Safety and tolerability of human neural stem cell implants for Huntington's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2, first-in-human interventional program implants hNSC-01 neural stem cells into the brains of eligible adults with genetically confirmed Huntington's disease to monitor safety and tolerability. Participants undergo neurosurgical implantation at a single center and are followed with MRI, clinical exams, blood tests and lumbar punctures to detect adverse events and biological signals. The study excludes people who are pregnant, have active HIV or hepatitis, or have implanted deep brain stimulation devices. Primary outcomes focus on safety, tolerability, and procedural feasibility with planned clinical and imaging follow-up.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California, Irvine
  Irvine, California, United States Recruiting

Study contacts

• Study coordinator: UCI Alpha Clinic
• Email: alphaclinic@hs.uci.edu
• Phone: 949-824-3990

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pridopidine for Huntington's Disease: a 1-year, randomized, placebo-controlled study

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• SKY-0515 for adults with Huntington's disease

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• Votoplam for adults with early symptomatic Huntington's disease

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• Comparing three social cognition tests in adults with early Huntington disease

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• Wearable monitoring of walking and arm movement in adults with neuromuscular or metabolic movement disorders

  This project uses a wrist/ankle wearable to continuously monitor walking and upper-limb movement in ambulant adults with neuromuscular diseases or obesity to see if digital measures like stride speed track real-life motor function.

  Recruiting Centre Hospitalier Universitaire de Liege · Liège · NCT07136844

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.