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Treatment for Acute Spinal Cord Injury

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Transplantation of bone marrow stromal cell
Sponsored by
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring Spinal cord Injury, Central nervous system, Regeneration, Bone marrow stromal cells, Transplantation

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kansai Medical University

Outcomes

Primary Outcome Measures

Motor function

Secondary Outcome Measures

Sensation

Full Information

First Posted
June 9, 2008
Last Updated
June 1, 2011
Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
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1. Study Identification

Unique Protocol Identification Number
NCT00695149
Brief Title
Treatment for Acute Spinal Cord Injury
Official Title
Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Spinal cord Injury, Central nervous system, Regeneration, Bone marrow stromal cells, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Transplantation of bone marrow stromal cell
Primary Outcome Measure Information:
Title
Motor function
Time Frame
six months
Secondary Outcome Measure Information:
Title
Sensation
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kansai Medical University
City
Moriguchi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
15144853
Citation
Ohta M, Suzuki Y, Noda T, Ejiri Y, Dezawa M, Kataoka K, Chou H, Ishikawa N, Matsumoto N, Iwashita Y, Mizuta E, Kuno S, Ide C. Bone marrow stromal cells infused into the cerebrospinal fluid promote functional recovery of the injured rat spinal cord with reduced cavity formation. Exp Neurol. 2004 Jun;187(2):266-78. doi: 10.1016/j.expneurol.2004.01.021.
Results Reference
background
PubMed Identifier
22232031
Citation
Saito F, Nakatani T, Iwase M, Maeda Y, Murao Y, Suzuki Y, Fukushima M, Ide C. Administration of cultured autologous bone marrow stromal cells into cerebrospinal fluid in spinal injury patients: a pilot study. Restor Neurol Neurosci. 2012;30(2):127-36. doi: 10.3233/RNN-2011-0629.
Results Reference
derived

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Treatment for Acute Spinal Cord Injury

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