Back to resultsAutologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Primary Purpose
Epilepsy
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Seizure frequency, Hippocampal volume, Adverse effects
Eligibility Criteria
Inclusion Criteria:
- temporal lobe medically refractory epilepsy patients with hippocampal atrophy
Exclusion Criteria:
- under 18 or over 65 years old patients
- previous neurological surgery
- other neurodegenerative diseases
Sites / Locations
- Instituto do Cerebro
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stem cell transplantation
Arm Description
Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.
Outcomes
Primary Outcome Measures
seizure frequency
Secondary Outcome Measures
adverse effects
hippocampal volume
cognitive performance
Full Information
NCT ID
NCT00916266
First Posted
April 24, 2009
Last Updated
July 29, 2015
Sponsor
Instituto do Cerebro de Brasilia
Collaborators
Hospital Sao Lucas da PUCRS, Instituto do Cerebro da PUCRS
1. Study Identification
Unique Protocol Identification Number
NCT00916266
Brief Title
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Official Title
Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto do Cerebro de Brasilia
Collaborators
Hospital Sao Lucas da PUCRS, Instituto do Cerebro da PUCRS
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Seizure frequency, Hippocampal volume, Adverse effects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stem cell transplantation
Arm Type
Experimental
Arm Description
Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.
Intervention Type
Procedure
Intervention Name(s)
Stem cell transplantation
Other Intervention Name(s)
BMMSC - Bone Marrow Mononuclear Stem Cells
Intervention Description
Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography
Primary Outcome Measure Information:
Title
seizure frequency
Time Frame
6 months
Secondary Outcome Measure Information:
Title
adverse effects
Time Frame
6 months
Title
hippocampal volume
Time Frame
6 months
Title
cognitive performance
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
temporal lobe medically refractory epilepsy patients with hippocampal atrophy
Exclusion Criteria:
under 18 or over 65 years old patients
previous neurological surgery
other neurodegenerative diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaderson C da Costa, MD, PhD
Organizational Affiliation
Instituto do Cerebro-PUCRS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Cerebro
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
16509149
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.
Results Reference
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PubMed Identifier
15509239
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.
Results Reference
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PubMed Identifier
22507676
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.
Results Reference
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PubMed Identifier
20080419
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.
Results Reference
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PubMed Identifier
22198377
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.
Results Reference
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Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
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