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Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

NCT01829750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2021-12-07

No results posted yet for this study

Summary

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

Conditions

Interventions

GENETIC

Cardiac progenitor cell infusion

(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group (Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.

Sponsors & Collaborators

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    collaborator OTHER

  • Okayama University

    lead OTHER

Principal Investigators

  • Hidemasa Oh, M.D., Ph.D. · Okayama University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT01829750 on ClinicalTrials.gov