Treatment for Acute Spinal Cord Injury

This study has been terminated.
Sponsor:
Information provided by:
Translational Research Informatics Center, Kobe, Hyogo, Japan
ClinicalTrials.gov Identifier:
NCT00695149
First received: June 9, 2008
Last updated: June 1, 2011
Last verified: June 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensation [ Time Frame: six months ] [ Designated as safety issue: Yes ]

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)
  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695149

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

Publications:
Additional 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
Study First Received: June 9, 2008
Last Updated: June 1, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

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

ClinicalTrials.gov processed this record on October 29, 2014