Clinical Trial

Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow derived human stromal cells, in treating Secondary Progressive Multiple Sclerosis (SPMS), compared to placebo. The study will assess the proportion of participants demonstrating improvement in walking ability, defined as a reduction in the average time to complete the Timed 25-Foot Walk (T25FW) at 6, 9, and 12 months compared to baseline. This will be analyzed by the mean change in walking speed across these time points. The study will also evaluate the incidence and nature of treatment-emergent adverse events (AEs). Participants will receive intrathecal administrations of NG01, by lumbar puncture, and will be followed up for 6 months after their fourth administration.
Trial Details
NCT Number NCT06961383
Lead Sponsor NeuroGenesis Ltd.
Conditions Secondary Progressive Multiple Sclerosis (SPMS)
Enrollment 45 participants
Start Date 2025-10-01
Primary Completion 2027-10-01 (estimated)
Study Completion 2028-03-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-07