Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Phase 1

Completed

• Conditions: Dilated Cardiomyopathy
• Interventions: Biological: CDC infusion

• Registration Number: NCT03129568
• Lead Sponsor: Okayama University

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.

Study Timeline

• Study Start: 2017-04-14
• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-23
• Study First Posted: 2017-04-26
• Primary Completion: 2018-09-17
• Study Completion: 2020-12-09
• Results First Submitted: 2021-09-30
• Results First Submitted QC: 2021-09-30
• Status Verified: 2021-11
• Results First Posted: 2021-11-01
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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.
• A patient with multiple organ failure.
• Active infection (including endocarditis).
• Sepsis.
• Active hemorrhagic disease (e.g. gastrointestinal bleeding, injury).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CDC infusion	CDC infusion	CDCs infusion by coronary intervention.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Ejection Fraction	6 months after protocol treatment	To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up.

Trial Locations

Locations (1)

Okayama University Hospital; 🇯🇵 Okayama, Japan