A Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke (ISS)
Launched by GARY STEINBERG, MD, PHD · Nov 10, 2020
Trial Information
Current as of May 08, 2025
Active, not recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety and tolerability of a treatment called NR1, which involves using neural stem cells, in people who have had a chronic ischemic subcortical stroke. An ischemic stroke happens when blood flow to the brain is blocked, and this trial specifically focuses on individuals who experienced this type of stroke between 6 and 60 months ago. The researchers will administer NR1 directly into the brain and are looking to see how well patients can handle this treatment without serious side effects.
To be eligible for this study, participants need to be between the ages of 18 and 75 and must have a history of ischemic subcortical stroke in specific areas of the brain. They should be able to understand and sign a consent form and be willing to take a medication called tacrolimus for a short time before and after receiving the treatment. However, people with certain conditions, such as recent strokes, major neurological diseases, or a history of cancer (except for some skin cancers), will not be eligible. Participants should know that this trial is currently active but not recruiting new patients, meaning they are not looking for more people to join at this time.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Age 18 - 75 years
- • History of ischemic subcortical stroke in the middle cerebral artery and/or lenticulostriate artery 6 to 60 months from time of stroke
- • Ability of subject to understand and provide written Informed Consent
- • Willing to take tacrolimus (Prograf) 2 days before and for 2 months after transplant
- Exclusion Criteria:
- • Stroke lesion less than 1 cubic centimeter or greater than 100 cubic centimeters measured by MRI
- • Index stroke is lacunar infarct less than 1 year old
- • History or presence of any major neurological disease
- • History of active cancer other than basal or squamous cell skin cancers
- • History of seizures
- • Pregnant or breast-feeding
About Gary Steinberg, Md, Phd
Dr. Gary Steinberg, MD, PhD, is a distinguished clinical trial sponsor known for his expertise in neurosurgery and stroke research. As a prominent figure in the medical community, he combines a robust academic background with clinical practice, focusing on innovative therapies and interventions aimed at improving patient outcomes in neurological disorders. His leadership in clinical trials drives advancements in treatment methodologies, fostering collaboration among researchers and healthcare professionals to translate scientific findings into practical applications. Dr. Steinberg is committed to enhancing the understanding of neurovascular diseases while prioritizing patient safety and ethical standards in research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Stanford, California, United States
Patients applied
Trial Officials
Gary K Steinberg, MD, PhD
Principal Investigator
Professor, Neurosurgery Department
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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