Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT01325103
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2011-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury
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': 'D033581', 'term': 'Stem Cell Transplantation'}], 'ancestors': [{'id': 'D017690', 'term': 'Cell Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Mesenchymal stem cell transplantation.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2011-03-28', 'studyFirstSubmitQcDate': '2011-03-28', 'lastUpdatePostDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury', 'timeFrame': 'Six months'}], 'secondaryOutcomes': [{'measure': 'Functional improvement in muscle strength', 'timeFrame': 'Six months', 'description': 'Functional improvement in muscle strength assessed by the Frankel scale.'}, {'measure': 'Improvement of sphincters control.', 'timeFrame': 'Six months', 'description': 'Improvement of sphincters control (anal and bladder).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal cord injury', 'Mesenchymal stem cells', 'Bone marrow'], 'conditions': ['Spinal Cord Injury']}, 'referencesModule': {'references': [{'pmid': '25406723', 'type': 'DERIVED', 'citation': 'Mendonca MV, Larocca TF, de Freitas Souza BS, Villarreal CF, Silva LF, Matos AC, Novaes MA, Bahia CM, de Oliveira Melo Martinez AC, Kaneto CM, Furtado SB, Sampaio GP, Soares MB, dos Santos RR. Safety and neurological assessments after autologous transplantation of bone marrow mesenchymal stem cells in subjects with chronic spinal cord injury. Stem Cell Res Ther. 2014 Nov 17;5(6):126. doi: 10.1186/scrt516.'}]}, 'descriptionModule': {'briefSummary': 'This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.', 'detailedDescription': 'The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 50 years old\n* Traumatic spinal cord injury at the thoracic or lumbar level\n* Classification Frankel A\n* Indication for spinal surgery for traumatic lesions of bone\n\nExclusion Criteria:\n\n* Section of the spinal anatomy\n* Open injuries\n* Active infectious diseases\n* Terminal patients\n* Neurodegenerative diseases\n* Primary hematologic diseases\n* Bone reflecting increased risk for spinal puncture\n* Coagulopathies\n* Hepatic dysfunction\n* Pregnancy\n* Other medical complications that contraindicate surgery, including major respiratory complications\n* Participation in another clinical trial\n* Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI'}, 'identificationModule': {'nctId': 'NCT01325103', 'briefTitle': 'Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Rafael'}, 'officialTitle': 'Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury', 'orgStudyIdInfo': {'id': 'SCI-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cell Transplantation', 'description': 'Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation.', 'interventionNames': ['Procedure: Stem Cell Transplantation']}], 'interventions': [{'name': 'Stem Cell Transplantation', 'type': 'PROCEDURE', 'otherNames': ['BMMSC - Bone Marrow Mesenchymal Stem Cells.'], 'description': 'All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.', 'armGroupLabels': ['Stem Cell Transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41256900', 'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital São Rafael', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}], 'overallOfficials': [{'name': 'Ricardo R. dos Santos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Milena Botelho P. Soares, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Marcus Vinícius P. Mendonça, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Cláudia B. Pinheiro, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Ticiana X. Ferreira, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Cristiane F. Villarreal, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Luiz Flávio M. Silva, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Marco A. Almeida, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}, {'name': 'Ubirajara B. Júnior, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Sao Rafael'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Rafael', 'class': 'OTHER'}, 'collaborators': [{'name': 'Oswaldo Cruz Foundation', 'class': 'OTHER'}, {'name': 'Irep Sociedade de Ensino Superior Médio e Fundamental Limitada', 'class': 'OTHER'}, {'name': 'Hospital Espanhol', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Phase 1 Study of Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury', 'investigatorFullName': 'Ricardo Ribeiro dos Santos', 'investigatorAffiliation': 'Hospital Sao Rafael'}}}}