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Saturday, October 18, 2014

Stem Cell Therapy in MS Looks Safe; Test of Efficacy Awaits Future Trials



by Richard Robinson

BOSTON—Intravenous infusion of autologous stem cells is safe in multiple sclerosis (MS), according to final results from a recently completed trial. But the single dose used in the trial provided no evidence of effectiveness. Another trial just getting underway suggests that intrathecal administration is also safe, but the question of whether multiple doses can help repair a damaged nervous system may remain even once the final trial results are known.

The cells used in both trials were mesenchymal stem cells (MSCs), derived from patient bone marrow and then purified and expanded in vitro.

“One of the reasons there has been such an interest in mesenchymal stem cells is that there are established methods to confirm purity and functional capacity,” said Jeffrey A. Cohen, MD, who led the intravenous trial. Dr. Cohen, director of the experimental therapeutics program at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, presented the findings in September at the joint meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).


 
A bone marrow harvest in progress. Image via Wikimedia Commons.

Results from the experimental autoimmune encephalitis (EAE) mouse model of MS provided the rationale for the therapy, showing that injected cells can migrate to the site of inflammation and aid in remyelination.

Dr. Cohen led a study in which 24 MS patients received a single intravenous infusion of 1-2 million cryopreserved autologous MSCs. Patients were followed for the two months it took for the withdrawn cells to be expanded, and then for six months after treatment. The last patient completed follow-up in January 2014.

Feasibility and safety were the primary outcomes for the Phase I trial. “Overall, we encountered no significant safety issues,” he said. “There were, in fact, very few if any side effects, and certainly no serious or severe adverse events.”

There was no indication of any increase in lesions, “but also no apparent benefit,” Dr. Cohen said. The researchers observed no change in either median or mean disability scores, although a few patients showed some improvement. “While there was no evidence of disease activation, there was also no evidence of benefit on any of these measures for patients as a group,” he said.

The results of the study “support the feasibility, safety, and tolerability” of intravenously administered MSCs for MS, Dr. Cohen said. But  “there are a number of issues that need to be resolved before moving to Phase II [trials],” including dose, number of treatments, whether cells from a disease-free donor might offer advantages, and whether cells should be cryopreserved, as they were in this study, or injected fresh from the expansion culture.

Meanwhile, Saud A. Sadiq, MD, FAAN, director of the Tisch MS Research Center of New York, is leading an ongoing study of infusion of autologous MSCs, which differs in several potentially important ways from Dr. Cohen’s study. The stem cells in his study are infused intrathecally, they are fresh — not cryopreserved — and patients receive three doses, not one. In addition, the MSCs are treated during the expansion process with growth factors to convert them to neural progenitor cells. “This reduces their lipidogenic and osteogenic potential, which had been thought to be a risk,” Dr. Sadiq explained.

The multiple dosing was based on preclinical work in the EAE mouse. “We found that a single dose had very little effect while multiple doses led to a sustained clinical benefit,” with improvement in the EAE clinical score and a decrease in demyelination and T-cell infiltration, he noted.

An unpublished initial clinical study in six patients, some of whom are now in their ninth year of follow-up, suggested the treatment was safe, with no formation of tumors or ectopic tissue.

That led to the current trial, in which 20 patients will receive three injections of up to 10 million cells each, spaced three months apart. So far, three patients have received at least one infusion; one patient had received two infusions at the time of the presentation. Dr. Sadiq said that so far there have been no adverse effects, except for spinal headache.

“We think that if there are any benefits, it is probably based on the growth factors that the cells secrete, the local immunoregulatory effects they would have, and migration to sites of injury,” Dr. Sadiq said. “We don’t think there is a direct remyelination by these cells.”

Dr. Cohen concurred. “We don’t think these cells directly replace cells in the nervous system,” he said. “If they promote repair, it is by enhancing intrinsic repair mechanisms.”

Look for the full discussion and more news from the ACTRIMS/ECTRIMS joint meeting in the Nov. 6 issue of Neurology Today. For more coverage of MS research, browse our archives here: http://bit.ly/NT-MS.


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Friday, October 17, 2014

Diagnosing MS with MRI


Widespread use of MRI (magnetic resonance imaging) has revolutionized the ability to diagnose multiple sclerosis. Disease-related changes in the brain or spinal cord are detected by MRI in more than 90% of people suspected of having MS.

What Is MRI?

MRI is a test that produces very clear pictures of the human body without the use of X-rays. It uses a large magnet, radio waves and a computer to produce these images.
MRI can often detect damaged areas in the brain or spinal cord that would be missed by other imaging techniques such as a CAT scan.

Why Do I Need to Get an MRI?

  • To detect MS. MRI is considered the best test to help diagnose MS. However, 5% of people with MS do not have abnormalities detected on MRI; thus, a "negative" scan does not completely rule out MS. In addition, some common changes of aging may look like MS on a MRI.
  • To track the progress of disease. Although they aren't widely needed, people with MS may get repeat scans to determine the status of their disease and how well their medications are working.

Is the MRI Exam Safe?

Yes. The MRI exam poses no risk to the average person if appropriate safety guidelines are followed. Many people who have had heart surgery and people with the following medical devices can be safely examined with MRI:
  • Artificial joints
  • Staples
  • Many cardiac valve replacements (check with your doctor)
  • Disconnected medication pumps
  • Vena cava filters
  • Brain shunt tubes for hydrocephalus
Some conditions may make an MRI exam a bad idea. Tell your doctor if you have any of the following conditions:
  • Heart pacemaker
  • Cerebral aneurysm clip (metal clip on a blood vessel in the brain)
  • Pregnancy
  • Implanted insulin pump (for treatment of diabetes), narcotics pump (for pain medication), or implanted spinal cord  stimulators  for chronic pain
  • Metal in the eye or eye socket
  • Cochlear (ear) implant for hearing impairment
  • Implanted spine stabilization rods (newer titanium rods and plates are fine)
  • Severe lung disease (such as tracheomalacia or bronchopulmonary dysplasia)
  • Heartburn
  • Obesity (weighing more than 300 pounds may limit which machine can be used)
  • Not able to lie on your  back for 30 to 60 minutes
  • Claustrophobia (which can be handled with sedation)

How Long Does the MRI Exam Take?

Allow two hours for your MRI exam. In most cases, the procedure takes 40 to 80 minutes; during that time, several dozen images may be taken.

What Happens Before the MRI Exam?


Personal items such as your watch, wallet (including any credit cards with magnetic strips that can be erased by the magnet), and jewelry should be left at home if possible or removed prior to the MRI scan. Secured lockers are available to store personal possessions.





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Biogen Idec and Gretchen Rubin Unveil MS Blueprint (TM), a New Online Tool to Help People with MS

October 2014

PRESS RELEASE 

MSBlueprint.com developed with guidance from MS organizations CAMBRIDGE, Mass. 

Living with a chronic condition like multiple sclerosis (MS) can be overwhelming for individuals and caregivers who have to balance the challenges of everyday life and work while juggling regular doctors’ visits and medications. To support people living with MS, Biogen Idec (NASDAQ:BIIB) has launched MS Blueprint™, a new program that encourages those impacted by MS to focus on activities that may bring joy to their lives every day. By visiting MSBlueprint.com, people can set goals, create personalized MS Blueprints, and take small steps toward a more positive life. 

MS Blueprint was inspired by happiness expert Gretchen Rubin’s approach to creating a more contented life, which she details in her New York Times best-selling book, The Happiness Project. As program ambassador, Gretchen is sharing her own tips and advice for getting the most enjoyment out of each day, and hopes to motivate those impacted by MS to address their challenging circumstances, focus on what makes them happy, and live in the present. 

“Much like my happiness project has allowed me to focus on the positive and bring more joy to my life, the MS Blueprint program is designed to do the same for the MS community,” said Gretchen Rubin. “I believe every small step—including the activities achieved through MS Blueprint—is a victory toward living a more enjoyable life. When you feel every day reflects how you want your life to be, that’s when you’re truly happiest.” 

Click here to continue reading and learn more about MS Blueprint - 
     

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DIET AND EXERCISE TIPS FOR LIVING WITH MS RELAPSES

The first step in managing MS relapse symptoms is to take the medications your doctor has prescribed for you. There are also several things you can do that will help enhance your overall sense of well-being.
Before you make any changes to your diet or exercise regimen, it's important to discuss them with your healthcare professional to determine what is best for you.

