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NCT Number: NCT01273857

Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology

Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output. Infants with the syndrome generally undergo a staged surgical approach in view of an ultimate Fontan procedure. Although long-term survival in patients with HLHS and related single ventricle physiology has improved markedly with advances in medical and surgical therapies, a growing number of infants will ultimately require heart transplantation for end-stage heart failure due to several potential disadvantages include a negative effect on right ventricular function, arrhythmia, additional volume load via regurgitation from the nonvalved shunt, and impaired growth of the pulmonary artery.

Risk factors for poor outcome of heart transplantation with HLHS and single ventricle physiology are older age at transplantation and previous Fontan operation. New strategies are needed to improve the underlying transplant risks proper for the Fontan failure patients.

Emerging evidence suggests that heart-derived stem/progenitor cells can be used to improved cardiac function in patients with ischemic heart disease. In this trial, the investigators aimed to test the safety and feasibility of intracoronary injection of autologous cardiac progenitor cells in patients with HLHS and related single ventricle anomalies and that could improve ventricular function at 3 months' follow up.

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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 Heart Failure Single Ventricle Univentricular Heart

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital

Okayama, 700-8558, Japan

About this study

Autologous cardiac progenitor cells are isolated from patients' own cardiac tissues obtained during palliative shunt procedure. Patients will receive 0.3 million/kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants with hypoplastic left heart syndrome and related single ventricle anomalies undergoing first to third palliative shunt surgeries will be recruited into the study.
  • Patients between 0 and 6 years of age are eligible if written informed consent can be obtained.

Exclusion criteria

  • Cardiogenic shock
  • Eisenmenger syndrome
  • Uncontrollable arrhythmia
  • Severe chronic diseases
  • Infections
  • Cancer
  • Unwillingness to participate

Treatment and study plan

Autologous cardiac progenitor cell transplantation

Procedure

Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.

Other names: Cardiosphere-derived cells

staged shunt procedure

Procedure

Norwood-Glenn, Glenn, or Fontan procedure will be applied

Primary outcomes

  1. Feasibility Evaluation and Major Cardiac Adverse Events Related to Transcoronary Infusion of Cardiac Progenitor Cells

    Time frame: 3 months to 1 year after cell transplantation

    Feasibility was assessed by number of participants discontinued the study due to adverse events or number of participants received unsuccessful cell delivery by study physician. Unsuccessful was defined as failure of coronary selection of guiding catheter or direct cell infusion.

    The primary end point is to monitor major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, new myocardial infarction, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards.

Secondary outcomes

  1. Serious Adverse Events

    Time frame: 3 months to 1 year after cell transplantation

    The incidence of hospitalization for heart failure, ventricular arrhythmia, general infection, and renal and hepatic dysfunction by CDC treatment.

Sponsors and collaborators

Lead sponsor

Okayama University

Other

Collaborators

  • National Cerebral and Cardiovascular Center, Japan

Registry information

Official study title

Phase I Study of Cardiac Progenitor Cell Therapy in Patients With Single Ventricle Physiology

Acronym: TICAP

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2011
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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