Medicine & Research

Pilot Study Finds Stem Cell Treatment Safe for MS Patients

Researchers found that stem cell transplantation may be safe and feasible for MS patients. Using stem cells harvested from the bone marrow of the test subjects, the Phase I study suggests that the procedure deserves further study.

Following up on prior studies that found that stem cells were safe and effective in the treatment of other diseases, 24 participants with relapsing forms of MS were involved in a study that tested the use of bone-marrow-derived, culture-expanded mesenchymal stem cells (MSCs). Led by Dr. Jeffrey Cohen of the Cleveland Clinic, researchers injected 16 women and eight men – 10 with relapsing-remitting and 14 with secondary-progressive MS – with MSCs and found that cell infusion was well-tolerated, and there were no treatment-related severe or serious adverse events.

While neither disease activation nor significant improvement was observed, researchers said that future trials to assess efficacy more definitively are warranted.

Cohen’s research was presented at the ACTRIMS-ECTRIMS MS Boston 2014.

Dr. Thrower: MS management has traditionally focused on three areas: treating relapses, managing symptoms, and preventing further progression. Hopefully, we will be able to add a fourth goal in the near future: reversing disability. While neural repair was considered an unattainable goal in the past, researchers are now attacking the problem on multiple fronts. Adult mesenchymal stem cells may be an option. Advantages of these cells are their ready availability and the fact that they come directly from the person, eliminating the risk of rejection. This report from Cleveland Clinic shows that their approach was safe. As stated, the next step will be showing that these stem cells can actually repair damage in the brain and spinal cord and reverse disability.
 
Study: Sleep Disorders Undiagnosed in MS Patients

The results of a new study suggest that sleep disorders are undiagnosed in multiple sclerosis patients. Researchers found that the sleep disorders may lie at the root of fatigue that affects MS patients.

The University of California, Davis medical researchers surveyed 2,375 MS patients and found that of them, 37.8 percent reported symptoms consistent with obstructive sleep apnea, 31.6 percent moderate to severe insomnia, and 36.8 percent restless legs syndrome. By comparison, only 4 percent, 11 percent, and 12 percent of the respondents reported being formally diagnosed with obstructive sleep apnea, insomnia, and restless legs syndrome. Of those in the survey, 81 percent of the MS patients were women, and 88 percent were Caucasian. The average age of participants was 54.

“This study shows that sleep disorder frequency, sleep patterns, and complaints of excessive daytime sleepiness suggest that sleep problems may be a hidden epidemic in the MS population, separate from MS fatigue,” said lead author Steven Brass, associate clinical professor and Director of the Neurology Sleep Clinical Program and Co-Medical Director of the UC Davis Sleep Medicine Laboratory.

The study was published online in the Journal of Clinical Sleep Medicine.

Dr. Thrower: Are you tired of being tired? Fatigue is the most common symptom seen in MS and, for many, the most bothersome. While fatigue can be a direct result of the MS itself, other factors, such as medications and disrupted sleep, may also contribute. This study shows how common sleep disorders are in MS. Clinical clues to an underlying sleep disorder include feeling fatigue upon first awakening or a history of snoring from the family, spouse, or partner. If a sleep disorder is suspected, the next step should be a referral to a sleep clinic for a sleep study.
 
New Drug Candidate Shows Promise in Treating MS

The results of a new drug candidate showed a reduced relapse rate and lower levels of new brain damage in MS patients. The drug also showed higher levels of safety for patients.

The drug candidate RPC1063, first discovered and synthesized at the Scripps Research Institute, was tested during a six-month Phase 2 study of 258 multiple sclerosis patients. The results of the drug candidate showed a reduction in the relapse rate by up to 53 percent and a decrease in new brain damage by more than 90 percent in MS patients. The drug also showed a strong safety profile with nearly all participants staying on the drug regimen during the trial period.

Receptos, a biopharmaceutical company in San Diego, is developing RPC1063 for approval by the U.S. Food and Drug Administration. The drug candidate is currently in a Phase 3 randomized, double-blind study involving 1,200 relapsing multiple sclerosis patients. The trial is expected to be completed in 2017.

“These data support our labs’ approach at TSRI that discovery of fundamental mechanisms in chemical biology provides the foundation for intelligent intervention in disease processes,” said Ed Rosen, Scripps California.

The new RPC1063 findings were presented at the MS Boston 2014 meeting.

Dr. Thrower: RPC1063 is a sphingosine 1-phosphate 1 receptor modulator (S1P1R) that works similarly to Gilenya (fingolimod). There are several types of sphingosine receptors in the human body, including in the heart. A potential side effect of fingolimod is a lowering of the heart rate due to the drug’s actions on these cardiac receptors. This side effect is generally transient and manageable. There is the hope that by having a drug that does not affect those cardiac receptors, like RPC1063, that this side effect could be eliminated completely. The effect of RPC1063 on relapse rates and new MRI lesions appears promising as well.
 
Study Finds Processing Speed, Cognitive Deficit Link

Kessler Foundation researchers found that slow processing speed explains executive deficits in multiple sclerosis patients.

Researchers examined two key variables: executive function and processing speed. The brain’s frontal lobe coordinates the mental skills that make up executive function. Examples include (but are not limited to) the ability to manage time and attention, switch focus, plan and organize, and remember details. Processing speed is the ability to quickly and efficiently respond to basic stimuli and is often defined as speed of completion of a task with reasonable accuracy.

The study measured executive functioning tasks in 50 MS patients, comparing them to 28 healthy individuals. Researchers found that on timed tasks of executive function, MS patients performed worse than healthy individuals. When the scientists controlled for speed, performance deficits disappeared. They also found no link between atrophy and performance when speed was controlled for.

“Our results point to slowed processing speed as the mechanism underlying deficits in executive function,” said Nancy Chiaravalloti, PhD, a co-author of the Kessler Foundation study. “Under-standing this association is an important step toward the development of effective cognitive rehabilitation strategies for individuals with MS. We should focus our efforts on two key domains – processing speed and memory.”

The study was published online in the journal Rehabilitation Psychology.

Dr. Thrower: Cognitive dysfunction is common in MS and is a leading cause of vocational disability. What this study shows is that some of the cognitive challenges faced by people with MS might be partially addressed by allowing more time to complete the task. The real world implications are significant. Healthcare providers may need to ask for more time for students with MS to complete an examination. Employers may need to consider adaptive requests to accommodate slowed processing speed. Cognitive symptoms in a person with MS may be magnified by fatigue and/or depression. Comprehensive neuro-psychological testing remains the best way of sorting out the root causes of cognitive symptoms.