Health TrialsbyHealthPanel

Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

ConditionSecondary Progressive Multiple Sclerosis (SPMS)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNeuroGenesis Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Documented clinical relapse during the 24 months prior to enrollment and/or evidence of enhancing lesions on an MRI obtained at screening.

Pregnancy, breast feeding or women with childbearing potential without an acceptable form of contraception.

History of a general chronic handicapping/incapacitating disease other than MS.

Participants with clotting disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • NG01 - Autologous bone marrow derived human stromal cells

    Biological/Vaccine

    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%

    Other intervention

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

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: 100x10^6 cellsExperimental treatment 1 intervention
Group B: 50x10^6 cellsExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Walking Ability

Proportion of participants who achieved improvement in walking ability over baseline by mean change in walking speed based on the Timed 25-Foot Walk (T25FW) test, averaged over visits at month-6, month-9 and month-12. Baseline is defined as the change in average timed walk compared to baseline (average timed walk at 6-, 9-, 12-months minus baseline \< 0)

Time frame
12 months
2

Incidence of Treatment-Emergent Adverse Events (AEs)

The occurrence of treatment-related AEs will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 following enrollment, NG01 or placebo administrations (intrathecal), and during the 6 months of follow-up.

Time frame
15 months

Secondary outcomes

1

Walking Speed

The change in walking speed will be assessed based on the average of two separate T25FW tests obtained during each study visit. The proportion of responders with 10, 15 or 20% improvement in walking speed will be assessed based on the average of two separate T25FW tests obtained during each study visit.

Time frame
12 months
2

Neuroimaging Parameters - Change in T2-hyperintense Lesion

Change in T2-hyperintense lesion number and volume will be assessed by 3 tesla (3T) brain Magnetic Resonance Imaging (MRI) using automated volumetric analysis.

Time frame
12 months
3

Neuroimaging Parameters - Change in T1-hypointense Lesion

Change in T1-hypointense lesion volume will be assessed by 3 tesla (3T) brain MRI using automated volumetric analysis.

Time frame
12 months
4

Neuroimaging Parameters - Change in Brain and Thalamus

Change in whole brain and thalamic volume will be assessed by 3 tesla (3T) brain MRI using automated volumetric analysis

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NeuroGenesis Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: