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

July 29, 2015 updated by: Jaderson Costa da Costa, Instituto do Cerebro de Brasilia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil
        • Instituto do Cerebro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • BMMSC - Bone Marrow Mononuclear Stem Cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
seizure frequency
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse effects
Time Frame: 6 months
6 months
hippocampal volume
Time Frame: 6 months
6 months
cognitive performance
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto do Cerebro de Brasilia

Collaborators

Hospital Sao Lucas da PUCRS
Instituto do Cerebro da PUCRS

Investigators

  • Principal Investigator: Jaderson C da Costa, MD, PhD, Instituto do Cerebro-PUCRS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

April 24, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimate)

June 9, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Stem cells in Epilepsy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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