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| ID | Type | Description | Link |
|---|---|---|---|
| IND1 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Transurethral dose escalation |
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| 2 | Other | Periurethral dose escalation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous muscle cell injection | Biological | Injection of autologous muscle cells |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wm Beaumont Hospital | Royal Oak | Michigan | 48073 | United States | ||
| Vanderbilt University Medical Center |
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| Label | URL |
|---|---|
| Autologous muscle derived cells for treatment of stress urinary incontinence in women | View source |
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66 participants were biopsied, 64 participants received injections.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I: Transurethral Injection | Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| Sunnybrook Health Sciences Center | Toronto | Ontario | M4N 3M5 | Canada |
| Part I: Periurethral Injection |
Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC. |
| FG002 | Part II: Transurethral Injection | Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC. |
| 10 Million AMDC |
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| 50 Million AMDC |
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| 100 Million AMDC |
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| 200 Million AMDC |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients Treated With AMDC | Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | During the study, 66 patients underwent a total of 78 biopsies. | Posted | Number | participants | at biopsy or between biopsy and treatment |
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| ||||||||||||||||||||||||||
| 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. | Posted | Number | Number of events | at biopsy or between biopsy and treatment |
|
| ||||||||||||||||||||||||||||
| 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. | Sixty-four patients underwent intrasphincteric injection of AMDC. | Posted | Number | participants | 30 days |
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| 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. | Posted | Number | Number of events | 30 days |
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| 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. | Posted | Number | participants | 12 months |
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Biopsy to treatment, 12 months Post-treatment
During the study, 66 patients underwent a total of 78 biopsies, and 64 patients underwent intrasphincteric injection of AMDC.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients | Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women | 8 | 66 | 18 | 66 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biopsy to treatment: Drug hypersensitiviy | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
| |
| Biopsy to treatment: Femoral neck fracture | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Angina unstable | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Cardiac failure congestive | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Enterocolitis infectious | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Intervertebral disc operation | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Myocardial infarction | Cardiac disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Small intestinal obstruction | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biopsy to treatment: Urinary tract infection | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Post-treatment: Urinary tract infection | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Jankowski, PhD | Cook MyoSite, Inc. | 412-963-7380 | Ron.Jankowski@CookMyosite.com |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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