Spinal Cord Injury
Conditions
Keywords
Spinal cord Injury, Central nervous system, Regeneration, Bone marrow stromal cells, Transplantation
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.
Interventions
PROCEDURETransplantation of bone marrow stromal cell
Sponsors
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor function | six months |
Secondary
| Measure | Time frame |
|---|---|
| Sensation | six months |
Countries
Japan
Outcome results
None listed