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Study of Autologous Bone Marrow Derived Mononuclear Cells for Treatment of Ebstein Anomaly

NCT02914171 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2022-04-26

No results posted yet for this 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

  • Ebstein Anomaly

Interventions

BIOLOGICAL

Autologous Bone Marrow-derived Mononuclear Cells

DEVICE

Insertable cardiac monitor

Following surgical Ebstein repair a Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) will be placed subcutaneously in the anterior chest to continuously monitor the subject's heart rhythm and to record cardiac information through automatic detection of arrhythmias.

Sponsors & Collaborators

  • Timothy J. Nelson

    lead OTHER

Principal Investigators

  • Muhammad Y Qureshi, MBBS · Mayo Clinic

  • Timothy J Nelson, MD, PhD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2021-03-18
Completion
2021-03-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914171 on ClinicalTrials.gov