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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00916266
First Posted: June 9, 2009
Last Update Posted: July 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  Purpose
This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.

Condition Intervention Phase
Epilepsy Procedure: Stem cell transplantation Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy

Resource links provided by NLM:


Further study details as provided by Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS:

Primary Outcome Measures:
  • seizure frequency [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • adverse effects [ Time Frame: 6 months ]
  • hippocampal volume [ Time Frame: 6 months ]
  • cognitive performance [ Time Frame: 6 months ]

Enrollment: 20
Study Start Date: July 2008
Study Completion Date: May 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00916266


Locations
Brazil
Instituto do Cerebro
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Instituto do Cerebro de Brasilia
Hospital Sao Lucas da PUCRS
Instituto do Cerebro da PUCRS
Investigators
Principal Investigator: Jaderson C da Costa, MD, PhD Instituto do Cerebro-PUCRS
  More Information

Publications:

Responsible Party: Jaderson Costa da Costa, MD, PhD, Hospital Sao Lucas da PUCRS
ClinicalTrials.gov Identifier: NCT00916266     History of Changes
Other Study ID Numbers: Stem cells in Epilepsy
First Submitted: April 24, 2009
First Posted: June 9, 2009
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS:
Seizure frequency
Hippocampal volume
Adverse effects

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Temporal Lobe
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial