Neural Stem Cell Therapy for Stroke

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Gary Steinberg, MD, PhD

Must be taking: Tacrolimus

Disqualifiers: Neurological disease, Cancer, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Single administration

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests if injecting special cells called NR1 into the brain can help people with spinal cord injuries and/or strokes by potentially repairing or improving brain function.

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, you must be willing to take tacrolimus (Prograf) starting 2 days before and continuing for 2 months after the transplant.

What data supports the effectiveness of the treatment NR1 for stroke?

Research shows that neural stem cells (NSCs) can help repair the brain after a stroke by promoting nerve regeneration and reducing inflammation. Studies in animals and some clinical trials suggest that NSCs can improve brain function and recovery by replacing damaged cells and supporting brain healing processes. ^{1 2 3 4 5}

Is neural stem cell therapy for stroke safe for humans?

Neural stem cell therapy for stroke has shown to be generally well tolerated in early trials, but some serious side effects have been linked to the surgical procedure used to deliver the cells. Common side effects in cell therapies can include immune reactions, seizures, and issues with blood clots, so it's important to weigh these risks when considering participation in a trial. ^{2 6 7 8 9}

How is the treatment NR1 different from other stroke treatments?

Neural stem cell therapy, like NR1, is unique because it uses stem cells to repair and regenerate brain tissue after a stroke, which is different from traditional treatments that mainly focus on managing symptoms. This therapy can replace damaged cells, reduce inflammation, and promote new blood vessel growth, offering a more comprehensive approach to recovery. ^{1 2 3 5 10}

Research Team

Gary K Steinberg, MD, PhD

Principal Investigator

Professor, Neurosurgery Department

Eligibility Criteria

This trial is for adults aged 18-75 who've had a stroke in specific brain arteries between 6 months to 5 years ago. Participants must understand the study, consent to it, and be willing to take tacrolimus medication before and after receiving stem cell treatment. People with very small or large stroke areas, recent certain types of strokes, major neurological diseases other than stroke, active cancer (except some skin cancers), seizures, or those pregnant/breastfeeding cannot join.

Inclusion Criteria

I had a stroke in a specific part of my brain between 6 months and 5 years ago.

I am between 18 and 75 years old.

Ability of subject to understand and provide written Informed Consent

Exclusion Criteria

I have had cancer before, but it wasn't skin cancer.

I have had seizures in the past.

Pregnant or breast-feeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intracerebral transplantation of Neural Stem Cells (NR1) at a single time-point post-injury

Single administration

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related adverse events and changes in Fugl Meyer motor score

12 months

Treatment Details

Interventions

• NR1

Trial Overview The trial is testing the safety of different doses of Neural Stem Cells (NR1) injected directly into the brain one time post-injury in people with chronic ischemic subcortical strokes. It aims to see how well participants tolerate this potential new treatment.

Participant Groups

Group I: Neural Stem cells injected intracerebrally Experimental Treatment 1 Intervention

Subject cohorts will be treated with increasing doses of Neural Stem Cells injected intracerebrally using a traditional 3+3 trial design

Who Is Running the Clinical Trial?

Gary Steinberg, MD, PhD

Lead Sponsor

Trials

1

Recruited

30+

Gary Steinberg

Lead Sponsor

Trials

1

Recruited

30+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials

70

Recruited

3,300+

References

1. India pubmed.ncbi.nlm.nih.gov

Neuroregeneration and functional recovery after stroke: advancing neural stem cell therapy toward clinical application. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Neural stem cell therapy for stroke: A multimechanistic approach to restoring neurological function. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Stem cell treatment of ischemic brain injury. [2009]

4. United States pubmed.ncbi.nlm.nih.gov

Neural stem cell transplantation in ischemic stroke: A role for preconditioning and cellular engineering. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Modulation of gene expression on a transcriptome-wide level following human neural stem cell transplantation in aged mouse stroke brains. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Transplantation of Directly Reprogrammed Human Neural Precursor Cells Following Stroke Promotes Synaptogenesis and Functional Recovery. [2023]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Analysis of Adverse Events Related to 720 Cases of Neural Progenitor Cell Transplantation. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The Dark Side of the Force - Constraints and Complications of Cell Therapies for Stroke. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Potential of adult neural stem cells in stroke therapy. [2008]