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Clinical Trials in the USA / NCT06961383
Starting soon Phase 2

Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

NCT06961383 · tracked via the Priya Life Science USA tracker
Sponsor
NeuroGenesis Ltd.
Phase
Phase 2
Started
2025-10-01
Last updated
2025-05-07

Condition(s) studied

Secondary Progressive Multiple Sclerosis (SPMS)

Investigational drug(s) / intervention(s)

NG01 - Autologous bone marrow derived human stromal cellsSodium Chloride 0.9%

NG01 - Autologous bone marrow derived human stromal cells: NG01 is a cellular therapy product of autologous stromal cells derived from the bone marrow of multiple sclerosis (MS) patients. NG01 is provided as a cell suspension for intrathecal injection.

Sodium Chloride 0.9%: The placebo for use in the NG01 clinical trial is 0.9% Sodium Chloride Solution for Injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participants aged 18 to 65 years old. 2. Diagnosis of SPMS. 3. 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. 4. EDSS at the screening visit from 3.5 to 6.5 at screening. 5. T25FW at the screening visit of from 8.0 to 25 seconds. Exclusion Criteria: 1. Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening. 2. Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception. 3. History of a general chronic handicapping/incapacitating disease other than MS. 4. Participants with clotting disorders 5. Participants unable to undergo an MRI scan. 6. Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer. 7. Laboratory tests out of normal ranges considered by the investigator as clinically significant. 8. Participants with history or current alcohol abuse or drug addiction. 9. Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS). 10. 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. 11. Participants who have ever received NG01/MSCs treatment. 12. 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. 13. Relapse occurring between screening and randomization. 14. Less than 6 months of the current disease-modifying therapy

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology Miami Florida
Hadassah University Hospital Jerusalem Israel

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06961383 on ClinicalTrials.gov ↗ ← All trials in the USA