Spinal cord injury
Conditions
Interventions
collection and transplantation of bone marrow cells
Sponsors
SUZUKI Yoshihisa
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Patients with spinal cord injuries classified as A or B on the ASIA impairment scale (2)Patients within 12 weeks after injury (3)Patients with partial spinal cord injury demonstrated by diagnostic imaging (4)Patients aged between 20 and 60 years at the acquisition of informed consent (5)Patients who submitted written informed consent by themselves
Exclusion criteria
Exclusion criteria: (1)Patients with a completely transected spinal cord (2)Patients with spinal shock (3)Patients with central spinal cord injury (4)Patients with organ failure with a SOFA score of 3 ponts or higher (5)Patients in whom hepatitis B,hepatitis C,human immunodeficiency virus infection adult T-cell leukemia, or parvovirus B19 infection could not be ruled out (6)Patients with malignant tumor or a history of malignant tumor within 5 years (7)Patients with one of the following diseases/disorders Myeloproliferative disorder or myelodysplastic syndrome Poorly controlled Ischemic heart disease Autoimmune disease Spinal stenosis Limb paralysis due to central nervous system disorder not attributed to spinal Liver dysfunction (SOFA score of 3 ponts or higher) Renal dysfunction (SOFA score of 3 ponts or higher) Poorly controlled psychiatric disorder (8)Patients who were participating in other clinical trials or who completed participation within 6 months (9)Patients who were pregnant or possibly pregnant (10)Other patients who were judged to be ineligible by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change between ASIA scores at the registration and that in 6 months later Improvement: Patient whose ASIA score decreases more than one | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Amount of change between motor scores of neurological classification at the registration and that in 6 months later (2) Amount of change between sensory scores of neurological classification at the registration and that in 6 months later (3) All of the adverse events from the treatment to 6 months later | — |
Countries
Japan
Contacts
Public ContactJunko Ubuyashiki
Tazuke Kofukai, Medical Research Institute, Kitano Hospital
Outcome results
None listed