A Phase 2 interventional study of NG01 - Autologous bone marrow derived human stromal cells and Sodium Chloride 0.9% in Secondary Progressive Multiple Sclerosis (SPMS), sponsored by NeuroGenesis Ltd.. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by NeuroGenesis Ltd. · Phase 2, Interventional, and Treatment
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.
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).
244 studies on the registry are indexed under Multiple Sclerosis, Chronic Progressive; 53 are open to participants now.
This study's planned enrollment of 45 is below the median of 54 across 189 interventional studies indexed under Multiple Sclerosis, Chronic Progressive.
Browse Multiple Sclerosis, Chronic Progressive studies →This is the only study on the registry with NeuroGenesis Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
15 participants with SPMS will receive 4 IT administrations of NG01 (100×10\^6 cells), 3 months apart
Biological: NG01 - Autologous bone marrow derived human stromal cells
15 participants with SPMS will receive 4 IT administrations of NG01 (50×10\^6 cells), 3 months apart
Biological: NG01 - Autologous bone marrow derived human stromal cells
15 participants with SPMS will receive 4 IT administrations of placebo solution, 3 months apart
Other: Sodium Chloride 0.9%
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.
The placebo for use in the NG01 clinical trial is 0.9% Sodium Chloride Solution for Injection
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
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
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
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
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
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
Efficacy - Finger Dexterity
Finger dexterity will be assessed by the 9-hole peg test (9HPT)
Time frame: 12 months
Quality of Life (QoL)
Quality of Life (QoL) will be assessed by 12-Item Short Form Survey (SF-12). Patients fill out a 12-question survey which is then scored by a clinician or researcher. The survey includes the following domains: 1. Limitations in physical activities because of health problems. 2. Limitations in social activities because of physical or emotional problems 3. Limitations in usual role activities because of physical health problems 4. Bodily pain 5. General mental health (psychological distress and well-being) 6. Limitations in usual role activities because of emotional problems 7. Vitality (energy and fatigue) 8. General health perceptions
Time frame: 12 months
Fatigue
Level of fatigue will be assessed by Modified Fatigue Impact Scale (MIFS-21). The scores are 0 (Never), 1(Rarely), 2 (Sometimes), 3 (Often), 4 (Almost always). Physical Subscale can range from 0 to 36. Cognitive Subscale can range from 0 to 40. Psychosocial Subscale can range from 0 to 8. The subscale scores are computed by adding raw scores on specific questions, in accordance with questionnaire instructions. Total MFIS Score can range from 0 to 84. It is computed by adding scores on the physical, cognitive, and psychosocial subscales.
Time frame: 12 months
Walking ability
Walking will be assessed by 12-item Multiple Sclerosis Walking Scale (MSWS-12). The original scoring provides options 1-5 for each item, with 1 meaning no limitation and 5 meaning extreme limitation on the gait-related item. In a version 2, three items are scored 1-3, and nine items are scored 1-5.
Time frame: 12 months
Efficacy - Congnition
Cognitive assessment will be done using the Symbol Digit Modalities Test (SDMT)
Time frame: 12 months
Change in Disability
Proportion of participants with no increase in month-3 confirmed disability worsening (CDW) will be assessed by Expanded Disability Status Scale (EDSS). The EDSS ranges from 0 to 10. Scores are in half unit steps - 3, 3.5, 4 and so on. The greater the level of disability, the higher the score out of ten.
Time frame: 12 months
Plan to share: No
Start is estimated for Oct 2025; primary completion for Oct 2027, 24 months later.
Of 25 phase 2 interventional studies under Multiple Sclerosis, Chronic Progressive, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Multiple Sclerosis, Chronic Progressive →