Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease

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;
• Diagnosis of any active infection, whether viral, bacterial, fungal or caused by another pathogen;
• Subject with contraindication to the exams performed in this study, for example, with pacemaker or surgical clip; Alcohol and drugs abuse (previously diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders - DSM V criteria);
• Use of illegal drugs;
• Tabagism;
• Smoker or quit smoking for less than 6 months;
• Positive result in one of the serum tests: HIV 1 and 2 (Anti-HIV-1,2), HTLV I and II, HBV (HBsAg, Anti-HBc), HCV (anti-HCV-Ab) and FTA-ABS (Treponema pallidum);
• History of drug allergy, including to contrast agents used in imaging tests or bovine-derived products;
• Using or expects to use immunosuppressant drugs or forbidden drugs (item 5.3) during the first three months after the first administration of the investigational product;
• Any clinical change that the investigator considers a risk to subject's enrollment in the study.