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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
Results First Received: May 12, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stress Urinary Incontinence
Interventions: Procedure: Muscle Biopsy
Biological: Injection of autologous stem cells

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Stem Cell Treatment

Muscle Biopsy and Injection of autologous stem cells

Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.

Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.


Participant Flow:   Overall Study
    Stem Cell Treatment
STARTED   1 
COMPLETED   1 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Stem Cell Treatment

Muscle Biopsy and Injection of autologous stem cells

Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.

Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.


Baseline Measures
   Stem Cell Treatment 
Overall Participants Analyzed 
[Units: Participants]
 1 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      1 100.0% 
Gender 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      1 100.0% 
Region of Enrollment 
[Units: Participants]
 
United States   1 


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

2.  Secondary:   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 ]

3.  Secondary:   Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)   [ Time Frame: 6 months ]

4.  Secondary:   Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a single patient compassionate use treatment.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Kenneth Peters MD
Organization: Beaumont Hospital - Royal Oak
phone: 248-551-0387
e-mail: Kenneth.Peters@Beaumont.org



Responsible Party: Kenneth Peters, MD, 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
Health Authority: United States: Food and Drug Administration