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

This study has been completed.
Sponsor:
Collaborator:
National Cerebral and Cardiovascular Center
Information provided by (Responsible Party):
Hidemasa Oh, Okayama University
ClinicalTrials.gov Identifier:
NCT01273857
First received: January 10, 2011
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypoplastic Left Heart Syndrome
Single Ventricle
Heart Failure
 Procedure: Autologous cardiac progenitor cell transplantation
Procedure: staged shunt procedure
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Cardiac Progenitor Cell Therapy in Patients With Single Ventricle Physiology

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • A Phase I Study of the Safety and Feasibility of Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology [ Time Frame: 3 months to 1 year after cell transplantation ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • A Phase I Study of the Safety and Feasibility of Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology [ Time Frame: 3 months to 1 year after cell transplantation ] [ Designated as safety issue: Yes ]
    Second end points include the rate of composite serious adverse events with death excluded and the rate of other complication.


Enrollment: 14
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Control
Subjects will undergo standard staged-procedures without cell infusion
 Procedure: staged shunt procedure
Norwood-Glenn, Glenn, or Fontan procedure will be applied
Experimental: Cell infusion
Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure
 Procedure: Autologous cardiac progenitor cell transplantation
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 Name: Cardiosphere-derived cells
Procedure: staged shunt procedure
Norwood-Glenn, Glenn, or Fontan procedure will be applied

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273857

Locations
Japan
Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
Okayama, Japan, 700-8558
Sponsors and Collaborators
Okayama University
National Cerebral and Cardiovascular Center
Investigators
Principal Investigator: Hidemasa Oh, M.D., Ph.D. Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital
  More Information

Additional Information:
Center for Innovative Clinical Medicine  This link exits the ClinicalTrials.gov site
Department of Cardiovascular Surgery  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Hidemasa Oh, MD., Ph.D., Okayama University
ClinicalTrials.gov Identifier: NCT01273857     History of Changes
Other Study ID Numbers: MHLW10103228
Study First Received: January 10, 2011
Last Updated: January 7, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Okayama University:
Cardiac progenitor cells
Cell therapy
Hypoplastic Left Heart Syndrome
Single Ventricle
 Norwood
Sano modification
Glenn
Fontan

Additional relevant MeSH terms:
Heart Failure
Hypoplastic Left Heart Syndrome
Heart Diseases
Cardiovascular Diseases
 Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013