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Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

This study has been completed.
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: November 13, 2016
Last verified: November 2016
March 8, 2012
November 13, 2016
October 2011
July 2012   (Final data collection date for primary outcome measure)
Study-Related Adverse Events [ Time Frame: 6 months ]
Adverse Event [ Time Frame: 6 months ]
No occurance of adverse events
Complete list of historical versions of study NCT01648491 on ClinicalTrials.gov Archive Site
  • Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
QOL [ Time Frame: 6 months ]
Improvement in QOL score.
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
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.
 
Completed
1
January 2016
July 2012   (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

Sexes Eligible for Study: Male
78 Years to 82 Years   (Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01648491
2011-204
No
Not Provided
No
Data will not be shared
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
William Beaumont Hospitals
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
William Beaumont Hospitals
November 2016

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