Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT00816803
Status:
COMPLETED
Last Update Posted:
2009-01-05
First Post:
2008-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell Transplant in Spinal Cord Injury Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-02', 'studyFirstSubmitDate': '2008-12-31', 'studyFirstSubmitQcDate': '2009-01-02', 'lastUpdatePostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of autologous BM transplant measured by absence of neuronal changes, infections or increased intracranial tension, and monitoring for any abnormal growth or tumor formation by MRI.', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Efficacy of BM cell transplant in improving neurological functions in patients with chronic SCI. Improvement in motor, sensory and sphincteric functions, and quality of life using ASIA scores and MRI.', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal cord injury'], 'conditions': ['Chronic Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '23452836', 'type': 'DERIVED', 'citation': 'El-Kheir WA, Gabr H, Awad MR, Ghannam O, Barakat Y, Farghali HA, El Maadawi ZM, Ewes I, Sabaawy HE. Autologous bone marrow-derived cell therapy combined with physical therapy induces functional improvement in chronic spinal cord injury patients. Cell Transplant. 2014 Apr;23(6):729-45. doi: 10.3727/096368913X664540. Epub 2013 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety of autologous bone marrow derived cell transplant in chronic spinal cord injury patients. The hypothesis is that the availability of bone marrow derived mesenchymal stem cells at the sites of injury promote neuronal regeneration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic spinal cord injury\n* No concomitant systemic disease\n* No progress on physiotherapy for at least 6 months\n* Duration of injury from 10 months to 3 years\n\nExclusion Criteria:\n\n* Non-traumatic spinal cord injury whether transverse myelitis or demyelination\n* Concomitant systemic disease\n* Progress can be observed on physiotherapy\n* Acute injury or duration of injury less than 10 months'}, 'identificationModule': {'nctId': 'NCT00816803', 'briefTitle': 'Cell Transplant in Spinal Cord Injury Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Autologous Bone Marrow Derived Cell Transplant in Spinal Cord Injury Patients', 'orgStudyIdInfo': {'id': 'EGY-SCI-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BM transplant with physiotherapy', 'description': 'Autologous BM transplant', 'interventionNames': ['Procedure: Autologous bone marrow transplant', 'Procedure: Physical therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Physiotherapy only', 'description': 'conventional physical therapy for chronic spinal cord injury.', 'interventionNames': ['Procedure: Physical therapy']}], 'interventions': [{'name': 'Autologous bone marrow transplant', 'type': 'PROCEDURE', 'armGroupLabels': ['BM transplant with physiotherapy']}, {'name': 'Physical therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['BM transplant with physiotherapy', 'Physiotherapy only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University School of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Al-Azhar University', 'class': 'OTHER'}, {'name': 'Medical Military Academy, Egypt', 'class': 'UNKNOWN'}, {'name': 'Alexandria University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Hatem E. Sabaawy, M, PhD, Assistant Professor of Medicine', 'oldOrganization': 'Cairo University, and the Cancer Institute of New Jersey, UMDNJ/RWJMS'}}}}