
973.768.6583 (cell)
LScrivo@KesslerFoundation.org
SOURCE: Kessler Foundation -
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Last Updated on Wednesday, 14 March 2012 09:44 |
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Autoinjector Pen for MS Drug Approved By FDA |
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Wednesday, 29 February 2012 09:35 |
Autoinjector Pen for MS Drug OK'd
By John Gever, Senior Editor, MedPage Today
Published: February 28, 2012
A pen-type intramuscular injector that allows multiple sclerosis patients to self-administer interferon-beta-1a (Avonex) has won FDA approval, the drug's manufacturer said.
Biogen Idec said the device is the first intramuscular autoinjector to be approved for MS. It uses a thinner and shorter needle (25 gauge, 5/8 inch length) than the prefilled syringes that have been the company's mainstay for administering the drug.
The firm said the new autoinjector has been tested in a phase IIIb trial, in which some 90% of patients were able to dose themselves correctly. A similar percentage said they preferred the device to the prefilled syringe.
Separately, prescribing information for Avonex has been updated to include an optional titration regimen at the start of therapy, the company announced.
The regimen calls for gradual dosage escalation over a four-week period, starting at 7.5 mcg and increasing in 7-mcg increments each week until the regular dose of 30 mcg is reached. A clinical trial in healthy volunteers indicated that severity of flu-like symptoms was reduced by 76% compared with starting treatment at 30 mcg/week.
During titration, patients must use the conventional prefilled syringes fitted with a special kit for delivering the reduced doses. Once the full dose is reached, patients may then switch to the autoinjector pen, Biogen Idec said.
Article Source: MedPage Today
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Research Study finds Damaged Myelin Not the Trigger |
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Monday, 27 February 2012 19:48 |
ScienceDaily (Feb. 27, 2012) — Millions of adults suffer from the incurable disease multiple sclerosis (MS). It is relatively certain that MS is an autoimmune disease in which the body's own defense cells attack the myelin in the brain and spinal cord. Myelin enwraps the nerve cells and is important for their function of transmitting stimuli as electrical signals. There are numerous unconfirmed hypotheses on the development of MS, one of which has now been refuted by the neuroimmunologists in their current research: The death of oligodendrocytes, as the cells that produce the myelin sheath are called, does not trigger MS.
Neurodegenerative hypothesis obsolete
With their research, the scientists disprove the so-called "neurodegenerative hypothesis," which was based on observations that certain patients exhibited characteristic myelin damage without a discernable immune attack. In the popular hypothesis, the scientists assume that MS-triggering myelin damage occurs without the involvement of the immune system. In this scenario, the immune response against myelin would be the result -- and not the cause -- of this pathogenic process.
The aim of the research project was to confirm or disprove this hypothesis based on a new mouse model. Using genetic tricks, they induced myelin defects without alerting the immune defense. "At the beginning of our study, we found myelin damage that strongly resembled the previous observations in MS patients," explains Burkhard Becher, a professor at the University of Zurich. "However, not once were we able to observe an MS-like autoimmune disease." In order to ascertain whether an active immune defense causes the disease based on a combination of an infection and myelin damage, the researchers conducted a variety of further experiments -- without success. "We were unable to detect an MS-like disease -- no matter how intensely we stimulated the immune system," says Ari Waisman, a professor from the University Medical Center Mainz. "We therefore consider the neurodegenerative hypothesis obsolete."
Article source: Science Daily
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Scientists discover molecular mechanism behind MS relapses |
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Sunday, 19 February 2012 20:05 |
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February 18, 2012
MS is an autoimmune disease of the central nervous system which affects approximately 100,000 people in the UK.
The research, directed by Dr Bruno Gran at The University of Nottingham, focused on a population of cells of the immune system known as regulatory T cells, which control and regulate the behaviour of other immune cells. The results of this study have been published in the Journal of Immunology.
Dr Bruno Gran, from the School of Clinical Sciences, said: "The connection between infections and MS is complex. We have known for many years that in some cases, infections can promote disease exacerbations (also known as "MS relapses"). Our study sheds light on a new mechanism that could explain how infections can trigger such relapses. This might have relevance to other autoimmune diseases as well"
When the immune system is functioning properly Regulatory T cells - also known as Tregs - keep in check the tendency of other cells of the immune system to over react and cause inflammation when the body is under attack from infectious agents such as bacteria or viruses.
The battle of the immune cells
In the battle that follows the research group discovered that bacteria and viruses activate certain receptors of the innate immune system - known as Toll-like receptors (TLRs), making the Tregs less inhibitory. The positive consequence is that inflammatory immune cells are more able to react against infectious agents and eliminate them. The problem is that such increased activity of inflammatory immune cells could also increase the occurrence of autoimmune reactions against organs such as the central nervous system.
Research led by award winning PhD student
Most of the experimental work was conducted in the laboratory by award winning PhD student Mukanthu Nyirenda under the supervision of Dr Gran in the Division of Clinical Neurology. The research was funded by the Multiple Sclerosis Society of Great Britain and Northern Ireland.
Last year Mukanthu received the University Endowed Postgraduate Prize in recognition of the progress he has made with his research. He is also a previous recipient of a Jacqueline Du Pre' Award of the Multiple Sclerosis International Federation.
Mukanthu said: "This publication is a very important part of the work leading to my doctoral dissertation, planned for 2012. I am grateful for the recognition and support given to me by the University with the Endowed Postgraduate Prize."
The study was carried out in collaboration with Professor Cris Constantinescu and other researchers at The University of Nottingham and experts at McGill University in Montreal.
Flirting with the enemy
The research team also found that when stimulated by molecules that activate TLRs, regulatory T cells become themselves functionally more similar to inflammatory T cells, another reason why autoimmune reactions could occur in relation to infections.
Although this part of the study focussed on healthy subjects, ongoing studies in Dr Gran's laboratory are comparing the properties of regulatory T cells in these people with those obtained from patients with MS. Other researchers have previously found that Tregs may in fact be defective in MS patients, and this study contributes to our understanding of how episodes of infections, known to influence the clinical course of MS, could in certain circumstances promote the occurrence of autoimmunity.
Source: University of Nottingham
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Last Updated on Sunday, 19 February 2012 20:30 |
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Choosing the Right Therapy for YOU |
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Wednesday, 15 February 2012 19:40 |
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By Cherie C. Binns RN BS MSCN -- February 15, 2012
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I receive a quarterly publication for MS Nurses entitled “Counseling Points” which may be found on the web at www.counselingpoints.com . It is written by MS nurses for MS nurses to assist them in patient communication in the clinical setting of the MS Clinic. The Winter issue for 2011 was entitled , Changing Treatment Paradigms in MS and dealt the fact that as we work with disease modifying therapies (DMTs) over time, one of the findings is that most of our first line therapies (Interferon Beta 1a and 1b(Betaseron, Evista, Rebif and Avonex) and Glaterimer Acetate (GA or Copaxone) seem to be equally effective across the Board in preventing relapses andall have a high safety record.
For CIS (Clinically Isolated Syndrome) All of the lower dose interferons seemed to work quite well and only half of those with CIS went on to develop Multiple Sclerosis within 5 years of being treated with these medications. Rebif (the highest dose Interferon) and Copaxone (GA) worked well over a 10 year span of use to prevent relapses and progression in the majority of patients who took them faithfully.
This article also stated that “As many as one quarter of people with MS discontinue therapy within the first 6 months of treatment, with studies showing that perceived lack of efficacy accounts for 30% to 52% of therapy discontinuation.”p6 (citations are in the article in the above web link).
Given the proven effectiveness of the drugs we have had available for the past 15+ years, why are patients so hesitant to stay on therapy? For some, as in the above statement, they feel like it is not helping. Is the Medical community giving patients false hope when prescribing a therapy to treat MS? These therapies are designed to slow the progression of MS by slowing the frequency of relapses thereby preventing some nerve damage over time that could ultimately cause a Person with MS (PWMS) to leave the work force or develop secondary complications that would see an overall deterioration in their health.
So the big question is, how do you choose a therapy that is right for you in your circumstances and with your lifestyle?
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Last Updated on Wednesday, 15 February 2012 19:45 |
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Potentially Harmful Supplements for People with MS |
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Tuesday, 14 February 2012 19:05 |
Take Note, that anything immune stimulating, is not good for Multiple Sclerosis
Alfalfa immune-stimulating
Aloe: may interact with steroids
Asian ginseng: immune-stimulating, possibly fatigue-producing, may interact with steroids
Astragalus: immune-stimulating
Bayberry: may interact with steroids
Beta-carotene: immune-stimulating, greater than 10,000 IU/day may produce toxic effects, avoid in smokers
Borage seed oil: possible liver toxicity
Cat’s claw: immune-stimulating
Chamomile: possibly fatigue-producing
Chaparral: possible liver toxicity
Coenzyme Q10: immune-stimulating, may interact with warfarin (Coumadin)
Comfrey: possible liver toxicity
DHEA: possibly immune-stimulating
Echinacea: immune-stimulating
Garlic: immune-stimulating
Goldenseal: possibly immune-stimulating, possibly fatigue-producing
Grapeseed extract: possibly immune-stimulating
Kava-kava: possible severe liver toxicity, possibly fatigue-producing
Licorice: may interact with steroids
Lobelia: multiple possible toxic effects
Melatonin: possibly immune-stimulating
Niacin: greater than 35 milligrams/day may produce toxic effects
Nettle: possibly fatigue-producing
Oligomeric proanthocyanidins: possibly immune-stimulating
Passionflower: possibly fatigue-producing
Pycnogenol: possibly immune-stimulating
Sage: possibly fatigue-producing
St. John’s wort: possibly fatigue-producing
Selenium: possibly immune-stimulating, greater than 200 micrograms/day may produce multiple toxic effects
Siberian ginseng: immune-stimulating, possibly fatigue-producing
Valerian: possibly fatigue-producing
Vitamin A: immune-stimulating, greater than 10,000 IU/day may produce toxic effects, avoid in smokers
Vitamin B6: greater than 50 milligrams/day may produce toxic effects
Vitamin C: immune-stimulating, greater than 1,000 milligrams/day may produce toxic effects, may interact with warfarin (Coumadin)
Vitamin D: greater than 2,000 IU/day may be harmful
Vitamin E: immune-stimulating, may interact with warfarin (Coumadin)
Vitamin K: may interact with warfarin (Coumadin)
Zinc: possibly immune-stimulating, may cause copper deficiency
Taken from the Rocky Mountain Center Website www.ms-cam.org
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Last Updated on Tuesday, 14 February 2012 19:12 |
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FDA OKs PML Risk Test for Patients on Tysabri |
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Friday, 20 January 2012 19:49 |
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The FDA has approved the first test for assessing the risk of progressive multifocal leukoencephalopathy (PML) in patients on natalizumab (Tysabri).
By Kristina Fiore, Staff Writer, MedPage Today
Published: January 20, 2012
SOURCE: Medical News Today
The Stratify JCV Antibody ELISA test screens for the presence of antibodies to the JC virus, a risk factor for PML in patients with multiple sclerosis or Crohn's disease who are taking the monoclonal antibody, the agency said in a statement.
