Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeuroGenesis Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- NG01 - Autologous bone marrow derived human stromal cells
- Sodium Chloride 0.9%
Treatment groups
45 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov