Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

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.

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

Condition
Secondary Progressive Multiple Sclerosis (SPMS)
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology, Miami, Florida, United States, 33136

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NeuroGenesis Ltd.,

Study Record Dates

2028-03-01