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Trial intelligence / Profile preview
Cellavita-HD Extension in Huntington's Disease
NCT04219241Phase 3
Key facts
- Status
- Unknown
- Start
- Feb 2020
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Azidus Laboratories Limited
- Modality
- Stem Cell Therapies
- Drugs
- NestaCell
- Conditions
- Huntington's disease (HD)
01
Overview
Phase 3, open-label, single-arm trial of NestaCell in Huntington's disease (HD), sponsored by Azidus Laboratories Limited. Primary endpoint: Unified Huntington's Disease Rating Scale Total Score at 24 months. Status: unknown.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Cellavita-HD
NestaCell (Cellavita-HD) Intravenous Administration
03
Who it enrols
Participants must have completed the Phase II ADORE-DH study and show potential for clinical benefit. Patients with history of malignant neoplasia, hypersensitivity to the product, or using immunosuppressive drugs are excluded.
04
Endpoints
Primary
Unified Huntington's Disease Rating Scale Total Score
Secondary
Unified Huntington's Disease Rating Scale Clinical Neurological Worsening
Body Mass Index
Columbia-Suicide Severity Rating Scale
Hamilton Depression Rating Scale
Magnetic Resonance Imaging CNS Assessment
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