Clinical Trial: Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy

Brief Summary: A phase 1 randomized-controlled 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 Summary: This trial consists of 2 studies. Seven consecutive patients will be enrolled to a phase 1a study to verify the procedural feasibility and safety, followed by a phase 1b study to randomly assign 24 patients in a 1:1 ratio to the CDC infusion group and the control arm.
Sponsor: Okayama University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in Ejection Fraction [ Time Frame: 6 months after protocol treatment ]

To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants compared with controls from baseline to 6 months of follow up.


Original Secondary Outcome: Same as current

Information By: Okayama University

Dates:
Date Received: April 14, 2017
Date Started: April 14, 2017
Date Completion: March 31, 2023
Last Updated: April 23, 2017
Last Verified: April 2017