A Prospective Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy

Okayama University1 site in 1 country5 target enrollmentApril 14, 2017

ConditionsDilated Cardiomyopathy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Dilated Cardiomyopathy
Sponsor: Okayama University
Enrollment: 5
Locations: 1
Primary Endpoint: Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.

Detailed Description

Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.

Registry

clinicaltrials.gov

Start Date

April 14, 2017

End Date

December 9, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Okayama University

Responsible Party

Principal Investigator

Hidemasa Oh, MD

Professor

Okayama University

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed as dilated cardiomyopathy.
•Patients aged under 18 years old.
•Cardiac ejection fraction \< 40%.

Exclusion Criteria

•Contradiction to cardiac magnetic resonance imaging.
•Cardiogenic shock.
•A patient with unstoppable extracorporeal circulation.
•A patient with lethal, uncontrollable arrhythmia.
•A patient with a complication of coronary artery disease.
•A patient with a complication of brain dysfunction due to circulatory failure.
•A patient with malignant neoplasm.
•A patient with a complication of a serious neurologic disorder.
•A patient with high-grade pulmonary embolism or pulmonary hypertension.
•A patient with high-grade renal failure.

Outcomes

Primary Outcomes

Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs.

Time Frame: 6 months after CDC treatment

Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.