Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-03-07 @ 10:56 PM
Study NCT ID:
NCT02061995
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2014-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D058866', 'term': 'Osteoporotic Fractures'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, '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': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-22', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-12', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cell biodistribution after intravenous infusion as assessed by SPECT/CT scan', 'timeFrame': '72 hours'}, {'measure': 'Potential occurrence of any AE or SAE, related to the product, using patient open non-directive questionnaire, physical examination and laboratory measurements', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Pain measured by the Visual Analogue Scale', 'timeFrame': '12 months'}, {'measure': 'Well-being score using SF-36 questionnaire', 'timeFrame': '12 months'}, {'measure': 'Occurrence of new vertebral fractures as assessed by X-ray', 'timeFrame': '12 months'}, {'measure': 'Bone mineral density evolution as assessed by Dual-energy X-ray absorptiometry (DEXA)', 'timeFrame': '12 months'}, {'measure': 'Measurement of bone formation and resorption markers', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bone Diseases', 'Metabolic Bone Diseases', 'Osteoporosis', 'Bone Fractures', 'Osteoporotic Fractures', 'Musculoskeletal Diseases'], 'conditions': ['Severe Osteoporosis']}, 'descriptionModule': {'briefSummary': 'Osteoporosis is a systemic skeletal disease characterized by low bone mass and microarchitectural deterioration of bone tissue, with a subsequent increase in bone fragility and susceptibility to fracture.\n\nOsteoporosis is one of the most common and debilitating chronic diseases, and a global health concern with a high prevalence not only in Western countries, but also in Asia and Latin America. Most efficacious anti-osteoporotic treatments either inhibit bone resorption like bisphosphonates or denosumab or increase bone formation like teripartide an anabolic agent. Anti-osteoporotic drugs have demonstrated safety and efficacy with an increase in bone mass and a decrease of fracture risk (at the hip) by 30 to 50% after 3 years of treatment (Black et al., 1996; Neer et al., 2001; Meunier et al., 2004). Despite the availability of pharmacological treatments, osteoporosis remains a significant health problem for patients who do not respond to the available treatments or fail to comply with their regimens.\n\nThe present phase 2a study aims to demonstrate the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of osteoporotic patients who do not respond to pharmacological treatments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of severe osteoporosis\n* Non-response to anti-osteoporotic treatment for over 2 years\n* Normal hematology function\n* Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements\n\nExclusion Criteria:\n\n* Positive serology for hepatitis B, hepatitis C, HIV, syphilis, HTLV-1\n* Current or past medical disease that could interfere with the evaluation of the efficacy, as judged by the investigator\n* Severe renal or hepatic impairment'}, 'identificationModule': {'nctId': 'NCT02061995', 'briefTitle': 'Phase 2a Study on Intravenous Infusion of Autologous Osteoblastic Cells in Severe Osteoporosis', 'organization': {'class': 'OTHER', 'fullName': 'Erasme University Hospital'}, 'officialTitle': 'Treatment of Severe Osteoporosis by Intravenous Infusion of Pre-osteoblastic Cells - An Open Pilot Study', 'orgStudyIdInfo': {'id': 'PREOB-OP1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PREOB® Intravenous Infusion', 'interventionNames': ['Drug: PREOB® Intravenous Infusion']}], 'interventions': [{'name': 'PREOB® Intravenous Infusion', 'type': 'DRUG', 'description': 'Each patient will undergo a single intravenous administration of PREOB®.', 'armGroupLabels': ['PREOB® Intravenous Infusion']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Anderlecht', 'country': 'Belgium', 'facility': 'Investigating site BE01', 'geoPoint': {'lat': 50.83619, 'lon': 4.31454}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasme University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}