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Safety Evaluation of Cellavita HD Administered Intravenously in Participants With Huntington's Disease

NCT02728115 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2022-11-02

No results posted yet for this study

Summary

Cellavita HD is a stem-cell therapy for Huntington's Disease. This is a first-in-human, non-randomized, phase I study in which participants with Huntington's Disease will receive three intravenous injections and will be followed for 5 years to evaluate safety and tolearability of product and preliminary evidence of effectiveness.

Conditions

  • Huntington Disease

Interventions

BIOLOGICAL

Cellavita HD Lower Dose

The first three participants enrolled in the study will be assigned to the lower dose arm with staggered treatment, with an interval of 30 days between the first administration of the first participant and the first administration of the second participant assigned to this arm. All participants will receive a total of 3 intravenous administration, one every 30 days.

BIOLOGICAL

Cellavita HD Higher dose

The last three participants enrolled in the study will be assigned to the higher dose arm with staggered treatment, with an interval of 30 days between the first administration of the first participant and the first administration of the second participant assigned to this arm. All participants will receive a total of 3 intravenous administration, one every 30 days.

Sponsors & Collaborators

  • Cellavita Pesquisa Científica Ltda

    collaborator OTHER

  • Azidus Brasil Scientific Research and Development Ltda

    collaborator OTHER

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-10-16
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Brazil

Study Locations

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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 NCT02728115 on ClinicalTrials.gov