NOT_YET_RECRUITING

Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)Secondary progressive multiple sclerosis Multiple sclerosis Autologous cell therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-10-01

Study Completion:2028-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:NOT_YET_RECRUITING

Study ID

NCT06961383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Flavia Nelson, MD

CONTACT

305-243-4015

fxn133@med.miami.edu

Study Locations (Sites)

University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: NeuroGenesis Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-10-01

Study Completion Date2028-03-01

Study Record Updates

Study Start Date2025-10-01

Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

Secondary progressive multiple sclerosis
Multiple sclerosis
Autologous cell therapy

Additional Relevant MeSH Terms

Secondary Progressive Multiple Sclerosis (SPMS)