Safety of Autologous Cord Blood Cells in HLHS Patients During Norwood Heart Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-16

Study Completion Date

2022-06-30

Brief Summary

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This study aims to evaluate the safety and feasibility of coronary infusion of autologous placental cord blood mononuclear cells during the Norwood heart operation in newborn hypoplastic left heart syndrome (HLHS) patients.

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Detailed Description

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This is a Phase I, open label safety study. Autologous cord blood mononuclear cells (stem cell containing, cord blood buffy coat fraction) was delivered by coronary infusion during the Norwood cardiopulmonary bypass operation in 10 antenatally diagnosed HLHS patients within 2-3 days of birth. Safety and clinical status monitoring was performed to Stage II surgical intervention for HLHS (at approximately 3 months of age). Treated patients will continue to be assessed beyond the trial during follow up between Stage II and III (Fontan) surgical interventions.

Conditions

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Hypoplastic Left Heart Syndrome Heart Defects, Congenital Pediatric Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Safety

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hCBMNC

Autologous human placental cord blood mononuclear cells (buffy coat fraction)

Group Type EXPERIMENTAL

Autologous Human Placental Cord Blood Mononuclear Cells

Intervention Type BIOLOGICAL

Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation

Interventions

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Autologous Human Placental Cord Blood Mononuclear Cells

Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation

Intervention Type BIOLOGICAL

Other Intervention Names

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Cord blood buffycoat mononuclear cells, incl stem cells

Eligibility Criteria

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Inclusion Criteria

* Male and females with antenatally diagnosed Hypoplastic Left Heart Syndrome (all types requiring Norwood operation)
* Written informed consent by parents/legal guardian
* Successful aseptic collection of autologous cord blood unit and transfer of buffy coat mononucleocyte fraction to cold storage pending cardiac surgery within 2-4 days

Exclusion Criteria

Patient:

* does not have autologous cord blood cells available at the time of cardiopulmonary bypass surgery
* has evidence of arrhythmia requiring anti-arrhythmia therapy
* has an additional congenital diagnosis that contributes to conditions such as an immune system disorder, immune deficiency, complex metabolic disorder, brain dysplasia or progressive neurological degenerative disorder
* has other clinical complexity deemed by the cardiac surgeon to make the patient unsuitable for inclusion in the trial

Mother:

• is serum positive for HIV, hepatitis or other significant pathogen and has known allergies to penicillin, streptomycin or other antibiotic

Minimum Eligible Age

2 Days

Maximum Eligible Age

4 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Salvatore Pepe

Trial Study Coordinator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salvatore Pepe

Role: PRINCIPAL_INVESTIGATOR

Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)

Christian P Brizard

Role: PRINCIPAL_INVESTIGATOR

Melbourne Children's Campus (incorporating The Royal Children's Hospital, Murdoch Children's Research Institute, the University of Melbourne Department of Paediatrics)