Status:
COMPLETED
Dose-response Evaluation of the Cellavita HD Product in Patients With Huntington's Disease
Lead Sponsor:
Azidus Brasil
Collaborating Sponsors:
Cellavita Pesquisa Científica Ltda
Conditions:
Huntington Disease
Eligibility:
All Genders
21-65 years
Phase:
PHASE2
Brief 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 Cellavi...
Detailed Description
This is a phase II dose-response study in which participants with HD will receive three intravenous injections of the investigational product or placebo (one every month for three months) a total of t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03252535
Start Date
January 15 2018
End Date
April 30 2021
Last Update
September 19 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Azidus Brasil Pesquisa Científica e Desenvolvimento Ltda.
Valinhos, São Paulo, Brazil, 13271-130