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: December 4, 2013
Last verified: December 2013
  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: Endpoint Classification: Safety/Efficacy Study
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:
  • Adverse Event [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    No occurence of adverse events


Secondary Outcome Measures:
  • QOL [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Improvement in QOL score.


Enrollment: 1
Study Start Date: March 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01648491

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Beaumont Hospital - Royal Oak
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

No publications provided

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
Last Updated: December 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014