Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis

Part of paid clinical trials in Miami, Florida.

Sponsor
NeuroGenesis Ltd.
Study ID
NCT06961383
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Secondary Progressive Multiple Sclerosis (SPMS)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • NG01 - Autologous bone marrow derived human stromal cells — BIOLOGICAL
    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
    The placebo for use in the NG01 clinical trial is 0.9% Sodium Chloride Solution for Injection

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Apr 2025
Primary completion
Oct 1, 2027
Completion
Mar 1, 2028

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 100x10^6 cells
    15 participants with SPMS will receive 4 IT administrations of NG01 (100×10\^6 cells), 3 months apart
  • Experimental: 50x10^6 cells
    15 participants with SPMS will receive 4 IT administrations of NG01 (50×10\^6 cells), 3 months apart
  • Placebo Comparator: Placebo
    15 participants with SPMS will receive 4 IT administrations of placebo solution, 3 months apart

Primary Outcome Measure

Walking Ability [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - NeurologyMiamiFlorida33136
Flavia Nelson, MD
[email protected]
305-243-4015
Flavia Nelson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Miami, FL

By research site
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology· Miami, FL

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