Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02156934
Status:
COMPLETED
Last Update Posted:
2015-12-04
First Post:
2014-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-03', 'studyFirstSubmitDate': '2014-06-02', 'studyFirstSubmitQcDate': '2014-06-03', 'lastUpdatePostDateStruct': {'date': '2015-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24hr voiding diary reduction', 'timeFrame': '1 month', 'description': 'Evaluation the 24hr voiding diary reduction by patient questionnaire 2hr pad test and cystourethroscopy and urodynamic.'}], 'secondaryOutcomes': [{'measure': 'incontinence quality of life (I-Qol)', 'timeFrame': '1month', 'description': 'Evaluation the increasing of incontinence quality of life (I-Qol) by questionnaire form.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['autologous stress urinary incontinence muscle derived cells'], 'conditions': ['Stress Urine Incontinency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://Royaninstitute.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to provide confirmation of efficacy of muscle derived stem cells (MDCs) for the treatment of SUI in women.', 'detailedDescription': 'The investigators will be assessed the 12-month potential efficacy of autologous muscle derived cells as therapy for stress urinary incontinence. A total of 20 women in whom stress urinary incontinence had not improved underwent intra-sphincter injection of low doses 50×106 of autologous muscle derived cells, which will be derived from biopsies of their deltoid muscle. Assessments will be made at 1, 3, 6 and 12 months after cell injection. Changes in stress urinary incontinence severity were evaluated by pad test, diary of incontinence episodes and quality of life surveys.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Stress Urinary Incontinence symptoms\n* Urodynamic stress incontinence confirmed with multichannel urodynamic testing\n* positive cough stress test\n* urgency score \\< stress score\n* Patient's age between 40 - 65 years\n* Desire to surgical correction of stress urinary incontinence or inadequate response to conservative treatment of SUI\n\nExclusion Criteria:\n\n* Post-void residual volume \\>100cc\n* Detrusor overactivity on preoperative multichannel urodynamic testing\n* History of previous synthetic, biologic or fascial sub-urethral sling or any other surgery on external genitalia, bladder neck, bladder or urethra\n* Desires future childbearing\n* Chronic inguinal or vulvar abscess or history of Hidradenitis Suppurative\n* History of bleeding diathesis or current anti-coagulation therapy\n* Inguinal lymphadenopathy or inguinal/vulvar mass\n* Current genitourinary fistula or urethral diverticulum\n* Current sever cystocele or rectocele\n* Active urinary infection\n* Non-treated urge incontinency or any significant voiding dysfunction\n* Neuromuscular disorders\n* Uncontrolled Diabetes\n* Reversible cause of incontinence (i.e. drug effect)\n* Contraindications for surgery"}, 'identificationModule': {'nctId': 'NCT02156934', 'briefTitle': 'Paraurethral Transplantation of Autologous Muscle Derived Stem Cells for Treatment of Stress Incontinency', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Royan Institute'}, 'officialTitle': 'Evaluation the Effect of Autologous Muscle Derived Stem Cells Injection Into the Paraurethral Tissues for Treatment of Stress Urinary Incontinency,The Randomized Clinical Trial Phase II', 'orgStudyIdInfo': {'id': 'Royan-Kidney-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Muscle derived stem cell', 'description': 'Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.', 'interventionNames': ['Biological: paraurethral injection']}], 'interventions': [{'name': 'paraurethral injection', 'type': 'BIOLOGICAL', 'description': 'Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.', 'armGroupLabels': ['Muscle derived stem cell']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Royan Institute', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Gourabi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Head of Royan Institute'}, {'name': 'Nasser Aghdami, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of Department of Regenerative Medicine & Cell therapy center of Royan Institute'}, {'name': 'Farzaneh Sharifiaghdas, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences'}, {'name': 'Farshad Zohrabi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences'}, {'name': 'Reza Moghadasali, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Regenerative Medicine And Royan Cell Therapy Center Royan Institute For stem Cell Biology and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royan Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}