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NCT02549625 · ClinicalTrials.gov registry record · Phase 1
Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells
A Phase 1 study of Congenital Heart Disease, sponsored by Timothy J Nelson, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT02549625: Completed Phase 1 study of Congenital Heart Disease, sponsored by Timothy J Nelson, MD, PhD.
NCT02549625 is a Phase 1 study of Congenital Heart Disease that has completed, run by Timothy J Nelson, MD, PhD. The registered enrollment target is 10 participants, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02549625, a Phase 1 study of Congenital Heart Disease, has completed, sponsored by Timothy J Nelson, MD, PhD.
- 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 (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single right ventricle systemic pumps. This procedure has the potential to foster a new strategy for congenital heart patients. This is an open-label study of autologous MNC derived from bone marrow with a 2-year follow-up to document 1) related serious adverse events and 2) monitor changes in cardiac structure and function.
Conditions Studied
Interventions
- BIOLOGICAL Autologous Bone Marrow-derived Mononuclear Cells
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-08 |
| Est. Completion | 2020-11 |
| Phase | Phase 1 |
What the finished NCT02549625 record still lists
NCT02549625 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 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Congenital Heart Disease appearing as the primary indexed condition, and to 1 intervention - of which Autologous Bone Marrow-derived Mononuclear Cells is the first listed.
NCT02549625 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT02549625 about?
NCT02549625 is a clinical study titled "Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells". The objective of this study is to determine the safety and feasibility of autologous mononuclear cells (MNC) collected from bone marrow (BM) and intracoronary delivery for individuals with declining performance of their single right ventricle systemic pumps. This procedure has the potential to foste...
What is the current status of trial NCT02549625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2015-08. Estimated completion is 2020-11.
What conditions does trial NCT02549625 study?
This clinical trial studies the following conditions: Congenital Heart Disease.
What interventions are being tested in trial NCT02549625?
The interventions under investigation include: Autologous Bone Marrow-derived Mononuclear Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT02549625?
This trial is sponsored by Timothy J Nelson, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02549625 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
Similar trials for Congenital Heart Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02549625's enrollment target sits among peer trials
10 63rd of 63 the lowest of 63 other Congenital Heart Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Congenital Heart Disease 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.
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