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Completed

NCT Number: NCT03129568

Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Laminopathies

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Okayama University Hospital

Okayama, 700-8558, Japan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

CDC infusion

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 from baseline to 6 months of follow up.

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Collaborators

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Registry information

Official study title

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

Acronym: TICAP-DCM

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Apr 26, 2017
Registry last updated
Nov 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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