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NCT02914171 · ClinicalTrials.gov registry record · Phase 1
Study of Autologous Bone Marrow Derived Mononuclear Cells for Treatment of Ebstein Anomaly
A Phase 1 study of Ebstein Anomaly, sponsored by Timothy J. Nelson.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02914171 is a Phase 1 study of Ebstein Anomaly that has completed, run by Timothy J. Nelson. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT02914171, a Phase 1 study of Ebstein Anomaly, has completed, sponsored by Timothy J. Nelson.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to the control group undergoing the same surgical procedure without cell delivery. This add-on procedure has the potential to foster a new strategy for individuals with congenital heart disease.This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) incidence and severity of adverse event and 2) monitor changes in cardiac structure and function.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Bone Marrow-derived Mononuclear Cells
- DEVICE Insertable cardiac monitor
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-09 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02914171
The ClinicalTrials.gov registry entry for NCT02914171 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Timothy J. Nelson, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Ebstein Anomaly appearing as the primary indexed condition, and to 2 interventions - of which Autologous Bone Marrow-derived Mononuclear Cells is the first listed.
NCT02914171 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.
Frequently Asked Questions
What is clinical trial NCT02914171 about?
NCT02914171 is a clinical study titled "Study of Autologous Bone Marrow Derived Mononuclear Cells for Treatment of Ebstein Anomaly". The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNS) collected from bone marrow (BM) and using an add-on intramyocardial delivery for individuals with Ebstein anomaly undergoing surgical intervention compared to the control group undergoing the...
What is the current status of trial NCT02914171?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2016-09. Estimated completion is 2021-03-18.
What conditions does trial NCT02914171 study?
This clinical trial studies the following conditions: Ebstein Anomaly.
What interventions are being tested in trial NCT02914171?
The interventions under investigation include: Autologous Bone Marrow-derived Mononuclear Cells (BIOLOGICAL), Insertable cardiac monitor (DEVICE).
Who is sponsoring clinical trial NCT02914171?
This trial is sponsored by Timothy J. Nelson, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02914171 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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