Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy (TICAP-DCM)

Okayama University

Status and phase: Completed; Phase 1

Conditions: Dilated Cardiomyopathy

Treatments: Biological: CDC infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT03129568

01F1701003

Details and patient eligibility

About

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.

Full description

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

Enrollment: 5 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

CDC infusion

Experimental group

Description:

CDCs infusion by coronary intervention.

Treatment:

Biological: CDC infusion