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NCT04236479 · ClinicalTrials.gov registry record · Phase 1
Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)
A Phase 1 study of Congenital Heart Disease (CHD), sponsored by Catherine Bollard.
- Active
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 1
- Study location
NCT04236479 is a Phase 1 study of Congenital Heart Disease (CHD) that is active but no longer recruiting, run by Catherine Bollard. The registered enrollment target is 17 participants, below the 212-participant average among 3 other Congenital Heart Disease (CHD) trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04236479, a Phase 1 study of Congenital Heart Disease (CHD), is active but no longer recruiting, sponsored by Catherine Bollard.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life
Conditions Studied
Interventions
- BIOLOGICAL BM-MSC
Study Locations (1)
District of Columbia
- Children's National Health System - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2026-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04236479
The ClinicalTrials.gov registry entry for NCT04236479 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 212-participant average among 3 other Congenital Heart Disease (CHD) trials with a reported enrollment target (92% lower). The listed sponsor is Catherine Bollard, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Congenital Heart Disease (CHD) appearing as the primary indexed condition, and to 1 intervention - of which BM-MSC is the first listed.
NCT04236479 reports 1 study location spanning 1 distinct geographic area - top geographies include District of Columbia.
Frequently Asked Questions
What is clinical trial NCT04236479 about?
NCT04236479 is a clinical study titled "Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)". The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who...
What is the current status of trial NCT04236479?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2020-07-29. Estimated completion is 2026-09.
What conditions does trial NCT04236479 study?
This clinical trial studies the following conditions: Congenital Heart Disease (CHD).
What interventions are being tested in trial NCT04236479?
The interventions under investigation include: BM-MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04236479?
This trial is sponsored by Catherine Bollard, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04236479 being conducted?
This trial has 1 study location across District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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