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NCT00474461 · ClinicalTrials.gov registry record · Phase 1

Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO)

A Phase 1 study of Coronary Artery Disease and Congestive Heart Failure, sponsored by University of Louisville.

Completed
Registry status
Phase 1
Development phase
33
Enrollment target
1
Study location

NCT00474461 is a Phase 1 study of Coronary Artery Disease and Congestive Heart Failure that has completed, run by University of Louisville. The registered enrollment target is 33 participants, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00474461, a Phase 1 study of Coronary Artery Disease and Congestive Heart Failure, has completed, sponsored by University of Louisville.

COMPLETED
Registry status
Phase 1
Development phase
33 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis is that CSCs infused into nonviable myocardial segments will regenerate infarcted myocardium by differentiating into cardiomyocytes and other cell types. According to our hypothesis, CSC infusion regenerates myocardium with consequent improvement in contractile function of the heart and general clinical status.

Interventions

  • BIOLOGICAL Treatment group

Study Locations (1)

Kentucky

  • Jewish Hospital - Louisville

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2009-02
Est. Completion 2013-09
Phase Phase 1

Sponsor

University of Louisville

217 total trials

What the Registry Record Tells You About NCT00474461

The ClinicalTrials.gov registry entry for NCT00474461 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,287-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (97% lower). The listed sponsor is University of Louisville, which has 217 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 1 intervention - of which Treatment group is the first listed.

NCT00474461 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.

Frequently Asked Questions

What is clinical trial NCT00474461 about?

NCT00474461 is a clinical study titled "Cardiac Stem Cell Infusion in Patients With Ischemic CardiOmyopathy (SCIPIO)". The purpose of this study is to investigate the safety of intracoronary cardiac stem cells (CSCs) therapy in humans. Currently, there is no effective intervention to regenerate (regrow) dead heart muscle after a heart attack. The central hypothesis is that CSCs infused into nonviable myocardial seg...

What is the current status of trial NCT00474461?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2009-02. Estimated completion is 2013-09.

What conditions does trial NCT00474461 study?

This clinical trial studies the following conditions: Coronary Artery Disease, Congestive Heart Failure.

What interventions are being tested in trial NCT00474461?

The interventions under investigation include: Treatment group (BIOLOGICAL).

Who is sponsoring clinical trial NCT00474461?

This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00474461 being conducted?

This trial has 1 study location across Kentucky. 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

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