Patient dosing has finished in a Phase 2 clinical trial testing NurOwn, BrainStorm Cell Therapeutics’ investigational cell-based therapy for people with progressive multiple sclerosis (MS), the company announced.
The trial’s top-line results are expected by April.
“Now that all dosing of the NurOwn Phase 2 progressive MS clinical trial is complete, we will shift our focus to completing all remaining patient clinical trial assessments and biomarker analyses,” Ralph Kern, MD, BrainStorm’s president and chief medical officer, said in a press release.
“We look forward to generating clinical trial top line results by the end of the first quarter 2021 and to advancing this promising treatment option based on a thorough analysis of the clinical trial outcomes,” Kern added.
Stacy Lindborg, PhD, BrainStorm’s executive vice president and head of global clinical research, noted that the full study data will be shared “with the MS scientific community at upcoming conferences and in subsequent publications” to “help advance understanding of progressive MS and the potential benefits of NurOwn as a treatment.”
NurOwn involves collecting mesenchymal stem cells (MSCs) from a patient’s own bone marrow, and expanding and maturating them into cells that produce high levels of neurotrophic factors (NTF) — molecules that promote nerve cell growth and survival. MSCs are stem cells that can generate a variety of other cell types.
The mature cells — called MSC-NTF cells — are then injected into the patient’s spinal canal to promote and support nerve cell repair. Using a patient’s own cells minimizes the risk of an immune reaction, as might occur with cells from a donor.
In MS, NurOwn is believed to promote the repair of myelin — the protective sheath around nerve fibers that is lost in MS — lessen the likelihood of further damage, and potentially slow disease progression.
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