Neural Stem Cell Therapy for Stroke

Recruiting in Palo Alto (17 mi)

Overseen byGary K Steinberg, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Gary Steinberg, MD, PhD

No Placebo Group

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.

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

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Exclusion Criteria

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

I have had seizures in the past.

Pregnant or breast-feeding

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Treatment Details

Interventions

NR1 (Stem Cell Therapy)

Trial OverviewThe 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

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