An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence

Study Overview
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Brief Summary
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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.

Official Title
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Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

Conditions
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Stress Urinary Incontinence, Cell Therapy

Intervention / Treatment
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* Biological: autologous muscle cell injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Transurethral dose escalation | Biological: autologous muscle cell injection<br>* Injection of autologous muscle cells<br>|
| Other: 2<br>Periurethral dose escalation | Biological: autologous muscle cell injection<br>* Injection of autologous muscle cells<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at biopsy or between biopsy and treatment | 
| 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. | at biopsy or between biopsy and treatment | 
| 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. | 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. | 30 days | 
| 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. | 12 months |