Natalizumab was pulled from the U.S. market in 2005 after the first of some 200 cases of PML came to light, but it was allowed back on the marketin 2006 after the development of a risk evaluation and mitigation strategy (REMS).
Risk of PML should be calculated not only by the antibody test results, but should also be based on the length of time the patient has been on natalizumab (more than two years increases the risk) and if the patient is taking other immunosuppresants, the FDA said.
Risk of developing PML is greatest -- about 11 in 1,000 -- if a patient has all three of these risk factors.
The agency warned that the test shouldn't be used alone in making a clinical decision about the risks and benefits of continuing on natalizumab treatment, and it is not diagnostic of PML.
The agency simultaneously updated the drug's warning label to reflect the new combination of risk factors for the disease.
Although many people are infected with the JC virus at some point in their lives, it's normally kept in check by the immune system, the agency said. However, biologic drugs may promote activation of the virus in immunocompromised patients.
A total of 201 cases of PML have been reported among approximately 96,582 patients treated with natalizumab through Jan. 4, 2012, the agency said, adding that there's currently no treatment, prevention, or cure for the condition.
The FDA reviewed the antibody test via the de novo reclassification process, an approval pathway for low- to moderate-risk devices that aren't comparable to anything already available on the market.
It's made by Focus Diagnostics and comarketed by Biogen Idec and Elan.
Remain up to date with MS news and information when registered here
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Last Updated on Friday, 20 January 2012 20:07 |
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National MS Society Convenes Summit to Explore Vitamin D Trials to Prevent MS |
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Friday, 20 January 2012 14:45 |
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Jan 17, 2012
Researchers and clinicians from around the globe gathered recently in Chicago to develop strategies for testing whether vitamin D supplements can prevent the development of MS. Participants discussed the latest findings relevant to vitamin D and MS and potential clinical trial designs, taking the first steps to making these exciting studies a reality. “Vitamin D and MS Prevention: An International Workshop,” was chaired by Colleen E. Hayes, PhD (University of Wisconsin-Madison) and Anne-Louise Ponsonby, PhD (Murdoch Children’s Research Institute, Canberra Australia), and was funded by the National MS Society.
Background: Research is increasingly pointing to a reduced level of vitamin D in the blood as a risk factor for developing MS. Years ago, MS researchers wondered why MS occurs less often in regions of the world where exposure to sunlight is high. Dr. Hayes – a professor of biochemistry and microbiology – and colleagues suggested that vitamin D, which is made by cells in the skin in response to sunlight, may suppress the immune response involved in MS. She and others have since shown that in lab mice, vitamin D can reduce the effects of EAE, an MS-like disease.
Epidemiologic studies (studies of who gets MS) have backed up laboratory studies. Dr. Ponsonby – an epidemiologist and public health physician – was a co-author of the Ausimmune Study, a comprehensive Australian study that showed that higher levels of sun exposure and higher blood levels of vitamin D were both associated with decreased risk of having a first demyelinating event, often the first indicator of subsequent MS.
The National MS Society has led the way in pursuing this avenue of MS research, funding much of Dr. Hayes’ work, first funding the Ausimmune study, and now, a new clinical trial testing whether vitamin D can reduce disease activity in people who have MS. Read more on clinicaltrials.gov.
The Meeting: Participants included experts in vitamin D studies, immunology, statistics, epidemiology, clinical MS research, pediatric MS, and MS biomarkers. The group began by bringing its vast experience to bear in discussing the promise and potential pitfalls of conducting “primary prevention studies” using vitamin D to potentially prevent MS before it occurs.
“We are people from all over the world and we have one common purpose – to stop this disease,” noted Dr. Hayes. “The research that has been done by the people in this room and others provides us with strong evidence that vitamin D may help.”
Alberto Ascherio, MD, DrPH (Harvard School of Public Health) and colleagues have published pivotal studies relating to several MS risk factors. His 2006 study – supported by the Society – compared levels of vitamin D in blood serum stored from military personnel during their service, and found that those with higher levels of vitamin D were at lower risk for later developing multiple sclerosis. Dr. Ascherio noted a major concern about designing vitamin D studies, based on his research. “Compliance is likely to be a major obstacle,” he said. “You have to worry about people in the placebo group that might take vitamin D anyway, and make the study powerful enough to account for that.”
Continue reading this article from the Nat'l MS Society website
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Last Updated on Friday, 20 January 2012 14:53 |
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MS Exercise: Staying Safe |
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Monday, 26 December 2011 10:05 |
Should people with multiple sclerosis exercise?
Definitely, says Tanuja Chitnis, MD, assistant professor of neurology and director of the Partners Pediatric MS Center at Massachusetts General Hospital for Children. In fact, she routinely recommends exercising two to three times a week to people living with MS as a part of a healthy lifestyle. And exercise has been found to have a number of benefits for people with multiple sclerosis, helping to control common symptoms of the disease such as fatigue, depression, and even bladder and bowel dysfunction.
Before starting any MS exercise program, however, it is wise to consult with your doctor. He or she may also recommend that you meet with a physical therapist who can develop a program of exercises that are specifically tailored to address your multiple sclerosis symptoms and to help you build strength and flexibility where you need it most.
MS Exercise: Getting Started
When starting an MS exercise program, remember to have fun, take it slowly, and listen to what your body is telling you. Jumping right in can lead to injury or fatigue, which may discourage you from maintaining your MS exercise routine over the long term. Your body can tell you if you're working too hard or if you can afford to turn up the intensity. If you experience pain during a workout, stop and check with an expert who can recommend an alternative to the exercise.
MS Exercise Classes
Check with your local MS support group or the National Multiple Sclerosis Society for help in finding fitness centers near you that have specific MS exercise classes geared to mobility-impaired people. If you don't have any MS exercise classes in your area, most instructors are willing to work with you to help meet your needs. Check in with the teachers before the beginning of the classes, and they can demonstrate alternatives to the movements or postures that might be difficult for you.
Some specific types of exercise you might want to try include:
- Yoga. This ancient regimen is a great way to stay flexible and has also been shown to have scientifically proven benefits for people living with MS. Yoga classes are offered at a variety of levels, from gentle to moderate to high intensity. When starting any new exercise routine, it's advisable to start slowly. If the intensity of the class is not clearly described on the schedule, call ahead to find out which class would be right for you. Another advantage of yoga is that it is highly modifiable. A good teacher can show you alternative postures if you explain your limitations before class.
Some styles of yoga, including "hot yoga" and "Birkram yoga," are practiced in hot rooms. Since people with multiple sclerosis can suffer from heat intolerance, it is a good idea to avoid these styles.
- Tai chi. The National Multiple Sclerosis Society (NMMS) reports that people with multiple sclerosis have used tai chi as a way to improve balance, and studies non-specific to MS indicate that tai chi can help not only with balance but with blood pressure and heart health as well. A staple of Chinese fitness, tai chi uses a series of slow, controlled movements to build muscle tone and increase flexibility. NMMS recommends tai chi for its adaptive nature. In fact, wheelchair tai chi is gaining in popularity in China and other countries.
- Aquatics. Water aerobics and other aquatic fitness programs are a great way for people with multiple sclerosis to exercise. Bodies are buoyant in water, which takes weight off the joints and allows for a greater range of movement. Exercising in water has an added benefit for people with MS: The cool temperature of the water can allow you to extend your workout without risk of overheating.
No matter what exercise you choose, one of the most important steps in any exercise program is the very first one: get moving!
Last Updated: 12/20/2011
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Personal Insights and Tools for Coping with MS |
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Tuesday, 20 December 2011 19:11 |
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The National MS Society
and MS Learn Online, presents
A Feature Presentation:
This four-part video series, on coping with MS, includes perspectives from people living with MS and conversations with Cathy-Lee Benbow, who will discuss coping techniques and strategies.
The importance of a support system
Building and maintaining healthy support
Educating family and friends about MS
Asking for help
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MS Research to Follow in 2012 - STOPPING MS IN ITS TRACKS, RESTORING LOST FUNCTION, ENDING MS FOREVER |
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Thursday, 08 December 2011 21:17 |
National MS Society Live Webcast December 13 Will Offer MS News You Can Use From Internationally Renowned Researchers
New York, NY (PRWEB) December 08, 2011
This year saw exciting research progress in efforts to stop multiple sclerosis, restore function that’s been lost and end the disease entirely. At least three emerging therapies are advancing through the pipeline toward FDA review while at least four clinical trials focusing on progressive MS continue to move forward.
New projects launched include clinical trials testing novel approaches to protecting the nervous system from MS damage; studies of adult stem cells and natural molecules that may stimulate repair of the nervous system to restore function; research on better treatments for symptoms; and studies on viruses and intestinal bacteria that may be involved in triggering immune attacks in people with MS.
The National MS Society continues its strategic support of cutting edge research and in 2011 has provided nearly $40 million to advance over 325 new and ongoing projects, ranging from discovery research to commercial therapy development. For a complete overview of the key potentially high-impact research results that occurred this year visit http://www.nationalmssociety.org/news/news-detail/index.aspx?nid=5766
Below is just a small sample or research that could change the lives of people living with MS in the near future. A live webcast to be held December 13, 8 PM ET, featuring internationally prominent MS investigators, will examine key MS research to follow in 2012.
STOPPING MS IN ITS TRACKS
New therapies showing positive results -- Several late-stage, phase III clinical trials in relapsing MS are making their way toward seeking marketing approval. These include oral teriflunomide, oral BG-12, and intravenous alemtuzumab. An application was accepted by the FDA to review teriflunomide for marketing approval.
Speeding diagnosis – An international panel revised and simplified the “McDonald Criteria” commonly used to diagnose MS, which is expected to reduce the emotionally wrenching wait for a confirmed answer to possible MS symptoms.
Early results support research of parasitic worms to treat MS -- At least two published studies reported results related to parasitic worms, called helminths, and their possible implications for treating MS. Further study, including the second phase of the clinical trial supported by the National MS Society, should determine whether a “probiotic” treatment approach using relatively harmless parasitic worms to alter immune activity will benefit people with MS.
New clinical trials involving people with progressive forms of MS
– Several clinical trials were launched involving people with progressive forms of MS.
These include:
- A trial by Novartis testing the oral immune modulator fingolimod in primary-progressive MS
- A trial by Biogen-Idec testing the immune modulator natalizumab in secondary-progressive MS
- An NIH trial testing the immune modulator rituximab in secondary-progressive MS
- An NIH trial testing the antioxidant Idebenone in primary-progressive MS
International Progressive MS Consortium launched – This group of MS societies and the MS International Federation met for the first time to establish mutual goals and priorities to drive research and to harness more resources aimed at progressive forms of MS.
RESTORING LOST FUNCTION
Initiative to repair and protect nervous system propelled progress -- The Nervous System Repair and Protection Initiative, funded through the National MS Society’s Promise: 2010 Campaign, set the stage for translating basic lab discoveries into clinical efforts to restore nerve function in people with MS. The initiative jump-started the field, trained scores of promising young investigators, produced over 180 research papers, and leveraged millions of dollars in new funding.
FDA approved Botox for treating urinary incontinence in MS and other neurologic conditions -- A new use for Botox® (onabotulinumtoxin A, Allergan, Inc.) was approved, providing an additional treatment option for people with MS or other neurologic disorders who experience urinary incontinence.
Research in many types of stem cells continued to progress –
- Cleveland investigators launched a clinical trial testing the safety of transplanting a patient’s own mesenchymal stem cells (derived from bone marrow) to treat relapsing MS.
- The National MS Society’s drug development subsidiary Fast Forward also announced an alliance to fund the development of Athersys’ MultiStem adult stem cell platform for the treatment of MS, including progressive forms, committing up to $640,000 to advance the program to the clinical development stage. Fast Forward has made 15 such investments to fill critical gaps between research discoveries and the drug development process since its inception in 2007.
Most women with MS have normal pregnancies, deliveries and birth outcomes – Investigators at the University of British Columbia, Vancouver, found that adverse pregnancy or birth outcomes did not differ among women with MS when compared with women without the disease in a large study.
First year’s progress from MS Societies’ initial studies on CCSVI and MS – Seven multi-disciplinary teams investigating CCSVI (chronic cerebrospinal venous insufficiency,http://www.nationalmssociety.org/ccsvi) in MS indicated that they were on track to provide essential data and critical analysis as these two-year projects move toward their completion. These studies were launched with over $ 2.4 million from the MS Society of Canada and the National MS Society (USA).
Walking a problem for many -- A survey conducted by Harris Interactive suggested that difficulty walking substantially interferes with activities of daily living and quality of life in a majority of people with MS, . Of those who had MS-related walking difficulty, 70% called it the most challenging aspect of MS, yet 40% of those surveyed “rarely or never” discussed walking problems with their doctors, supporting the need for early recognition and management of mobility problems experienced bypeople with MS.
ENDING MS FOREVER
Global consortium doubles number of MS risk Genes identified -- The International MS Genetics Consortium and collaborators identified 29 new genetic variants associated with MS, and confirmed 23 others previously associated with the disease, verifying a major role for the immune system in the development of MS. The results are now to be confirmed and expanded in an independent, second large-scale set of cases with a research grant from the National MS Society.
More on the role of vitamin D and sun exposure and MS risk -- Higher levels of sun exposure and higher blood levels of vitamin D were both associated with decreased risk of having a first neurological event that can be the first indicator of MS, according to a large study in Australia.
International summit convened on vitamin D and MS prevention December 12-13 – This Chicago meeting brings together experts to begin constructing a plan for how to design a clinical trial to test whether vitamin D supplements can prevent MS in people at high risk for developing the disease. .
Vitamin D levels low in African Americans with MS -- African Americans with MS have significantly lower levels of vitamin D than African Americans who do not have MS, says a new study, but these levels are not linked to disease severity, according to investigators at the University of California, San Francisco.
New studies collecting data aimed at ending MS forever
- The possibility that children diagnosed with MS may offer a window to early triggering events is the basis of a new study at the University of California, San Francisco, one of six centers in the network of Pediatric MS Centers established by the National MS Society. The multi-site study will investigate possible environmental triggering factors including common viral infections, vitamin D levels, exposure to smoking and others
- Investigators at the University of California, San Francisco, are recruiting African Americans with MS and their family members across the country for studies aimed at identifying genes that make people susceptible to MS.
- Researchers from the Harvard Medical School, Brigham and Women’s Hospital, and Partners Multiple Sclerosis Center are recruiting 5,000 subjects who have at least one first-degree relative with a diagnosis of MS. The goal is to identify the genetic, environmental and immune profiles that may increase a person’s risk of developing MS.
Source: From the Front Lines from The National MS Society
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Last Updated on Thursday, 08 December 2011 21:37 |
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Diagnosing Multiple Sclerosis - What Makes It So Difficult? |
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Thursday, 17 November 2011 08:51 |
Know the signs and symptoms your doctor will look for in examining you for multiple sclerosis.
Besides the fact that no single test can detect the disease, MS symptoms can mimic those of a number of other conditions, and they can change over time. Symptoms can also vary from person to person — and from day to day in the same person.
Here’s what you should know.
Symptoms of Multiple Sclerosis
Some early symptoms of MS are:
- Numbness or tingling in parts of the body, usually an arm or leg
- Unexplained weakness, dizziness and fatigue
- Blurry vision, double vision or blindness
Other symptoms include:
- Muscle spasms
- Impairment of the sense of touch and the ability to feel temperature changes and pain
- Problems with balance and coordination
- Tremor
- Slurred speech
- Bladder and bowel problems
- Sexual problems
- Depression
- Mild difficulties with concentration, attention, memory and poor judgment
- Moderate to severe pain
- Heat sensitivity
To diagnose the disease, healthcare providers use a number of tools and tests that often help rule out other possible causes.
Multiple Sclerosis Diagnosis: Tools and Tests
- Medical history: Doctors ask for details about personal health history and family health history and also question patients carefully about symptoms, their duration and their onset.
- Physical examination: A physical exam will most likely include tests to determine the health of nerves and muscles. Doctors may look for weakness in specific parts of the body, uncoordinated eye movements, and problems with balance, vision, and speech.
- Magnetic resonance imaging (MRI): If doctors possibly suspect MS after a physical exam, they will probably order additional diagnostic tests, starting with an MRI. During an MRI, a patient's body is placed within a magnetic field and scanned by radio waves. This combination creates detailed pictures of the part of the body being examined. In MS, doctors take scans of the brain or spine depending on the symptoms and physical exam. The resulting pictures can show patches, or scars, in the central nervous system where myelin has been destroyed. These areas are referred to as plaques. Since other disorders can cause these patches, an MRI scan can't provide definitive evidence of multiple sclerosis. But doctors rely primarily on MRIs to see evidence of the disease. MRIs are also important in tracking the progress of the disease, and doctors may order new tests from time to time to monitor a patient's condition. Researchers also use the test to see if experimental treatments have an effect on scarring in the central nervous system.
- Cerebrospinal fluid collection (CSF collection): If the diagnosis is still not clear, doctors may take a sample of spinal fluid. Patients typically lie on their sides with their knees bent up. The doctor administers a local anesthetic in the lower spine and, using another needle, takes out a sample of the spinal fluid. Doctors examine the sample for abnormalities associated with MS, such as increases in white blood cells and high levels of an antibody called immunoglobulin G.
- Evoked response tests (ERTs): These electronic tests, sometimes called evoked potential tests, measure the speed of brain connections. The most common ERTs are the visual evoked response test (VER), the brainstem auditory evoked response test (BAER) and the sensory evoked response test (SER). In each, doctors attach wires to a patient's scalp. Then, depending on the test, they give patients visual, auditory, or sensory stimulation. These stimuli are a checkerboard pattern patients see on a monitor, a series of clicks they hear through earphones, or short electrical impulses they feel on an arm or leg. The tests measure the speed of visual, hearing, and sensory pathways and can detect damaged areas in the brain.
Last Updated: 11/15/2011
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Progressive MS News: Opexa's Tovaxin(R) being fast-tracked |
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Wednesday, 09 November 2011 11:46 |
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THE WOODLANDS, Texas, Nov 08, 2011 (BUSINESS WIRE) -- Opexa Therapeutics, Inc., announced today that its lead drug candidate Tovaxin(R) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with Secondary Progressive Multiple Sclerosis (SPMS).
The FDA's Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. According to the FDA, products with a Fast Track designation often receive priority review, which may offer a significant benefit in that, historically, the review time of a priority product is almost half that of a standard review. Additionally, as per the FDA, Fast Track priority review products are more likely to be approved on the first review cycle than those without the designation. Fast Track also entitles Opexa to more frequent interactions and dialogue with the FDA, further benefiting the development of Tovaxin.
"Patients with progressive forms of multiple sclerosis (MS) are faced with no proven effective treatment options, so the Fast Track designation for Tovaxin is meaningful as it should enable Tovaxin to move more rapidly through the regulatory process, once it is proven to be efficacious," commented Dr. Mark Freedman, M.D., FRCP, FAAN, Professor of Medicine at the University of Ottawa and Director of the Multiple Sclerosis Research Unit at the Ottawa Hospital. "Novel therapies such as Tovaxin offer hope for patients with a diagnosis of progressive MS."
"The receipt of Fast Track designation from the FDA represents an important step in our strategy to advance Tovaxin through the clinical and regulatory process," said Neil K. Warma, President & Chief Executive Officer of Opexa. "We look forward to working closely with the FDA throughout the process as we recognize the need to develop a new, efficacious therapy to serve Secondary Progressive MS patients and realize the benefit Tovaxin could offer. Based on this positive FDA milestone, our encouraging data in SPMS and supportive discussions with key opinion leaders, clinicians and patients, we have accelerated our plans for SPMS and are planning to initiate a Phase IIb clinical trial with Tovaxin in SPMS subject to securing the necessary resources, while remaining committed to further advancing Tovaxin in Relapsing Remitting MS at a later date. For Opexa, moving forward in progressive MS, an area which we believe represents a higher unmet medical need, could further differentiate the company and Tovaxin from other MS treatments."
SPMS is characterized by a steady accrual of irreversible disability, despite, in some cases, reversible relapses, remissions, or clinical plateau. Only one product is currently approved in the United States specifically for the indication of SPMS. Opexa believes that a significant unmet medical need exists for the safe and effective treatment of SPMS.
Read More
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Written by Stuart Schlossman
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Monday, 17 October 2011 18:59 |
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What is CCSVI?
A Basic Definition
The Technical Definition
The Origin and History of CCSVI
A Basic Definition
CCSVI stands for “Chronic Cerebrospinal Venous Insufficiency,” a condition where people have obstructed blood flow in the veins that drain the central nervous system (the brain and spinal cord). Research indicates that CCSVI is significantly correlated with multiple sclerosis.1, 2,3,4 - As a result of these venous abnormalities, the blood flow rate through the central nervous system back toward the heart may become slowed, and blood may reflux back toward the brain and spine.1
People with CCSVI have one or more of the following blockages of the veins that drain blood from the central nervous system:
- Stenosis is an abnormal narrowing of the veins that restricts blood flow. Types of stenoses include the collapse of the vein, twisting of the vein, ring-like narrowings in the vein, and other similar obstructions
- An abnormal valve, septum, flap, or membrane that blocks or inhibits blood flow through the veins
- Atresia, hypoplasia, or agenesis are severe venous problems, including veins that are partially closed, underdeveloped, minimally formed, or almost entirely missing
Click here to see an animation that shows how stenosis in veins draining the central nervous system can cause CCSVI. This animation was provided by Dr. Zamboni.
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Last Updated on Monday, 17 October 2011 19:39 |
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Bladder Dysfunction and Management |
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Tuesday, 23 August 2011 07:48 |
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Source: National MS Society
Bladder dysfunction, which occurs in at least 80% of people with MS, can usually be managed quite successfully. Treatment strategies for bladder management include dietary and fluid management, medications, and intermittent or continual catheterization (inserting a thin tube into the bladder to remove urine).
