Autologous Bone Marrow Stem Cell Transplantation in Patients With Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Procedure: Stem Cell Transplantation

• Registration Number: NCT01325103
• Lead Sponsor: Hospital Sao Rafael

Brief Summary

This research investigates the use of autologous bone marrow stem cells in patients with spinal cord injury.

Detailed Description

The aim of this study is to evaluate autologous bone marrow stem cells transplantation as a safe and potentially beneficial treatment for patients with spinal cord injury.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2011-03-28
• Study First Submitted QC: 2011-03-28
• Study First Posted: 2011-03-29
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-05
• Last Update Submitted: 2017-11-27
• Last Update Posted: 2017-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Age between 18 and 50 years old
• Traumatic spinal cord injury at the thoracic or lumbar level
• Classification Frankel A
• Indication for spinal surgery for traumatic lesions of bone

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Exclusion Criteria

• Section of the spinal anatomy
• Open injuries
• Active infectious diseases
• Terminal patients
• Neurodegenerative diseases
• Primary hematologic diseases
• Bone reflecting increased risk for spinal puncture
• Coagulopathies
• Hepatic dysfunction
• Pregnancy
• Other medical complications that contraindicate surgery, including major respiratory complications
• Participation in another clinical trial
• Use of metal implants close to vascular structures (such as cardiac pacemaker or prosthesis) that contraindicate MRI

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem Cell Transplantation	Stem Cell Transplantation	Patients with spinal cord injury that will undergo autologous bone marrow stem cell transplantation.

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of bone marrow stem cell transplantation in patients with spinal cord injury	Six months

Secondary Outcome Measures

Name	Time	Method
Improvement of sphincters control.	Six months	Improvement of sphincters control (anal and bladder).
Functional improvement in muscle strength	Six months	Functional improvement in muscle strength assessed by the Frankel scale.

Trial Locations

Locations (1)

Hospital São Rafael; 🇧🇷 Salvador, Bahia, Brazil