Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

Summary

Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.

Conditions

• Hypoplastic Left Heart Syndrome

Interventions

BIOLOGICAL

Autologous (self) mononuclear cells derived from umbilical cord blood

The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair.

PROCEDURE

Stage II Surgical repair

This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.

Sponsors & Collaborators

• University of Oklahoma

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Ochsner Health System

  collaborator OTHER

• Children's of Alabama

  collaborator OTHER

• Children's Hospital Medical Center, Cincinnati

  collaborator OTHER

• Timothy J Nelson, MD, PhD

  lead OTHER

Principal Investigators

• Frank Cetta, MD · Mayo Clinic

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

• Joseph W. Rossano, M.D. · Children's Hospital of Philadelphia

• David M. Overman, M.D. · Children's Minnesota

• Ram Kumar Subramanyan, M.D., Ph.D. · Children's Hospital Los Angeles

• James Jaggers, M.D. · Children's Hospital Colorado

• Benjamin Peeler, M.D. · Ochsner Health System

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

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

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

12 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-06

Primary Completion

2022-05-22

Completion

2026-02-28

FDA Drug

Yes

Countries

• United States

Study Locations