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

July 2, 2013 updated by: Clínica Las Condes. LIT INNOVA CORFO
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
    • RM
      • Santiago, RM, Chile, 7591468
        • Clinica Las Condes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal Stem cells
Procedure: Autologous Mesenchymal Stem Cells
Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional improvement in muscle strength
Time Frame: 1 year
According to motor index score
1 year
Functional Improvement in sphincters control
Time Frame: 1 year
1 year
Functional improvement in spasticity control
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

June 1, 2014

Study Registration Dates

First Submitted

September 25, 2012

First Submitted That Met QC Criteria

September 25, 2012

First Posted (Estimate)

September 27, 2012

Study Record Updates

Last Update Posted (Estimate)

July 3, 2013

Last Update Submitted That Met QC Criteria

July 2, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIT-2012-ACF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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