Safety and Tolerability Study of Human Neural Stem Cells for Huntington's Disease
ConditionHuntington Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLeslie Thompson
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
Are pregnant
Test positive for human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B at Screening
Have an implanted deep brain stimulation device.
Trial design
Treatments tested in this trial
- hNSC-01
Treatment groups
21 Participants
are divided into 4 treatment groupsSponsors and collaborators
Leslie Thompson
Lead sponsor
University of California, Irvine
Sponsor institution
California Institute for Regenerative Medicine (CIRM)
Collaborator
University of California, Irvine
Collaborator
Source ClinicalTrials.gov