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

Phase 2

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Autologous Mesenchymal Stem Cells

• Registration Number: NCT01694927
• Lead Sponsor: Clínica Las Condes. LIT INNOVA CORFO

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 available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem cells	Autologous Mesenchymal Stem Cells	-

Primary Outcome Measures

Name	Time	Method
Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients	3 months

Secondary Outcome Measures

Name	Time	Method
Functional improvement in muscle strength	1 year	According to motor index score
Functional Improvement in sphincters control	1 year
Functional improvement in spasticity control	1 year

Trial Locations

Locations (1)

Clínica Las Condes; 🇨🇱 Santiago, RM, Chile