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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Procedure: Stem cell transplantation

• Registration Number: NCT00916266
• Lead Sponsor: Instituto do Cerebro de Brasilia

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 Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-04-24
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-09
• Primary Completion: 2011-11
• Study Completion: 2012-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stem cell transplantation	Stem cell transplantation	Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.

Primary Outcome Measures

Name	Time	Method
seizure frequency	6 months

Secondary Outcome Measures

Name	Time	Method
adverse effects	6 months
hippocampal volume	6 months
cognitive performance	6 months

Trial Locations

Locations (1)

Instituto do Cerebro; 🇧🇷 Porto Alegre, RS, Brazil