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A phase 1 trial of a new treatment to reset the immune systems of multiple sclerosis patients shows the therapy is safe and highly effective.

Multiple Sclerosis Breakthrough

German researchers today unveiled the results of a study on a new procedure that safely resets a multiple sclerosis (MS) patient’s immune system. It can reduce the body’s attacks on the protective myelin sheath that insulates nerve cells in the brain.

For this small Phase 1 trial, which was a collaboration between Northwestern University’s Feinberg School of Medicine, University Hospital Zurich in Switzerland, and University Medical Center Hamburg-Eppendorf in Germany, ten patients were selected. Eight patients with relapsing-remitting MS (RRMS) and two with secondary progressive MS (SPMS) were enrolled initially, but one RRMS patient withdrew before the procedure.

Multiple sclerosis is an autoimmune disease in which the immune system attacks the myelin covering that insulates nerve cells in the central nervous system, which includes the brain and spinal cord. MS is a chronic, degenerative, and often disabling disease affecting more than 400,000 people in the U.S. and more than 1.2 million people worldwide. Symptoms can range from mild numbness to paralysis and blindness.

Pressing the Immune System’s “Reset” Button

The study involved giving patients a single infusion of their own white blood cells, or T-cells, which were processed and then reintroduced into the body. The T-cells were used to deliver billions of myelin antigens into the bloodstream, forcing the patients’ immune systems to recognize the antigens as harmless and build up a tolerance to them. An antigen is a substance that the body believes is a harmful invader. When the body detects an antigen, it releases antibodies to find and destroy it.

In patients with MS, the body creates antibodies to fight very specific antigens, in this case myelin-specific peptides, residing in the central nervous system. The seven antigens researchers used in this study were all proteins found in myelin. Using more than one antigen increased the odds that the correct antigen targeted by the patient’s immune system would be included.

The patients’ T-cells were isolated and then coupled with all seven antigens used in the trial. The coupling was achieved using a chemical cross-linker called EDC that allows the antigens to stick to the T-cells but does not, itself, become part of that bond.

These T-cells, with their antigen hitchhikers, were then rinsed twice to remove the cross-linker and re-suspended in the patient’s blood plasma. This cocktail of antigen-spiked T-cells, suspended in plasma, was then given to the patient through an IV. The process from start to finish took about nine hours.

Seeing Dramatic Results

The results showed that the therapy was safe and reduced the patients’ immune system attacks on myelin by as much as 50 to 75 percent.

“The therapy stops autoimmune responses that are already activated and prevents the activation of new autoimmune cells,” said Dr. Stephen D. Miller, Ph.D., a professor of microbiology and immunology at the Feinberg School of Medicine in Chicago, Ill., in an interview with Healthline. “Our approach leaves the function of the normal immune system intact. That’s the holy grail.”

According to the study, the side effects of the treatment were virtually non-existent. The only effect of note was one patient’s complaint about a “metallic taste” after the injection.

“This treatment should not lead to any major side effects (that is our hope and expectation) and be highly specific, i.e. leave normal immune responses that we need to defend ourselves against infections untouched,” the study’s principal investigator Dr. Roland Martin told Healthline.

What This Could Mean for MS Patients

For the hundreds of thousands of M.S. sufferers in the United States, this is perhaps the most promising news of a non-drug treatment to surface in years. Although there has been much recent excitement over FDA approval of several new drug therapies for MS, they are all part of either a daily, every-other-day, weekly, or monthly regimen to which a patient is indefinitely tied, at a cost that many cannot afford.

For safety reasons, this trial was conducted in a hospital setting, but if approved, the treatment will most likely be an outpatient procedure.

A single-dose treatment with no side effects, performed in an outpatient setting, that leaves a patient’s immune system intact sounds almost too good to be true. However, further testing is necessary to validate the safety and effectiveness of the procedure. “At this point we are trying to acquire funding to carry this process into a phase 2a trial,” Miller said.

When asked how long it might take to complete additional trials and the FDA approval process, Miller speculates, “Realistically, this could take three to four years.” Compared to other trials for new drugs and treatments, however, three to four years is practically the blink of an eye.

“The phase 2a trial is fully planned, and we have approached various funding sources, among them the European Union,” Martin said. “We have also begun to discuss the project with pharmaceutical and biotech companies and hope to find support in the near future. The phase 2a trial will most likely be a two to four center study, and if a US center is interested, we are very open as long as this would not create a major extra hurdle with respect to regulatory filings.”

70 injections away from 2 years plus on Copaxone. My neurologist wants to put me on Ampyra and Gilenya but, apparently my docs aren’t communicating. Test that my neuro ordered, my dr. did. yet still haven’t sent the results back to the neuro. Wish they’d make up already. The last thing I need is MS AND my medical support team having a tiff.

All jokes aside, this disease gets me down sometimes. Not just by making parts of my leg numb and the worst times. I went three days last week ignoring all my medication just thinking to myself; “none of it is going to make me better. So why bother?” After just three days I was stiff and aching, everything hurt and I’d gotten out of my funk. No one knows this because I tell everyone I’m fine and I don’t look like I’m falling apart. It just hasn’t changed me on the outside and I don’t think the people around are equipped to handle any other answer than “I’m fine”

Going on 5 years plus and I’m fine. 🙂

Life as a dad with MS isn’t easy, life as a dad with MS can be hard but, I WILL carry my boy into the end zone.

Every hour of every day, someone else is diagnosed with MS. MS defined my 31st birthday. No parties,  my present was a diagnosis of multiple sclerosis after a week in the hospital. It may have hit me harder than normal. Within 6 months my mood swings and heat sensitivity had cost me my career. In the next 2 years I’d lose equilibrium, endurance, and see my feelings of worthlessness, and my flawed attempts to make myself feel worth something, take more of my health and my family away from me. I don’t ever want another human being to suffer all I have or worst. I don’t ever want my son to give up, like I first did.That’s why I registered for Walk MS 2012 and that’s why I’m asking you to support my fund raising efforts with a tax-deductible donation.

The National Multiple Sclerosis Society is dedicated to ending the devastating effects of MS but they can’t do it without our help. It’s faster and easier than ever to support this cause that’s so important to me. Simply click on the link at the bottom of this message. If you prefer, you can send your contribution to the address listed below.

Any amount, great or small, helps to make a difference in the lives of people with MS. I appreciate your support and look forward to letting you know how I do.

P.S. If you would like more information about the National Multiple Sclerosis Society, how proceeds from Walk MS are used, or the other ways you can get involved in the fight against MS, please visit nationalmssociety.org.

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Interesting news from across the Atlantic.

Research Proving Link Between Virus And MS Could Point The Way To Treatment And Prevention.

Seems I blew by injection 500, 86 nights ago! Should be 587 but, I’m trying to stretch the last few injections of Copaxone seeing as how they are the last for a while. I’ve got my application out to AssistRX and hopefully I qualify. I don’t know what options i have other than that. I don’t make enough on my disability check to cover my rent, phone, electric, food for myself and a three year-old, a monthly “High-Risk” insurance policy, and the inevitable co-pay. Our esteemed governor has decided that if you make more than $900 monthly on disability, you no longer require medicaid. Does he not know that the median rent in New Jersey is around $1000 a month, unless you live in a subsidized project, which has a 2 year plus waiting list.

I guess he’s too busy embarrassing our state with his Tony Soprano antics, campaigning for Mitt Romney. Funny, Gov.Christie comes out against “The Jersey Shore”, and then acts like a member of the cast every chance he gets. Enough…

Day 597-Back of right arm
Had to ask mom for help tonight with my injection, as I tried my best to keep the shots 2 inches from the previous weeks. I’ve been having issues with body temperature lately. Last night and tonight where 37* outdoors, my thermostat set to 65* with drafty windows and a huge draft from the A/C still in my bedroom window, and I had to place a cold towel on my head and my T-shirt collar was/is moist from sweating. I don’t know wat else to do…open a window? Oh the joys of MS.

Be well!

After the premier tonight of Game Of Thrones you’ll understand the title of this post. Game Of Thrones, a book I read 8 years ago and thought no one would ever make anything mainstream from it but, I wished they would. HERE WE ARE tonight on HBO “A GAME OF THRONES” comes to life, albeit with the “A” of it’s book title.

BE WELL: When you are healthy, even when you are fighting a chronic illness embrace it. Grab those moments with both hands.

LIVE WELL: Live up to your abilities and beyond if you can. You never know when they’ll no longer be there.

NO REGRETS: Regret will kill you as sure as disease.

Well that’s all for Sunday afternoon, my son is napping, I’m waiting for his mom to arrive and the Rangers are home for Game 3 against the Cap. LET’S GO RANGERS!!!

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