UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Olfactory mucosa transplantation for regenerative medcine of functional recovery in spinal cord injury
Title of the study (Brief title)	Olfactory mucosa transplantation for regenerative medcine of functional recovery 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	This clinical study aims to evaluate the effectiveness of olfactory mucosa transplantation for chronic spinal cord injury patients who apply for advanced medical technology of"olfactory mucosa transplantation for regenerative treatment in spinal cord" in Osaka university hospital. In addition, this study conducts technical training for "olfactory mucosa transplantation for regenerative treatment in spinal cord", and increases joint research facilities at all times while trying to spread the relevant technique.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1)SF-36(PF) (2)AIS
Key secondary outcomes	1) SF-36(BP,GH,VT,SF,RE,MH,PCS,MCS,RCS) 2)AIS 3)SCIM 4)ASIA scoring 5)EMG 6)AE

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 Other
Interventions/Control_1	olfactory mucosa transplantation
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	16 years-old <
Age-upper limit	40 years-old >=
Gender	Male and Female
Key inclusion criteria	1.age 16-40, 2.over 12 months after injury 3.AISA score A and B 4.shorter than 3 cm in the lesion by MRI 5.no disorder in olfactory by CT scan 6.normal olfactory function 7.no MRSA, MRSE 8.letter of consent
Key exclusion criteria	1.bleeding 2.mental disorder 3.low in CTCAE grade 4.tumor 5.RPR screening 6.disease of the hepatobiliary system 7.kidney disorder 8.respiratory disorder 9.low blood pressure 10.high blood sugar 11.muscle atrophy 12.others
Target sample size	10

Research contact person
Name of lead principal investigator	Koichi Iwatsuki
Organization	Osaka University
Division name	Neurosurgery
Address	2-2 Yamada-oka Suita Osaka
TEL	06-6879-3657
Email	kiwatsuki@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Yuichiro Ohnishi
Organization	Osaka University
Division name	Neurosurgery
Address	2-2 Yamada-oka Suita Osaka
TEL	06-6879-3657
Homepage URL
Email	ohnishi@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	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	Grants in aid for scientific research
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 11 Month 09 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 11 Month 09 Day
Anticipated trial start date	2015 Year 11 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 11 Month 09 Day
Last modified on	2016 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022714