Safety Study of Autologous Umbilical Cord Blood Cells for Treatment of Hypoplastic Left Heart Syndrome

Summary

This is a Phase I study to determine the safety and feasibility of injections of autologous umbilical cord blood (UCB) cells into the right ventricle of Hypoplastic Left Heart Syndrome (HLHS) children undergoing a scheduled Glenn surgical procedure.

The investigators are doing this research study to find out if autologous stem cells from the individual's own umbilical cord blood can be used to strengthen the muscle of the right side of their heart. This will help determine the safety and feasibility of using cell-based regenerative therapy as an additional treatment for the management of HLHS.

Conditions

• Hypoplastic Left Heart Syndrome

Interventions

BIOLOGICAL

autologous cell-based delivery

autologous cells (derived from "self")

Sponsors & Collaborators

• University of Oklahoma

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Children's Hospitals and Clinics of Minnesota

  collaborator OTHER

• Children's Hospital Los Angeles

  collaborator OTHER

• Children's Hospital Colorado

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Timothy J Nelson, MD, PhD

  lead OTHER

Principal Investigators

• Timothy J Nelson, M.D., Ph.D. · Mayo Clinic

• Muhammad Y Qureshi, MBBS · Mayo Clinic

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

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

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

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

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

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

18 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-05-15

Primary Completion

2021-04-28

Completion

2021-04-28

Countries

• United States

Study Locations