News

A British board that recommends what treatments the National Health Service should cover has advised the system to use only Extavia (interferon beta 1b) as a treatment for MS patients who continue to have relapses. Cost was at the heart of the National Institute for Health and Care…

A combination therapy of low-dose methylprednisolone and interferon (IFN)-beta-secreting stem cells is effective in a mouse model of multiple sclerosis (MS), a new Korean study suggests. The research, “Effective combination of methylprednisolone and interferon β-secreting mesenchymal stem cells in a model of multiple sclerosis,” appeared in the…

American CryoStem has received a warning letter from the U.S. Food and Drug Administration (FDA) for marketing its adipose-derived stem cell product Atcell without required regulatory approval, and for "significant deviations" from manufacturing processes that potentially raise safety concerns. The company has 15 working days to respond to the concerns raised by the agency and detail how they will be corrected, or risk "enforcement actions," the FDA said in a Jan. 4 press release. Studies suggest that mesenchymal stem cells can be used to alleviate symptoms and possibly treat several degenerative disorders, including multiple sclerosis. Atcell is a therapy based on the ability of mesenchymal stem cells isolated from adipose tissue (fatty tissue) to transform into a subset of mature cells, which include adipose cells, bone cells, and cartilage cells. Although not approved for use, Atcell is being distributed directly to physicians to treat patients affected by several life-threatening diseases, including Parkinson’s disease, amyotrophic lateral sclerosis, stroke, and multiple sclerosis, the FDA said in its release. It is administered intravenously, intrathecally (injection or infusion into the central nervous system) or by aerosol inhalation. The product is designed to be used in the same individual (autologous use) the cells are collected from, an approach intended to reduce risk. The cells are extracted using the company’s proprietary Cellect collection system. They are then expanded in the laboratory using the company's ASCelerate SF-M serum free (animal-product free) media, providing compounds needed for the cells to survive and proliferate. Stem cells put through this process are  ready to be used as therapy or to be stored for future use. A recent FDA inspection found that Atcell’s manufacturing steps are not in line with current good manufacturing practice requirements. Specifically, the manipulation of the adipose tissue was more than "minimal," the FDA reported, changing "relevant characteristics" of the original tissue that could introduce contamination by microorganisms or product defects and represent a "risk of harm" to patients. Because of this manipulation, FDA review is required by law to ensure Atcell's safety and efficacy, the agency said. Evidence of an inadequately controlled manipulation environment, lack of control of components used in production, and insufficient and inadequately validated product testing were also reported. “The use of Atcell raises potential significant safety concerns, due in part to the fact that there is little basis on which to predict how the product will perform in a patient,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “In addition, this product may also cause harm to patients who may put their trust in an unproven therapy and make the decision to delay or discontinue medical treatments proven to be safe and effective,” Marks added. American CyroStem, based in New Jersey, did respond to observations raised by the FDA at the time of its inspection. But they were found inadequate to support Atcell’s marketing, and failed to acknowledge that FDA approval was required, either by filing a biological license or investigational new drug application. “As part of our comprehensive policy framework for the efficient development and regulation of cell-based regenerative medicine, we’re going to be stepping up enforcement activities against those who manufacture and market products in ways that put patients at risk,” said Scott Gottlieb, FDA commissioner. “We see great promise from the field of cell based regenerative medicine, but there are also novel risks,” Gottlieb added. Healthcare professionals and patients who have used Atcell are asked to report any adverse events related to the treatment using the FDA’s MedWatch Online Voluntary Reporting Form. Completed forms can be submitted online, or via fax to 1-800-FDA-0178.  

The nerve-cell-protecting myelin sheath’s failure to remove cholesterol after the membrane has been damaged limits its ability to regenerate, German researchers report. Their finding has important implications for multiple sclerosis because a hallmark of the disease is nerve cell deterioration stemming from damaged myelin. Cholesterol is a waxy, fatty substance…

A Phase 3 clinical trial evaluating AB Science’s masitinib as a treatment for progressive multiple sclerosis can continue without having to add patients, an independent review board has decided. The decision indicates that the therapy has been effective enough that its population base does not need to be expanded, the…

MMJ International Holdings is seeking a patent for a part-cannabinoid and part-non-cannabinoid treatment for multiple sclerosis and other diseases. The company said in a news release that it filed the patent request ahead of Phase 2 clinical trials of the formulation.  The therapy was developed by MMJ Bioscience, an affiliate of MMJ International…

Iranian researchers have identified another herpes virus that may increase the risk of a person developing multiple sclerosis. The team identified the human herpesvirus 6, or HHV6, as a potential risk factor for MS through a meta-analysis of several studies. They published their findings, “Relationship of Human…

