Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-25 @ 4:01 PM
Study NCT ID:
NCT03369457
Status:
UNKNOWN
Last Update Posted:
2019-04-16
First Post:
2017-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Mesenchymal stromal cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-06-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-12', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2017-12-06', 'lastUpdatePostDateStruct': {'date': '2019-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of differences in Colony Forming Units (CFU) percentage', 'timeFrame': '6 months', 'description': 'Formation of CFUs will be evaluated in the three different samples (acetabular bone chips, femoral bone chis or bone marrow aspirated) and CFUs will be counted in each sample'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the osteogenic potential in the three different cell populations', 'timeFrame': '1 year', 'description': 'Evaluation of Alizarin red stain. Analysis of bone markers (RUNX2, Collagen type I, Collagen type X, Alkaline Phosphatase)'}, {'measure': 'Evaluation of the chondrogenic potential in the three different cell populations', 'timeFrame': '1 year', 'description': 'Evaluation of Alcian blue stain in pellet culture. Analysis of chondrogenic markers (Collagen type II and SOX9)'}, {'measure': 'Evaluation of the adipogenic potential in the three different cell populations', 'timeFrame': '1 year', 'description': 'Evaluation of Oil red stain. Analysis of adipogenic markers (Peroxisome proliferator-activated receptor gamma (PPAR-γ), Lipoprotein lipase (LPL))'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complications; Implant, Orthopedic']}, 'referencesModule': {'references': [{'pmid': '31191688', 'type': 'DERIVED', 'citation': 'Nguyen VT, Tessaro I, Marmotti A, Sirtori C, Peretti GM, Mangiavini L. Does the Harvesting Site Influence the Osteogenic Potential of Mesenchymal Stem Cells? Stem Cells Int. 2019 May 2;2019:9178436. doi: 10.1155/2019/9178436. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The aim of hip replacement surgery is to re-establish the physiological hip function and to obtain a stable fixation between the prosthetic components and the native bone. Commonly, the fixation is obtained by bone ingrowth between the prosthesis and the native bone. Thus, the quality of the patient's bone stock is essential to achieve this aim. However, several clinical conditions may impair the bone stock; therefore, in these cases bone grafts are necessary to improve the prosthetic fixation. The gold standard is represented by autologous bone grafts (from iliac crest or from acetabular bone chips) or allogeneic bone grafts from cadaveric femoral heads. Nevertheless, the osteogenic potential of multipotent cells derived from different anatomical regions has never been examined.\n\nThus, the aim of this study is to isolate multipotent cells from acetabular or femoral bone chips and from bone marrow aspirate of the same patient and to compare their osteogenic potential. The results of this study may reveal differences, which may have a clinical relevance for hip replacement surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '13 patients undergoing hip replacement surgery will be selected. Samples from acetabulum, proximal femur (head of the femur) and from bone marrow will be collected for each patient.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing hip replacement and affected by:\n\n 1. hip osteoarthritis\n 2. mild developmental dysplasia of the hip\n* 18 ≤ Body Mass Index (BMI) ≤ 30 kg/m2\n\nExclusion Criteria:\n\n* Rheumatoid arthritis\n* Patients under pharmacological treatment for bone metabolic disorders\n* Patient affected by metabolic disorders, which may affect bone metabolism\n* Presence of bone metastases\n* Presence of bone infections\n* Patients undergoing hip revision surgeries\n* Obesity (BMI ≥30kg/m2)'}, 'identificationModule': {'nctId': 'NCT03369457', 'acronym': 'EMPHA', 'briefTitle': 'Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions', 'organization': {'class': 'OTHER', 'fullName': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio"}, 'officialTitle': 'Analysis of the Osteogenic Potential of Multipotent Cells From Different Anatomical Regions in Hip Replacement Surgery', 'orgStudyIdInfo': {'id': 'EMPHA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Isolation of multipotent cells', 'type': 'BIOLOGICAL', 'description': "Isolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential"}]}, 'contactsLocationsModule': {'locations': [{'zip': '20161', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Laura Mangiavini', 'role': 'CONTACT'}], 'facility': 'IRCCS Istituto Ortopedico Galeazz', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}], 'centralContacts': [{'name': 'Laura Mangiavini, Dr', 'role': 'CONTACT', 'email': 'laura.mangiavini@grupposandonato.it', 'phone': '00390266214930'}], 'overallOfficials': [{'name': 'Laura Mangiavini', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto Ortopedico Galeazzi'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}