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CompletedNCT00916266Updated Jul 31, 2015

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

A Phase 1 interventional study of Stem cell transplantation in Epilepsy, sponsored by Instituto do Cerebro de Brasilia. Completed at 1 site in Brazil. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Instituto do Cerebro de Brasilia · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
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Study summary

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

Read the 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

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Conditions studied

  • Epilepsy

Keywords

  • Seizure frequency
  • Hippocampal volume
  • Adverse effects
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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's enrollment of 20 is below the median of 50 across 1,206 interventional studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Instituto do Cerebro de Brasilia is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • temporal lobe medically refractory epilepsy patients with hippocampal atrophy

Exclusion criteria

Exclusion Criteria:

  • under 18 or over 65 years old patients
  • previous neurological surgery
  • other neurodegenerative diseases
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

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.

    Procedure: Stem cell transplantation

Interventions

  • ProcedureStem cell transplantation

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

    Also known as: BMMSC - Bone Marrow Mononuclear Stem Cells

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What researchers measure

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

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Study locations

1 site
  • Instituto do Cerebro
    Porto Alegre, RS, Brazil
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References and documents

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. doi: 10.3171/jns.2006.104.1.70. PubMed 16509149 ↗
  • 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. PubMed 15509239 ↗
  • 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. PubMed 22507676 ↗
  • 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. PubMed 20080419 ↗
  • 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. PubMed 22198377 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00916266
Lead sponsor
Instituto do Cerebro de Brasilia
Collaborators
Hospital Sao Lucas da PUCRS, Instituto do Cerebro da PUCRS
Responsible party
Jaderson Costa da Costa (MD, PhD, Hospital Sao Lucas da PUCRS) — Principal investigator
First posted
Jun 9, 2009
Start date
Jul 2008
Primary completion
Nov 2011
Completion
May 2012
Last update
Jul 31, 2015

Study contacts

Jaderson C da Costa, MD, PhD
principal investigator · Instituto do Cerebro-PUCRS

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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