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:
Information provided by (Responsible Party):
Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier:
NCT00847535
First received: February 18, 2009
Last updated: July 21, 2014
Last verified: July 2014
  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: 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:

Primary Outcome Measures:
  • Number of Participants That Experienced Biopsy Procedure-related Adverse Events [ Time Frame: at biopsy or between biopsy and treatment ] [ 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.


  • Biopsy Procedure-related Adverse Events [ Time Frame: at biopsy or between biopsy and treatment ] [ 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 presented 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 presented 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 ] [ 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: 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

Ages Eligible for Study:   18 Years and older
Genders 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
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: 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

No publications provided

Responsible Party: Cook ( Cook MyoSite )
ClinicalTrials.gov Identifier: NCT00847535     History of Changes
Other Study ID Numbers: 08-006, IND1
Study First Received: February 18, 2009
Results First Received: November 12, 2013
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 28, 2014