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NCT01648491 Clinical Trial

Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Stress Urinary Incontinence Clinical Trial

Official title:
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01648491
Other study ID # 2011-204
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 8, 2012
Last updated July 11, 2015
Start date March 2011
Est. completion date June 2016

Study information
Verified date July 2015
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1
Est. completion date June 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Male
Age group 78 Years to 82 Years
Eligibility Inclusion Criteria:

- urinary incontinence

- failed urinary incontinence (UI) treatments

Exclusion Criteria:

- does not meet inclusion criteria, gender and age limit

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Muscle Biopsy
Biopsy of thigh muscle to obtain stem cell core.
Biological:
• Injection of autologous stem cells
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.

Locations
Country Name City State
United States Beaumont Hospital - Royal Oak Royal Oak Michigan
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (2)
Lead Sponsor Collaborator
Kenneth Peters, MD William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Event No occurence of adverse events 6 months Yes
Secondary Quality of Life (QOL) questionnaire Improvement in QOL score. 6 months No
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