Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-27 @ 11:20 PM
Study NCT ID:
NCT01435434
Status:
UNKNOWN
Last Update Posted:
2014-03-04
First Post:
2011-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2011-09-04', 'studyFirstSubmitQcDate': '2011-09-15', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical and radiological bony union at 3 months and 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['subjects sustaining Non union/delayed fractures and requiring surgical intervention for treatment'], 'conditions': ['Non Union/Delayed Fractures']}, 'descriptionModule': {'briefSummary': 'The study is a prospective, trial to test the safety and feasibility of injecting autologous, isolated, sterile centrifuged NBMC, and Ignite® DBM in the treatment of high risk non union/delayed fractures. Another objective is to turn this procedure to a standard care protocol in our department .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Ages: 18 to 65\n2. Males- not involved in active military duty.\n3. Females-non child bearing potential, or females of child-bearing potential who have a negative pregnancy test (hCG urine) within 72 hours of informed consent.\n4. Subjects must be available for follow-up for 1 year. 5"Hard to heal" fracture include the following: A. Fracture of the distal third of the tibial bone B. Segmental or open (II, IIIa an IIIB) fractures of the the tibia or femur diaphysis C.Articular fracture of the lower extremity (distal femur, tibial plateau and tibial pilon fractures) with significant metaphyseal comminution and/or bone loss.\n\nExclusion Criteria:\n\n1. Active systemic or local infection.\n2. History of malignancy, radiotherapy, or chemotherapy for malignancy (except BCC of the skin)\n3. Pathological Fractures.\n4. Prior Fracture or Prior operation in the current fracture'}, 'identificationModule': {'nctId': 'NCT01435434', 'briefTitle': 'Mononucleotide Autologous Stem Cells and Demineralized Bone Matrix in the Treatment of Non Union/Delayed Fractures', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'lieb001-CTIL-HMO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sepax, ignite, fracture healing', 'description': 'the mesenchymal cells will be separated by sepax separation system and demineralized bone matrix will be done using IGNITE INJECTABLE REPAIR GRAFT', 'interventionNames': ['Device: the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.']}], 'interventions': [{'name': 'the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.', 'type': 'DEVICE', 'armGroupLabels': ['sepax, ignite, fracture healing']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}