Watch Your Diet

Eat a wide variety of food:
  • Each day, choose from each of the five basic food groups (grains, vegetables, fruits, dairy, meat and beans)
  • Be sure to include foods high in complex carbs (whole grains, fruit and vegetables)
Cut back on fat and cholesterol:
  • Eat low-fat dairy products
  • Eat lean cuts of meat
  • Limit your meat consumption to 3 or 4 ounces a day
  • Limit the fat you add to foods, such as butter, oils, dressings, and spreads
Reduce sugar intake:
  • Drink less canned soda and sweetened beverages
  • Drink more water
  • Replace sugar in recipes with seasonings like vanilla extract, mint, cinnamon, or ginger
Avoid too much sodium:
  • Add less than one-half teaspoon of salt per day to your food
  • Add flavor to recipes with onions, garlic, parsley, celery, basil, or rosemary

Add Moderate Exercise

When you have MS, it's important not to overstress your body. This may cause fatigue. However, there are things you can do that can help with the stiffness and fatigue that MS relapses can cause:
  • Work with a physical therapist to tailor an exercise program that's right for you
  • Think of exercise as more than running, jumping, or similar aerobic activities. Try to make stretching exercises a part of your day
  • Don't overexert yourself as this will raise your core body temperature and may make symptoms worse

Manage Your Day

Save your energy:
  • Balance periods of activity with periods of rest
  • Plan a daily or weekly schedule of activities and alternate heavy and light tasks
  • Pace yourself; rest before you become exhausted
  • Plan menus before you go to the store and take a shopping list with you
  • Use the same grocery store so you'll know where items are located
  • Set priorities: focus on things that are important and don't feel guilty about not finishing unimportant tasks

Make Your Space MS-Friendly

CLICK HERE to continue reading this information directly from the Source for this information




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My Body, My Self - written by The Wheelchair Kamikaze

Posted: 16 Oct 2014 11:45 PM PDT

In Mel Brooks’ 1981 comedy “The History of the World, Part 1”, a scene set during the French Revolution features a member of the aristocracy rushing to tell King Louis XVI, “It is said that the people are revolting!” His Majesty quickly replies, “You said it, they stink on ice”. The exchange is an amusing play on words which succinctly and humorously sums up the crux of the social upheaval engulfing France at the end of the 18th century. Substitute me for the King of France and the words “your body” for “the people”, and you’ve got a pretty good idea of what’s going on inside me, both physically and mentally, courtesy my creeping paralysis. My body is in full revolt, increasingly refusing to obey my commands, and I find the situation along with my withering body itself completely repellent. My body is revolting, and it stinks on ice (not literally, I hope, for the sake of those who get close enough to smell me).

The mind-body connection is a strong one, but multiple sclerosis can be a buzz saw intent on breaking that bond. As the disease progresses it forces one to separate body from mind, as the “self” becomes more and more divorced from the body that serves as its vessel. Despite lofty ideals about looking beyond the physical to the person within, our sense of self can’t help but be intricately entwined with our physical state; our identities, for better or worse, are in so many ways shaped by our outward appearance, a dynamic that seems ever on the increase in a culture obsessed with beauty.

We live in a society that idolizes physical beauty to the point of absurdity, elevating the utterly talentless but extraordinarily beautiful to fame and fortune and fueling in many an obsession with physical perfection. This incessant quest for beauty has in turn birthed entire industries devoted to indulging this ravenous appetite for youthful good looks, which only further feeds our insatiable societal lust for flawless appearance. Billions of dollars are made catering to a population infatuated by comeliness, with cosmetics, fad diets, exercise crazes, and plastic surgery all exploding to the sound of cash registers ringing and money changing hands.

Though we pay lip service to the idea that beauty is only skin deep, study after study has shown that in modern Western society those perceived as physically attractive have a quantifiable advantage over those not similarly blessed. There are, of course, exceptions to the rule, and beauty is by no means a sure ticket to happiness. Indeed, for some it can become a curse – think Marilyn Monroe – but our popular culture covertly and overtly continuously pounds home the message that the spoils of life most often go to those deemed gloriously pretty or handsome. I’m not sure that anyone can be immune to this pervasive zeitgeist, and I certainly was no exception back in my healthy days, although my relationship with my body even pre-MS had a long history of discord.

Growing up I was as skinny as they come. I’m not talking merely thin, I’m talking Boney Maroney, stick figure, almost comically scrawny. In addition to earning the nickname “Bones”, until I was 15 or so I was also quite short, and as a skinny little pipsqueak I was often subject to teasing not only by other kids but sometimes by adults as well. While it’s considered bad manners in grown-up circles to talk about a heavy person’s weight, it seems no such taboo exists when it comes to the extremely thin, regardless of their age. Being teased by other kids was bad enough, but I quickly developed a smart and scathing wit with which to defend myself from their juvenile barbs. Hurtful comments made by adults, though, often struck home hard, and I can still vividly remember some of the most boorish comments directed my way by adults who should have known better, the combined effects of which spawned massive insecurities that persist to this day.