Bladder dysfunction occurs when MS lesions block or delay transmission of nerve signals in areas of the central nervous system that control the bladder and urinary sphincter. The sphincter is the muscle surrounding the opening of the bladder, that controls the storage and outflow of urine. It is this muscle that gives people voluntary control over urination.
Symptoms and Complications
Symptoms of bladder dysfunction can include:
- Frequency and/or urgency of urination
- Hesitancy in starting urination
- Frequent nighttime urination (known as nocturia)
- Incontinence (the inability to hold in urine)
These symptoms can be caused by a “spastic” bladder that is unable to hold the normal amount of urine, or by a bladder that does not empty properly and retains some urine in it. Retaining urine can lead to complications such as repeated infections or kidney damage.
Left untreated, bladder dysfunction also could cause emotional and personal hygiene problems that can interfere with normal activities of living and socialization. It is therefore important to seek appropriate medical evaluation and treatment early, so that the cause of the bladder symptoms can be determined and treated, and complications avoided.
The related PDF documents require the Adobe Reader and will open in a new browser window. Download the Adobe Reader.
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Last Updated on Thursday, 17 November 2011 09:03 |
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Early Signs and Symptoms of Multiple Sclerosis |
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Monday, 08 August 2011 17:26 |
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Multiple Sclerosis early signs, symptoms can be in such a mild form as not to be initially detectable.
MS early symptoms and signs appear at the onset of the disease, usually between the ages of 20 and 40. MS early symptoms and signs vary in duration and severity from one individual to the other and at different times in the same individual. The most recurrent are:
walking difficulties
the sensation of having a weak or numb limb
cold or tingling feet
facial pain (Neuralgia)
blurred vision
Less common MS early symptoms include:
lack of coordination
cognitive difficulties
slurred speech
sudden onset of paralysis
As the disease progresses other symptoms can appear.
MS pain
MS pain is the type of pain that affects the central nervous system and pain syndromes are common amongst MS patients. Almost 50% of MS patients suffer s from chronic pain. There are several types of MS pain. The main types are:
Neuralgia, which is a stabbing pain in the face; it is usually treated with anticonvulsants.
Dysesthesias, which is a burning, aching body pain; it is usually treated with anticonvulsants and sometimes with antidepressants which act on the nervous central system.
Lhermitte sign, which is a brief, electric shock like sensation that runs down the spine and is caused by bending the neck forward or backward. It is controlled by means of a soft collar.
A chronic sensation of ‘pins and needles’, which is treated similarly to acute Dysesthesias.
Muscle spasm and cramps, which are treated with anti-inflammatory drugs.
Back and skeleton pains, which are treated with heat, massage and physical therapy.
Multiple Sclerosis early signs, symptoms can be in such a mild form as not to be initially detectable.
MS early symptoms and signs appear at the onset of the disease, usually between the ages of 20 and 40. MS early symptoms and signs vary in duration and severity from one individual to the other and at different times in the same individual.
The most recurrent are:
- walking difficulties
- the sensation of having a weak or numb limb
- cold or tingling feet
- facial pain (Neuralgia)
- blurred vision
Less common MS early symptoms include:
- lack of coordination
- cognitive difficulties
- slurred speech
- sudden onset of paralysis
As the disease progresses other symptoms can appear.
MS pain
MS pain is the type of pain that affects the central nervous system and pain syndromes are common amongst MS patients. Almost 50% of MS patients suffer s from chronic pain. There are several types of MS pain. The main types are:
- Neuralgia, which is a stabbing pain in the face; it is usually treated with anticonvulsants.
- Dysesthesias, which is a burning, aching body pain; it is usually treated with anticonvulsants and sometimes with antidepressants which act on the nervous central system.
- Lhermitte sign, which is a brief, electric shock like sensation that runs down the spine and is caused by bending the neck forward or backward. It is controlled by means of a soft collar.
- A chronic sensation of ‘pins and needles’, which is treated similarly to acute Dysesthesias.
- Muscle spasm and cramps, which are treated with anti-inflammatory drugs.
- Back and skeleton pains, which are treated with heat, massage and physical therapy.
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Last Updated on Monday, 08 August 2011 17:35 |
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Regenerative Medicine (Myelin Repair) in MS: Where are we today? |
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Written by Stuart Schlossman
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Wednesday, 06 July 2011 17:12 |
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By Cherie C. Binns RN BS MSCN
Several weeks ago, I was asked by Stuart to get some information on the current state of myelin repair therapies as they relate to Multiple Sclerosis. At the time, I was reading a book written by a friend from my college days about his nearly thirty years of study of aging of cells, regeneration of cells and the potential therapeutic effects that would come of developing a technology that would take a single cell, reprogram it and allow it to become nerve tissue or heart muscle. He could see great promise for the cure of many illnesses and, as a result, the prolongation of life with a far greater quality than is currently in existence. The book is The Immortal Cell by Michael D. West, PhD and is available on Amazon for those interested in the process of developing these technologies and making them work.
After my conversation with Stuart, I researched where we were as a society in stem cell therapies and success with treatment. I also searched the database at www.clinicaltrials.gov for “Multiple Sclerosis + stem cells” and was pleased to see a list of 26 clinical trials. However, as I looked closely at each trial, 5 were already closed with no data on the site, 2 were for scleroderma NOT multiple sclerosis, one was for Devic’s, NOT multiple sclerosis, and one was for NMO (neuromyelitis optica) NOT multiple sclerosis. Of the remaining 15 trials listed, one was in Jerusalem, one in Germany, one in Spain, two in China and two in Thailand. Of the 8 trials in the USA, two had not yet started recruiting, three were active and no longer recruiting and only three were currently accepting subjects into the trial.
