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 August 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: August 29, 2014
Last verified: August 2014

May 14, 2013
August 29, 2014
May 2012
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01856049 on ClinicalTrials.gov Archive Site
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Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients

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.

Not Provided
Interventional
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Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hypoplastic Left Heart Syndrome (HLHS)
Other: Collection of umbilical cord blood
No Intervention: Umbilical Cord Blood Collection
Intervention: Other: Collection of umbilical cord blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact: Julia M Thebiay (507) 538-8425 thebiay.julia@mayo.edu
United States
 
NCT01856049
11-007176
No
Timothy J. Nelson, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Timothy J Nelson, M.D., Ph.D. Mayo Clinic
Mayo Clinic
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP