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Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT01648491
First received: March 8, 2012
Last updated: May 12, 2014
Last verified: May 2014

March 8, 2012
May 12, 2014
March 2011
December 2014   (final data collection date for primary outcome measure)
Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
No occurence of adverse events
Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
No occurance of adverse events
Complete list of historical versions of study NCT01648491 on ClinicalTrials.gov Archive Site
QOL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Improvement in QOL score.
Same as current
Not Provided
Not Provided
 
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

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

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Stress Urinary Incontinence
  • 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.
Experimental: Stem Cell treatment
Muscle Biopsy and Injection of autologous stem cells
Interventions:
  • Procedure: Muscle Biopsy
  • Biological: Injection of autologous stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1
December 2014
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • urinary incontinence
  • failed urinary incontinence (UI) treatments

Exclusion Criteria:

- does not meet inclusion criteria, gender and age limit

Male
78 Years to 82 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01648491
2011-204
No
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
William Beaumont Hospitals
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
William Beaumont Hospitals
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP