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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694927
First Posted: September 27, 2012
Last Update Posted: July 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile
  Purpose
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 Intervention Phase
Spinal Cord Injury Procedure: Autologous Mesenchymal Stem Cells Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients

Resource links provided by NLM:


Further study details as provided by Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile:

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

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

  • Functional Improvement in sphincters control [ Time Frame: 1 year ]
  • Functional improvement in spasticity control [ Time Frame: 1 year ]

Estimated Enrollment: 30
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal Stem cells Procedure: Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 65 Years   (Child, 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
Information from the National Library of Medicine

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
Chile
Clínica Las Condes
Santiago, RM, Chile, 7591468
Sponsors and Collaborators
Clínica Las Condes. LIT INNOVA CORFO
Investigators
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

Publications:
Responsible Party: Clínica Las Condes. LIT INNOVA CORFO, Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile
ClinicalTrials.gov Identifier: NCT01694927     History of Changes
Other Study ID Numbers: LIT-2012-ACF-001
First Submitted: September 25, 2012
First Posted: September 27, 2012
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:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System