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
  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
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
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: May 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014