Treatment for spinal cord injury patients with bone-marrow cells
- Conditions
- Spinal cord injury
- Registration Number
- JPRN-jRCTb051200014
- Lead Sponsor
- SUZUKI Yoshihisa
- Brief Summary
The clinical research has been done in four cases with ASIA A. More cases were needed to assess the effectiveness of the treatment. No severe adverse events were seen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4
(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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of change between ASIA scores at the registration and that in 6 months later<br>Improvement: Patient whose ASIA score decreases more than one
- Secondary Outcome Measures
Name Time Method (1) Amount of change between motor scores of neurological classification at the registration and that in 6 months later<br>(2) Amount of change between sensory scores of neurological classification at the registration and that in 6 months later<br>(3) All of the adverse events from the treatment to 6 months later