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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011637
Receipt No. R000013610
Scientific Title Olfactory mucosal transplantation in spinal cord injury
Date of disclosure of the study information 2013/09/03
Last modified on 2013/09/03

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Basic information
Public title Olfactory mucosal transplantation in spinal cord injury
Acronym Olfactory mucosal transplantation in spinal cord injury
Scientific Title Olfactory mucosal transplantation in spinal cord injury
Scientific Title:Acronym Olfactory mucosal transplantation in spinal cord injury
Region
Japan

Condition
Condition Spinal cord injury
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The olfactory mucosa is transplanted to chronic spinal cord injury patients to see their recovery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes dictation,vital sign, physiological examination, preoperative motor and sensory evaluation,
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 maneuver
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
7 years-old <
Age-upper limit
40 years-old >=
Gender Male and Female
Key inclusion criteria age, over 12 months after the injury,AISA score , MRI , CT scan
Key exclusion criteria bleeding,mental disorder,alcohol abuse, infection,
disturbance of consciousness,kidney disorder,breathing disorder,hypopiesis,diabetes
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshimine Toshiki
Organization Osaka University
Division name Neurosurgery
Zip code
Address 2-2 Yamadaoka Suita
TEL 06-6879-3657
Email kiwatsuki@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoriko Takahashi
Organization Osaka University
Division name Neurosurgery
Zip code
Address 2-2 Yamadaoka Suita
TEL 06-6879-3657
Homepage URL
Email ytakahashi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Neurosurgery, Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Health, Labour and Welfare Ministry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2013 Year 09 Month 03 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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 09 Month 03 Day
Last modified on
2013 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013610


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