A sudden growth spurt when I was about 15 years old took care of the pipsqueak part of my problem, but I remained superduper skinny for years to come. When I graduated college I was 6 feet tall and weighed in at a whopping 120 pounds soaking wet. Fortunately, sitting atop that emaciated frame was a face that was kind of cute, and much to my delight and amazement I discovered that there were women who actually like skinny men. I naturally gravitated towards artsy social circles and wound up lead singer of a punk rock band, a role in which thin was most definitely in. In the underground music scene in the 1980s there was more than a touch of heroin addict chic, and I had the decided advantage of being as thin as a junkie without actually having to take drugs. I’d managed to find a social scene in which my being the skinniest guy around was actually an advantage. Go figure.

My body finally filled out in my late 20s, but I always remained on the thin side. Nobody was ever going to mistake me for Adonis. Although I was considered attractive, and was sometimes even called handsome, the insecurities that first took root when I was a skinny little nebbish lived on and I fought hard to overcome a shyness that at times bordered on social anxiety. I’ve been told that some found me aloof or even standoffish, but in reality I more often than not was quaking in my boots. That scrawny little 10-year-old was never far from the surface, a mind-body connection that persisted far into adulthood even though it no longer reflected my physical reality.

Now an entirely different kind of mind-body connection, or, more correctly, a mind-body disconnection plagues me. Just around the time that I had become comfortable in my own skin – thank you, decades of psychotherapy – a little problem called multiple sclerosis reared its ugly head. While walking my pooch along the Hudson 11 ½ years ago, I developed a slight limp in my right leg. All too soon that limp was joined by a weakening right arm, and whatever dastardly bastard was causing this distress refused to release its grip. Fast forward a decade plus and this beastly disease has just about fully consumed my right side and is gluttonously munching away at my left. My mind reels in horror at the damage that has already been done and can barely stand to contemplate that which may lie just beyond the horizon. But the me that existed before my illness struck still resides within, inevitably changed by the experience but ever yet struggling to maintain itself.

In a situation surreal but all too real, I find myself (and my self) trapped in a body that increasingly not only refuses to obey my wishes but seems to have a mind of its own. I sometimes put my disease to the test, concentrating intently, face contorted with effort, commanding my right ankle to flex, but much to my overwhelming chagrin and frustration, nothing ever happens. Absolutely nothing. Many nights, though, just about the time when I’m ready to go to sleep, my entire right leg will shudder and quake in muscle spasms beyond my control, violent enough to shake the bed frame, the tremors coming in waves every 30 seconds or so for hours on end despite the pharmaceutical cocktail meant to quell them. All the while, inside, buried deep within the fear, anguish, and disgust brought on by my illness lays that kernel of the old me, observing it all in utter disbelief.

Since the onset of my disease, the divide between my essence and the body that contains it has grown from a slight fissure into a great chasm. I’ll occasionally struggle from my wheelchair to stand in front of a mirror, trying to strike a pose that suggests some semblance of normalcy, imagining that if someone were to glimpse me at that precise moment they might not guess I was so afflicted. But then I see in my reflection that my right arm has withered, the fingers on my emaciated right hand curl unnaturally inward, and my right wrist and elbow stay unbent only by my precariously lodging them against the side of my body. In shorts my legs reveal themselves to be sticks, as if they remembered who they were back in my skinny youth and decided to reprise the role. My once lean stomach has become a bulbous belly, courtesy years of sitting in a wheelchair. This is not the me that I hold in my mind’s eye, and yet this is the reality of the body I now possess, a body that will become only more and more unfamiliar with time barring some incredible medical intervention.

This decrepit circumstance has forced me to break the mind-body connection that we are so conditioned to accept as reality. Though I struggled to embrace my physical self in my younger days, I must reject the physical decay that now besets me, as for sure this defective mass of flesh and bone does not define me. My mind remains sharp, maybe too sharp, and my sense of self is more pronounced now than ever, albeit in an increasingly disembodied state. I don’t know if consciousness survives our ultimate physical demise, but I do know that the essence of who I am is increasingly independent of the physical form that maintains it.

In a strange paradox, I have become more sure of the person I am these days than I ever was back when my body was whole. I’m privy to insights I likely never would have attained if not for my unfortunate situation. It’s a strange life, this existence within an existence, but it is life nonetheless, not one I ever would have chosen but one in which holds within it not only sorrow and frustration but also still moments of contentment and sometimes even joy. Along with my sense of self those two most vital elements of life, joy and contentment, have by necessity undergone their own bits of revision, reshaped and reimagined by a me that more and more severs the connection between body and mind.

My body is revolting, and you said it, it stinks on ice… Ha!



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