Trial Outcomes & Findings for Autologous Cell Therapy for Female Stress Urinary Incontinence (NCT NCT01008943)
NCT ID: NCT01008943
Last Updated: 2021-07-01
Results Overview
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.
COMPLETED
PHASE2
16 participants
at biopsy or between biopsy and treatment, approximately 6 weeks
2021-07-01
Participant Flow
Participant milestones
| Measure |
Autologous Muscle-Derived Cells (AMDC)
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Autologous Muscle-Derived Cells (AMDC)
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Autologous Cell Therapy for Female Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 Participants
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Age, Continuous
|
61 years
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at biopsy or between biopsy and treatment, approximately 6 weeksPopulation: One patient experienced procedural dizziness.
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.
Outcome measures
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=22 Biopsies
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
|
1 participants
|
PRIMARY outcome
Timeframe: 30 daysAMDC 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.
Outcome measures
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 Participants
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Number of Participants That Experienced Injection Procedure-related Adverse Events
|
6 participants
|
PRIMARY outcome
Timeframe: 30 daysAMDC 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.
Outcome measures
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 Participants
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Injection Procedure-related Adverse Events
Abdominal pain lower
|
2 events
|
|
Injection Procedure-related Adverse Events
Dysuria
|
4 events
|
|
Injection Procedure-related Adverse Events
Micturition urgency
|
1 events
|
|
Injection Procedure-related Adverse Events
Urinary tract infection
|
1 events
|
PRIMARY outcome
Timeframe: 12 monthsIf 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.
Outcome measures
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 Participants
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Number of Participants That Experienced AMDC Product-related Events
|
0 participants
|
Adverse Events
Autologous Muscle-Derived Cells (AMDC)
Serious adverse events
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 participants at risk
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Injury, poisoning and procedural complications
Fibula fracture
|
6.2%
1/16 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Autologous Muscle-Derived Cells (AMDC)
n=16 participants at risk
Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
|
|---|---|
|
Gastrointestinal disorders
After AMDC treatment: Abdominal pain lower
|
12.5%
2/16 • Number of events 2 • 12 months
|
|
General disorders
After AMDC treatment: Generalised oedema
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
After biopsy, before AMDC: Procedural dizziness
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Blood creatinine increased
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Blood urea increased
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Blood urine
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Hemoglobin decreased
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Platelet count decreased
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Protein urine present
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: Residual urine volume increased
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Investigations
After AMDC treatment: White blood cell count increase
|
12.5%
2/16 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
After AMDC treatment: Dysuria
|
31.2%
5/16 • Number of events 5 • 12 months
|
|
Renal and urinary disorders
After AMDC treatment: Micturition urgency
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
After biopsy, before AMDC: Urethral dilatation
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
After AMDC treatment: Urinary retention
|
12.5%
2/16 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
After AMDC treatment: Urinary tract infection
|
18.8%
3/16 • Number of events 3 • 12 months
|
|
Reproductive system and breast disorders
After AMDC treatment: Menorrhagia
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Reproductive system and breast disorders
After AMDC treatment: Menstruation irregular
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
After AMDC treatment: Influenza
|
6.2%
1/16 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
After AMDC treatment: Ophthalmologic treatment
|
6.2%
1/16 • Number of events 1 • 12 months
|
Additional Information
Scott Snyder, PhD, Director of Clinical Science and Biostatistics
Cook Medical
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60