UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020734 |
|---|---|
| Receipt number | R000023350 |
| Scientific Title | Pivotal study about efficiency and safety of JTEC-01 made from revertant mosaicism in epidermolysis bullosa |
| Date of disclosure of the study information | 2016/01/26 |
| Last modified on | 2018/05/17 22:59:02 |
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Basic information
Public title
Pivotal study about efficiency and safety of JTEC-01 made from revertant mosaicism in epidermolysis bullosa
Acronym
Pivotal study of J-TEC-01 from revertant mosaicism for epidermolysis bullosa
Scientific Title
Pivotal study about efficiency and safety of JTEC-01 made from revertant mosaicism in epidermolysis bullosa
Scientific Title:Acronym
Pivotal study of J-TEC-01 from revertant mosaicism for epidermolysis bullosa
Region
| Japan |
Condition
Condition
recessive dystrophic epidermolysis bullosa or junctional epidermolysis bullosa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We evaluate the rate of epithelialization at 4 week after the grafting of JTEC-01 to the ulcer, which is cultured from revertant mosaicism areas in epidermolysis bullosa.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the individual rate of epithelialization (%) at 4 week after the graft
Key secondary outcomes
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
| Device,equipment | Other |
Interventions/Control_1
transplanting of J-TEC-01 from revertant mosaicism to skin ulcer or erosion.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)patients diagnosed as severe recessive dystrophic epidermolysis bullosa or junctional epidermolysis bullosa
(2)patients whose causative mutations are identified in COL7A1, COL17A1, LAMA3, LAMB3 or LAMC3.
(3)patients who have one or more ulcers to be grafted with J-TEC-01
(4)patients who clinically have skin area with revertant mosaicism resistant to mechanical stimuli.
(5)patients who have competence and from which we can obtain document consent
(6)20 years of age or older
Key exclusion criteria
(1)patients who have allergy to particular antibiotics (Penicillin, Kanamycin, Amphotericin B) .
(2)patients who have allergy to caw, mouse or pig.
(3)patients who participate in other clinical trials within 6 month.
(4)patients who have malignant tumor or past history of malignancy within 3years (except cutaneous malignancy).
(5)those who are pregnant or nursing mum, or patients who are planning pregnancy during the study.
(6)patients whom the investigators judge inappropriate as a subject for the study
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fujita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-7387
yfujita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Fujita |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Dermatology
Zip code
Address
North 15, West 7, Kita-ku, Sapporo 060-8638, Japan
TEL
+81-11-706-7387
Homepage URL
yfujita@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
National Institute of Biomedical Innovation
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 26 | 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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | Month | 25 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023350
