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

Condition Intervention
Stress Urinary Incontinence
Procedure: Muscle Biopsy
Biological: Injection of autologous stem cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

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

Secondary Outcome Measures:
  • 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.


Enrollment: 1
Study Start Date: October 2011
Study Completion Date: January 2016
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   78 Years to 82 Years   (Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01648491

Locations
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
Principal Investigator: Kenneth M Peters, MD William Beaumont Hospitals
  More Information

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01648491     History of Changes
Other Study ID Numbers: 2011-204
Study First Received: March 8, 2012
Results First Received: May 12, 2016
Last Updated: November 13, 2016
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Data will not be shared

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2017