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Trial record 5 of 44 for:    "Hypoplastic left heart syndrome"

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
  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: None (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 Susana Cantero Peral, M.D., Ph.D., Mayo Clinic:

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

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
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
  • Mother is willing to provide a blood sample for serology testing

Exclusion Criteria:

  • Individuals unwilling to participate
  Contacts and Locations
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
Contact: Kathryn E Lenn 507-266-6391 lenn.kathryn@mayo.edu
Contact: Karen S Miller 507-266-5510 miller.karen1@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Susana Cantero Peral, MD PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Susana Cantero Peral, M.D., Ph.D. Mayo Clinic
  More Information

Responsible Party: Susana Cantero Peral, M.D., Ph.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01856049     History of Changes
Other Study ID Numbers: 11-007176
First Submitted: May 14, 2013
First Posted: May 17, 2013
Last Update Posted: October 17, 2017
Last Verified: October 2017
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:
Syndrome
Hypoplastic Left Heart Syndrome
Disease
Pathologic Processes
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities