UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000825 |
|---|---|
| Receipt number | R000000981 |
| Scientific Title | Treatment of Spinal Cord Injury with Olfactory Mucosa Autgrafts in Human Spinal Cord Injury : Phase 1 and 2 Clinical Study |
| Date of disclosure of the study information | 2007/09/14 |
| Last modified on | 2012/10/15 16:23:44 |
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Basic information
Public title
Treatment of Spinal Cord Injury with Olfactory Mucosa Autgrafts in Human Spinal Cord Injury : Phase 1 and 2 Clinical Study
Acronym
Olfactory Mucosa Autgrafts(MP0603)
Scientific Title
Treatment of Spinal Cord Injury with Olfactory Mucosa Autgrafts in Human Spinal Cord Injury : Phase 1 and 2 Clinical Study
Scientific Title:Acronym
Olfactory Mucosa Autgrafts(MP0603)
Region
| Japan |
Condition
Condition
spinal cord injury
Classification by specialty
| Neurology | Orthopedics | Urology |
| Neurosurgery | Emergency medicine | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Olfactory mucosa is a readily accessible source of olfactory ensheathing and stem-like progenitor cells for neural repair. To determin the safety and feasibility of transplanting olfactory mucosa into patients with injured spinal cords, a human pilot clinical study is conducted. Furthermore the drug to accelerate the axonal regeneration is supposed to be added.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
infection and malignant neoplasm
Key secondary outcomes
Effeicacy
ASIA scoring,SSEP,MEG,MEP
urinary function
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Olfactory Mucosa Autografts(+)
Fasudil Hydrochloride Hydrate(+)
Interventions/Control_2
Olfactory Mucosa Autografts(+)
Fasudil Hydrochloride Hydrate(-)
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
| 7 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.ASIA or Frankel A or B.
2.MRI :The length of the injury part doesn't exceed 3 cm and be single.
3.CT :It doesn't admit an intranasal.
4.MRSA and MRSE isn't detected.
5.The sense of smell is normal.
6.The equal to or more than 6 month elapse after carrier wound.
Key exclusion criteria
1.It bleeds at the spinal cord.
2.Mental disease.
3.Alcohol dependence
4.Consciousness disorder.
5.Malignant tumor/
6.HIV, HBV, HCV, HTLV, CMV,syphilis.
7.Liver or Renal fault.
8.Respiratory fault.
9.Hypotension. Diabetes.
10.When judged not to suit
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Yoshimine |
Organization
Osaka University Medical School
Division name
Department of Neurosurgery
Zip code
Address
2-2 YAMADAOKA SUITA OSAKA, 565-0871 JAPAN
TEL
06-6879-3652
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Iwatsuki |
Organization
Osaka University Medical School
Division name
Department of Neurosurgery
Zip code
Address
2-2 YAMADAOKA SUITA OSAKA, 565-0871 JAPAN
TEL
06-6879-3652
Homepage URL
kiwatsuki@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Osaka University Medical School
Institute
Department
Personal name
Funding Source
Organization
center of excellence
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
The director of the Medical Center for Translational Research
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 09 | Month | 14 | 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
| 2006 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | 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
| 2007 | Year | 09 | Month | 14 | Day |
Last modified on
| 2012 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000981
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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