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

Phase 2

Completed

Conditions: Cell Therapy
Stress Urinary Incontinence

Interventions: Biological: autologous muscle cell injection

Registration Number: NCT00847535

Lead Sponsor: Cook MyoSite

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 66

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	autologous muscle cell injection	Periurethral dose escalation
1	autologous muscle cell injection	Transurethral dose escalation

Primary Outcome Measures

Name	Time	Method
Injection Procedure-related Adverse Events	30 days	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	12 months	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.
Biopsy Procedure-related Adverse Events	at biopsy or between biopsy and treatment	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 Biopsy Procedure-related Adverse Events	at biopsy or between biopsy and treatment	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	30 days	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.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Wm Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Sunnybrook Health Sciences Center
🇨🇦
Toronto, Ontario, Canada