Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD

Summary

Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery. They want to see if there are changes in the electrical activity, the structure, and the function of the heart following this stem cell-based therapy. Researchers will compare the results from people who receive the stem cells to the results from people who do not receive the stem cells.

Conditions

• Congenital Heart Disease, SRV Dependent

Interventions

BIOLOGICAL

Autologous mononuclear cells

Autologous mononuclear cells delivered into right ventricle at time of Stage III Fontan surgery.

Sponsors & Collaborators

• Mayo Clinic

  collaborator OTHER

• University of Oklahoma

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Children's of Alabama

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• Timothy J Nelson, MD, PhD

  lead OTHER

Principal Investigators

• Joseph Dearani · Mayo Clinic

• Harold M Burkhart · Children's Hospital Oklahoma University Medical Center

• Joseph w Rossano · Children's Hospital of Philadelphia

• David M Overman · Children's Minnesota

• John D Cleveland, MD · Children's Hospital Los Angeles

• James Jaggers, MD · Children's Hospital Colorado

• Benjamin Peeler, MD · Ochsner Health System

• Waldemer Carlo, M.D. · University of Alabama at Birmingham

• James Tweddell, M.D. · Children's Hospital Medical Center, Cincinnati

• Jason Maynes, MD · The Hospital forSick Children

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2023-05-24

Completion

2025-08-30

FDA Drug

Yes

Countries

• United States

Study Locations