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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014