Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease (NCT03252535) | Clinical Trial Compass
CompletedPhase 2
Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Brazil49 participantsStarted 2018-01-15
Plain-language 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.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria
✓. Provide a written, signed and dated Informed Consent Form;
✓. Male and female subjects aged ≥ 21 and ≤ 65 years;
✓. Have a confirmatory diagnosis report (PCR) of Huntington's disease with a number of CAG repeats in chromosome 4 higher than or equal to 40, and lower than or equal to 50 (if the subject did not perform the exam and/or if he/she does not have an available result for this exam, a new exam must be performed);
✓. A score of 5 points or higher for the motor evaluation of the UHDRS scale (Unified Huntington's Disease Rating Scale) at enrollment;
✓. Score of 8 to 11 points for the functional capacity of the UHDRS scale at enrollment.
Exclusion criteria
✕. Subject who participated in clinical trials protocols within the last twelve (12) months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless, at the investigator's opinion, the subject would have a direct benefit from it;
✕. Diagnosis of juvenile Huntington's disease;
✕. Diagnosis of epilepsy;
✕. Diagnosis of major cognitive disorder;
✕. Active decompensated psychiatric illness;
✕. Current or prior history of neoplasm;
✕. Current history of gastrointestinal, hepatic, renal, endocrine, pulmonary, hematological, immunological, metabolic pathology or severe uncontrolled cardiovascular diseases;