Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT00916266
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2009-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2009-04-24', 'studyFirstSubmitQcDate': '2009-06-08', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'seizure frequency', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'adverse effects', 'timeFrame': '6 months'}, {'measure': 'hippocampal volume', 'timeFrame': '6 months'}, {'measure': 'cognitive performance', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Seizure frequency', 'Hippocampal volume', 'Adverse effects'], 'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '16509149', 'type': 'BACKGROUND', 'citation': 'Paglioli E, Palmini A, Portuguez M, Paglioli E, Azambuja N, da Costa JC, da Silva Filho HF, Martinez JV, Hoeffel JR. Seizure and memory outcome following temporal lobe surgery: selective compared with nonselective approaches for hippocampal sclerosis. J Neurosurg. 2006 Jan;104(1):70-8. doi: 10.3171/jns.2006.104.1.70.'}, {'pmid': '15509239', 'type': 'BACKGROUND', 'citation': 'Paglioli E, Palmini A, Paglioli E, da Costa JC, Portuguez M, Martinez JV, Calcagnotto ME, Hoefel JR, Raupp S, Barbosa-Coutinho L. Survival analysis of the surgical outcome of temporal lobe epilepsy due to hippocampal sclerosis. Epilepsia. 2004 Nov;45(11):1383-91. doi: 10.1111/j.0013-9580.2004.22204.x.'}, {'pmid': '22507676', 'type': 'BACKGROUND', 'citation': 'Friedrich MA, Martins MP, Araujo MD, Klamt C, Vedolin L, Garicochea B, Raupp EF, Sartori El Ammar J, Machado DC, Costa JC, Nogueira RG, Rosado-de-Castro PH, Mendez-Otero R, Freitas GR. Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant. 2012;21 Suppl 1:S13-21. doi: 10.3727/096368912x612512.'}, {'pmid': '20080419', 'type': 'BACKGROUND', 'citation': 'Costa-Ferro ZS, Vitola AS, Pedroso MF, Cunha FB, Xavier LL, Machado DC, Soares MB, Ribeiro-dos-Santos R, DaCosta JC. Prevention of seizures and reorganization of hippocampal functions by transplantation of bone marrow cells in the acute phase of experimental epilepsy. Seizure. 2010 Mar;19(2):84-92. doi: 10.1016/j.seizure.2009.12.003. Epub 2010 Jan 18.'}, {'pmid': '22198377', 'type': 'BACKGROUND', 'citation': 'Costa-Ferro ZS, Souza BS, Leal MM, Kaneto CM, Azevedo CM, da Silva IC, Soares MB, Ribeiro-dos-Santos R, Dacosta JC. Transplantation of bone marrow mononuclear cells decreases seizure incidence, mitigates neuronal loss and modulates pro-inflammatory cytokine production in epileptic rats. Neurobiol Dis. 2012 May;46(2):302-13. doi: 10.1016/j.nbd.2011.12.001. Epub 2011 Dec 11.'}]}, 'descriptionModule': {'briefSummary': 'This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.', '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 temporal lobe refractory epilepsy. We are mainly evaluating seizure frequency, hippocampal volume an cognitive performance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* temporal lobe medically refractory epilepsy patients with hippocampal atrophy\n\nExclusion Criteria:\n\n* under 18 or over 65 years old patients\n* previous neurological surgery\n* other neurodegenerative diseases'}, 'identificationModule': {'nctId': 'NCT00916266', 'briefTitle': 'Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cerebro de Brasilia'}, 'officialTitle': 'Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy', 'orgStudyIdInfo': {'id': 'Stem cells in Epilepsy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stem cell transplantation', 'description': 'Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.', 'interventionNames': ['Procedure: Stem cell transplantation']}], 'interventions': [{'name': 'Stem cell transplantation', 'type': 'PROCEDURE', 'otherNames': ['BMMSC - Bone Marrow Mononuclear Stem Cells'], 'description': 'Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography', 'armGroupLabels': ['stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto do Cerebro', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Jaderson C da Costa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Cerebro-PUCRS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cerebro de Brasilia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sao Lucas da PUCRS', 'class': 'OTHER'}, {'name': 'Instituto do Cerebro da PUCRS', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jaderson Costa da Costa', 'investigatorAffiliation': 'Hospital Sao Lucas da PUCRS'}}}}