Transplantation of NG-01 cells offers neuroprotection for people with progressive multiple sclerosis (MS), according to results from a placebo-controlled phase 2 clinical trial. The announcement of the positive results was recently made by NeuroGenesis and Hadassah Medical Center.
“This novel trial evaluated not only the clinical effects induced by the stem cell therapy, but also the effects on the most reliable and accepted biomarker of neuro-degeneration, NFL [NF-L; neurofilament light],” Dimitrios Karussis, lead principal investigator and director of the MS Center at Hadassah Medical Center said.
“We therefore believe that our findings are extremely encouraging and taken together with the long-term clinical results, that showed stabilization and even functional improvement in 22 out of the 24 participants up to 4 years after the initiation of treatment, provide substantial optimism for the future of management of progressive MS and neurodegenerative diseases in general.”
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Treatment with intrathecally injected NG-01 stem cells led to a median reduction of 63.5% in the levels of NF-L when compared to baseline pretreatment measurements. The reduction was superior to 50% in 9 out of 15 participants who received intrathecal NG-01 injection.
The decrease in NF-L levels correlated with functional improvement, with most (8/9) patients showing stable or improved performance in the Expanded Disability Status Scale at 6 months, as well as improved disability score even after a follow-up of 12 months.
In contrast, the placebo group showed a median increase of 47.5% in the levels of NF-L, which suggests deterioration of patients’ condition. Moreover, treatment with intravenous NG-01 injection did not provide significant improvement. To analyze the impact of NG-01 cell therapy in the levels of NF-L, the researchers collected cerebrospinal fluid samples at baseline and at 6 months after treatment from 48 participants with progressive MS.
“We are currently working on expanding our manufacturing capacity in the US in preparation for our multi-center Phase 2b trial in secondary progressive MS that is planned to begin in late 2022,” Tal Gilat, chief executive officer of NeuroGenesis said.
NeuroGenesis and Hadassah Medical Center report positive NF-L biomarker results from a phase 2 study in progressive multiple sclerosis treated with NG-01 cells therapy. News release. NeuroGenesis; Hadassah Medical Center; March 1, 2022.
Clinical efficacy of autologous mesenchymal bone marrow stem cells in active & progressive multiple sclerosis. ClinicalTrials.gov. June 18, 2014. Updated August 1, 2019. Accessed March 4, 2022.