Phase 2 study of treatment for spinal cord injury(ASIA impairment scale A,B) with autologous mononuclear cells derived from bone marrow
- Conditions
- Spinal cord injury
- Registration Number
- JPRN-UMIN000015741
- Lead Sponsor
- Department of plastic surgery, Kitano hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
1.Patients with spinal cord injuries classified as A or B on the ASIA impairment scale
2.Patients within 3 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.Patient with spinal shock
3.Patients with central spinal cord injury
4.Patients with organ failure with a SOFA score of 3 points 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
?Autoimmune disease
?Spinal stenosis
?Limb paralysis due to central nervous
system disorder not attributed to spinal
cord injury
?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 To investigate the recovery of motor and sensory function after transplantaion of bone marrow-derived mononuclear cells into cerebrospinal fluid of patients with subacute spinal injury
- Secondary Outcome Measures
Name Time Method Type and grade of adverse events<br>Frequency of adverse events