UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019694
Receipt number R000022714
Scientific Title Olfactory mucosa transplantation for regenerative medcine of functional recovery in spinal cord injury
Date of disclosure of the study information 2015/11/09
Last modified on 2016/07/21 20:51:17

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Basic information

Public title

Olfactory mucosa transplantation for regenerative medcine of functional recovery in spinal cord injury

Acronym

Olfactory mucosa transplantation for regenerative medcine of functional recovery in spinal cord injury

Scientific Title

Olfactory mucosa transplantation for regenerative medcine of functional recovery in spinal cord injury

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Koichi Iwatsuki

Organization

Osaka University

Division name

Neurosurgery

Zip code


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

1st name
Middle name
Last name Yuichiro Ohnishi

Organization

Osaka University

Division name

Neurosurgery

Zip code


Address

2-2 Yamada-oka Suita Osaka

TEL

06-6879-3657

Homepage URL


Email

ohnishi@nsurg.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



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)



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

2015 Year 11 Month 09 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2015 Year 11 Month 09 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022714


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name