Multiple Sclerosis News Today brought you daily coverage of important discoveries, treatment developments, clinical trials, and other events dealing with multiple sclerosis throughout 2017. We look forward to providing more news to MS patients, family members, and caregivers during 2018. As a reminder of what mattered most to you in…

The U.S. Food and Drug Administration (FDA) has updated a safety bulletin about gadolinium-based contrast agents (GBCAs), after studies raised new concerns about them. Doctors often use GBCAs to diagnose multiple sclerosis (MS), monitor disease activity and verify the effectiveness of MS therapies. Gadolinium is a metal ion, or electrically charged molecule, that…

Researchers at GlaxoSmithKline (GSK) have identified the histamine receptor 3 (H3R) as a potential new therapeutic target for promoting remyelination in patients with multiple sclerosis (MS). Their study “Histamine Receptor 3 negatively regulates oligodendrocyte differentiation and remyelination,” appeared in the journal PLOS One. Regrowth of myelin is known as…

Tailored molecular treatments for specific disabilities may be a breakthrough for multiple sclerosis (MS) patients, finds a new study by researchers at University of California-Los Angeles (UCLA). The study, “Cell-specific and region-specific transcriptomics in the multiple sclerosis model: Focus on astrocytes,” appeared in the journal Proceedings…

An international panel of multiple sclerosis (MS) experts has proposed revising the McDonald criteria guidelines to improve and expedite the diagnosis of this disease. Co-chaired by Dr. Jeffrey Cohen of the Cleveland Clinic and Dr. Alan Thompson of the University College London, the 30-member panel reviewed newly available research…

A deterioration in multiple sclerosis patients' handwriting aligns with drops in their movement, sensory and cognitive skills, a study reports. MS includes loss of hand dexterity and finger movement control. This affects a patient's capacity to manipulate objects and coordinate hand movement, skills needed in handwriting. Previous studies have shown that MS patients had less handwriting rhythm and control than healthy people. This time researchers decided to compare the handwriting movements of both MS patients and healthy volunteers. The research involved 19 MS patients and 22 healthy age-matched controls. The team asked participants to write a specific sentence on a digitizing tablet. They discovered that the way MS patients wrote was much different than those of the controls. The patients took a lot longer to write each word and to achieve spacing between words. This led to them taking a much longer time overall to write a sentence than healthy people. In addition, analysis of handwriting strokes showed that MS patients' writing wasn't as smooth as that of healthy people. Researchers also found a correlation between patients’ movement abilities and cognitive status on the one hand and their handwriting ability on the other. The team said it believed “these findings might be very useful when planning rehabilitative task-oriented interventions focused on handwriting abilities.” In fact, rehabilitation specialists should consider evaluating “both the motor movement and the cognitive status of PwMS [patients with MS] in order to tailor the intervention."

Treatment with Gilenya (fingolimod) may limit cerebral gray matter atrophy in relapsing-remitting multiple sclerosis (RRMS) patients, researchers at Boston’s Brigham and Women’s Hospital have found. Their report, “A two-year study using cerebral gray matter volume to assess the response to fingolimod therapy in multiple sclerosis,” appeared in the…

Clomipramine, an approved antidepressant, shows potential in treating people with progressive multiple sclerosis (MS)  — a disease form with few treatments — by protecting nerves from various processes thought to underly progressive MS, early research shows. The lab and animal study, which focused on already-approved treatments, was titled “Systematic…

Zinbryta (daclizumab) may not be the best follow-up therapy for relapsing–remitting multiple sclerosis patients who stop taking Tysabri (natalizumab) for safety reasons, a case study suggests. An article on the 25-year-old patient’s case, titled “Disease reactivation after switching from natalizumab to daclizumab,” was published in…

A large U.K. survey assessing the frequency of chickenpox and shingles in multiple sclerosis (MS) patients suggests a link between these diseases and MS, researchers report, suggesting their findings could help in decisions regarding immunosuppressive treatments and varicella-zoster virus vaccinations. Results of the study “Prevalence of a history of…

People with multiple sclerosis (MS) have a lower overall lifetime risk of cancer relative to a general population matched by area, age, sex and habits like tobacco use and alcohol consumption, new research reports, suggesting this lesser risk might be due to the nature of MS itself or to disease…

Britain’s National Health Service should cover the multiple sclerosis therapy Extavia, the National Institute for Health and Care Excellence (NICE) has recommended. The health service usually follows the institute’s recommendations. So NICE’s endorsement means there is a good chance the health service will begin covering the Extavia prescriptions that…

