Treatment for Acute Spinal Cord Injury

Phase 1

Terminated

• Conditions: Spinal Cord Injury

• Registration Number: NCT00695149
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Brief Summary

This clinical trial aims to treat a damaged spinal cord by injecting your own bone marrow stromal cells (autologous bone marrow stromal cells) into cerebrospinal fluid through the lumbar puncture, and assess the safety and efficacy of the procedure.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2008-06-09
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-11
• Primary Completion: 2008-12
• Study Completion: 2010-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-01
• Last Update Posted: 2011-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Spinal cord injury is confirmed with MRI
• Methylprednisolone therapy according to this study can be started within 8 hours after the injury
• Bone marrow stromal cells (BMSCs) incubation can be started within 72 hours after the injury
• Age between 15 and 60
• With the informed consent of obtaining bone marrow and injecting incubated BMSCs.

Exclusion Criteria

• Complete disruption of spinal cord
• Central spinal cord injury
• Spinal canal stenosis before the injury
• Brain or spinal cord disease before the injury
• Positive serologic test in at least one of the following; HBs antigen, HCV antibody, HIV antibody, or HTLV-1 antibody
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Motor function	six months

Secondary Outcome Measures

Name	Time	Method
Sensation	six months

Trial Locations

Locations (1)

Kansai Medical University; 🇯🇵 Moriguchi, Osaka, Japan