Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Procedure: Muscle Biopsy; Biological: Injection of autologous stem cells

• Registration Number: NCT01648491
• Lead Sponsor: Kenneth Peters, MD

Brief Summary

Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Detailed Description

Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2012-03-08
• Primary Completion: 2012-07
• Study First Submitted QC: 2012-07-19
• Study First Posted: 2012-07-24
• Study Completion: 2016-01
• Results First Submitted: 2016-05-12
• Status Verified: 2016-11
• Results First Submitted QC: 2016-11-13
• Last Update Submitted: 2016-11-13
• Results First Posted: 2017-01-10
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• urinary incontinence
• failed urinary incontinence (UI) treatments

Exclusion Criteria

• does not meet inclusion criteria, gender and age limit

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell treatment	Muscle Biopsy	Muscle Biopsy and Injection of autologous stem cells
Stem Cell treatment	Injection of autologous stem cells	Muscle Biopsy and Injection of autologous stem cells

Primary Outcome Measures

Name	Time	Method
Study-Related Adverse Events	6 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire	Baseline and 6 months	The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible.
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)	6 months	The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse.
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)	6 months	The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Very Much Better, 2 Much Better, 3 A Little Better, 4 No Change, 5 A Little Worse, 6 Much Worse, and 7 Very Much Worse.

Trial Locations

Locations (2)

Beaumont Hospital - Royal Oak; 🇺🇸 Royal Oak, Michigan, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States