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CompletedNCT00847535Updated Sep 8, 2023Results posted

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

A Phase 2 interventional study of autologous muscle cell injection in Stress Urinary Incontinence and Cell Therapy, sponsored by Cook MyoSite. Completed at 3 sites in 2 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-08.

Sponsored by Cook MyoSite · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2008, registered Feb 2009).
Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Stress Urinary Incontinence
  • Cell Therapy
03

In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 66 is close to the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Cook MyoSite is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Other
    1

    Transurethral dose escalation

    Biological: autologous muscle cell injection

  • Other
    2

    Periurethral dose escalation

    Biological: autologous muscle cell injection

Interventions

  • Biologicalautologous muscle cell injection

    Injection of autologous muscle cells

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at biopsy or between biopsy and treatment

  2. 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.

    Time frame: at biopsy or between biopsy and treatment

  3. 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.

    Time frame: 30 days

  4. 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.

    Time frame: 30 days

  5. 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.

    Time frame: 12 months

07

Results

Posted Jan 1, 2014

Participant flow

Participant flow — Overall Study
MilestonePart I: Transurethral InjectionPart I: Periurethral InjectionPart II: Transurethral Injection
Started242416
10 million amdc880
50 million amdc880
100 million amdc888
200 million amdc008
Completed222215
Not completed221
Withdrew: Withdrawal by subject211
Withdrew: Lost to follow-up010

Outcome measures

PrimaryNumber 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.

Time frame:
at biopsy or between biopsy and treatment
Reported as:
Number · participants
Number of Participants That Experienced Biopsy Procedure-related Adverse Events
participantsPatients With Biopsy
Number of Participants That Experienced Biopsy Procedure-related Adverse Events3
PrimaryBiopsy 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.

Time frame:
at biopsy or between biopsy and treatment
Reported as:
Number · Number of events
Biopsy Procedure-related Adverse Events
Number of eventsPatients With Biopsy
Wound hematoma2
Post procedural hemorrhage1
Joint swelling1
Feeling hot1
Procedural dizziness1
Hyperhidrosis1
PrimaryNumber 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.

Time frame:
30 days
Reported as:
Number · participants
Number of Participants That Experienced Injection Procedure-related Adverse Events
participantsPatients Treated With AMDC
Number of Participants That Experienced Injection Procedure-related Adverse Events8
PrimaryInjection 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.

Time frame:
30 days
Reported as:
Number · Number of events
Injection Procedure-related Adverse Events
Number of eventsPatients Treated With AMDC
Dysuria3
Vulvovaginal pruritis3
Pelvic/abdominal pain2
Hematuria2
Vulvovaginal burning sensation1
Sensation of foreign body1
Pollakiuria1
Micturition urgency1
PrimaryNumber 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.

Time frame:
12 months
Reported as:
Number · participants
Number of Participants That Experienced AMDC Product-related Adverse Events
participantsPatients Treated With AMDC
Number of Participants That Experienced AMDC Product-related Adverse Events0

Adverse events

Collected over Biopsy to treatment, 12 months Post-treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patients—8/66 (12.1%)18/66 (27.3%)
Most frequent serious events
Most frequent serious events
EventPatients
Post-treatment: Angina unstableCardiac disorders1/64
Post-treatment: Cardiac failure congestiveCardiac disorders1/64
Post-treatment: Enterocolitis infectiousGastrointestinal disorders1/64
Post-treatment: Intervertebral disc operationSurgical and medical procedures1/64
Post-treatment: Intervertebral disc protrusionMusculoskeletal and connective tissue disorders1/64
Post-treatment: Myocardial infarctionCardiac disorders1/64
Post-treatment: Small intestinal obstructionGastrointestinal disorders1/64
Biopsy to treatment: Drug hypersensitiviyImmune system disorders1/66
Biopsy to treatment: Femoral neck fractureMusculoskeletal and connective tissue disorders1/66
Most frequent other events
Most frequent other events
EventPatients
Post-treatment: DysuriaRenal and urinary disorders5/64
Post-treatment: Urinary tract infectionRenal and urinary disorders5/64
Post-treatment: BronchitisRespiratory, thoracic and mediastinal disorders4/64
Post-treatment: PollakiuriaRenal and urinary disorders4/64
Biopsy to treatment: Urinary tract infectionRenal and urinary disorders4/66

Baseline characteristics

Age, Continuous
Age, Continuous(years)Patients Treated With AMDC
Mean54 ± 1
Sex: Female, Male
Sex: Female, Male(Participants)Patients Treated With AMDC
Female64
Male0
08

Study locations

3 sites
  • Wm Beaumont Hospital
    Royal Oak, Michigan 48073, United States
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
  • Sunnybrook Health Sciences Center
    Toronto, Ontario M4N 3M5, Canada
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00847535
Lead sponsor
Cook MyoSite
Responsible party
Sponsor
First posted
Feb 19, 2009
Start date
Oct 9, 2008
Primary completion
Nov 2, 2011
Completion
Nov 2, 2011
Results posted
Jan 1, 2014
Last update
Sep 8, 2023

Study contacts

Kenneth Peters, MD
principal investigator · William Beaumont Hospitals
View the source record on ClinicalTrials.gov ↗

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