Autologous Cell Therapy for Female Stress Urinary Incontinence

A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence
• Intervention / Treatment: Biological: Autologous Muscle Derived Cells

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N2T9
      • Foothills Medical Centre
  • Ontario
    • Toronto, Ontario, Canada, M4N 3 M5
      • Sunnybrook Health Sciences Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• SUI with normal detrusor activity confirmed with urodynamics
• Bladder capacity >200 ml
• Incontinence has not shown any improvement for at least -6 months
• Failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)

Exclusion Criteria:

• Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability
• Neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)
• Uncontrolled diabetes
• Pregnant, lactating, or plans to become pregnant during course of the study
• Morbid obesity (defined as 100 pounds over their ideal body weight, or BMI ≥40) and not expected to benefit from treatment
• Current or acute conditions involving cystitis or urethritis
• Scheduled to receive radiation treatment to the vicinity, or history of radiation treatment to the urethra or adjacent structures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: Autologous Muscle Derived Cells; Urethral injection of autologous muscle-derived cells

What is the study measuring?

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, 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.	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 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

Collaborators and Investigators

• Sponsor: Cook MyoSite
• Investigators: Principal Investigator: Lesley K. Carr, MD, Sunnybrook Health Sciences Center

Publications and helpful links

Helpful Links

• Autologous muscle derived cells for treatment of stress urinary incontinence in women

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2010
• Primary Completion (Actual): September 21, 2012
• Study Completion (Actual): September 21, 2012

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 5, 2009
• First Posted (Estimate): November 6, 2009

Study Record Updates

• Last Update Posted (Actual): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 29, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 09-013