Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
NCT ID: NCT01694927
Last Updated: 2013-07-03
Study Results
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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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2012-01-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mesenchymal Stem cells
Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
Interventions
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Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
Eligibility Criteria
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Inclusion Criteria
* Cervical (under C4), thoracic o lumbar spine lesion
* Complete or Incomplete SCI
* Platelet count over 100.000/ul
Exclusion Criteria
* Active infectious diseases
* Pregnancy
* Neurodegenerative diseases
* Primary hematologic diseases
* Coagulopathies
* Hepatic dysfunction
* Pregnancy
2 Years
65 Years
ALL
No
Sponsors
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Clínica Las Condes. LIT INNOVA CORFO
OTHER
Responsible Party
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Clínica Las Condes. LIT INNOVA CORFO
Clinical Researcher LIT. Innova CORFO 09IEI6568
Principal Investigators
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Andrés Chahín, MD
Role: PRINCIPAL_INVESTIGATOR
Clínica Las Condes, Santiago
Rodrigo M Mardones, MD
Role: STUDY_DIRECTOR
Clínica Las Condes, Santiago
Catalina Larrain, MD
Role: STUDY_CHAIR
Clínica Las Condes, Santiago
Locations
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Clínica Las Condes
Santiago, RM, Chile
Countries
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References
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Pal R, Venkataramana NK, Bansal A, Balaraju S, Jan M, Chandra R, Dixit A, Rauthan A, Murgod U, Totey S. Ex vivo-expanded autologous bone marrow-derived mesenchymal stromal cells in human spinal cord injury/paraplegia: a pilot clinical study. Cytotherapy. 2009;11(7):897-911. doi: 10.3109/14653240903253857.
Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Moviglia GA, Fernandez Vina R, Brizuela JA, Saslavsky J, Vrsalovic F, Varela G, Bastos F, Farina P, Etchegaray G, Barbieri M, Martinez G, Picasso F, Schmidt Y, Brizuela P, Gaeta CA, Costanzo H, Moviglia Brandolino MT, Merino S, Pes ME, Veloso MJ, Rugilo C, Tamer I, Shuster GS. Combined protocol of cell therapy for chronic spinal cord injury. Report on the electrical and functional recovery of two patients. Cytotherapy. 2006;8(3):202-9. doi: 10.1080/14653240600736048.
Other Identifiers
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LIT-2012-ACF-001
Identifier Type: -
Identifier Source: org_study_id
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