What side effects are associated with this type of intervention?

Common treatments for ischemic stroke that have neuroprotective or neuroregenerative properties include medications like amphetamines, piracetam, acetylcholinesterase inhibitors (e.g., donepezil, galantamine), and memantine. Amphetamines can cause side effects such as increased heart rate, hypertension, and potential for abuse. Piracetam is generally well-tolerated but can cause nervousness, weight gain, and hyperkinesia. Acetylcholinesterase inhibitors may lead to gastrointestinal issues, muscle cramps, and insomnia. Memantine is associated with dizziness, headache, and confusion. These treatments aim to improve cognitive and language functions post-stroke but come with varying side effect profiles.

What prior FDA approvals exist?

FDA-approved treatments for ischemic stroke primarily include thrombolytics like alteplase (tPA), which dissolves blood clots to restore blood flow. While these treatments are effective in the acute phase, there are limited FDA-approved neuroprotective or neuroregenerative agents specifically for ischemic stroke. Research is ongoing in this area, with investigational therapies like stem cell treatments (e.g., NR1) being studied for their potential to promote neuroregeneration and improve outcomes in chronic ischemic stroke patients.

What other types of research exist?

Promising alternatives to NR1 for ischemic stroke patients include: 1) Stem cell therapies such as mesenchymal stem cells (MSCs) which have shown potential in promoting neuroregeneration and functional recovery. 2) Neuroprotective agents like edaravone, which has been used to reduce oxidative stress and neuronal damage. 3) Advanced rehabilitation techniques incorporating brain-computer interfaces (BCIs) and robotic-assisted therapy to enhance neuroplasticity and motor recovery.

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Stem Cell Therapy

Neural Stem Cell Therapy for Stroke

Phase 1 & 2

Recruiting

Led By Gary K Steinberg, MD, PhD

Research Sponsored by Gary Steinberg, MD, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

History of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke

Age 18 - 75 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-12 months

Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and tolerated by people with chronic ISS who have or have not had a cortical stroke.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed here, side effects may include typical risks associated with brain surgery such as infection or bleeding at the injection site. Tacrolimus can cause immune suppression leading to increased risk of infections and other possible side effects like kidney problems or high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fugl Meyer (FM) motor score

Incidence of Treatment-Emergent Adverse Events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Neural Stem cells injected intracerebrallyExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ischemic stroke include thrombolytics, which dissolve blood clots to restore blood flow; antiplatelet agents, which prevent new clots from forming; and anticoagulants, which reduce the blood's ability to clot. Neuroprotective or neuroregenerative agents, such as the NR1 being studied, aim to protect brain tissue from damage and promote recovery by supporting neural cell survival and regeneration. These treatments are crucial for ischemic stroke patients as they not only address the immediate blockage but also help in minimizing long-term neurological deficits and improving overall recovery outcomes.

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Who is running the clinical trial?

Gary Steinberg, MD, PhDLead Sponsor

Gary SteinbergLead Sponsor

California Institute for Regenerative Medicine (CIRM)OTHER

65 Previous Clinical Trials

3,145 Total Patients Enrolled

Media Library

NR1 (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04631406 — Phase 1 & 2

Ischemic Stroke Research Study Groups: Neural Stem cells injected intracerebrally

Ischemic Stroke Clinical Trial 2023: NR1 Highlights & Side Effects. Trial Name: NCT04631406 — Phase 1 & 2

NR1 (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04631406 — Phase 1 & 2

Ischemic Stroke Patient Testimony for trial: Trial Name: NCT04631406 — Phase 1 & 2

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