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Autologous Cell Therapy for Female Stress Urinary Incontinence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT01008943
First received: November 5, 2009
Last updated: November 2, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention Phase
Stress Urinary Incontinence
Biological: Autologous Muscle Derived Cells
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Canadian Prospective Nonrandomized Study of Autologous Cell Therapy for Female Stress Urinary Incontinence

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Number of Participants That Experienced Biopsy Procedure-related Adverse Events [ Time Frame: at biopsy or between biopsy and treatment, approximately 6 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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.

  • Injection Procedure-related Adverse Events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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 Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 16
Study Start Date: July 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Biological: Autologous Muscle Derived Cells
Urethral injection of autologous muscle-derived cells

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01008943

Locations
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N2T9
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3 M5
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Lesley K. Carr, MD Sunnybrook Health Sciences Center
  More Information

Additional Information:
Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT01008943     History of Changes
Other Study ID Numbers: 09-013 
Study First Received: November 5, 2009
Results First Received: October 1, 2015
Last Updated: November 2, 2015
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016