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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007599
Receipt No. 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

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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
Email 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
Email yo-suzuki@kitano-hp.or.jp

Sponsor
Institute Department of plastic surgery, Kitano hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008869

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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