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

• ClinicalTrials.gov Identifier: NCT00916266
• Recruitment Status: Completed
• First Posted: June 9, 2009
• Last Update Posted: July 31, 2015
• Sponsor: Instituto do Cerebro de Brasilia
• 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

Tracking Information

• First Submitted Date: April 24, 2009
• First Posted Date: June 9, 2009
• Last Update Posted Date: July 31, 2015
• Study Start Date: July 2008
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 8, 2009): seizure frequency [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 8, 2009)

• adverse effects [ Time Frame: 6 months ]
• hippocampal volume [ Time Frame: 6 months ]
• cognitive performance [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
• Official Title: Phase 1 Study of Autologous Bone Marrow Stem Cells Transplantation in Patients With Temporal Lobe Epilepsy
• Brief Summary: This research investigates the use of autologous bone marrow stem cells for the treatment of medically refractory temporal lobe epilepsy patients.
• 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
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy

Intervention

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

Study Arms

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.

Intervention: Procedure: Stem cell transplantation

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 8, 2009): 20
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2012
• Actual Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Brazil

Administrative Information

• NCT Number: NCT00916266
• Other Study ID Numbers: Stem cells in Epilepsy
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jaderson Costa da Costa, Hospital Sao Lucas da PUCRS
• 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

• PRS Account: Instituto do Cerebro de Brasilia
• Verification Date: July 2015