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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Timothy J. Nelson, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01856049
First received: May 14, 2013
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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 Intervention
Hypoplastic Left Heart Syndrome (HLHS)
Other: Collection of umbilical cord blood

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Percent of samples contaminated [ Time Frame: 14 days after collection ] [ Designated as safety issue: No ]
  • Percent of cells that are viable following post thaw analysis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Umbilical Cord Blood Collection Other: Collection of umbilical cord blood

  Eligibility

Genders 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
  • Mother is willing to provide a blood sample for serology testing

Exclusion Criteria:

  • Individuals unwilling to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01856049

Contacts
Contact: Karen P Krucker, RN (507) 255-4774 krucker.karen@mayo.edu
Contact: Julia M Thebiay (507) 538-8425 thebiay.julia@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Timothy T Nelson, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Timothy J Nelson, M.D., Ph.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Timothy J. Nelson, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01856049     History of Changes
Other Study ID Numbers: 11-007176
Study First Received: May 14, 2013
Last Updated: February 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
HLHS
Hypoplastic Left Heart Syndrome
UCB (umbilical cord blood)
Umbilical cord blood
Cord blood
Cardiac regeneration

Additional relevant MeSH terms:
Hypoplastic Left Heart Syndrome
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014