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Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

Primary Purpose

Stress Urinary Incontinence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Muscle Biopsy
Injection of autologous stem cells
Sponsored by
Kenneth Peters, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Urinary Incontinence

Eligibility Criteria

78 Years - 82 Years (Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • urinary incontinence
  • failed urinary incontinence (UI) treatments

Exclusion Criteria:

- does not meet inclusion criteria, gender and age limit

Sites / Locations

  • Beaumont Hospital - Royal Oak
  • William Beaumont Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stem Cell treatment

Arm Description

Muscle Biopsy and Injection of autologous stem cells

Outcomes

Primary Outcome Measures

Study-Related Adverse Events

Secondary Outcome Measures

Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire
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)
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)
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.

Full Information

First Posted
March 8, 2012
Last Updated
November 13, 2016
Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT01648491
Brief Title
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Official Title
Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kenneth Peters, MD
Collaborators
William Beaumont Hospitals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stem Cell treatment
Arm Type
Experimental
Arm Description
Muscle Biopsy and Injection of autologous stem cells
Intervention Type
Procedure
Intervention Name(s)
Muscle Biopsy
Intervention Description
Biopsy of thigh muscle to obtain stem cell core.
Intervention Type
Biological
Intervention Name(s)
Injection of autologous stem cells
Intervention Description
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Primary Outcome Measure Information:
Title
Study-Related Adverse Events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire
Description
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.
Time Frame
Baseline and 6 months
Title
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)
Description
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.
Time Frame
6 months
Title
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
78 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: urinary incontinence failed urinary incontinence (UI) treatments Exclusion Criteria: - does not meet inclusion criteria, gender and age limit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth M Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital - Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will not be shared

Learn more about this trial

Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use

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