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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: Completed Phase 2 study of Stress Urinary Incontinence and Cell Therapy, sponsored by Cook MyoSite.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received. All biopsy procedure-related events either self-resolved or were easily treated.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2008-10-09 |
| Est. Completion | 2011-11-02 |
| Phase | Phase 2 |
What the finished NCT00847535 record still lists
NCT00847535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 161-participant average among 35 other Stress Urinary Incontinence trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Stress Urinary Incontinence
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00847535's enrollment target sits among peer trials
66 27th of 35 higher than 8 of 35 other Stress Urinary Incontinence trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stress Urinary Incontinence 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.
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