NCT06961383Not yet recruitingPhase 2
Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
A Double Blind, Randomized, Placebo Controlled Phase 2b Study to Evaluate the Safety and Clinical Efficacy of Treatment With the Autologous Cell Therapy Product, NG01, in Patients With Secondary Progressive Multiple Sclerosis
Source: ClinicalTrials.gov · Last updated 7 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- First submitted
- 21 Apr 2025
- Start date
- 1 Oct 2025
- Primary completion date
- 1 Oct 2027
- Lead sponsor
- NeuroGenesis Ltd.
- Diseases
- Multiple sclerosis
- NCT number
- NCT06961383
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 45
- From 1 Oct 2025 to the primary completion date, 1 Oct 2027
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.
- Participants with history or current alcohol abuse or drug addiction.
- Participation in another research study involving an investigational product (IP) in the 90 days prior to inclusion, or planned use of another IP during the study duration.
- Participants who have ever received NG01/MSCs treatment.
Other illness
- History of a general chronic handicapping/incapacitating disease other than MS.
- Participants with clotting disorders
- Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.
- Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
- Less than 6 months of the current disease-modifying therapy
Lab values
- Laboratory tests out of normal ranges considered by the investigator as clinically significant.
Other
- Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.
- Participants unable to undergo an MRI scan.
- Participants who, in the opinion of the investigator, are unable to fully comprehend the consenting process or likely to be non-compliant with the study procedures or for whom long-term follow-up seems difficult to achieve.
- Relapse occurring between screening and randomization.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hadassah University Hospital Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.