Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome
Public ClinicalTrials.gov record NCT03779711. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
Study identification
- NCT ID
- NCT03779711
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 95 participants
Conditions and interventions
Conditions
Interventions
- Autologous (self) mononuclear cells derived from umbilical cord blood Biological
- Stage II Surgical repair Procedure
Biological · Procedure
Eligibility (public fields only)
- Age range
- Up to 12 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 5, 2019
- Primary completion
- May 21, 2022
- Completion
- Jan 31, 2026
- Last update posted
- Jul 7, 2025
2019 – 2026
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 35233 | — |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Ocshner Medical Center | New Orleans | Louisiana | 70121 | — |
| Children's Hospitals of Minnesota | Minneapolis | Minnesota | 55404 | — |
| Cincinnati Children's Hospital and Medical Center | Cincinnati | Ohio | 45529 | — |
| Oklahoma University Medical Center | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03779711, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03779711 live on ClinicalTrials.gov.