IMPAQ Health has created a calculator that will help New York State residents compare the cost of hundreds of health insurance plans. The NYPlanCosts Calculator should be particularly beneficial to people with one of eight chronic conditions — multiple sclerosis, rheumatoid arthritis, heart disease, hepatitis C, diabetes, HIV, schizophrenia, breast cancer and…

The U.S. Food and Drug Administration has given fingolimod a Breakthrough Therapy designation as a treatment for children 10 years and older and adolescents with relapsing multiple sclerosis. Novartis is marketing it in the United States under the brand name Gilenya for adults with relapsing MS. It has yet to approved…

Multiple sclerosis patients with additional diseases, high cholesterol levels or a history of migraine headaches are more likely to experience relapses than other patients, a Canadian study shows. The report, “Comorbidity increases the risk of relapse in multiple sclerosis,” was published in the journal Neurology. Researchers…

A cell recycling process helps trigger an immune response against myelin, the protective layer covering nerve cell axons to aid in signal transmission, a multiple sclerosis (MS) study indicates. When University of Zurich researchers eliminated the process, mice developed much milder forms of an MS-like disease. Loss of myelin is the…

University of Huddersfield researchers have developed a blood test for diagnosing multiple sclerosis that avoids the invasive, painful process of collecting fluid from the brain and spine. The team at the British discussed the test in an article titled “Sphingosine and dihydrosphingosine as biomarkers for multiple sclerosis identified by…

A University of Cambridge researcher, Robin Franklin, has been awarded the 2017 Barancik Prize for Innovation in MS Research for his work on myelin repair and as a potential way of treating multiple sclerosis (MS). Franklin is a senior scientist at the Wellcome Trust-MRC Cambridge Stem Cell…

U.S. neurologists are increasingly prescribing Genentech’s Ocrevus (ocrelizumab) to their multiple sclerosis patients, Spherix Global Insights reports. Another good sign for Genentech is that, in just three months, neurologists have increased by 50 percent their estimate of the numbers of relapsing-remitting MS patients who could benefit from Ocrevus.

Multiple sclerosis patients should be routinely assessed for chronic and, especially, neuropathic pain in order to properly diagnose and treat this condition, which appears to directly affect the degree of a patient's disability, a new study reports. Pain is one of the most disabling clinical symptoms of MS, associated with suffering, distress, and lower quality of life. Many studies have investigated the prevalence of chronic pain in MS patients but with highly varying results: estimates range from 29 percent up to 92 percent. This disparity is likely due to methodological differences between the studies, as well as differences in the studied population. The result is the prevalence of pain in MS is still unclear, and underdiagnoses of pain in this patient population likely. Researchers in Italy conducted a single-center study to determine the prevalence and characteristics of chronic pain, defined as constant pain for more than three months, in a population of MS patients. Pain was evaluated using validated tools, and the results were analyzed in relation to clinical features such as disease duration and disability. In total, 374 MS patients with different disease severities were assessed for pain. Results found an overall prevalence of chronic pain of 52.1, most frequently affecting the lower limbs. Neuropathic pain, which refers to pain resulting from a lesion or disease impacting the sensory nervous system, was the most frequent type of chronic pain, affecting 23.7 percent of the patients analyzed. Pain intensity was also found to be significantly higher in patients with neuropathic pain compared to those with non-neuropathic pain. Researchers measured patients' disability using the Expanded Disability Status Scale. They determined that patients with chronic pain, and especially those with chronic neuropathic pain, had significantly higher EDSS scores (meaning greater disability) than those without such pain. Both these patient groups were also more likely to be on long-term pain medications: 33 percent of MS patients with neuropathic pain, and 24 percent of those with chronic pain. These results indicate that pain is underdiagnosed and undertreated in MS patients, and a factor that may contribute to increased disability. “Our results suggest that clinical disability is higher in MS patients with chronic pain and, in particular, in those with neuropathic pain,” the researchers concluded. “The present study supports the routine assessment of neuropathic pain in MS patients.”

Researchers further explored how our internal biological clock — known as circadian rhythm — influences immune system responses. Disruptions to that rhythm are associated with immune diseases like multiple sclerosis (MS), although in ways not fully understood and, the study suggests, may affect response to treatment. A natural 24-hour cycle that exists…

A natural metabolite called taurine may boost the effectiveness of existing multiple sclerosis (MS) therapies, researchers say. Taurine helps oligodendrocytes, which are cells responsible for myelin production, to fully mature and activate the remyelination process of damaged nerve cells. The findings were reported in the study, “…

Blood levels of the nerve damage marker neurofilament light provide a reliable picture of multiple sclerosis activity in both the relapsing-remitting and progressive forms of the disease, a Swedish study reports. The University of Gothenburg researchers also discovered a close link between its levels in blood and spinal fluid. This means the…