NCT06961383
Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
Not Yet Recruiting · Phase 2 · NeuroGenesis Ltd. · registry updated 2025-05-07
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Participants aged 18 to 65 years old.
- Diagnosis of SPMS.
- Documented EDSS worsening over the 2 years prior to study entry of ≥1 point for participants with EDSS \<6.0 at screening, and ≥0.5 point for participants with EDSS ≥6.0 at screening, or a documented worsening of at least 20% in the T25FW. If documented T25fW or EDSS is not available, a written summary of the clinical evidence of disability worsening over the previous 2 years and retrospective assessment of EDSS score from data up to 2 years prior to screening, must be submitted for central review by adjudication committee.
- EDSS at the screening visit from 3.5 to 6.5 at screening.
- T25FW at the screening visit of from 8.0 to 25 seconds.
Exclusion
- Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.
- Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.
- History of a general chronic handicapping/incapacitating disease other than MS.
- Participants with clotting disorders
- Participants unable to undergo an MRI scan.
- Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.