Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-30 @ 9:49 AM
Study NCT ID:
NCT00847535
Status:
COMPLETED
Last Update Posted:
2023-09-08
First Post:
2009-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014550', 'term': 'Urinary Incontinence, Stress'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Ron.Jankowski@CookMyosite.com', 'phone': '412-963-7380', 'title': 'Ron Jankowski, PhD', 'organization': 'Cook MyoSite, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Biopsy to treatment, 12 months Post-treatment', 'description': 'During the study, 66 patients underwent a total of 78 biopsies, and 64 patients underwent intrasphincteric injection of AMDC.', 'eventGroups': [{'id': 'EG000', 'title': 'Patients', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women', 'otherNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Biopsy to treatment: Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Biopsy to treatment: Drug hypersensitiviy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Biopsy to treatment: Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Enterocolitis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Intervertebral disc operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Post-treatment: Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants That Experienced Biopsy Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Biopsy', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at biopsy or between biopsy and treatment', 'description': '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.\n\nAll biopsy procedure-related events either self-resolved or were easily treated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'During the study, 66 patients underwent a total of 78 biopsies.'}, {'type': 'PRIMARY', 'title': 'Biopsy Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With Biopsy', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'classes': [{'title': 'Wound hematoma', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Post procedural hemorrhage', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Joint swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Feeling hot', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Procedural dizziness', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Hyperhidrosis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at biopsy or between biopsy and treatment', 'description': '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.\n\nAll biopsy procedure-related events either self-resolved or were easily treated.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Experienced Injection Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With AMDC', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': '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.\n\nAll injection procedure-related events self-resolved or were easily treated.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Sixty-four patients underwent intrasphincteric injection of AMDC.'}, {'type': 'PRIMARY', 'title': 'Injection Procedure-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With AMDC', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'classes': [{'title': 'Dysuria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal pruritis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Pelvic/abdominal pain', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hematuria', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal burning sensation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sensation of foreign body', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Pollakiuria', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Micturition urgency', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days', 'description': '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.\n\nAll injection procedure-related events self-resolved or were easily treated.', 'unitOfMeasure': 'Number of events', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants That Experienced AMDC Product-related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients Treated With AMDC', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': '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.\n\nNo adverse events reported during the study were adjudicated as AMDC product-related.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part I: Transurethral Injection', 'description': '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.'}, {'id': 'FG001', 'title': 'Part I: Periurethral Injection', 'description': '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.'}, {'id': 'FG002', 'title': 'Part II: Transurethral Injection', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': '10 Million AMDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '50 Million AMDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': '100 Million AMDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': '200 Million AMDC', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '66 participants were biopsied, 64 participants received injections.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients Treated With AMDC', 'description': 'Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2011-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2009-02-18', 'resultsFirstSubmitDate': '2013-11-12', 'studyFirstSubmitQcDate': '2009-02-18', 'lastUpdatePostDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-12', 'studyFirstPostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants That Experienced Biopsy Procedure-related Adverse Events', 'timeFrame': 'at biopsy or between biopsy and treatment', 'description': '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.\n\nAll biopsy procedure-related events either self-resolved or were easily treated.'}, {'measure': 'Biopsy Procedure-related Adverse Events', 'timeFrame': 'at biopsy or between biopsy and treatment', 'description': '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.\n\nAll biopsy procedure-related events either self-resolved or were easily treated.'}, {'measure': 'Number of Participants That Experienced Injection Procedure-related Adverse Events', 'timeFrame': '30 days', 'description': '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.\n\nAll injection procedure-related events self-resolved or were easily treated.'}, {'measure': 'Injection Procedure-related Adverse Events', 'timeFrame': '30 days', 'description': '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.\n\nAll injection procedure-related events self-resolved or were easily treated.'}, {'measure': 'Number of Participants That Experienced AMDC Product-related Adverse Events', 'timeFrame': '12 months', 'description': '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.\n\nNo adverse events reported during the study were adjudicated as AMDC product-related.'}]}, 'conditionsModule': {'conditions': ['Stress Urinary Incontinence', 'Cell Therapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/24582537', 'label': 'Autologous muscle derived cells for treatment of stress urinary incontinence in women'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient has SUI with normal detrusor activity confirmed with urodynamics\n* Patient has bladder capacity \\>200 mL\n* Patient's incontinence has not shown any improvement for at least -6 months\n* Patient has failed prior treatments (e.g., behavior modification, bladder exercises, biofeedback, electrical stimulation, bulking injections, urethral suspensions and/or drug therapy)\n\nExclusion Criteria:\n\n* Patient has known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities with high pressure instability\n* Patient has a neuromuscular disorder (e.g., muscular dystrophy, multiple sclerosis)\n* Patient has uncontrolled diabetes\n* Patient is pregnant, lactating, or plans to become pregnant during the course of the study\n* 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\n* Patient has current or acute conditions involving cystitis or urethritis\n* Patient is scheduled to receive radiation treatment to the vicinity\n* Patients with a history of radiation treatment to the urethra or adjacent structures"}, 'identificationModule': {'nctId': 'NCT00847535', 'briefTitle': 'An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells as Therapy for Stress Urinary Incontinence', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook MyoSite'}, 'officialTitle': 'Muscle Cell Mediated Therapy for Stress Urinary Incontinence: An Investigation of the Safety of 4 Different Doses of Autologous Muscle Derived Cells.', 'orgStudyIdInfo': {'id': '08-006'}, 'secondaryIdInfos': [{'id': 'IND1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '1', 'description': 'Transurethral dose escalation', 'interventionNames': ['Biological: autologous muscle cell injection']}, {'type': 'OTHER', 'label': '2', 'description': 'Periurethral dose escalation', 'interventionNames': ['Biological: autologous muscle cell injection']}], 'interventions': [{'name': 'autologous muscle cell injection', 'type': 'BIOLOGICAL', 'description': 'Injection of autologous muscle cells', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48073', 'city': 'Royal Oak', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wm Beaumont Hospital', 'geoPoint': {'lat': 42.48948, 'lon': -83.14465}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Kenneth Peters, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corewell Health East'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook MyoSite', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}