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

November 23, 2021 updated by: Hidemasa Oh, MD, Okayama University

Phase I Study of Cardiac Progenitor Cell Therapy 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Okayama, Japan, 700-8558
        • Department of Regenerative Medicine, Center for Innovative Clinical Medicine, Okayama University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: staged shunt procedure
Norwood-Glenn, Glenn, or Fontan procedure will be applied
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 Names:
  • Cardiosphere-derived cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months to 1 year after cell transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months to 1 year after cell transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okayama University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

January 10, 2011

First Submitted That Met QC Criteria

January 10, 2011

First Posted (ESTIMATE)

January 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 26, 2021

Last Update Submitted That Met QC Criteria

November 23, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHLW10103228

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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