Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-27 @ 6:51 PM
Study NCT ID:
NCT01585857
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ADIPOA - Clinical Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-04-24', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recording of Serious Adverse Events', 'timeFrame': 'during 365 days following injection', 'description': 'Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.'}], 'secondaryOutcomes': [{'measure': 'Functional status of the knee', 'timeFrame': 'during 365 days following injection', 'description': 'Efficacy will be assessed by measuring:\n\n* WOMAC (Western Ontario and McMaster Universities osteoarthritis index),\n* Short Arthritis assessment Scale (SAS),\n* range of motion of the target knee joint,\n* imaging through MRI evaluation, dGEMRIC and T1rho MRI.'}, {'measure': 'Evaluation of Quality of life', 'timeFrame': 'during 365 days following injection', 'description': 'Quality of life will be assessed by measuring:\n\n* pain-specific assessment\n* global patient assessment (visual analog scale, Short-Form 8)\n* decrease in rescue paracetamol medication.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Osteoarthritis']}, 'referencesModule': {'references': [{'pmid': '27217345', 'type': 'DERIVED', 'citation': 'Pers YM, Rackwitz L, Ferreira R, Pullig O, Delfour C, Barry F, Sensebe L, Casteilla L, Fleury S, Bourin P, Noel D, Canovas F, Cyteval C, Lisignoli G, Schrauth J, Haddad D, Domergue S, Noeth U, Jorgensen C; ADIPOA Consortium. Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation Trial. Stem Cells Transl Med. 2016 Jul;5(7):847-56. doi: 10.5966/sctm.2015-0245. Epub 2016 May 23.'}]}, 'descriptionModule': {'briefSummary': 'Primary:\n\nTo study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA).\n\nSecondary:\n\nTo study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* OA diagnosis should fulfil the criteria of the American College of Rheumatology (ACR) with moderate or severe medial and/ or external femorotibial knee osteoarthritis (OA) (stage 3 or 4) and indication total knee arthroplasty.\n\nExclusion Criteria:\n\n* Any disease or medication affecting the bone or cartilage metabolism, including corticoids.'}, 'identificationModule': {'nctId': 'NCT01585857', 'briefTitle': 'ADIPOA - Clinical Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'A Phase I, Prospective, Bi-centric,Single -Arm, Open-label, Dose-escalating Clinical Trial to Evaluate the Safety of a Single Injection of Autologous Adipose Derived Mesenchymal Stromal Cells in the Treatment of Severe Osteoarthritis of the Knee Joint', 'orgStudyIdInfo': {'id': '8606'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '2 x 10E6 ASC intra-articular injection (5 ml)', 'interventionNames': ['Biological: Autologous adipose derived stem cells administrated for intra-articular use']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '10 x 10E6 ASC intra-articular injection (5 ml)', 'interventionNames': ['Biological: Autologous adipose derived stem cells administrated for intra-articular use']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': '50 x 10E6 ASC intra-articular injection (5 ml)', 'interventionNames': ['Biological: Autologous adipose derived stem cells administrated for intra-articular use']}], 'interventions': [{'name': 'Autologous adipose derived stem cells administrated for intra-articular use', 'type': 'BIOLOGICAL', 'description': 'Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.', 'armGroupLabels': ['Group 2', 'Group 3']}, {'name': 'Autologous adipose derived stem cells administrated for intra-articular use', 'type': 'BIOLOGICAL', 'description': 'Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '97074', 'city': 'Würzburg', 'country': 'Germany', 'facility': 'Orthopädische Klinik', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Christian Jorgensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}