Spinal cord injury
Conditions
Interventions
Intra-thecal injection of G-CSF mobilized autologous CD34+ cell from peripheral blood collected by apheresis.
Sponsors
WATANABE Tsuyoshi
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 from the patient, or the guardian or the proxy
Exclusion criteria
Exclusion criteria: 1) Transection of the spinal cord with the MRI 2) Spinal shock 3) Central spinal cord injury 4) Organ failure of SOFA scale 3 or greater 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 10 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 15 cm or larger in its longest diameter on computed tomography 19) Allergic reaction or adverse reaction to G-CSF or apheresis 20) Allergic reaction or adverse reaction to the mouse-derived protein or the other reagents 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 (symptomatic cerebral infarction, etc.); renal dysfunction (hemodialysis, etc.); severe psychiatric disorders 24) Pregnancy 25) Participating in other clinical studies or within 6 months after completion 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 Safety: all adverse events, those seriousness, severity, and frequency. Efficacy: proportion of responder at 24 weeks after the therapy by grade A and B of the American Spinal Injury Association (ASIA) impairment scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Changes in muscle function grading in each patient for 24 weeks after the therapy by grade A and B of ASIA impairment scale. 2) Changes in sensory grading of touch and pin prick in each patient for 24 weeks after the therapy by grade A and B of ASIA impairment scale. 3) Changes in the score of Spinal Cord Independence Measure version III (SCIM-III) in each patient before transplantation, 4, 8, 12, 24 and 48 weeks after the therapy. 4) Equipment performance | — |
Countries
Japan
Contacts
Public ContactNorimasa Harada
Shonan Kamakura General Hospital
Outcome results
None listed