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NCT00847535 · ClinicalTrials.gov registry record · Phase 2

An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

A Phase 2 study of Stress Urinary Incontinence and Cell Therapy, sponsored by Cook MyoSite.

Completed
Registry status
Phase 2
Development phase
66
Enrollment target
3
Study locations

NCT00847535 is a Phase 2 study of Stress Urinary Incontinence and Cell Therapy that has completed, run by Cook MyoSite. The registered enrollment target is 66 participants, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (59% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT00847535, a Phase 2 study of Stress Urinary Incontinence and Cell Therapy, has completed, sponsored by Cook MyoSite.

COMPLETED
Registry status
Phase 2
Development phase
66 participants
Enrollment target
3
Study locations

Study Summary

This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.

Interventions

  • BIOLOGICAL autologous muscle cell injection

Study Locations (3)

Michigan

  • Wm Beaumont Hospital - Royal Oak

Tennessee

  • Vanderbilt University Medical Center - Nashville

Ontario

  • Sunnybrook Health Sciences Center - Toronto

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2008-10-09
Est. Completion 2011-11-02
Phase Phase 2

Sponsor

Cook MyoSite

5 total trials

What the Registry Record Tells You About NCT00847535

The ClinicalTrials.gov registry entry for NCT00847535 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (59% lower). The listed sponsor is Cook MyoSite, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Stress Urinary Incontinence appearing as the primary indexed condition, and to 1 intervention - of which autologous muscle cell injection is the first listed.

NCT00847535 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Michigan, Tennessee, Ontario.

Frequently Asked Questions

What is clinical trial NCT00847535 about?

NCT00847535 is a clinical study titled "An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence". This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.

What is the current status of trial NCT00847535?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2008-10-09. Estimated completion is 2011-11-02.

What conditions does trial NCT00847535 study?

This clinical trial studies the following conditions: Stress Urinary Incontinence, Cell Therapy.

What interventions are being tested in trial NCT00847535?

The interventions under investigation include: autologous muscle cell injection (BIOLOGICAL).

Who is sponsoring clinical trial NCT00847535?

This trial is sponsored by Cook MyoSite, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00847535 being conducted?

This trial has 3 study locations across Michigan, Tennessee, Ontario. 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.