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

This study is currently recruiting participants.
Verified October 2017 by Susana Cantero Peral, M.D., Ph.D., Mayo Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT01856049
First Posted: May 17, 2013
Last Update Posted: October 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Susana Cantero Peral, M.D., Ph.D., Mayo Clinic
May 14, 2013
May 17, 2013
October 17, 2017
May 2012
December 2017   (Final data collection date for primary outcome measure)
  • Percent of samples contaminated [ Time Frame: 14 days after collection ]
  • Percent of cells that are viable following post thaw analysis [ Time Frame: 5 years ]
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
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Hypoplastic Left Heart Syndrome (HLHS)
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.
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.
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
100
December 2017
December 2017   (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
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact: Kathryn E Lenn 507-266-6391 lenn.kathryn@mayo.edu
Contact: Karen S Miller 507-266-5510 miller.karen1@mayo.edu
United States
 
 
NCT01856049
11-007176
No
Not Provided
Plan to Share IPD: No
Susana Cantero Peral, M.D., Ph.D., Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Susana Cantero Peral, M.D., Ph.D. Mayo Clinic
Mayo Clinic
October 2017

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