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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 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.

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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

Congenital Heart Disease

Interventions

  • BIOLOGICAL Autologous Bone Marrow-derived Mononuclear Cells

Study Locations (1)

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2015-08
Est. Completion 2020-11
Phase Phase 1

Sponsor

Timothy J Nelson, MD, PhD

5 total trials

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What the Registry Record Tells You About NCT02549625

The ClinicalTrials.gov registry entry for NCT02549625 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, below the 474-participant average among 63 other Congenital Heart Disease trials with a reported enrollment target (98% lower). The listed sponsor is Timothy J Nelson, MD, PhD, which has 5 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.