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
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Instituto do Cerebro de Brasilia:

Primary Outcome Measures:
  • seizure frequency [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: April 24, 2009
Last Updated: July 29, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Instituto do Cerebro de Brasilia:
Seizure frequency
Hippocampal volume
Adverse effects

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

ClinicalTrials.gov processed this record on August 02, 2015