Treatment for Acute Spinal Cord Injury

NCT ID: NCT00695149

Last Updated: 2011-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2010-03-31

Brief Summary

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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

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Conditions

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Spinal Cord Injury

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Transplantation of bone marrow stromal cell

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Locations

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Kansai Medical University

Moriguchi, Osaka, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type BACKGROUND
PMID: 15144853 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22232031 (View on PubMed)

Other Identifiers

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UHA_SCI0401

Identifier Type: -

Identifier Source: org_study_id

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