Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

Okayama University5 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dilated Cardiomyopathy

Interventions

CDC infusionBIOLOGICAL

Injection of CDCs (0.3 million per kg of body weight).

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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).

Locations (1)

Okayama University Hospital

Okayama, Japan

Outcomes

Primary Outcomes

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

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.

Time frame: 6 months after CDC treatment

Secondary Outcomes

Change in Ejection Fraction

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.

Time frame: 6 months after protocol treatment

Data from ClinicalTrials.gov

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