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The Autologous Cell Therapy for Female SUI study is a clinical trial to determine the safety and potential effectiveness of a single dose of 200 million Cook MyoSite Autologous Muscle Derived Cells for treatment of Stress Urinary Incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Muscle Derived Cells | Biological | Urethral injection of autologous muscle-derived 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, approximately 6 weeks |
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesley K. Carr, MD | Sunnybrook Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N2T9 | Canada | ||
| Sunnybrook Health Sciences 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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| ID | Title | Description |
|---|---|---|
| FG000 | Autologous Muscle-Derived Cells (AMDC) | Intrasphincteric injection of 200 million AMDC for treatment of SUI in women |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Autologous Muscle-Derived Cells (AMDC) | Intrasphincteric injection of 200 million AMDC for treatment of 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 |
| 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. | One patient experienced procedural dizziness. | Posted | Number | participants | at biopsy or between biopsy and treatment, approximately 6 weeks | Biopsies | Biopsies |
|
12 months
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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 | Autologous Muscle-Derived Cells (AMDC) | Intrasphincteric injection of 200 million AMDC for treatment of SUI in women |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment | Patient fractured the proximal end of fibula when fell horse-riding, which required medical intervention and resulted in persistent or significant disability or incapacity. It was adjudicated as not related to study procedures or AMDC treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| After AMDC treatment: Abdominal pain lower | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Scott Snyder, PhD, Director of Clinical Science and Biostatistics | Cook Medical | 765-463-7537 | ssnyder@medinst.com |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 12 months |
| Toronto |
| Ontario |
| M4N 3 M5 |
| Canada |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Biopsies |
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| 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. | Posted | Number | participants | 30 days |
|
|
|
| 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 | events | 30 days |
|
|
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| Primary | Number of Participants That Experienced AMDC Product-related 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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| 1 |
| 16 |
| 12 |
| 16 |
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| After AMDC treatment: Generalised oedema | General disorders | MedDRA 15.0 | Systematic Assessment |
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| After biopsy, before AMDC: Procedural dizziness | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Blood creatinine increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Blood urea increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Blood urine | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Hemoglobin decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Platelet count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Protein urine present | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Residual urine volume increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: White blood cell count increase | Investigations | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Micturition urgency | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| After biopsy, before AMDC: Urethral dilatation | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment | Urethra dilated immediately proceding the injection procedure to allow passage of the needle into the urethra. |
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| After AMDC treatment: Urinary retention | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Urinary tract infection | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Menorrhagia | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Menstruation irregular | Reproductive system and breast disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Influenza | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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| After AMDC treatment: Ophthalmologic treatment | Surgical and medical procedures | MedDRA 15.0 | Systematic Assessment |
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| 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 |
| Title | Measurements |
|---|---|
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| Urinary tract infection |
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