Status:
NOT_YET_RECRUITING
Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
Lead Sponsor:
NeuroGenesis Ltd.
Conditions:
Secondary Progressive Multiple Sclerosis (SPMS)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 Progressi...
Detailed Description
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 NG0...
Eligibility Criteria
Inclusion
- 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.
- T25FW at the screening visit of from 8.0 to 25 seconds.
Exclusion
- 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
- Participants unable to undergo an MRI scan.
- Participants with uncontrolled hepatic disorders, renal or cardiovascular disease, or cancer.
- Laboratory tests out of normal ranges considered by the investigator as clinically significant.
- Participants with history or current alcohol abuse or drug addiction.
- Untreated or uncontrolled psychiatric disorders, or positive suicidal risk assessed by Columbia-Suicide Severity Rating Scale (C-SSRS).
- 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.
- Participants who have ever received NG01/MSCs treatment.
- 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.
- Relapse occurring between screening and randomization.
- Less than 6 months of the current disease-modifying therapy
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06961383
Start Date
October 1 2025
End Date
March 1 2028
Last Update
May 7 2025
Active Locations (2)
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1
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology
Miami, Florida, United States, 33136
2
Hadassah University Hospital
Jerusalem, Israel