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Muscle Derived Cell Therapy for Bladder Exstrophy Epispadias Induced Incontinence

NCT01011777 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-01-28

No results posted yet for this study

Summary

The aim of this study is to study safety, tolerability and efficacy of muscle derived cell (MDC) therapy in children with bladder exstrophy epispadias induced urinary incontinence.

Conditions

Interventions

DRUG

MDC

After the biopsy the MDC expansion process takes approximately 21 days after which cells are harvested and cryopreserved for future injection. The MDC product is stored in single use vials, with each vial containing approximately 2.6 x 10\^7 total cells. The volume of each vial will be 1.3ml. This study uses a single dose of approximately 2.0 x 10\^7 cells administered endoscopically into the external urethral sphincter in 12 injections of 0.1ml each. Six months post-initial MDC injection, group 1 participants with persistent bladder capacity less than 100cc and group 2 participants with persistent urinary incontinence as defined in eligibility criteria may undergo repeat injections of MDC at 6 month intervals for up to a total of 4 injections.

Sponsors & Collaborators

Principal Investigators

  • John P Gearhart, MD · Brady Urological Institute, Department of Pediatric Urology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2020-01-23
Completion
2020-01-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01011777 on ClinicalTrials.gov