Criteria for these trials are strict. Persons must have had MS between 5 and 15 years and be between the ages of 18 and 50. They must have tried the injectable medications and been found to have failed them. They cannot have taken Novantrone or Tysabri. They must not have had Cytoxan (or immuran, methotrexate, CellCept) within three months of entering the trial or IV steroids within the month of entering the trial. All trials require that the person be walking when they enter the study.
The proposed approach in these trials is to remove the patient’s own blood cells and process them to target just the stem cells in the blood. Those stem cells would then be modified by electrical charges to redirect the way they grow and work so that they will, when reinfused, go directly to the brain and spinal cord repairing damaged myelin and nerve tissue. These are Phase I trials which means the safety is being established in humans so trial size is very small (10-20 persons). In two of these trials, the patient must undergo complete immune system shut down with chemo therapy and radiation of bone marrow prior to receiving the infusion of their modified stem cells back into their systems. For full information available to the public on what I have described about these trials, follow this link:
http://clinicaltrials.gov/ct2/results?term=Multiple+sclerosis+and+stem+cells
Dr. Timothy Vollmer, in his September 2009 issue of eMS news, describes what these open clinical trials seek to do. He writes:
This second type of stem cell transplant is called a hematopoietic stem cell transplantation (HSCT). The blood stem cells that are transferred in an HSCT are typically obtained from bone marrow. In the past, the procedure for obtaining these blood stem cells from the bone marrow was quite grueling and required general anesthesia. Today, however, hematopoietic stem cells are generally collected from the peripheral blood, making the procedure less invasive. (Per Dr. West, “the mortality rate in the bone marrow stem cell patients is commonly about 30%” hence the use of peripheral blood)
In order to perform an HSCT, doctors first collect a patient’s stem cells (from peripheral blood) and then destroy his/her immune system through the use of chemotherapy and radiation. Once that process is complete, the saved blood cells are re-injected and the person’s body begins to rebuild the wiped out blood cells, bone marrow, and consequently the immune system. This process is called engraftment. As mentioned above, the thought behind this procedure is that by destroying and then reconstituting the immune system, it will ‘reset’ and therefore no longer attack itself, thus halting or at least reducing disease progression.
West’s biomedical company GERON worked diligently for 15 years on this technology once it was working in the laboratory to get it to show promise in an animal model but were never successful in making the transition to a human host. Here is what West is currently working on as it relates to MS http://cellcureneurosciences.com/aboutCCN.htm . This link includes a paper on the Animal Model of MS and how it is responding to this new approach to therapy. To quote Dr. West in an email I received from him this morning:
The opportunity:
Because hES cells can become all the cell types in the human body, at least two therapeutic strategies for MS become apparent. First, it may become possible to produce large quantities of the cells that produce myelin and to introduce those cells into the brain to repair the damage done during the course of the disease. Second, it may be possible to generate the blood-forming cells called bone marrow stem cells so that the immune system that attacks the myelin in MS can be removed from the body and replaced with new blood forming cells that do not have that destructive potential. In a third possibility, the day may come when both strategies are used, that is, the immune cells that attack myelin are removed, replace with new blood cells that do not attack the CNS, and then myelin-producing cells are introduced to repair the damage done in the course of the disease.
Where we are at:
The biotechnology company Geron Corporation led in the early isolation of hES cells. In January 2009, the FDA approved Geron’s first clinical trial which utilized hES-derived myelinating cells for the treatment of thoracic spinal cord injury. This trial is currently in Phase I (safety studies) in humans. Bretzner et al (2011) have argued that Geron should consider the merits of testing their product on MS patients instead. Their argument is based on the apparent efficacy of Geron’s myelinating cells in mouse models of MS, and the fact that some pharmaceutical agents targeting myelination while not showing efficacy in spinal cord injury, nevertheless show promise in MS. While Geron is currently not enrolling MS patients in its trials, it appears they may do so in the future, or assuming that their product is eventually approved by the FDA, it may be used at that time off label for MS patients.
The Myelin Repair Foundation (MRF) is in the same boat. They have over 100 strains of cells that look promising and techniques that can change the function of embryonic stem cells and cells from an individual (autologous) which can then be reprogrammed and introduced back into the person. So far they are years away from actualizing this into a treatment for multiple sclerosis. Their progress is highlighted in the brochure at this site:
http://www.myelinrepair.org/documents/2941-MyelinRepair_BrochureFULLP8R2.pdf . The MRF also has a video which may help explain how they are approaching this cell technology which can be found here: http://www.youtube.com/embed/juEqDbag88c?rel=0.
Many of the researchers working for the MRF are mentioned in West’s book The Immortal Cell, so have been working on this technology already for more than two decades and are still not ready to bring this to a human model.
In summary, while stem cell therapies hold great promise for the treatment of such illnesses or conditions as Multiple Sclerosis, Parkinson’s, Spinal Cord injury, Heart Disease, Diabetes, the technologies have been intensely studied since the mid 1980s without a reliable crossover from the animal model to the human model. There are small studies currently being conducted on humans but these come with potential of severe side effects and potential loss of life.
It is not apparent that a “cure” for MS via this approach or even a reliable repair of myelin in the human host will be available for another 10 years, if even then. The reason for this is that when a treatment has been developed, it must then be subject to rigorous safety and dosing trials then go to the FDA for approval. Many of us have been around to see how long it took to get our first line drugs (the interferons and GA) to market then the resulting battles with Tysabri and Gilenya. Nothing, currently, is closer than that window of 10 years out in the field of stem cell regenerative medicine to treat or cure Multiple Sclerosis.
Respectfully submitted by: Cherie C. Binns RN BS MSCN on July 5, 2011
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Last Updated on Wednesday, 06 July 2011 17:27 |
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