NG01 Cell Therapy for Multiple Sclerosis

Not yet recruiting at 1 trial location

Overseen By Flavia Nelson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: NeuroGenesis Ltd.

Disqualifiers: Pregnancy, Clotting disorders, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 9 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cell therapy called NG01 to determine if it can improve walking ability in people with Secondary Progressive Multiple Sclerosis (SPMS). Participants will receive injections of either NG01 or a placebo, and researchers will measure changes in walking speed over time. The trial will also monitor any side effects from the treatment. Individuals with SPMS who have experienced worsening walking ability over the past two years might be suitable for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in SPMS treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that participants should have been on their current disease-modifying therapy for at least 6 months.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that NG01 Cell Therapy, which uses a person's own bone marrow cells, is being tested to help people with Secondary Progressive Multiple Sclerosis (SPMS). Past patients experienced improved movement and quality of life after receiving NG01.

Regarding safety, studies have found that this treatment is generally well-tolerated. Reports of better movement and thinking abilities suggest positive results without major safety issues. However, the treatment involves injections into the spine, which can sometimes cause headaches or discomfort.

Overall, current studies provide encouraging information on safety, but discussing potential risks and benefits with the study team is always important for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about NG01 Cell Therapy for multiple sclerosis, particularly for secondary progressive multiple sclerosis (SPMS), because it offers a unique approach compared to current treatments like interferons or immunosuppressive therapies. NG01 uses stem cells, potentially providing a regenerative effect by repairing damaged tissues in the nervous system. This cell-based therapy is delivered directly into the spinal fluid, which could enhance its ability to target and repair areas of neurological damage more effectively than conventional medications. With two different dosage arms in the trial, researchers are keen to determine the most effective cell concentration, offering hope for a more personalized treatment strategy.

What evidence suggests that NG01 Cell Therapy might be an effective treatment for Secondary Progressive Multiple Sclerosis?

Research has shown that NG01 Cell Therapy may help treat multiple sclerosis. One study demonstrated that NG01 improved movement, thinking, and overall quality of life for patients with progressive forms of the disease. Specifically, 16 patients walked better after 12 months. This suggests that NG01 could aid individuals with Secondary Progressive Multiple Sclerosis (SPMS) in improving their walking. In this trial, participants will receive different dosages of NG01 Cell Therapy—either 50x10^6 cells, 100x10^6 cells, or a placebo. The therapy uses special cells from the patient's own bone marrow to potentially repair or protect nerve cells in the brain and spine. These early results are promising, but further research is needed to confirm them. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Secondary Progressive Multiple Sclerosis (SPMS). Participants should be able to complete the Timed 25-Foot Walk test. Specific eligibility criteria are not provided, but typically include age range, disease severity, and no conflicting health conditions.

Inclusion Criteria

I have been diagnosed with Secondary Progressive Multiple Sclerosis.

My disability has worsened in the last 2 years as per EDSS or T25FW scores.

My disability level is moderate to severe but I can still walk.

Exclusion Criteria

My condition worsened or I had new symptoms in the last 2 years.

I am not pregnant, breastfeeding, and if capable of childbearing, I use effective contraception.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Run-in

Participants undergo a 4-month run-in period before treatment begins

16 weeks

Treatment

Participants receive 4 intrathecal administrations of NG01 or placebo, 3 months apart over a 9-month period

9 months

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• NG01 Cell Therapy

Trial Overview The study tests NG01 cell therapy involving autologous bone marrow derived human stromal cells given through spinal injections versus a placebo of saline solution. It measures improvement in walking speed over time and monitors any adverse events after treatment.

How Is the Trial Designed?

Group I: 50x10^6 cells Experimental Treatment 1 Intervention

15 participants with SPMS will receive 4 IT administrations of NG01 (50×10\^6 cells), 3 months apart

Group II: 100x10^6 cells Experimental Treatment 1 Intervention

15 participants with SPMS will receive 4 IT administrations of NG01 (100×10\^6 cells), 3 months apart

Group III: Placebo Placebo Group 1 Intervention

15 participants with SPMS will receive 4 IT administrations of placebo solution, 3 months apart

Who Is Running the Clinical Trial?

NeuroGenesis Ltd.

Lead Sponsor

Published Research Related to This Trial

The article has been retracted due to significant concerns about image reuse and misrepresentation of data, which undermines the integrity of the research.

Despite the authors' disagreement with the retraction, the editorial office confirmed that the issues found in the article represent a serious violation of scientific publishing standards.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RETRACTED: Neural Stem Cells Engineered to Express Three Therapeutic Factors Mediate Recovery from Chronic Stage CNS Autoimmunity Li, X., Zhang, Y., Yan, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06961383

NCT06961383 | Study of NG01 Cell Therapy in Secondary ... 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 ...

2. firstwordpharma.com firstwordpharma.com/story/6228832

NeuroGenesis Announces Positive Phase 2 Extension ... Study shows NG01 improved mobility, cognition, and quality of life, marking a step forward in treatment for progressive multiple sclerosis.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/neurogenesis-multiple-sclerosis-trial/

NeuroGenesis announces positive data from multiple ... NeuroGenesis announces positive data from multiple sclerosis trial ... Walking ability improved significantly in 16 patients after 12 months of ...

4. withpower.com withpower.com/trial/phase-2-neoplasm-metastasis-9-2025-d5331

NG01 Cell Therapy for Multiple Sclerosis What data supports the effectiveness of the NG01 Cell Therapy treatment for multiple sclerosis? Research on similar cell therapies shows promise in treating ...

5. ctv.veeva.com ctv.veeva.com/study/study-of-ng01-cell-therapy-in-secondary-progressive-multiple-sclerosis

Study of NG01 Cell Therapy in Secondary Progressive ... The goal of this clinical trial is to assess the safety and efficacy of repeated intrathecal (IT) injection of NG01, autologous bone marrow ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06961383

Study of NG01 Cell Therapy in Secondary Progressive ... 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 ...

7. scivisionpub.com scivisionpub.com/pdfs/safety-and-efficacy-of-stem-cell-therapy-on-the-treatment-for-multiple-sclerosis-4157.pdf

Safety and Efficacy of Stem Cell Therapy on the Treatment for ... Results: aHSCT achieves durable immune “resetting” and superior relapse and disability outcomes compared with high-efficacy. DMTs in aggressive ...