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To study the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) for patients that have undergone prior prostate surgery.
This preliminary, prospective, single-arm clinical study will evaluate the safety and potential efficacy of Autologous Muscle Derived Cells for Urinary Sphincter Repair (AMDC-USR) for the treatment of male stress urinary incontinence (SUI) that develops following prostate surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMDC-USR | Experimental | Cell treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| autologous muscle-derived cells (AMDC) | Biological | Cell treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery. | 24 months |
| Volume of Post-void Residual (PVR) Urine | Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction. | 1, 3, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Beaumont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami School of Medicine | Miami | Florida | 33136 | United States | ||
| Emory University Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | AMDC-USR | Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 17, 2015 |
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| 1, 3, 6, and 12 months |
| Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. | 1, 3, 6, and 12 months |
| Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL. | 1, 3, 6, and 12 months |
| Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity. | Baseline, 1, 3, 6, and 12 months |
| Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms. | Baseline, 1, 3, 6, and 12 months |
| Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit. | 1, 3, 6, and 12 months |
| Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 1-Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, and 7-Very much worse. Percentages of participants in each category were determined at each visit. | 1, 3, 6, and 12 months |
| Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms. | Baseline, 1, 3, 6, and 12 months |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| McKay Urology | Charlotte | North Carolina | 28207 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Muscle Biopsy |
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| AMDC Injection |
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| 1-Month Follow Up |
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| 3-Month Follow Up |
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| 6-Month Follow Up |
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| 12-Month Follow Up |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AMDC-USR | Single intraurethral injection of 150 x 10^6 autologous muscle-derived cells (AMDCs). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
| ||||||||||||||||||||||
| Age, Customized | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| |||||||||||||||||||||||
| Urinary Incontinence Type | Count of Participants | Participants |
| |||||||||||||||||||||||
| 24-hour Pad Test Weight | A test in which the participant wears specific absorbent pads dispensed by the clinic. The pads are weighed to record the pre-test weight prior to dispensing to the participant. The participant must wear the absorbent pads for 24 hours. The participant returns the used absorbent pads to the clinic, and the clinic records the post-test weight to determine urinary leakage for the 24 hour period. The difference in weights represent the amount of urine leaked. | Median | Full Range | grams |
| |||||||||||||||||||||
| Incontinence Quality of Life (I-QOL) | The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to 100, with higher scores indicating a better QOL. | Median | Full Range | scores on scales |
| |||||||||||||||||||||
| International Consultation on Incontinence Questionnaire (ICIQ) | The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity. | Median | Full Range | scores on scales |
| |||||||||||||||||||||
| International Prostate Symptom Score (IPSS) | The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms. | Median | Full Range | scores on scales |
| |||||||||||||||||||||
| International Index of Erectile Function (IIEF) | The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction (ED). Scored from 5 to 25, with lower scores indicating less ED symptoms. | Median | Full Range | scores on scales |
| |||||||||||||||||||||
| Patient Global Impression of Severity (PGI-S) Questionnaire | The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. | Count of Participants | Participants |
|
| 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 | Rate of Product-related, Biopsy Procedure-related, and Injection Procedure-related Adverse Events | Safety of AMDC-USR following treatment of SUI in male patients who have undergone prior prostate surgery was determined by the frequency and severity of adverse events related to study procedures and study product through 24 months following treatment of SUI in male patients who have undergone prior prostate surgery. | All subjects enrolled (biopsied) | Posted | Number | events | 24 months |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Volume of Post-void Residual (PVR) Urine | Post void residual volume (PVR) was assessed through 12 months post-treatment to monitor potential retention or obstruction. | All subjects injected | Posted | Median | Full Range | millileters | 1, 3, 6, and 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Amount of Urine Leakage (Median 24 Hour Pad Weight) | Change in the amount of urine leakage from baseline was assessed by 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. | All subjects injected | Posted | Median | Full Range | grams | 1, 3, 6, and 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With a Change From Baseline in Amount of Urine Leakage (Categorial ≥50% Reduction in 24-hour Pad Weight) | Change in the amount of urine leakage from baseline was assessed by a 24-hour pad test at 1, 3, 6, and 12 months post-treatment. Amount of urine leakage experienced by subject at home during a 24-hour period; all pads used during test period are weighed before and after use and differences in weights represent the amount of urine leaked. | All subjects injected | Posted | Count of Participants | Participants | 1, 3, 6, and 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Patient-reported Quality of Life (QOL) - Incontinence Quality of Life (I-QOL) Questionnaire | Median change from baseline in patient-reported quality of life (QOL) was assessed by the Incontinence Quality of Life (I-QOL) questionnaire at 1, 3, 6 and 12 months post-treatment. The I-QOL questionnaire was a validated, 22-item tool used to assess QOL of participants with urinary incontinence. Scored 0 to100, with higher scores indicating a better QOL. | All subjects injected | Posted | Median | Full Range | points | 1, 3, 6, and 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Patient-reported Symptom Severity- International Consultation on Incontinence Questionnaire (ICIQ) | Median change from baseline in patient-reported symptom severity was assessed by the International Consultation on Incontinence Questionnaire (ICIQ) questionnaire at 1, 3, 6, and 12 months