Unique ID issued by UMIN | UMIN000007599 |
---|---|
Receipt number | R000008869 |
Scientific Title | Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow |
Date of disclosure of the study information | 2012/03/29 |
Last modified on | 2013/10/26 10:42:30 |
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Japan |
Spinal cord injury
Neurology | Orthopedics | Neurosurgery |
Plastic surgery | Emergency medicine | Intensive care medicine |
Rehabilitation medicine |
Others
NO
To evaluate the safety and efficacy of mononuclear cells transplantaion therapy for spinal cord injury
Safety,Efficacy
Phase I,II
Type and grade of adverse events
Frequency of adverse events
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
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Maneuver |
Intrathecal single injection of autologous mononuclear cells
20 | years-old | <= |
60 | years-old | >= |
Male and Female
1. Patient whose ASIA classification is A, B or C (at the time of registration)
2. Patient who can participate in the study between 3 weeks and 1 year after injury (at the time of registration)
3. Patient who has partial damage in the spinal cord diagnosed by MR imaging
4. Patient who has provided written informed consent to participate in the study
1. Patient whose spinal cord is transected completely
2. Patient with central spinal cord injury
3. Patient whose SOFA score is more than 3 (at the time of registration)
4. Patient with hepatitis B, hepatitis C, HIV, ATL,or papovavirus B19
5. Patient with malignant tumor within 5 years before registration
6. Patient with myeloproliferative disease
Patient with myelodysplastic syndrome
Patient with ischemic heart disease, difficult to control
Patient with autoimmune disease
Patient with spinal canal stenosis
Patient with motor paralysis in the extremities due to the dysfunction of central nervous system before spinal cord injury
Patient with hepatic dysfunction
Patient with renal failure
Patient with psychological diseases, difficult to control
7. Patient with history of participation of other clinical researches within 6 months before registration
Patient who is a participant in other studies
8. Patient who is pregnancy or suspicion of pregnancy
9. Patient who is judged to be inappropriate as a participant in this study by researchers
10
1st name | |
Middle name | |
Last name | Yoshihisa Suzuki |
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Plastic surgery, 5th laboratory
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
06-6312-1221
yo-suzuki@kitano-hp.or.jp
1st name | |
Middle name | |
Last name | Yoshihisa Suzuki |
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Plastic surgery, 5th laboratory
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
06-6312-1221
http://www.kitano-hp.or.jp/etcproject/keisei/kenkyu_keisei/index.html
yo-suzuki@kitano-hp.or.jp
Department of plastic surgery, Kitano hospital
Ministry of Education, Culture, Sports, Science and Technology
NO
公益財団法人田附興風会医学研究所北野病院(大阪府)
2012 | Year | 03 | Month | 29 | Day |
Unpublished
Completed
2011 | Year | 12 | Month | 28 | Day |
2012 | Year | 03 | Month | 01 | Day |
2014 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 29 | Day |
2013 | Year | 10 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008869