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Treatment for Acute Spinal Cord Injury

This study has been terminated.
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan Identifier:
First received: June 9, 2008
Last updated: June 1, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Spinal Cord Injury
Procedure: Transplantation of bone marrow stromal cell
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells

Resource links provided by NLM:

Further study details as provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:

Primary Outcome Measures:
  • Motor function [ Time Frame: six months ]

Secondary Outcome Measures:
  • Sensation [ Time Frame: six months ]

Enrollment: 5
Study Start Date: July 2005
Study Completion Date: March 2010
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00695149

Kansai Medical University
Moriguchi, Osaka, Japan, 570-8507
Sponsors and Collaborators
Translational Research Informatics Center, Kobe, Hyogo, Japan
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00695149     History of Changes
Other Study ID Numbers: UHA_SCI0401
Study First Received: June 9, 2008
Last Updated: June 1, 2011

Keywords provided by Translational Research Informatics Center, Kobe, Hyogo, Japan:
Spinal cord Injury
Central nervous system
Bone marrow stromal cells

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System processed this record on May 25, 2017