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

NCT ID: NCT00916266

Last Updated: 2015-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-05-31

Brief Summary

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

Detailed Description

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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

Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stem cell transplantation

Patients with refractory temporal lobe epilepsy that are transplanted with autologous bone marrow stem cells in order to provide seizure control.

Group Type EXPERIMENTAL

Stem cell transplantation

Intervention Type PROCEDURE

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

Interventions

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Stem cell transplantation

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

Intervention Type PROCEDURE

Other Intervention Names

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BMMSC - Bone Marrow Mononuclear Stem Cells

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Sao Lucas da PUCRS

OTHER

Sponsor Role collaborator

Instituto do Cerebro da PUCRS

UNKNOWN

Sponsor Role collaborator

Instituto do Cerebro de Brasilia

OTHER

Sponsor Role lead

Responsible Party

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Jaderson Costa da Costa

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaderson C da Costa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cerebro-PUCRS

Locations

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Instituto do Cerebro

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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Paglioli E, Palmini A, Portuguez M, Paglioli E, Azambuja N, da Costa JC, da Silva Filho HF, Martinez JV, Hoeffel JR. Seizure and memory outcome following temporal lobe surgery: selective compared with nonselective approaches for hippocampal sclerosis. J Neurosurg. 2006 Jan;104(1):70-8. doi: 10.3171/jns.2006.104.1.70.

Reference Type BACKGROUND
PMID: 16509149 (View on PubMed)

Paglioli E, Palmini A, Paglioli E, da Costa JC, Portuguez M, Martinez JV, Calcagnotto ME, Hoefel JR, Raupp S, Barbosa-Coutinho L. Survival analysis of the surgical outcome of temporal lobe epilepsy due to hippocampal sclerosis. Epilepsia. 2004 Nov;45(11):1383-91. doi: 10.1111/j.0013-9580.2004.22204.x.

Reference Type BACKGROUND
PMID: 15509239 (View on PubMed)

Friedrich MA, Martins MP, Araujo MD, Klamt C, Vedolin L, Garicochea B, Raupp EF, Sartori El Ammar J, Machado DC, Costa JC, Nogueira RG, Rosado-de-Castro PH, Mendez-Otero R, Freitas GR. Intra-arterial infusion of autologous bone marrow mononuclear cells in patients with moderate to severe middle cerebral artery acute ischemic stroke. Cell Transplant. 2012;21 Suppl 1:S13-21. doi: 10.3727/096368912x612512.

Reference Type BACKGROUND
PMID: 22507676 (View on PubMed)

Costa-Ferro ZS, Vitola AS, Pedroso MF, Cunha FB, Xavier LL, Machado DC, Soares MB, Ribeiro-dos-Santos R, DaCosta JC. Prevention of seizures and reorganization of hippocampal functions by transplantation of bone marrow cells in the acute phase of experimental epilepsy. Seizure. 2010 Mar;19(2):84-92. doi: 10.1016/j.seizure.2009.12.003. Epub 2010 Jan 18.

Reference Type BACKGROUND
PMID: 20080419 (View on PubMed)

Costa-Ferro ZS, Souza BS, Leal MM, Kaneto CM, Azevedo CM, da Silva IC, Soares MB, Ribeiro-dos-Santos R, Dacosta JC. Transplantation of bone marrow mononuclear cells decreases seizure incidence, mitigates neuronal loss and modulates pro-inflammatory cytokine production in epileptic rats. Neurobiol Dis. 2012 May;46(2):302-13. doi: 10.1016/j.nbd.2011.12.001. Epub 2011 Dec 11.

Reference Type BACKGROUND
PMID: 22198377 (View on PubMed)

Other Identifiers

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Stem cells in Epilepsy

Identifier Type: -

Identifier Source: org_study_id

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