UMIN-CTR Clinical Trial
| 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 |
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Basic information
Public title
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Acronym
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Scientific Title
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Scientific Title:Acronym
Phase 1/2 study of treatment for spinal cord injury with autologous mononuclear cells derived from bone marrow
Region
| Japan |
Condition
Condition
Spinal cord injury
Classification by specialty
| Neurology | Orthopedics | Neurosurgery |
| Plastic surgery | Emergency medicine | Intensive care medicine |
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of mononuclear cells transplantaion therapy for spinal cord injury
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Type and grade of adverse events
Frequency of adverse events
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intrathecal single injection of autologous mononuclear cells
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Suzuki |
Organization
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Plastic surgery, 5th laboratory
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
yo-suzuki@kitano-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Suzuki |
Organization
The Tazuke Kofukai Medical Research Institute, Kitano Hospital
Division name
Plastic surgery, 5th laboratory
Zip code
Address
2-4-20 Ohgimachi, Kita-ku, Osaka, Japan
TEL
06-6312-1221
Homepage URL
http://www.kitano-hp.or.jp/etcproject/keisei/kenkyu_keisei/index.html
yo-suzuki@kitano-hp.or.jp
Sponsor or person
Institute
Department of plastic surgery, Kitano hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
公益財団法人田附興風会医学研究所北野病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 29 | Day |
Last modified on
| 2013 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008869
