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Phase I Safety and Feasibility Study of Intracoronary Delivery of Autologous Bone Marrow Derived Mononuclear Cells

NCT02549625 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-05-14

No results posted yet for this 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

  • Congenital Heart Disease

Interventions

BIOLOGICAL

Autologous Bone Marrow-derived Mononuclear Cells

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Timothy J Nelson, MD, PhD

    lead OTHER

Principal Investigators

  • Timothy J Nelson, M.D., Ph.D. · Mayo Clinic

  • Muhammad Y Qureshi, MBBS · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-11-30
Completion
2020-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT02549625 on ClinicalTrials.gov