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

NCT03252535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-09-19

Study results available
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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.

Conditions

  • Huntington Disease

Interventions

BIOLOGICAL

Cellavita HD lower dose

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).

BIOLOGICAL

Cellavita HD higher dose

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).

OTHER

Placebo

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).

Sponsors & Collaborators

  • Cellavita Pesquisa Científica Ltda

    collaborator OTHER

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

  • Joyce Macedo da Silva, MD · Azidus Brasil Scientific Research and Development Ltda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-03-23
Completion
2021-04-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03252535 on ClinicalTrials.gov