Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
This study is testing a cell therapy called NG01 for people with Secondary Progressive Multiple Sclerosis (SPMS). NG01 uses your own bone marrow cells. Researchers want to see if NG01 is safe and if it can help improve walking ability compared to a placebo (a salt water solution). You might be able to join if you are 18 to 65 years old, have SPMS, and your walking or disability has worsened recently. The study will measure how well you can walk after 12 months and track any side effects for 15 months. This study is currently recruiting 45 participants.
- Study design
- This is a Phase 2b, randomized, double-blind, placebo-controlled study with three groups, enrolling 45 participants.
- What's involved
- You would receive four injections over nine months and have clinical and safety assessments throughout this period.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 9-month treatment period, participants will be followed clinically for an additional 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study of NG01 Cell Therapy in Secondary Progressive Multiple Sclerosis
At a glance
Conditions
NCT06961383
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Hadassah University Hospital
Jerusalem, Israelstudy coordinator listed
University of Miami Hospital & Clinics - Sylvester Comprehensive Cancer Center - Neurology
Miami, Floridastudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Walking Ability12 months
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)
- Incidence of Treatment-Emergent Adverse Events (AEs)15 months
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.