A Phase 2 interventional study of Autologous Muscle Derived Cells in Stress Urinary Incontinence, sponsored by Cook MyoSite. Completed at 2 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-01.
Sponsored by Cook MyoSite (part of Cook Group Incorporated) · Phase 2, Interventional, and Treatment
The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
670 studies on the registry are indexed under Urinary Incontinence, Stress; 122 are open to participants now.
This study's enrollment of 16 is below the median of 69 across 520 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Cook MyoSite is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Biological: Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells
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.
Time frame: at biopsy or between biopsy and treatment, approximately 6 weeks
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.
Time frame: 30 days
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.
Time frame: 30 days
Number of Participants That Experienced AMDC Product-related 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.
Time frame: 12 months
| Milestone | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Started | 16 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| participants | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Number of Participants That Experienced Biopsy Procedure-related Adverse Events | 1 |
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.
| participants | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Number of Participants That Experienced Injection Procedure-related Adverse Events | 6 |
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.
| events | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Abdominal pain lower | 2 |
| Dysuria | 4 |
| Micturition urgency | 1 |
| Urinary tract infection | 1 |
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.
| participants | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Number of Participants That Experienced AMDC Product-related Events | 0 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Autologous Muscle-Derived Cells (AMDC) | — | 1/16 (6.3%) | 12/16 (75%) |
| Event | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Fibula fractureInjury, poisoning and procedural complications | 1/16 |
| Event | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| After AMDC treatment: DysuriaRenal and urinary disorders | 5/16 |
| After AMDC treatment: Urinary tract infectionRenal and urinary disorders | 3/16 |
| After AMDC treatment: Abdominal pain lowerGastrointestinal disorders | 2/16 |
| After AMDC treatment: White blood cell count increaseInvestigations | 2/16 |
| After AMDC treatment: Urinary retentionRenal and urinary disorders | 2/16 |
| After AMDC treatment: Generalised oedemaGeneral disorders | 1/16 |
| After biopsy, before AMDC: Procedural dizzinessInjury, poisoning and procedural complications | 1/16 |
| After AMDC treatment: Blood creatinine increasedInvestigations | 1/16 |
| After AMDC treatment: Blood urea increasedInvestigations | 1/16 |
| After AMDC treatment: Blood urineInvestigations | 1/16 |
| Age, Continuous(years) | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Mean | 61 ± 2 |
| Sex: Female, Male(Participants) | Autologous Muscle-Derived Cells (AMDC) |
|---|---|
| Female | 16 |
| Male | 0 |
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Urinary Incontinence, Stress →