Safety and Tolerability Study of Human Neural Stem Cells for Huntington's Disease

Part of paid clinical trials in Irvine, California.

Sponsor
Leslie Thompson
Study ID
NCT07451613
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • hNSC-01 — BIOLOGICAL
    neural stem cell therapy

Study Details

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.

Key Dates

Start date
Apr 6, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2028
Completion
Jan 31, 2031

Study Design

Enrollment
21 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 after 6 and 12 weeks after dosing. [ Time Frame: Safety is assessed 6 weeks following each surgery for Cohort A and 12 weeks following cohort B-D completion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, IrvineIrvineCalifornia92697
UCI Alpha Clinic
[email protected]
949-824-3990

Find similar trials in Irvine, CA

By condition
Huntington disease
By specialty
NeurologyBrain disorders
By research site
University of California, Irvine· Irvine, CA

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