post-treatment. The ICIQ questionnaire was a validated 4-item tool used to assess symptom severity of participants with urinary incontinence. Scored 0 to 21, with lower scores indicating a better symptom severity. | All subjects injected | Posted | Median | Full Range | scores on a scale | Baseline, 1, 3, 6, and 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Median Change in Patient-reported Incontinence Symptom Severity - International Prostate Symptom Score (I-PSS) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the International Prostate Symptom Score (I-PSS) questionnaire. The I-PSS was a validated questionnaire used to assess the severity of three urine storage symptoms (frequency, nocturia, urgency), four voiding symptoms (feeling of incomplete emptying, intermittency, straining, and a weak stream) and the degree of bother associated with those symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms, and 20 to 35 indicates severe symptoms. | All subjects injected | Posted | Median | Full Range | scores on a scale | Baseline, 1, 3, 6, and 12 months |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Severity (PGI-S) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Severity (PGI-S) questionnaire. The PGI-S was a global assessment of symptom severity compared with severity before treatment started. Ratings that could be selected were: 1-normal, 2-mild, 3-moderate, and 4-severe. Percentages of participants in each category were determined at each visit. | All subjects injected | Posted | Count of Participants | Participants | 1, 3, 6, and 12 months |
|
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| Secondary | Distribution of Patient-reported Incontinence Symptom Severity Scores - Patient Global Impression of Improvement (PGI-I) Questionnaire | Patient-reported incontinence symptom severity was assessed by questionnaires at 1, 3, 6, and 12 months post-treatment using the Patient Global Impression of Improvement (PGI-I) questionnaire. The PGI-I was a global assessment of symptom severity in which participants selected the following ratings: 1-Very much better, 2-Much better, 3-A little better, 4-No change, 5-A little worse, 6-Much worse, and 7-Very much worse. Percentages of participants in each category were determined at each visit. | All subjects injected | Posted | Count of Participants | Participants | 1, 3, 6, and 12 months |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Median Change From Baseline in Patient-reported Erectile Dysfunction (ED) - Index of Erectile Function (IIEF-5) Questionnaire | SUI and ED can be comorbidities that develop following prostate surgery; median change from baseline in patient-reported Erectile Dysfunction (ED) was assessed by the 5-Item International Index of Erectile Function (IIEF-5). The IIEF-5 questionnaire was a validated 5-item tool used to assess to presence and severity of erectile dysfunction. Scored from 5 to 25, with lower scores indicating less ED symptoms. | All subjects injected | Posted | Median | Full Range | scores on a scale | Baseline, 1, 3, 6, and 12 months |
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Adverse events were monitored from enrollment through study exit - 24 months total.
All adverse events were collected at baseline, 1 month, 3 months, 6 months, 12 months, and 24 months post-treatment. Any adverse events occurring in ≥ 5% of participants are reported. Adverse events assessed as AMDC product-related or biopsy procedure-related were reported regardless of frequency threshold. No injection procedure-related adverse events were reported.
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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 | AMDC-USR | Single intraurethral injection of 150 x 10^6 Autologous Muscle-Derived Cells (AMDCs) | 0 | 25 | 4 | 25 | 9 | 25 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 15.0 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Micturition urgency | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment | Study Product-Related Adverse Event |
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| Pollakiuria | Renal and urinary disorders | MedDRA version 15.0 | Systematic Assessment | Study Product-Related Adverse Event |
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| Post procedural contusion | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency |
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| Post procedural swelling | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Procedural nausea | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event, AEs with ≥5% Frequency |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 15.0 | Systematic Assessment | 1 Event Biopsy Procedure-Related Adverse Event, 1 Event Not Related to Study Product or Procedures, AEs with ≥5% Frequency |
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| Hypoaesthesia | Nervous system disorders | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA version 15.0 | Systematic Assessment | Biopsy Procedure-Related Adverse Event |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA version 15.0 | Systematic Assessment | AEs Not Related to Study Product or Procedures with ≥5% Frequency |
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| Sinusitis | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | AEs Not Related to Study Product or Procedures with ≥5% Frequency |
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| Fall | Injury, poisoning and procedural complications | MedDRA version 15.0 | Systematic Assessment | AEs Not Related to Study Product or Procedures with ≥5% Frequency |
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| Laceration | Infections and infestations | MedDRA version 15.0 | Systematic Assessment | AEs Not Related to Study Product or Procedures with ≥5% Frequency |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ron Jankowski, PhD | Cook MyoSite Incorporated | 412-963-7380 | Ron.Jankowski@CookMyosite.com |
| Aug 26, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Mixed Urinary Incontinence, Urge Predominant |
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| Moderate |
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| Severe |
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| Title | Measurements |
|---|---|
|
| Biopsy procedure-related adverse events |
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| Title | Denominators | Categories |
|---|
| Post void residual volume 1 month |
| |||||
| Post void residual volume 3 months |
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| Post void residual volume 6 months |
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| Post void residual volume 12 months |
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| No change |
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| A little worse |
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| No change |
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| A little worse |
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| No change |
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| A little worse |
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