CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 23 enrolled
Drug / intervention
Autologous Muscle Derived Cellsbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02463448
NCT02463448Phase 1Completed
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Autologous Muscle Derived Cells for Underactive Bladder

Jason Gilleran·interventional·Posted Jun 4, 2015·Updated Jan 19, 2022

In Brief

A Phase 1 clinical trial evaluating Autologous Muscle Derived Cells for Urinary Retention and Urinary Incontinence. Completed, enrolled 23 participants across 1 site.

Detailed Summary

This is a prospective, open-label, Phase 1, single center study evaluating the safety and efficacy of Autologous Muscle Derived Cells as a treatment for chronic Underactive Bladder.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Retention, Urinary Incontinence
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 4, 2015
Enrollment StartNov 16, 2016
Primary CompletionDec 1, 2019
Study CompletionNov 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.1 years ago

Interventions

Autologous Muscle Derived Cellsbiological

A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall.