Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-01 @ 9:05 PM
Study NCT ID:
NCT06662604
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-29
First Post:
2024-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007570', 'term': 'Jaw Cysts'}], 'ancestors': [{'id': 'D001845', 'term': 'Bone Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016025', 'term': 'Bone Transplantation'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-10-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-02-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2024-10-25', 'studyFirstSubmitQcDate': '2024-10-26', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cyst volume', 'timeFrame': 'preoperative and 3, 6 months postoperative.', 'description': 'volumetric analysis of cystic defect 3, 6 months after treatment .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maxillary cyst', 'bone marrow stem cells', 'platelet rich fibrin PRF', 'bone graft', 'bone reconstruction', 'jaw cyst'], 'conditions': ['Maxillary Cyst']}, 'referencesModule': {'references': [{'pmid': '37918253', 'type': 'BACKGROUND', 'citation': 'Liu M, Liu Y, Luo F. The role and mechanism of platelet-rich fibrin in alveolar bone regeneration. Biomed Pharmacother. 2023 Dec;168:115795. doi: 10.1016/j.biopha.2023.115795. Epub 2023 Nov 2.'}, {'pmid': '37277026', 'type': 'BACKGROUND', 'citation': 'Matsumura-Matsuo M, To M, Okudera T, Matsuo M. Regeneration processes of alveolar bone and microvascular changes after the application of platelet-rich fibrin. J Oral Biosci. 2023 Sep;65(3):218-225. doi: 10.1016/j.job.2023.05.004. Epub 2023 Jun 3.'}, {'pmid': '30210552', 'type': 'BACKGROUND', 'citation': 'Fitzsimmons REB, Mazurek MS, Soos A, Simmons CA. Mesenchymal Stromal/Stem Cells in Regenerative Medicine and Tissue Engineering. Stem Cells Int. 2018 Aug 19;2018:8031718. doi: 10.1155/2018/8031718. eCollection 2018.'}, {'pmid': '23129455', 'type': 'BACKGROUND', 'citation': "Manfrini M, Di Bona C, Canella A, Lucarelli E, Pellati A, D'Agostino A, Barbanti-Brodano G, Tognon M. Mesenchymal stem cells from patients to assay bone graft substitutes. J Cell Physiol. 2013 Jun;228(6):1229-37. doi: 10.1002/jcp.24276."}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/31799249/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Will the use of bone marrow stem cells with platelet rich fibrin enhance and accelerate the bone regeneration in the upper jaw cystic defects ?', 'detailedDescription': 'Reconstruction of critical size bone defect in maxillofacial surgery is a great challenge, current practice of bone reconstruction still having problems like delay in bone regeneration (up to 12 months) and bone graft failure and low availability of autogenous bone graft.\n\nlast decade stem cells therapy gained great interest, in many studies Bone marrow stem cells showed promising result in bone regeneration enhancing .\n\nPlatelet Rich Fibrin PRF also capability of enhancing bone and tissue regeneration by releasing of certain protein molecules call growth factors that initiate sequential biological events resulting in stem cells migration into the site of bone defect and differentiation to bone formation cells (osteoblast cells ).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range 18-50 years\n* Patients with a critical size maxillary cyst. (\\>3 cm)\n* Patients that free of any significant medical conditions that could affect healing or outcomes.\n\nExclusion Criteria:\n\n* Patients with large jaw cyst that endanger vital structures\n* Patients with significant medical condition\n* age under 18 years'}, 'identificationModule': {'nctId': 'NCT06662604', 'briefTitle': 'Using of Bone Marrow Stem Cell Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Reconstruction of Upper Jaw Bony Cystic Defects, Comparing with Platelet Rich Fibrin with Bone Graft', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Bone Marrow Stem Cells Concentrate with Platelet Rich Fibrin and Bone Graft in Bone Regeneration of Maxillary Cystic Defects Versus Platelet Rich Fibrin with Bone Graft (a Randomized Controlled Trial)', 'orgStudyIdInfo': {'id': 'OMFS 3-3-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A (Stem cells ,PRF group) intervention group', 'interventionNames': ['Biological: Bone marrow stem cells concentrate , platelet rich fibrin , bone graft']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B (PRF group)', 'interventionNames': ['Biological: platelet rich fibrin and bone graft']}], 'interventions': [{'name': 'Bone marrow stem cells concentrate , platelet rich fibrin , bone graft', 'type': 'BIOLOGICAL', 'description': 'All participants will be treated with Bone marrow stem cells concentrate , platelet rich fibrin , bone graft.', 'armGroupLabels': ['Group A (Stem cells ,PRF group) intervention group']}, {'name': 'platelet rich fibrin and bone graft', 'type': 'BIOLOGICAL', 'description': 'All participants will treated with platelet rich fibrin PRF , bone graft.', 'armGroupLabels': ['Group B (PRF group)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Motea Abdulsalm Sanad, PHD', 'role': 'CONTACT', 'email': 'matea.sanad@dentistry.cu.edu.eg', 'phone': '+20 1090696248'}, {'name': 'Tareq El-Ghareeb, Professor', 'role': 'CONTACT', 'email': 't.elghareeb@dentistry.cu.edu.eg', 'phone': '+201282931864'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Motea Abdulsalam Sanad', 'investigatorAffiliation': 'Cairo University'}}}}