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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916266
• Other study ID #: Stem cells in Epilepsy
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2009
• Last updated: July 29, 2015
• Start date: July 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2015
• Source: Instituto do Cerebro de Brasilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe

Intervention

Procedure:
• Stem cell transplantation
Transplantations with autologous bone marrow mononuclear stem cells by selective posterior cerebral artery angiography

Locations

Country	Name	City	State
Brazil	Instituto do Cerebro	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Instituto do Cerebro de Brasilia	Hospital Sao Lucas da PUCRS, Instituto do Cerebro da PUCRS

Country where clinical trial is conducted

Brazil, 

References & Publications (5)

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. — View Citation

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. — View Citation

Friedrich MA, Martins MP, Araújo 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure frequency		6 months	Yes
Secondary	adverse effects		6 months	Yes
Secondary	hippocampal volume		6 months	Yes
Secondary	cognitive performance		6 months	Yes