Autologous Stem Cells for Urinary Incontinence: Single Patient Compassionate Use
1 other identifier
interventional
1
1 country
2
Brief Summary
Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedFirst Posted
Study publicly available on registry
July 24, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
January 10, 2017
CompletedJanuary 10, 2017
November 1, 2016
9 months
March 8, 2012
May 12, 2016
November 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Study-Related Adverse Events
6 months
Secondary Outcomes (3)
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire
Baseline and 6 months
Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA)
6 months
Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I)
6 months
Study Arms (1)
Stem Cell treatment
EXPERIMENTALMuscle Biopsy and Injection of autologous stem cells
Interventions
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
Eligibility Criteria
You may qualify if:
- urinary incontinence
- failed urinary incontinence (UI) treatments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kenneth Peters, MDlead
- Corewell Health Eastcollaborator
Study Sites (2)
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, 48073, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This is a single patient compassionate use treatment.
Results Point of Contact
- Title
- Kenneth Peters MD
- Organization
- Beaumont Hospital - Royal Oak
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth M Peters, MD
Corewell Health East
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 8, 2012
First Posted
July 24, 2012
Study Start
October 1, 2011
Primary Completion
July 1, 2012
Study Completion
January 1, 2016
Last Updated
January 10, 2017
Results First Posted
January 10, 2017
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share
Data will not be shared