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| Name | Class |
|---|---|
| Corewell Health East | OTHER |
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Determine safety and effectiveness of the technique using autologous stem cells in the treatment of urinary incontinence in one male subject.
Autologous stem cells will be obtained from the subject by needle biopsy, sent to a lab for multiplication and after about 6 weeks time will be injected into the subjects urethra.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell treatment | Experimental | Muscle Biopsy and Injection of autologous stem cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Muscle Biopsy | Procedure | Biopsy of thigh muscle to obtain stem cell core. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Study-Related Adverse Events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible. |
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Inclusion Criteria:
Exclusion Criteria:
- does not meet inclusion criteria, gender and age limit
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth M Peters, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital - Royal Oak | Royal Oak | Michigan | 48073 | United States | ||
| William Beaumont Hospital |
Data will not be shared
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| ID | Title | Description |
|---|---|---|
| FG000 | Stem Cell Treatment | Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Stem Cell Treatment | Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. |
| 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 |
| 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 | Study-Related Adverse Events | Posted | Number | Adverse Events | 6 months |
|
|
6 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 | Stem Cell Treatment | Muscle Biopsy and Injection of autologous stem cells Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. |
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This is a single patient compassionate use treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenneth Peters MD | Beaumont Hospital - Royal Oak | 248-551-0387 | Kenneth.Peters@Beaumont.org |
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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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| Injection of autologous stem cells |
| Biological |
After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra. |
|
| Baseline and 6 months |
| Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA) | The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse. | 6 months |
| Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I) | The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 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. | 6 months |
| Royal Oak |
| Michigan |
| 48073 |
| United States |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Assessment of Severity (PGI-S) Questionnaire | The PGI-S is comprised of two questions. Question 1 asks the patient to describe how their urinary tract condition is now. Responses are 1 Normal, 2 Mild, 3 Moderate and 4 Severe. Question 2 asks the patient "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?" Responses are 1 Delighted, 2 Pleased, 3 Mostly Satisfied, 4 Mixed, 5 Mostly Dissatisfied, 6 Unhappy and 7 Terrible. | Posted | Number | units on a scale | Baseline and 6 months |
|
|
|
| Secondary | Quality of Life (QOL) Described by the Patient's Response on the Global Response Assessment (GRA) | The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 1 Markedly Improved, 2 Moderately Improved, 3 Slightly Improved, 4 No Change, 5 Slightly Worse, 6 Moderately Worse, and 7 Markedly Worse. | Posted | Number | units on a scale | 6 months |
|
|
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| Secondary | Quality of Life (QOL) Described by the Patient's Response on the Patient Global Impression of Improvement (PGI-I) | The PGI-I is a global index used to rate the response of a condition to a therapy. The patient's response describes their current condition compared to before they were treated. Responses are: 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. | Posted | Number | units on a scale | 6 months |
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| 0 |
| 1 |
| 0 |
| 1 |
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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 |
|---|---|
|
| Question 2: 6 Months Post-Injection Score |
|