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Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy

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ClinicalTrials.gov Identifier: NCT00916266
Recruitment Status : Completed
First Posted : June 9, 2009
Last Update Posted : July 31, 2015
Sponsor:
Collaborators:
Hospital Sao Lucas da PUCRS
Instituto do Cerebro da PUCRS
Information provided by (Responsible Party):
Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS

Tracking Information
First Submitted Date  ICMJE April 24, 2009
First Posted Date  ICMJE June 9, 2009
Last Update Posted Date July 31, 2015
Study Start Date  ICMJE July 2008
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2009)
seizure frequency [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00916266 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2009)
  • adverse effects [ Time Frame: 6 months ]
  • hippocampal volume [ Time Frame: 6 months ]
  • cognitive performance [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Official Title  ICMJE Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE Procedure: Stem cell transplantation
Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography
Other Name: BMMSC - Bone Marrow Mononuclear Stem Cells
Study Arms  ICMJE Experimental: stem cell transplantation
Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.
Intervention: Procedure: Stem cell transplantation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 8, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00916266
Other Study ID Numbers  ICMJE Stem cells in Epilepsy
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS
Study Sponsor  ICMJE Instituto do Cerebro de Brasilia
Collaborators  ICMJE
  • Hospital Sao Lucas da PUCRS
  • Instituto do Cerebro da PUCRS
Investigators  ICMJE
Principal Investigator: Jaderson C da Costa, MD, PhD Instituto do Cerebro-PUCRS
PRS Account Instituto do Cerebro de Brasilia
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP