Stem Neurological Disease The Problem: Multiple Sclerosis (MS) is a chronic and unpredictable central nervous system disorder that affects the brain and spinal cord. It is an autoimmune disease, which means the immune system mistakenly attacks healthy parts if the body as if they were foreign and dangerous. The fact that our central nervous system has a limited capacity for regeneration is one of the main reasons for progressive neurological decline in chronic diseases such as MS, ALS (Amyotrophic Lateral Disease), Parkinson’s disease, Alzheimer’s disease as well as brain and spinal trauma and stroke. There is no cure, but there is hope. New research is showing positive results. The Solution: Stem cells from adult bone marrow effectively suppress inflammation. Research at Hadassah Hospital in Jerusalem is showing that stem cells not only protect damaged neurons and prevent cell death, but also repair/regenerate damaged cells. These features make stem cells potential candidates for therapies in inflammatory and degenerative diseases. -The Research: In 2015, Hadassah started a double blind, randomised, phase IIb efficacy clinical trial in MS. It is the first in the world to use the intrathecal (spinal) method. The aim of this trial is to assess and improve the efficacy of stem cell transplantation and define the optimal conditions of their administration (one vs multiple injections; intrathecal vs intravenous injection) in MS patients. To assess efficacy, Hadassah intends to use the most advanced technologies for identifying regeneration of the central nervous system and myelin. The trial, under the direction of Professor Dimitrios Karussis, head of the Multiple Sclerosis Center at Hadassah Hospital’s Department of Neurology, has 48 patients in a double blind, placebo-controlled study. The novel concept of injecting stem cells directly into the spinal fluid is aimed at getting the cells to circulate to the various damaged areas of the central nervous system. The Results: In MS patients, there is a clear trend towards neurological improvement, including substantial improvement in motor function. These findings demonstrate for the first time that intrathecal injection of stem cells in patients with MS is a clinically feasible and relatively safe procedure that provides significant clinical benefits. In the latest study in 2016, 87% of patients responded positively to their treatment, with no serious side effects observed to date. Disability was stabilised during the first six months following the treatment. Results indicated a halt of the progression of the disease. Disability showed a clear trend for improvement including substantial increases in motor function. Hadassah Hospital has the advantage of more than ten years experience with the clinical application of stem cells in neurological diseases and uses its unique protocol of direct injection into the spinal fluid. In addition, Hadassah’s novel and patented type of modified (“neutralised”) stem cells will be used in future trials. The exciting findings observed so far in Hadassah’s stem cell research in MS patients may change the face of neurology. Promising results in MS are likely to have application for treatment in other cases of brain degeneration, such as ALS, Alzheimers, Parkinson’s, stroke and spinal trauma. Hadassah has conducted research into stem cell transplantation in two trials with MS patients and a smaller study with ALS patients. The findings in both groups have been encouraging, with no major side effects being recorded. The Trial: The trial, under the direction of Professor Karussis, has 48 patients in a double blind, placebo-controlled study. The novel concept of injecting stem cells directly into the spinal ﬂuid is aimed at getting the cells to circulate to the various damaged areas of the central nervous system. “I believe we are in the early stages of something new and revolutionary with this harvested stem cell infusion therapy. I am confident that within the next three to five years, we may provide a treatment to patients that can stop the progression of these diseases and induce some kind of recovery. Preliminary results of our trial have seen wheelchair-bound patients getting back on their own two feet.” Prof Dimitrios Karussis, Head, Multiple Sclerosis Center, Department of Neurology, Hadassah Hospital Case Study: Mark Lewis Mark is one of the UK’s most successful media lawyers. He was instrumental in bringing the case against News of the World, as a result of the 2011 phone hacking scandal. Mark was diagnosed with MS when he was 24. By 2016 he was using a wheelchair and mobility scooter. and had given up driving. He says, I wish I could say to you I never feel sorry for myself but I always feel sorry for myself – I have moments of absolute depression. My health had gone rapidly into a downward spiral. I heard about the medical trial in Hadassah. As a lawyer, all my working life I’d done trials, often very high profile, with a philosophy that every case at trial is 50/50. Either you win or you lose. This was my most important trial. It was not just about cosmetic appearance but whether I would be able to work. My memory is unaffected, but my body was failing. The research at Hadassah is miraculous. I joke that if there is a place where a miracle could happen, then Jerusalem is a suitable candidate. Within two hours of my treatment, I could walk again without a stick and the pain that showed the onset of MS when I was 28 disappeared. 28 years, more than half my life, and it just disappeared within two hours of the transfusion. I honestly feel that the treatment is not just life changing, but as my wife Mandy says “life giving”. It is a new lease of life. Case Study: Malia Litman Malia says, In 1999, I was too young, too busy, and I felt too good to have multiple sclerosis. I had been a nurse, so I knew that people with MS are in wheelchairs. But I did have multiple sclerosis. There was no explanation. There was no cure. As time passed my symptoms got worse. The turning point came because of a fall in gravel at my daughter’s school. I had fallen before, but this fall was not only the result of balance issues, but sheer weakness and fatigue. In 2013 I fell in the middle of the night and broke my leg. We installed handicapped railings in the bathroom. Muscles that I had previously used for walking had atrophied. I knew it was time to get more aggressive with my MS treatment. I researched the internet. Of all the physicians in the world, Prof Karussis’ Stem Cell research at Hadassah Hospital in Jerusalem seemed the most promising. His scientific method was sound. His results were exciting, and verifiable. Side effects seemed unlikely since he used the patient’s own stem cells taken through bone marrow extraction. After my first stem cell infusion, I realised immediate benefits. In less than 24 hours my speech improved. I had enhanced strength in my weakest leg, and improvement in fine motor skills. The greatest change was a profound difference in fatigue. I may never walk without assistance, but I am a realist who believes in miracles. Hadassah Hospital and Prof Karussis have made my dreams become a reality. I will forever be indebted to them for giving me the miracle of hope.