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

a study on Huntington's Disease

Summary

Eligibility
for people ages 18-65 (full criteria)
Location
at Irvine, California
Dates
study started
study ends around
Principal Investigator
by Ravi Rajmohan

Description

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.

Official Title

Phase 1B/2A Study of the Safety and Tolerability of Human Neural Stem Cells for Huntington's Disease

Keywords

Huntington Disease, Huntington's disease, stem cell, REGEN4HD, hNSC-01

Eligibility

For people ages 18-65

Please note this may not be a complete list of eligibility criteria.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Are pregnant
  • Test positive for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B at Screening
  • Have an implanted deep brain stimulation device.

Location

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States

Lead Scientist at UC Irvine

  • Ravi Rajmohan
    Assistant Clinical Professor, Neurology, School of Medicine. Authored (or co-authored) 19 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Leslie Thompson
ID
NCT07451613
Phase
Phase 1/2 Huntington's Disease Research Study
Study Type
Interventional
Participants
Expecting 21 study participants
Last Updated
Contact us about this trial