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Hadassah Stem Cell Therapy May Help MS Patients Walk Again

 


Innovative Stem Cell Therapy Developed by Hadasa-University Medical Center And NeuroGenesis is important Clinical Improvements in patients with progressive multiple sclerosis, according to the results of Phase II clinical trials.

The results of a placebo-controlled trial that found that treatment not only stopped the disease from progressing, but even reversed it, were published in a peer-reviewed journal at Oxford University. brain.

Multiple sclerosis (MS) is an autoimmune disease that plagues more than 2.3 million people worldwide, according to the US-based National Multiple Sclerosis Society. The disease causes damage to myelin (a cover that protects nerves and promotes the efficient transmission of nerve impulses) and nerve cells in the central nervous system, ultimately leading to neuropathy.

People with multiple sclerosis often experience tingling and numbness in their limbs, have problems walking and using their hands, and may eventually become paralyzed. This condition is also related to virus problems.

To date, not only are there no known treatments, but people with advanced MS have few, if any, practical treatments. What is present is aimed at reducing the incidence of recurrence or slowing the progression of the disease.

The development of Hadassah, known as NG-01, uses an “autologous subpopulation of mesenchymal stem cells.” In layman’s terms, treatment uses cells derived from the bone marrow of patients with multiple sclerosis to ensure that there are no elements of rejection. The cells are injected directly into the patient’s spinal cord and into the central nervous system.

The cells then migrate to the site of injury, creating a “repair ecosystem” in the lesion area, explained Tal Gilat, CEO of NeuroGenesis.

NeuroGenesis, CEO, Tal Gilat (Credit: COURTESY)NeuroGenesis, CEO, Tal Gilat (Credit: COURTESY)

The process is relatively simple and takes about 20 minutes under local anesthesia. Patients are free to go home after spending several hours in the hospital for observation.

This technology was further developed by Neurogenesis under license from Hadassah’s technology transfer company, Hadassah.

“Patient improvement was often very dramatic,” Gilat said.

Almost 60% of patients showed no evidence of disease activity throughout the treatment period, compared to 10% in the placebo group. This means that the progression of the disease has been reduced by 85%.

Approximately 20% of patients treated with stem cells in the cerebrospinal fluid showed improvement after the first injection. After 6 months, 73% not only did not experience disease progression, but also improved.

Improvements included improved walking ability, increased muscle strength, neurological improvement in cognitive function, and improved manual dexterity. Functional MRI also showed improvements in motor function. Gilat described patients who can walk again, including those who have transitioned from difficulty moving to 10 miles of running.Professor Dimitrios Calsis of Hadassah (Credit: HADASSAH UNIVERSITY MEDICAL CENTER)Professor Dimitrios Calsis of Hadassah (Credit: HADASSAH UNIVERSITY MEDICAL CENTER)
“Currently, there are several excellent treatment options for relapsing-remitting multiple sclerosis, but we offer effective treatments for progressive multiple sclerosis that can significantly slow the progression of the disorder. “It’s not enough,” said Professor Dimitrios Calsis of Hadassah, who led the study. “This trial provides promising results, suggesting the potential for new approaches that not only slow the progression of the disease, but may also induce improvement in progressive MS and promote repair mechanisms,” he said. Said.

Forty-eight patients participated in the Phase II trial. However, approximately 140 patients were treated during Phase I trials and through compassionate use in Hadassah.

There were no serious treatment-related side effects in any of the studies. Currently, the results are short-term and require continuous treatment to maintain efficacy. “It doesn’t address the root cause of the disease, which is still unknown. It’s improving the symptoms,” Gilat said.

Karussis added: “On the other hand, if small and medium-sized studies show positive results and large-scale studies have not yet confirmed results, we should always be careful. On the other hand, looking at the results of these patients, we We need to work hard … these are certainly very powerful findings. ”Gilat said Hadassah and NeuroGenesis also conducted early-stage trials using treatment for patients with amyotrophic lateral sclerosis. (ALS) Good results were obtained.

NeuroGenesis met with the US Food and Drug Administration to share data from the first trial. It may then begin a multicenter Phase III trial in the United States and begin the application process for approval. Karussis estimated that it could happen in 2-5 years.

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