Treatment for Acute Spinal Cord Injury
Clinical Study of Treatment for Acute Spinal Cord Injury Using Cultured Bone Marrow Stromal Cells
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2005
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 9, 2008
CompletedFirst Posted
Study publicly available on registry
June 11, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedJune 2, 2011
June 1, 2011
3.4 years
June 9, 2008
June 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Motor function
six months
Secondary Outcomes (1)
Sensation
six months
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kansai Medical University
Moriguchi, Osaka, 570-8507, Japan
Related Publications (2)
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.
PMID: 15144853BACKGROUNDSaito 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.
PMID: 22232031DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 9, 2008
First Posted
June 11, 2008
Study Start
July 1, 2005
Primary Completion
December 1, 2008
Study Completion
March 1, 2010
Last Updated
June 2, 2011
Record last verified: 2011-06