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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: Completed Phase 1 study of Ebstein Anomaly, sponsored by Timothy J. Nelson.
NCT02914171 is a Phase 1 study of Ebstein Anomaly that has completed, run by Timothy J. Nelson. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety assessment of adverse events from time of index procedure will be analyzed by counts and percents using the chi-square test and Cochran-Armitage test for trends, and the two groups compared using the Fisher exact test. A Fisher's exact test with a 0.05 two-sided significance level will have 80% power to detect a difference in a sample size of 10 in each group. Thus having reasonable power to distinguish common rates for adverse events from very rare rates. Analysis of cardiac adverse even
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 |
What the finished NCT02914171 record still lists
NCT02914171 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02914171's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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