Treatment for Acute Spinal Cord Injury

Phase 2TerminatedNCT00695149

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan5 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Spinal Cord Injury

Interventions

Transplantation of bone marrow stromal cellPROCEDURE

Eligibility

Sex: ALLMin age: 15 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

Kansai Medical University

Moriguchi, Osaka, Japan

Outcomes

Primary Outcomes

Motor function

Time frame: six months

Secondary Outcomes

Sensation

Time frame: six months

Data from ClinicalTrials.gov

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