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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.”

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Yeah…I’m a Star Wars geek.

Day 294: Right hip.
Injections to the hip always suck for me, even after 82 injections to the hips.
There was no site reaction, no itchiness, just the the “OH WOW THAT SUCKS!” sting of the injection.

Went to see my pain management doctor today; got scheduled for a few injections to my spine. Yipee *can you feel the sarcasm?* But, a little pain to get rid of the knife wedged between my vertebrae is well worth it.

Visited my new neurologist today too. Was very surprised that he spent 45 minutes discussing my disease, the diagnosis, the events surrounding the diagnosis. The doc was like an MS detective. I was really happy to see he was very knowledgeable about MS, research, new drugs etc…even though I’m his only MS patient.

After completing my physical examination; reflex, sensation, etc. He came to the conclusion that my back and leg problems were not caused by MS but, rather my obesity. I explained to him that I had gotten my weight under control on several occasions, once losing almost 100lbs. through a vegetarian diet and exercise but, my inability to exercise now was hampering any serious weight loss. He advised me to give it an honest try at losing some weight on my own again.If my mobility issues became a problem he would recommended Lap Band surgery and said he would aggressively seek it through my primary care Dr.

The thinking being the weird nerve sensations I feel, aren’t caused by my MS but, rather by my extremely high blood sugar. My leg weakness and knee problems, fatigue, etc. all problems reduced by losing weight.

Well, I’m not totally for it but, at least it’s not vanity causing me to do it. And the band can always be adjusted once my weight is under control. 😦

The Neurologist also ordered some blood work, wanting to be sure of various things before putting me on Gelinya, the oral MS disease modifying therapy. So no more needles after the blood work, no more self injections. This, the doctor said, was the one thing he could do on my initial visit. Since, I had been reffered to him following an MS event, he had no fear of disrupting a treatment that was working well for me.

He asked about my progression, commenting “Yeah, that’s what it does, picks you apart.” When I bumped into him trying to climb the examination table and said “I’m sorry”, he grabbed me by the shoulders, helped me position myself on the table, and replied “You, have NOTHING to be sorry about.You’re sick.” Echoing what my big brother says every time he hears me apologizing for everything.

On a side note: When I switch from disease modifying therapies….what will I call my blog???

Dr. Lamazov also said he’d brush up on Ampyra, the MS walking drug, for me because he didn’t know enough about it to comfortably write dosing amounts, etc. Wow, a doctor who, not only obviously had been paying attention at the beginning of the visit but, was also open to learn a little more about what I wanted. What an AWESOME neurologists’ visit.

TODAY WAS A GOOD DAY!

BE WELL, LIVE WELL, NO REGRETS

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