Spinal cord injury
Conditions
Interventions
Intra-thecal injection of G-CSF mobilized autologous peripheral blood derived CD34+ cell.
Sponsors
Center for Clinical and Translational Science, Shonan Kamakura General Hospital, Tokushukai Medical Group.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Cervical and thoracic spinal cord injury patients with ASIA impairment score A and B 2) Within 4 to 16 weeks after injury 3) Incomplete spinal cord injury detectable with MRI 4) Enable to obtain the written consent
Exclusion criteria
Exclusion criteria: 1) Transection of the spinal cord with the MRI 2) Spinal shock 3) Central spinal cord injury 4) Organ failure more than SOFA scale 3 5) Disturbance of consciousness (Japan Come Scale (JCS) III-200 or III-300) 6) Severe respiratory disorder 7) Hematologic disease (leukemia, myeloproliferative disorders, myelodysplastic syndromes, or sickle cell disease) 8) Autoimmune disorders 9) Liver cirrhosis 10) Interstitial pneumonitis or history 11) Malignancy or history of malignancy most recently 12) Positive for following viral infectious disease, HBV, HCV, HIV, ATL, Parvovirus B19. 13) White blood cell count, under 2,000/micro L or greater than 15,000/micro L 14) Platelet count, under 100,000/micro L 15) Hemoglobin concentration, under 8 g/dL 16) Aspartate aminotransferase (GOT) or alanine aminotransferase (GPT), three times greater than normal value 17) Serum albumin, under 2 g/dL 18) Splenomegaly on computed tomography 19) Allergic reaction or adverse reaction to G-CSF, the other reagents, or apheresis 20) Allergic reaction or adverse reaction to the mouse-derived protein 21) Severe multiple injury or multiple organ failure 22) Hemophilia 23) Uncontrolled ischemic heart disease including receiving a cardiovascular surgery or percutaneous coronary intervention within 12 months; severe spinal and peripheral nerve disease; tetraplegia due to brain disorder (brain injury, cerebral infarction, etc.); renal dysfunction (hemodialysis, etc.); or severe psychiatric disorders 24) Pregnancy 25) Participating in other clinical studies within 6 months 26) Ineligible patients on this clinical study based on other clinical evidence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and efficacy evaluation of the therapy for 48 weeks | — |
Countries
Japan
Contacts
Public ContactMasahiko TANAKA
Shonan Kamakura General Hospital Neurosurgery
Outcome results
None listed