UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013361 |
|---|---|
| Receipt number | R000015589 |
| Scientific Title | Long-term follow-up clinical study of cultured epithelial autografts (CEA, J-TEC-01) for patients with giant congenital melanocytic nevi. |
| Date of disclosure of the study information | 2014/03/10 |
| Last modified on | 2016/03/23 16:22:31 |
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Basic information
Public title
Long-term follow-up clinical study of cultured epithelial autografts (CEA, J-TEC-01) for patients with giant congenital melanocytic nevi.
Acronym
Long-term follow-up clinical study of cultured epithelial autografts (CEA, J-TEC-01) for patients with giant congenital melanocytic nevi.
Scientific Title
Long-term follow-up clinical study of cultured epithelial autografts (CEA, J-TEC-01) for patients with giant congenital melanocytic nevi.
Scientific Title:Acronym
Long-term follow-up clinical study of cultured epithelial autografts (CEA, J-TEC-01) for patients with giant congenital melanocytic nevi.
Region
| Japan |
Condition
Condition
Giant Congenital Melanocytic Nevus (GCMN)
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate long-term safety in patients with GCMN to whom J-TEC-01 have been transplanted in the clinical study (protocol No. 3SI-GCMN001).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State of the grafted site after complete epithelialization; incidence rates of adverse event and failure; safety
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
drawing blood
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The patients or their legal representatives have given written informed consent.
2) The patients to whom J-TEC-01 have been transplanted in the clinical study (protocol No. 3SI-GCMN001).
Key exclusion criteria
1) The patients who are participating or will participate in other clinical studies.
2) The patients who are considered ineligible by the principal investigator or subinvestigator.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeaki hayashi |
Organization
Japan Tissue Engineering Co.,Ltd
Division name
Clinical Development Dept.
Zip code
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
shigeaki_hayashi@jpte.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanji Oshima |
Organization
Japan Tissue Engineering Co.,Ltd
Division name
Clinical Development Dept.
Zip code
Address
6-209-1 Miyakitadori, Gamagori, Aichi 443-0022, Japan
TEL
0533-66-2020
Homepage URL
kanji_oshima@jpte.co.jp
Sponsor or person
Institute
Japan Tissue Engineering Co.,Ltd
Institute
Department
Personal name
Funding Source
Organization
Japan Tissue Engineering Co.,Ltd
Organization
Division
Category of Funding Organization
Profit 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
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 10 | 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
| 2014 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 11 | Month | 13 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 06 | Day |
Last modified on
| 2016 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015589
