At a glance
ClinicalIndex Comparison Record- ✓Age 21-65 years
- ✓Confirmed Huntington's disease diagnosis with CAG repeats 40-50 on chromosome 4
- ✓Motor UHDRS score ≥5 at enrollment
- ✓Functional capacity UHDRS score 8-11 at enrollment
- ✕Juvenile Huntington's disease
- ✕Epilepsy or major cognitive disorder
- ✕Active decompensated psychiatric illness
- ✕Current or prior history of cancer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dose-Response Evaluation of the Investigational Product Cellavita HD After Intravenous Administration in Patients With Huntington's Disease
In Brief
A Phase 2 clinical trial evaluating Cellavita HD lower dose, Cellavita HD higher dose, and 1 other intervention for Huntington Disease. Completed, enrolled 49 participants across 1 site.
Detailed Summary
Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a prospective, phase II, single-center, randomized (2:2:1), triple-blind, placebo controlled study, with two test doses of Cellavita HD product.
Study Details
Timeline
Interventions
The participants will receive a total of 9 intravenous administrations of 1x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
The participants will receive a total of 9 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).