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Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01648491
Recruitment Status : Completed
First Posted : July 24, 2012
Results First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Study Description
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Brief Summary:
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.

Condition or disease Intervention/treatment Phase
Stress Urinary Incontinence Procedure: Muscle Biopsy Biological: Injection of autologous stem cells Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Study Start Date : October 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : January 2016

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Stem Cell treatment
Muscle Biopsy and Injection of autologous stem cells
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Study-Related Adverse Events [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   78 Years to 82 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • urinary incontinence
  • failed urinary incontinence (UI) treatments

Exclusion Criteria:

- does not meet inclusion criteria, gender and age limit

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01648491


Locations
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United States, Michigan
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
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Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
More Information
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Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01648491    
Other Study ID Numbers: 2011-204
First Posted: July 24, 2012    Key Record Dates
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
 Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders