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NCT00869024 · ClinicalTrials.gov registry record · Phase 1

Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement

A Phase 1 study, sponsored by University of Minnesota.

Completed
Registry status
Phase 1
Development phase
25
Enrollment target

NCT00869024: Completed Phase 1 study, sponsored by University of Minnesota.

NCT00869024 is a Phase 1 study that has completed, run by University of Minnesota. The registered enrollment target is 25 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00869024, a Phase 1 study, has completed, sponsored by University of Minnesota.

COMPLETED
Registry status
Phase 1
Development phase
25 participants
Enrollment target

Study Summary

The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future. The cells will be obtained by aspiration or withdrawal of fluid from your bone marrow from your pelvic bone using a needle and syringe. This would not take place until 24-48 hours prior to your planned left ventricular assist device implantation. During the surgery the surgeons will inject the prepared cells that were taken from your bone marrow and inject it into your heart muscle. This study will test whether receiving your own bone marrow cells directly into your heart will help your heart to recover function after placement of a left ventricular assist device.

Primary Outcome

Safety as measured by the total number of adverse events per group.

Interventions

  • BIOLOGICAL Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2011-11-10
Est. Completion 2016-03-29
Phase Phase 1
University of Minnesota

966 total trials

What the finished NCT00869024 record still lists

NCT00869024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% lower).

The record links to 0 conditions, and to 1 intervention - of which Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells is the first listed.

NCT00869024 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00869024 about?

NCT00869024 is a clinical study titled "Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement". The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future. The cells will be obtained by aspiration or withdrawal of fluid from you...

What is the current status of trial NCT00869024?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 25 participants. The study started on 2011-11-10. Estimated completion is 2016-03-29.

What interventions are being tested in trial NCT00869024?

The interventions under investigation include: Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT00869024?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00869024's enrollment target sits among peer trials

25 1495th of 2000 higher than 481 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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Source: ClinicalTrials.gov NCT00869024, the US trial registry maintained by the National Library of Medicine. NCT00869024 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.