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Completed

NCT Number: NCT01829750

Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)

The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease. Patients with preoperative high-risk group or whose cardiac function did not recover postoperatively eventually have no choice other than heart transplantation.

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Key information

Conditions

Hypoplastic Left Heart Syndrome Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Single Left Ventricle Single Right Ventricle Univentricular Heart

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Okayama University

Okayama, 700-8558, Japan

About this study

Following the safety verification of the Phase I study (TICAP trial) that has been implemented and completed, the efficacy will be verified in this Phase II clinical study. The rationale of this study is based on the animal studies that transplanted cardiac progenitor cells may regenerate damaged myocardium by giving rise to cardiac muscle and vascular cell types. Preclinical and phase I studies indicate the possibilities of cardiac function improvements and reduced myocardial fibrosis by progenitor cell infusion.

The efficacy of cell transplantation is assessed as the primary endpoint of the Phase II clinical study. The improvements of cardiac ejection fraction assessed by echocardiography, ventriculography, and cardiac MRI, which are conducted before and after treatment, are assessed as the evaluation items. The absolute values of the improvement of cardiac ejection fraction obtained by the above three imaging modalities before and after treatment are compared between two groups of the transplantation group and non-transplantation group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age: Age is 0 year or more and 20 years or less at the time of enrollment.
  • The patients have functional single ventricular physiology with the indication to have stage-2 or -3 palliative surgeries.
  • The ventricular ejection fraction <60%.

Exclusion criteria

  • 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 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

Cardiac progenitor cell infusion

Genetic

(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group

(Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1.

Primary outcomes

  1. Cardiac function

    Time frame: 3 Months

    The primary outcome measure is to evaluate the cardiac function improvement by echocardiography, ventriculography, and cardiac MRI, which are conducted before and 3 months after surgical treatment.

Secondary outcomes

  1. Cardiac function

    Time frame: 12 Months

    The secondary outcome measure is to determine the cardiac function improvements by three different imaging modalities at 12 months after treatment.

Other outcomes

  1. Clinical symptoms

    Time frame: 3 and 12 Months

    Clinical symptoms and BNP levels will be assessed at 3- and 12-months after treatment and compared with control group.

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Collaborators

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

Registry information

Official study title

Phase 2 Study of Intracoronary Infusion of Cardiac Progenitor Cells in Patients With Univentricular Heart Disease

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2013
Registry last updated
Dec 7, 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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