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Treatment for Acute Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT00695149
Recruitment Status : Terminated
First Posted : June 11, 2008
Last Update Posted : June 2, 2011
Sponsor:
Information provided by:
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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells
Study Start Date : July 2005
Actual Primary Completion Date : December 2008
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. Sensation [ Time Frame: six months ]


Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695149


Locations
Japan
Kansai Medical University
Moriguchi, Osaka, Japan, 570-8507
Sponsors and Collaborators
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00695149     History of Changes
Other Study ID Numbers: UHA_SCI0401
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: June 2011

Keywords provided by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan:
Spinal cord Injury
Central nervous system
Regeneration
Bone marrow stromal cells
Transplantation

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System