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

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.
 
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

Tracking Information
First Submitted Date  ICMJE September 25, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date July 3, 2013
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01694927 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
Official Title  ICMJE Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Procedure: Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
Study Arms  ICMJE Experimental: Mesenchymal Stem cells
Intervention: Procedure: Autologous Mesenchymal Stem Cells
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 25, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694927
Other Study ID Numbers  ICMJE LIT-2012-ACF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clínica Las Condes. LIT INNOVA CORFO, Clinica las Condes, Chile
Study Sponsor  ICMJE Clínica Las Condes. LIT INNOVA CORFO
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Clinica las Condes, Chile
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP