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Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

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ClinicalTrials.gov Identifier: NCT01856049
Recruitment Status : Recruiting
First Posted : May 17, 2013
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Susana Cantero Peral, M.D., Ph.D., Mayo Clinic

Study Description
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Brief Summary:

Cell-based cardiac regeneration has been the focus of acquired, adult heart disease for many years. However, congenital heart disease with severe structural abnormalities may also be reasonable targets for cell-based therapies. Interestingly, the pediatric heart is naturally growing and may be the most amendable to regenerative strategies. Therefore, identifying autologous cells (cells from the patient's own body) would be important to initiate these studies.

This study aims to validate the use of umbilical cord blood as a source of autologous cells for the purpose of cardiac repair of congenital heart disease. Cells will be isolated from the cord blood to help us determine the feasibility of collection, processing, and storage of these samples at the time of birth of infants with prenatal diagnosis of hypoplastic left heart syndrome. This study may be useful for the development of pre-clinical and clinical studies aimed at the long-term goal of repairing damaged heart muscle.


Condition or disease Intervention/treatment Phase
Hypoplastic Left Heart Syndrome (HLHS) Other: Collection of umbilical cord blood Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
Study Start Date : May 2012
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Umbilical Cord Blood Collection
Umbilical Cord Blood is drawn from the umbilical cord of newborn babies diagnosed with Hypoplastic Left Heart Syndrome, before placental detachment. Cord blood is packaged in a Credo Cube, and sent at a temperate state to the manufacturer immediately after draw. At least 65 mL of cord blood is needed to produce a stem cell product during manufacturing. Once processed, the patient's autologous cord blood stem cells will be frozen for their potential future use in a clinical trial.
 Other: Collection of umbilical cord blood
Cord blood will be processed in the temperate state it was collected to produce a pure, stem cell product identifiable to patients with Hypoplastic Left Heart Syndrome, and will be stored at a frozen state for their potential, future use in a clinical trial.


Outcome Measures
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Primary Outcome Measures :
  1. Percent of samples contaminated [ Time Frame: 14 days after collection ]
  2. Percent of cells that are viable following post thaw analysis [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any pregnant woman, regardless of age, with a prenatal diagnosis of HLHS
  • One or both parents willing to consent to the storage of umbilical cord blood for the specific purpose of regenerative research

Exclusion Criteria:

  • Individuals unwilling to participate
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856049


Contacts
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Contact: Lori A Riess 507-538-7730 riess.lori@mayo.edu
Contact: Karen S Miller 507-266-5510 miller.karen1@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lori A Riess    507-538-7730    hlhs@mayo.edu   
Principal Investigator: Susana Cantero Peral, MD PhD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Somya Shankar, BS    267-425-1984    shankars1@email.chop.edu   
Principal Investigator: Jack Rychik, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Susana Cantero Peral, M.D., Ph.D. Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Susana Cantero Peral, M.D., Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01856049    
Other Study ID Numbers: 11-007176
First Posted: May 17, 2013    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Susana Cantero Peral, M.D., Ph.D., Mayo Clinic:
HLHS
Hypoplastic Left Heart Syndrome
UCB (umbilical cord blood)
 Umbilical cord blood
Cord blood
Cardiac regeneration
Additional relevant MeSH terms:
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Hypoplastic Left Heart Syndrome
Syndrome
Disease
Pathologic Processes
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities