Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-06-23 @ 7:40 PM
Study NCT ID:
NCT02469792
Status:
UNKNOWN
Last Update Posted:
2017-07-21
First Post:
2015-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015187', 'term': 'Lipectomy'}, {'id': 'D001182', 'term': 'Arthroscopy'}], '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'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-19', 'studyFirstSubmitDate': '2015-06-09', 'studyFirstSubmitQcDate': '2015-06-09', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of serious adverse events (SAEs) and serious adverse reactions (SARs)', 'timeFrame': '2 weeks after treatment'}], 'secondaryOutcomes': [{'measure': 'Quality of life monitoring', 'timeFrame': 'Follow up to completion (up to 24 weeks after treatment)', 'description': 'Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)'}, {'measure': 'Knee pain intensity monitoring', 'timeFrame': 'Follow up to completion (up to 24 weeks after treatment)', 'description': 'Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)'}, {'measure': 'Changes in knee joint structures', 'timeFrame': 'Follow up to completion (up to 24 weeks after treatment)', 'description': "Changes in knee joint structure assessed by:\n\n1. X-ray (joint space width, bone contour, presence of osteophytes and sclerosis);\n2. MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments);\n3. Ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis)"}, {'measure': 'Changes in knee function', 'timeFrame': 'Follow up to completion (up to 24 weeks after treatment)', 'description': 'Changes in knee function assessed by questionnaire: Knee Society Score (KSS)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament', 'Ligament rupture', 'Intraarticular injection', 'ADRC', 'Adipose-derived regenerative cells', 'Adipose tissue', 'Stem cells'], 'conditions': ['Anterior Cruciate Ligament Partial Rupture']}, 'descriptionModule': {'briefSummary': "Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.", 'detailedDescription': 'Patients with verified diagnosis partial rupture of anterior cruciate ligament will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery)\n* Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test)\n* Patient is familiar with Participant information sheet\n* Patient signed informed consent form\n\nNon-inclusion Criteria:\n\n* Knee osteoarthritis grade III and grade IV\n* Medical history of autoimmune diseases\n* Patients prescribed for immunosuppressive treatment\n* Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics\n* Subcompensated or decompensated forms of chronic diseases of internal organs\n* Significant weight loss (\\> 10% of body weight in the previous year) of unknown etiology\n* Medical history of venous thromboembolism or estimated high risk of venous thromboembolism\n* Clinically significant abnormalities in results of laboratory tests\n* Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and 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* Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times\n* Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior lipoaspiration\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* Patient's refusal from compliance with the requirements of contraception during the participation in research\n* Chronic kidney disease IV - V stages (creatinine clearance \\< 30 mL/min estimated by Cockroft-Gault formula)\n* Confirmed syphilis, HIV, hepatitis B or C infections\n\nDropout Criteria:\n\n* Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02469792', 'briefTitle': 'Effectiveness and Safety of Autologous ADRC for Treatment of Anterior Cruciate Ligament Partial Rupture', '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 Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture', 'orgStudyIdInfo': {'id': 'RU-CCH-03-01-14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADRC injection', 'description': 'Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into anterior cruciated ligament.', 'interventionNames': ['Procedure: Liposuction', 'Device: ADRC isolation', 'Procedure: Arthroscopic surgery', 'Other: Intraarticular administration of autologous ADRC']}], 'interventions': [{'name': 'Liposuction', 'type': 'PROCEDURE', 'armGroupLabels': ['ADRC injection']}, {'name': 'ADRC isolation', 'type': 'DEVICE', 'description': "ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol", 'armGroupLabels': ['ADRC injection']}, {'name': 'Arthroscopic surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['ADRC injection']}, {'name': 'Intraarticular administration of autologous ADRC', 'type': 'OTHER', 'armGroupLabels': ['ADRC injection']}]}, 'contactsLocationsModule': {'locations': [{'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; Center for Biomedical Technologies', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Sergey V Ivannikov, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I.M. Sechenov First Moscow State Medical University'}, {'name': 'Ilya I Eremin, 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; Center for Biomedical Technologies'}]}, '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'}}}}