Back to resultsAn Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Primary Purpose
Stress Urinary Incontinence, Cell Therapy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
autologous muscle cell injection
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- Patient has SUI with normal detrusor activity confirmed with urodynamics
- Patient has bladder capacity >200 mL
- Patient's incontinence has not shown any improvement for at least -6 months
- Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion Criteria:
- Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
- Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
- Patient has uncontrolled diabetes
- Patient is pregnant, lactating, or plans to become pregnant during the course of the study
- Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
- Patient has current or acute conditions involving cystitis or urethritis
- Patient is scheduled to receive radiation treatment to the vicinity
- Patients with a history of radiation treatment to the urethra or adjacent structures
Sites / Locations
- Wm Beaumont Hospital
- Vanderbilt University Medical Center
- Sunnybrook Health Sciences Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
1
2
Arm Description
Transurethral dose escalation
Periurethral dose escalation
Outcomes
Primary Outcome Measures
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Biopsy Procedure-related Adverse Events
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Number of Participants That Experienced Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Injection Procedure-related Adverse Events
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Number of Participants That Experienced AMDC Product-related Adverse Events
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00847535
Brief Title
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Official Title
Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 9, 2008 (Actual)
Primary Completion Date
November 2, 2011 (Actual)
Study Completion Date
November 2, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook MyoSite
4. Oversight
5. Study Description
Brief Summary
This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Cell Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Transurethral dose escalation
Arm Title
2
Arm Type
Other
Arm Description
Periurethral dose escalation
Intervention Type
Biological
Intervention Name(s)
autologous muscle cell injection
Intervention Description
Injection of autologous muscle cells
Primary Outcome Measure Information:
Title
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
Description
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Time Frame
at biopsy or between biopsy and treatment
Title
Biopsy Procedure-related Adverse Events
Description
Biopsy was required to generate AMDC products. Biopsy procedure-related events were defined as systemic responses to the biopsy procedure or injury at the biopsy site. Since biopsy occurred prior to AMDC treatment, results are presented independent of AMDC dose received.
All biopsy procedure-related events either self-resolved or were easily treated.
Time Frame
at biopsy or between biopsy and treatment
Title
Number of Participants That Experienced Injection Procedure-related Adverse Events
Description
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Time Frame
30 days
Title
Injection Procedure-related Adverse Events
Description
AMDC treatment was administered via intrasphincteric injection. Injection procedure-related events were defined as systemic responses to the injection procedure or genitourinary events occurring within 30 days of the injection procedure that could be attributed to cystoscopy or catheterization. Since these events could be attributed to the injection procedure, results are considered independent of AMDC dose received.
All injection procedure-related events self-resolved or were easily treated.
Time Frame
30 days
Title
Number of Participants That Experienced AMDC Product-related Adverse Events
Description
If an immune response after injection or any urinary retention occurred and seemed suspicious, the physicians were consulted to determine whether the effect was likely related to the AMDC product.
No adverse events reported during the study were adjudicated as AMDC product-related.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has SUI with normal detrusor activity confirmed with urodynamics
Patient has bladder capacity >200 mL
Patient's incontinence has not shown any improvement for at least -6 months
Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)
Exclusion Criteria:
Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
Patient has uncontrolled diabetes
Patient is pregnant, lactating, or plans to become pregnant during the course of the study
Patient is morbidly obese (defined as 100 pounds over their ideal body weight, or BMI ≥40) and would not be expected to benefit from treatment
Patient has current or acute conditions involving cystitis or urethritis
Patient is scheduled to receive radiation treatment to the vicinity
Patients with a history of radiation treatment to the urethra or adjacent structures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Peters, MD
Organizational Affiliation
William Beaumont Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wm Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/24582537
Description
Autologous muscle derived cells for treatment of stress urinary incontinence in women
Learn more about this trial
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
We'll reach out to this number within 24 hrs