NCT00847535

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Typical duration for phase_2

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2011

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

January 1, 2014

Completed
Last Updated

September 8, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

February 18, 2009

Results QC Date

November 12, 2013

Last Update Submit

August 25, 2023

Conditions

Stress Urinary IncontinenceCell Therapy

Outcome Measures

Primary Outcomes (5)

  • 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

Study Arms (2)

1

OTHER

Transurethral dose escalation

Biological: autologous muscle cell injection

2

OTHER

Periurethral dose escalation

Biological: autologous muscle cell injection

Interventions

autologous muscle cell injectionBIOLOGICAL

Injection of autologous muscle cells

12

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wm Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Related Links

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Ron Jankowski, PhD
Organization
Cook MyoSite, Inc.
Ron.Jankowski@CookMyosite.com
412-963-7380

Study Officials

  • Kenneth Peters, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

October 9, 2008

Primary Completion

November 2, 2011

Study Completion

November 2, 2011

Last Updated

September 8, 2023

Results First Posted

January 1, 2014

Record last verified: 2023-08

Locations

US(2)CA(1)