NCT00916266

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2009

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 9, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

3.3 years

First QC Date

April 24, 2009

Last Update Submit

July 29, 2015

Conditions

Epilepsy

Keywords

Seizure frequencyHippocampal volumeAdverse effects

Outcome Measures

Primary Outcomes (1)

  • seizure frequency

    6 months

Secondary Outcomes (3)

  • adverse effects

    6 months

  • hippocampal volume

    6 months

  • cognitive performance

    6 months

Study Arms (1)

stem cell transplantation

EXPERIMENTAL

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

Stem cell transplantationPROCEDURE

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

Also known as: BMMSC - Bone Marrow Mononuclear Stem Cells
stem cell transplantation

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • temporal lobe medically refractory epilepsy patients with hippocampal atrophy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Cerebro

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (5)

  • 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.

    PMID: 16509149BACKGROUND

  • 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.

    PMID: 15509239BACKGROUND

  • 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.

    PMID: 22507676BACKGROUND

  • 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.

    PMID: 20080419BACKGROUND

  • 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.

    PMID: 22198377BACKGROUND

MeSH Terms

Conditions

Epilepsy

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jaderson C da Costa, MD, PhD

    Instituto do Cerebro-PUCRS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 24, 2009

First Posted

June 9, 2009

Study Start

July 1, 2008

Primary Completion

November 1, 2011

Study Completion

May 1, 2012

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BR(1)