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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00916266
First received: April 24, 2009
Last updated: July 29, 2015
Last verified: July 2015

April 24, 2009
July 29, 2015
July 2008
November 2011   (final data collection date for primary outcome measure)
seizure frequency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00916266 on ClinicalTrials.gov Archive Site
  • adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • hippocampal volume [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • cognitive performance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy

This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.

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

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Epilepsy
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
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
May 2012
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00916266
Stem cells in Epilepsy
Yes
Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS
Instituto do Cerebro de Brasilia
  • Hospital Sao Lucas da PUCRS
  • Instituto do Cerebro da PUCRS
Principal Investigator: Jaderson C da Costa, MD, PhD Instituto do Cerebro-PUCRS
Instituto do Cerebro de Brasilia
July 2015

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