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

• Sponsor: Clínica Las Condes. LIT INNOVA CORFO (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01694927
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 29
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury	Procedure: Autologous Mesenchymal Stem Cells	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Autologous Mesenchymal Stem Cells in Spinal Cord Injury (SCI) Patients
• Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Jun 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety of Autologous Expanded Mesenchymal Stem Cells transplantation in SCI patients [3 months]

Secondary Outcome Measures

1. Functional improvement in muscle strength [1 year]

   According to motor index score

2. Functional Improvement in sphincters control [1 year]

3. Functional improvement in spasticity control [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Clínica Las Condes. LIT INNOVA CORFO, Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile
• ClinicalTrials.gov Identifier: NCT01694927
• Other Study ID Numbers: LIT-2012-ACF-001
• First Posted: Sep 27, 2012
• Last Update Posted: Jul 3, 2013
• Last Verified: Jul 1, 2013

• Keywords provided by Clínica Las Condes. LIT INNOVA CORFO, Clinical Researcher LIT. Innova CORFO 09IEI6568, Clinica las Condes, Chile: Mesenchymal stem cell; Spinal cord injury
• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jul 3, 2013