This trial is active, not recruiting.

Condition stress urinary incontinence
Treatments muscle biopsy, injection of autologous stem cells
Sponsor Kenneth Peters, MD
Collaborator William Beaumont Hospitals
Start date March 2011
End date June 2016
Trial size 1 participant
Trial identifier NCT01648491, 2011-204


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Muscle Biopsy and Injection of autologous stem cells
muscle biopsy
Biopsy of thigh muscle to obtain stem cell core.
injection of autologous stem cells
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.

Primary Outcomes

Adverse Event
time frame: 6 months

Secondary Outcomes

Quality of Life (QOL) questionnaire
time frame: 6 months

Eligibility Criteria

Male participants from 78 years up to 82 years old.

Inclusion Criteria: - urinary incontinence - failed urinary incontinence (UI) treatments Exclusion Criteria: - does not meet inclusion criteria, gender and age limit

Additional Information

Official title Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Principal investigator Kenneth M Peters, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by William Beaumont Hospitals.