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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
Select...
I had a stroke in a specific part of my brain between 6 months and 5 years ago.
Select...
I am between 18 and 75 years old.

Timeline

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

Find a Location

Who is running the clinical trial?

Gary Steinberg, MD, PhDLead Sponsor
Gary SteinbergLead Sponsor
California Institute for Regenerative Medicine (CIRM)OTHER
64 Previous Clinical Trials
3,127 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What characteristics make a person an ideal candidate for this research?

"This clinical trial is open to those aged 18-75 with a wake-up stroke. A maximum of 30 individuals are authorized for enrollment."

Answered by AI

To what extent is this research being conducted with test subjects?

"Affirmative. Clinicaltrials.gov data indicates that this clinical trial, which began recruiting on the 4th of January 2021, is still in search of participants. 30 individuals are sought from a single location."

Answered by AI

Is the opportunity for enrollment in this trial still available?

"According to information on clinicaltrials.gov, this investigation is still enrolling individuals who meet the criteria. The project was initially posted on April 1st 2021 and has most recently been updated on May 6th 2022."

Answered by AI

Does this investigation accept participants of all ages, including those over 30?

"Subject qualifications for this clinical trial necessitate that participants are between 18 and 75 years of age. There are 70 trials available to individuals below the age of majority, while 1253 studies can be found for people over 65."

Answered by AI

Who else is applying?

What state do they live in?
New York
California
North Carolina
Other
How old are they?
65+
18 - 65
What site did they apply to?
Stanford Health Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Aspirin (Ecotrin Low Strength) 81 Mg Oral Tbec Dr Tab. Improve outcome potentials and live wholy and full and well.
PatientReceived no prior treatments

How responsive is this trial?

Most responsive sites:
  1. Stanford Health Center: < 24 hours
Average response time
  • < 2 Days
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)
Gary Steinberg, MD, PhD 2021. "A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects With Chronic Ischemic Subcortical Stroke (ISS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04631406.
All > Anterior Ischemic Optic Neuropathy
~5 spots leftby Dec 2024
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