• Safety Study of Human Neural Stem Cells Injections for Secondary Progressive Multiple Sclerosis Patients

  NCT03282760

  CompletedInterventionalPhase 1Updated Jul 12, 2021
• Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Progressive Multiple Sclerosis

  NCT03355365

  CompletedInterventionalPhase 2Updated Jun 11, 2025
• Clinical Efficacy of Autologous Mesenchymal Bone Marrow Stem Cells in Active & Progressive Multiple Sclerosis

  NCT02166021

  CompletedInterventionalPhase 2Updated Aug 1, 2019
• Intrathecal Administration of Autologous Mesenchymal Stem Cell-derived Neural Progenitors (MSC-NP) in Patients With Multiple Sclerosis

  NCT01933802

  CompletedInterventionalPhase 1Updated Mar 19, 2018
• Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS

  NCT03696485

  WithdrawnInterventionalPhase 1Phase 2Updated Apr 18, 2024
• Autologous Mesenchymal Bone Marrow Stromal Cells Secreting Neurotrophic Factors (MSC-NTF), in Patients With Amyotrophic Lateral Sclerosis (ALS)

  NCT01777646

  CompletedInterventionalPhase 2Updated Mar 8, 2018

ClinicalTrials.gov ID

NCT06961383

Lead Sponsor

NeuroGenesis Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

45Estimated

Last Update Posted

May 7, 2025Actual

Start Date

Oct 1, 2025Estimated

Primary Completion Date

Oct 1, 2027Estimated

Completion Date

Mar 1, 2028Estimated

Official Title

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

Brief 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.

Detailed Description

This is a multi-center, international Phase 2b, dose finding, randomized, double-blinded, placebo-controlled, three arm study, designed to assess the safety and efficacy of 4 IT administrations of NG01, compared to placebo, with a 4-month run-in period followed by a period of 9 months treatment with 6 months of follow-up, in patients with SPMS. Participants will continue to receive their customary MS treatment regimen at a stable dose.

The study will enroll 45 participants with secondary progressive multiple sclerosis (SPMS), randomized in a 1:1:1 ratio, to receive four intrathecal administrations-3 months apart over a 9-month period-of either high-dose NG01, low-dose NG01, or placebo. All participants will undergo clinical and safety assessments throughout the 9-month treatment period.

Upon completion of the 9-month treatment period, double-blind treatment and assessment period, participants will be followed clinically for an additional 6 months. The primary clinical outcome assessment and magnetic resonance imaging (MRI) acquisition for imaging assessments will occur post-treatment initiation (baseline).

• Secondary Progressive Multiple Sclerosis (SPMS)

• NG01 - Autologous bone marrow derived human stromal cells
• Sodium Chloride 0.9%

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

NeuroGenesis Ltd.INDUSTRY

petroupanayiota@gmail.com972-2-6776639