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

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

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.

Study Overview

• Status: Completed
• Conditions: Stress Urinary Incontinence; Cell Therapy
• Intervention / Treatment: Biological: autologous muscle cell injection

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Center
• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Wm Beaumont Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 1; Transurethral dose escalation	Biological: autologous muscle cell injection; Injection of autologous muscle cells
Other: 2; Periurethral dose escalation	Biological: autologous muscle cell injection; Injection of autologous muscle 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
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

Collaborators and Investigators

• Sponsor: Cook MyoSite
• Investigators: Principal Investigator: Kenneth Peters, MD, William Beaumont Hospitals

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): October 9, 2008
• Primary Completion (Actual): November 2, 2011
• Study Completion (Actual): November 2, 2011

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimated): February 19, 2009

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: 08-006; IND1