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Clinical Extension Study for Safety and Efficacy Evaluation of Cellavita-HD Administration in Huntington's Patients.

NCT04219241 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2022-10-28

No results posted yet for this study

Summary

Cellavita-HD is a stem-cell therapy for Huntington's Disease. Open label, single treatment, extension study for long-term safety and efficacy evaluation of Cellavita-HD intravenous administration in Huntington's disease patients who participated of ADORE-DH trial.

Conditions

  • Huntington Disease

Interventions

BIOLOGICAL

Cellavita-HD

The participants will receive a total of 12 intravenous administrations of 2x10\^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 180 days (total of 4 cycles).

Sponsors & Collaborators

  • Cellavita Pesquisa Científica Ltda

    collaborator OTHER

  • Azidus Brasil

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-02-10
Primary Completion
2022-12-31
Completion
2022-12-31

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 NCT04219241 on ClinicalTrials.gov