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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile
ClinicalTrials.gov Identifier:
NCT01694927
First received: September 25, 2012
Last updated: July 2, 2013
Last verified: July 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Clinica las Condes, Chile:

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

Secondary Outcome Measures:
  • Functional improvement in muscle strength [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    According to motor index score

  • Functional Improvement in sphincters control [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Functional improvement in spasticity control [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 25, 2012
Last Updated: July 2, 2013
Health Authority: Chile: Ministry of Health

Keywords provided by Clinica las Condes, Chile:
Mesenchymal stem cell
Spinal cord injury

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014