Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02869061
Status:
UNKNOWN
Last Update Posted:
2016-08-16
First Post:
2016-08-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001748', 'term': 'Urinary Bladder Neck Obstruction'}, {'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D014524', 'term': 'Urethral Obstruction'}, {'id': 'D014522', 'term': 'Urethral Diseases'}, {'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': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015187', 'term': 'Lipectomy'}], 'ancestors': [{'id': 'D003357', 'term': 'Cosmetic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D050110', 'term': 'Bariatric Surgery'}, {'id': 'D049088', 'term': 'Bariatrics'}, {'id': 'D000073319', 'term': 'Obesity Management'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-11', 'studyFirstSubmitDate': '2016-08-08', 'studyFirstSubmitQcDate': '2016-08-11', 'lastUpdatePostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serious adverse events', 'timeFrame': '4 weeks after injection of ADRC suspension', 'description': 'Frequency, type and severity of serious adverse events (SAE)'}, {'measure': 'Serious adverse reactions', 'timeFrame': 'Time Frame: 4 weeks after injection of ADRC suspension', 'description': 'Frequency, type and severity of serious adverse reactions (SAR)'}], 'secondaryOutcomes': [{'measure': 'Changes of the volume of residual urine', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Influence of the procedure on the volume of residual urine assessed by ultrasonography'}, {'measure': 'Urodynamic changes - 1', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Influence of the intervention on urinary flow rate: maximum flow rate'}, {'measure': 'Urodynamic changes - 2', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Influence of the intervention on urinary flow rate: average flow rate'}, {'measure': 'Urodynamic changes - 3', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Influence of the intervention on urinary flow rate: total volume voided'}, {'measure': 'Urodynamic changes - 4', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Influence of the intervention on urinary flow rate: maximum flow time'}, {'measure': 'Quality of life monitoring - 1', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Quality of life estimated by validated questionnaire: the Short Form (SF-36).'}, {'measure': 'Quality of life monitoring - 2', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Quality of life estimated by validated questionnaire: International Prostatic Symptom Score (IPSS).'}, {'measure': 'Bladder neck restenosis control', 'timeFrame': 'Follow up to completion (48 weeks after intervention)', 'description': 'Revision of bladder neck structure by retrograde urethrography'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bladder neck obstruction', 'Bladder outlet obstruction', 'Benign prostatic hyperplasia', 'Urinary bladder neck obstruction', 'Bladder neck contracture', 'Bladder neck stricture', 'Bladder neck stenosis', 'Transurethral resection of the prostate', 'Prostatectomy', 'Stromal vascular fraction (SVF)', 'Adipose-derived regenerative cells (ADRC)', 'Adipose tissue', 'Stem cells'], 'conditions': ['Bladder Neck Obstruction', 'Bladder Outlet Obstruction', 'Benign Prostatic Hyperplasia', 'Urinary Bladder Neck Obstruction']}, 'descriptionModule': {'briefSummary': "Autologous adipose-derived regenerative cells (ADRC) will be extracted from lipoaspirate by enzymatic digestion from a portion of the fat harvested from the patient's front abdominal wall. Transurethral bladder neck resection followed by the injection of ADRCs suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.", 'detailedDescription': "Fat tissue obtainment:\n\nSubjects will undergo liposuction under local anesthesia. In this procedure, Ringer's solution with the anesthetic lidocaine and vasoconstrictor adrenaline infused into the adipose compartment to minimize blood loss and contamination of the tissue by peripheral blood cells. 15 minutes later a hollow blunt-tipped 3 mm cannula introduced into the subcutaneous space through small (0.5 cm) incision. The cannula attached to syringe and under gentle suction moved through the adipose compartment, mechanically disrupting the fat tissue. Aspirate volume - approximately 150-200 cc. Procedure time - 30 minutes.\n\nADRC isolation:\n\nHarvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 9.5 ml of normal saline.Obtained ADRC divided into 2 portions. First portion (0.5 mL) used for counting, viability and sterility assessment. The second portion (9 ml) placed into sterile syringe for injection.\n\nSurgery:\n\nTransurethral endoscopic loop resection of bladder neck will be performed.\n\nAutologous ADRC administration:\n\nInjection of ADRC suspension will be performed immediately after bladder neck resection. 9 to 18 injections (0.5 to 1.0 mL each) will be injected with endoscopic needle into the bladder neck close to the site of resection. All injections will be performed during single procedure."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Bladder neck contracture after transurethral prostate resection.\n* Obstructive pattern of urine flow rate with maximum flow rate below 15 mL/s\n* Patient is familiar with Participant information sheet\n* Patient signed informed consent form\n\nNon-inclusion Criteria:\n\n* Contraindications for spinal, epidural or inhalation anesthesia\n* Urethral strictures\n* Genitourinary inflammatory diseases\n* Prostate-specific antigen (PSA) level above 4 ng/mL\n* Contraindications for local anesthesia or history of allergy for local anesthetics\n* Systemic glucocorticoid and/or immunosuppressant therapy\n* Any condition that might limit compliance (dementia, mental disorders, narcotic drug or alcohol abuse etc.)\n* Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion\n* Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy\n* Clinically significant abnormalities in results of laboratory tests\n* Patient received anticoagulants at least 12 hours prior the liposuction\n* Medical history of heterotopic ossifications\n* Patients prescribed for glycoprotein inhibitors treatment\n\nExclusion Criteria:\n\n* Patient's refusal from the further participation in trial\n* Chronic kidney disease IV- V stages (creatinine clearance \\< 30 mL/min estimated by Cockcroft-Gault formula)\n* Confirmed syphilis, HIV, hepatitis B or C infections"}, 'identificationModule': {'nctId': 'NCT02869061', 'briefTitle': 'Effectiveness and Safety of Adipose-derived Regenerative Cells for Reduction of Risk of Bladder Neck Contracture', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation'}, 'officialTitle': 'Effectiveness and Safety of Local Endoscopically-assisted Administration of Autologous Adipose-derived Regenerative Cells for Reduction of Risk of Postoperative Bladder Neck Contracture in Male Patients', 'orgStudyIdInfo': {'id': 'RU-CCH-01-02-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADRC injection', 'description': 'Subjects will be undergone liposuction under local anesthesia. Adipose-derived regenerative cells (ADRC) will be isolated from lipoaspirate by enzymatic digestion. Transurethral bladder neck resection followed by the injection of ADRC suspension will be performed. This is a single arm study with no control. All patients receive cell therapy.', 'interventionNames': ['Procedure: Liposuction', 'Procedure: Transurethral bladder neck resection.', 'Biological: ADRC', 'Other: ADRC isolation']}], 'interventions': [{'name': 'Liposuction', 'type': 'PROCEDURE', 'armGroupLabels': ['ADRC injection']}, {'name': 'Transurethral bladder neck resection.', 'type': 'PROCEDURE', 'armGroupLabels': ['ADRC injection']}, {'name': 'ADRC', 'type': 'BIOLOGICAL', 'otherNames': ['Adipose-derived regenerative cells'], 'description': 'Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.', 'armGroupLabels': ['ADRC injection']}, {'name': 'ADRC isolation', 'type': 'OTHER', 'description': 'ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in up to 9.5 ml of normal saline.', 'armGroupLabels': ['ADRC injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': 'I.M. Sechenov First Moscow State Medical University', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '121359', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Denis V Butnaru, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University'}, {'name': 'Andrey A Pulin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation'}, {'name': 'Andrey Z Vinarov, MD, PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'I.M. Sechenov First Moscow State Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}