30 Participants Needed

Neural Stem Cell Therapy for Stroke

CR
Overseen ByClinical Research Coordinator
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Gary Steinberg, MD, PhD
Must be taking: Tacrolimus
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.46789

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.467910

Who Is on the Research Team?

GK

Gary K Steinberg, MD, PhD

Principal Investigator

Professor, Neurosurgery Department

Are You a Good Fit for This Trial?

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.
Ability of subject to understand and provide written Informed Consent
I am willing to take tacrolimus before and after my transplant.

Exclusion Criteria

I have had cancer before, but it wasn't skin cancer.
I have had seizures in the past.
Pregnant or breast-feeding
See 3 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Neural Stem cells injected intracerebrallyExperimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

Neuroregeneration and functional recovery after stroke: advancing neural stem cell therapy toward clinical application. [2021]
Neural stem cell therapy for stroke: A multimechanistic approach to restoring neurological function. [2022]
Stem cell treatment of ischemic brain injury. [2009]
Neural stem cell transplantation in ischemic stroke: A role for preconditioning and cellular engineering. [2022]
Modulation of gene expression on a transcriptome-wide level following human neural stem cell transplantation in aged mouse stroke brains. [2022]
Efficacy and safety of human-derived neural stem cell in patients with ischaemic stroke: study protocol for a randomised controlled trial. [2022]
Transplantation of Directly Reprogrammed Human Neural Precursor Cells Following Stroke Promotes Synaptogenesis and Functional Recovery. [2023]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Analysis of Adverse Events Related to 720 Cases of Neural Progenitor Cell Transplantation. [2018]
The Dark Side of the Force - Constraints and Complications of Cell Therapies for Stroke. [2022]
Potential of adult neural stem cells in stroke therapy. [2008]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security