Cell Therapy, Stress Urinary Incontinence
Conditions
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.
Interventions
BIOLOGICALautologous muscle cell injection
Injection of autologous muscle cells
Sponsors
Cook MyoSite
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Experienced Biopsy Procedure-related Adverse Events | 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 | 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 | 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 | 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 | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
66 participants were biopsied, 64 participants received injections.
Participants by arm
| Arm | Count |
|---|---|
| Patients Treated With AMDC Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. | 64 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | Patients Treated With AMDC |
|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 1 |
| Sex: Female, Male Female | 64 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 66 |
| serious Total, serious adverse events | 8 / 66 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Wound hematoma | 2 Number of events |
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Post procedural hemorrhage | 1 Number of events |
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Joint swelling | 1 Number of events |
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Feeling hot | 1 Number of events |
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Procedural dizziness | 1 Number of events |
| Patients With Biopsy | Biopsy Procedure-related Adverse Events | Hyperhidrosis | 1 Number of events |
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients With Biopsy | Injection Procedure-related Adverse Events | Dysuria | 3 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Vulvovaginal pruritis | 3 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Pelvic/abdominal pain | 2 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Hematuria | 2 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Vulvovaginal burning sensation | 1 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Sensation of foreign body | 1 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Pollakiuria | 1 Number of events |
| Patients With Biopsy | Injection Procedure-related Adverse Events | Micturition urgency | 1 Number of events |
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Biopsy | Number of Participants That Experienced AMDC Product-related Adverse Events | 0 participants |
Primary
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
Population: During the study, 66 patients underwent a total of 78 biopsies.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Biopsy | Number of Participants That Experienced Biopsy Procedure-related Adverse Events | 3 participants |
Primary
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
Population: Sixty-four patients underwent intrasphincteric injection of AMDC.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Biopsy | Number of Participants That Experienced Injection Procedure-related Adverse Events | 8 participants |