A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

An initial feasibility and safety study evaluating the use of autologous tissue engineered vascular grafts as extra cardiac total cavopulmonary connection (EC TCPC) conduits in children with single ventricle anomalies.

Condition or disease	Intervention/treatment	Phase
Single Ventricle Cardiac Anomaly	Combination Product: Tissue Engineered Vascular Grafts	Phase 1

Detailed Description:

This investigation is a prospective, nonrandomized phase 1 clinical trial determining the safety of the use of tissue engineered vascular grafts as conduits for EC TCPC. Primary end points of the study will include determination of graft failure rates and graft related morbidity and mortality. Graft failure will be defined as any graft narrowing/occlusion or dilation/rupture requiring surgical or endovascular intervention. Graft related morbidity and mortality will include any post-operative complication such as any thromboembolic or infectious event that requires treatment and is thought likely to be caused by the tissue engineered vascular graft as determined by the investigators and confirmed by the data safety monitoring board. All appropriate patients requiring EC TCPC who meet study inclusion/exclusion criteria will be evaluated for enrollment in the clinical trial. After obtaining informed consent from the patient's parents, patients with single ventricle cardiac anomalies will undergo EC TCPC using a tissue engineered conduit. Post-operative care and monitoring will follow an established, standardized, clinical algorithm in which the patient's clinical status including complications and measurements of graft function will be serially evaluated and recorded over a three year period using physical examination, echocardiography, and MRA.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	4 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Study Investigating the Clinical Use of Tissue Engineered Vascular Grafts in Congenital Heart Surgery
Study Start Date :	December 2009
Actual Primary Completion Date :	December 26, 2017
Actual Study Completion Date :	January 23, 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Tissue Engineered Vascular Grafts	Combination Product: Tissue Engineered Vascular Grafts; Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance angiography (MRA)

Outcome Measures

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Primary Outcome Measures :

1. graft failure requiring intervention [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. graft growth [ Time Frame: 3 years ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	1 Year to 100 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• single ventricle cardiac anomaly requiring extra cardiac total cavopulmonary connection (EC TCPC).

Exclusion Criteria:

• incomplete inferior vena cava (IVC)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205

Sponsors and Collaborators

Christopher Breuer

Doris Duke Charitable Foundation

Gunze Limited

Investigators

Study Chair:	Christopher K Breuer, MD	Nationwide Children's Hospital, Columbus, Ohio
Study Chair:	Toshiharu Shinoka, MD/PhD	Nationwide Children's Hospital, Columbus, Ohio
Principal Investigator:	Mark Galantowicz, MD	Nationwide Children's Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Christopher Breuer, Director of Tissue Engineering, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:	NCT01034007 History of Changes
Other Study ID Numbers:	NCHIRB12-00357
First Posted:	December 17, 2009
Last Update Posted:	March 2, 2018
Last Verified:	February 2018

Keywords provided by Christopher Breuer, Nationwide Children's Hospital:

tissue engineered vascular graft

Additional relevant MeSH terms:

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities