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Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients (MSC-SCI)

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ClinicalTrials.gov Identifier: NCT01694927
Recruitment Status : Unknown
Verified July 2013 by Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile.
Recruitment status was:  Enrolling by invitation
First Posted : September 27, 2012
Last Update Posted : July 3, 2013
Sponsor:
Information provided by (Responsible Party):
Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile

Study Description
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Brief Summary:
The aim of this study is to evaluate the use of autologous expanded mesenchymal stem cells intralesional transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Autologous Mesenchymal Stem Cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
Study Start Date : January 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal Stem cells Procedure: Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Functional improvement in muscle strength [ Time Frame: 1 year ]
    According to motor index score

  2. Functional Improvement in sphincters control [ Time Frame: 1 year ]
  3. Functional improvement in spasticity control [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • American Spinal Injury Association Impairment (ASIA) Scale A, B and C
  • Cervical (under C4), thoracic o lumbar spine lesion
  • Complete or Incomplete SCI
  • Platelet count over 100.000/ul

Exclusion Criteria:

  • Acute SCI (less than 3 months)
  • Active infectious diseases
  • Pregnancy
  • Neurodegenerative diseases
  • Primary hematologic diseases
  • Coagulopathies
  • Hepatic dysfunction
  • Pregnancy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694927


Locations
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Chile
Clínica Las Condes
Santiago, RM, Chile, 7591468
Sponsors and Collaborators
Clínica Las Condes. LIT INNOVA CORFO
Investigators
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Principal Investigator: Andrés Chahín, MD Clínica Las Condes, Santiago
Study Director: Rodrigo M Mardones, MD Clínica Las Condes, Santiago
Study Chair: Catalina Larrain, MD Clínica Las Condes, Santiago
More Information
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Publications of Results:

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Responsible Party: Clínica Las Condes. LIT INNOVA CORFO, Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile
ClinicalTrials.gov Identifier: NCT01694927    
Other Study ID Numbers: LIT-2012-ACF-001
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: July 3, 2013
Last Verified: July 2013
Keywords provided by Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile:
Mesenchymal stem cell
Spinal cord injury
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System