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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00847535
First Posted: February 19, 2009
Last Update Posted: August 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook MyoSite )
  Purpose
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.

Condition Intervention Phase
Stress Urinary Incontinence Cell Therapy Biological: autologous muscle cell injection Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.

Resource links provided by NLM:


Further study details as provided by Cook Group Incorporated ( Cook MyoSite ):

Primary Outcome Measures:
  • Number of Participants That Experienced Biopsy Procedure-related Adverse Events [ Time Frame: 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.


  • Biopsy Procedure-related Adverse Events [ Time Frame: 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 [ Time Frame: 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.


  • Injection Procedure-related Adverse Events [ Time Frame: 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 [ Time Frame: 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.



Enrollment: 66
Study Start Date: September 2008
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Transurethral dose escalation
Biological: autologous muscle cell injection
Injection of autologous muscle cells
2
Periurethral dose escalation
Biological: autologous muscle cell injection
Injection of autologous muscle cells

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847535


Locations
United States, Michigan
Wm Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Canada, Ontario
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Cook MyoSite
Investigators
Principal Investigator: Kenneth Peters, MD William Beaumont Hospitals
  More Information

Additional Information:
Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT00847535     History of Changes
Other Study ID Numbers: 08-006
IND1
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: November 12, 2013
Results First Posted: January 1, 2014
Last Update Posted: August 10, 2015
Last Verified: July 2015

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