Treatment for Acute Spinal Cord Injury | NCT00695149

Studies
Treatment for Acute Spinal Cord Injury

NCT00695149

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Status

Terminated

Last Update Posted

Jun 2, 2011Estimated

Enrollment

5Actual

Phase

Phase 1Phase 2

Conditions

Spinal Cord Injury

Interventions

Transplantation of bone marrow stromal cell

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Dec 2008Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jun 9, 2008

First Submission Date that Met QC Criteria

Jun 10, 2008

First Posted Date

Jun 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2011

Last Update Posted Date

Jun 2, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanOTHER

Collaborators

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Name	Type	Description	Arm Group Labels	Other Names
Transplantation of bone marrow stromal cell	Procedure

Measure	Description	Time Frame
Motor function		six months

Measure	Description	Time Frame
Sensation		six months

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kansai Medical University		Moriguchi	Osaka	570-8507	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15144853	Background	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.
22232031

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System