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Researcher Wins National MS Society Grant to Study Patients’ Emotional Processing Challenges

A $44,000 National Multiple Sclerosis Society grant will allow a researcher at the Kessler Foundation to advance her work on multiple sclerosis patients’ emotional processing challenges. Dr. Helen Genova, Kessler’s assistant director of neuropsychology and neuroscience research, has been studying cognitive dysfunction in people with various diseases, including MS. In addition to neurological problems,…

American CyroStem Warned by FDA to Stop Using Stem Cell Therapy Without Approval and to Correct Safety Issues

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.  

Top 10 Multiple Sclerosis Articles of 2017

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…

GSK Researchers Identify Potential Target for Therapeutics to Promote MS Remyelination

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…

MS Patients’ Handwriting Ability Correlates with Movement, Sensory and Cognitive Impairment, Study Shows

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."

Clomipramine, an Antidepressant, Shows Potential in Treating Progressive MS in Early Study

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…

IMPAQ Creates Health Insurer Cost Comparison Calculator for New York State Residents

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…