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Completed

NCT Number: NCT00916266

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Instituto do Cerebro

Porto Alegre, Rio Grande do Sul, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

stem cell transplantation

Procedure

Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography

Other names: BMMSC - Bone Marrow Mononuclear Stem Cells

Primary outcomes

  1. seizure frequency

    Time frame: 6 months

Secondary outcomes

  1. adverse effects

    Time frame: 6 months

  2. hippocampal volume

    Time frame: 6 months

  3. cognitive performance

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Instituto do Cerebro de Brasilia

Other

Collaborators

  • Hospital Sao Lucas da PUCRS
  • Instituto do Cerebro da PUCRS

Registry information

Official study title

Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jun 9, 2009
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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