Phase 1B/2A Study of the Safety and Tolerability of Human Neural Stem Cells for Huntington's Disease
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
The purpose of this research study is to determine whether an implantation of hNSC-01 is a safe and tolerable study intervention for Huntington's disease. This study is the first time that hNSC-01 is being tested in people.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Have decision-making capacity and be able to provide written informed consent.
• Are between 18 to 65 years of age
• Have genetically confirmed diagnosis of Huntington's Disease
• Able to undergo MRI scans, tolerate neurosurgical procedure, blood draws and lumbar puncture.
Locations
United States
California
University of California, Irvine
RECRUITING
Irvine
Contact Information
Primary
UCI Alpha Clinic
alphaclinic@hs.uci.edu
949-824-3990
Time Frame
Start Date: 2026-04-06
Estimated Completion Date: 2031-01
Participants
Target number of participants: 21
Treatments
Active_comparator: Cohort A
Unilateral, low dose
Active_comparator: Cohort B
Bilateral, low dose
Active_comparator: Cohort C
Bilateral, mid-dose
Active_comparator: Cohort D
Bilateral, high dose
Related Therapeutic Areas
Sponsors
Leads: Leslie Thompson
Collaborators: University of California, Irvine, California Institute for Regenerative Medicine (CIRM)