Umbilical Cord Blood Collection and Processing for Cardiac Regeneration in Hypoplastic Left Heart Syndrome Patients
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| ClinicalTrials.gov Identifier: NCT01856049 |
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Recruitment Status :
Recruiting
First Posted : May 17, 2013
Last Update Posted : August 21, 2018
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
- Percent of samples contaminated [ Time Frame: 14 days after collection ]
- Percent of cells that are viable following post thaw analysis [ Time Frame: 5 years ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
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
| Contact: Kathryn E Lenn | 507-266-6391 | lenn.kathryn@mayo.edu | |
| Contact: Karen S Miller | 507-266-5510 | miller.karen1@mayo.edu |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact: Kathryn Lenn, MHA 507-266-6391 HLHS@mayo.edu | |
| Principal Investigator: Susana Cantero Peral, MD PhD | |
| United States, Pennsylvania | |
| Children's Hospital of Philadelphi | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Kellyn Handforth, MPH 267-425-6614 handforthk@email.chop.edu | |
| Principal Investigator: Jack Rychik, MD | |
| Principal Investigator: | Susana Cantero Peral, M.D., Ph.D. | Mayo Clinic |
| 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 Posted: | May 17, 2013 Key Record Dates |
| Last Update Posted: | August 21, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Susana Cantero Peral, M.D., Ph.D., Mayo Clinic:
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HLHS Hypoplastic Left Heart Syndrome UCB (umbilical cord blood) |
Umbilical cord blood Cord blood Cardiac regeneration |
Additional relevant MeSH terms:
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Syndrome Hypoplastic Left Heart Syndrome Disease Pathologic Processes Heart Defects, Congenital |
Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |