UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034566 |
|---|---|
| Receipt number | R000039393 |
| Scientific Title | Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia |
| Date of disclosure of the study information | 2018/10/20 |
| Last modified on | 2018/10/19 09:46:24 |
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Basic information
Public title
Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Acronym
Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia
Scientific Title
Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Scientific Title:Acronym
Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia
Region
| Japan |
Condition
Condition
Congenital esophageal atresia
Classification by specialty
| Gastrointestinal surgery | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assess the safety and efficacy of autologous oral mucosal epidermal cell sheet transplantation after balloon dilatation in patients with intractable anastomotic re-stricture after repair of congenital esophageal atresia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Serious adverse events
Key secondary outcomes
Symptoms related to anastomotic stricture (e.g.: dysphagia), degree of anastomotic stricture, cell sheet engraftment, frequency of balloon dilatation, adverse events
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
| Other |
Interventions/Control_1
Transplant autologous oral mucosal epidermal cell sheet endoscopically to the dilated site after endoscopic balloon dilatation
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
| 1 | years-old | <= |
Age-upper limit
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patient presents with anastomotic re-stricture after repair of congenital esophageal atresia
(2)Patient present with anastomotic re-stricture after five or more balloon dilatation treatments
Key exclusion criteria
(1) Patient's oral mucosal tissue can't be picked up
(2) Patient is infected with HBV, HCV, HIV, HTLV or syphilis
(3) Patieny's Hb <10.0 g/dL
(4) Patient's WBC <4,000/mm3, >=10,000/mm3
(5) Patient's PLT <100,000/mm3
(6) Patient's AST, ALT >=100 IU/L
(7) Patient developed hypersensitivity to drug or pig-derived ingredient
(8) Patient has severe complication irrelevant to anastomotic re-stricture
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Fujino |
Organization
National center for child health and development
Division name
Division of surgery, Department of surgical subspecialties
Zip code
Address
2-10-1 Okura Setagaya Tokyo 157-8535
TEL
03-3416-0181
fujino-a@ncchd.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Fujino |
Organization
National center for child health and development
Division name
Division of surgery, Department of surgical subspecialties
Zip code
Address
2-10-1 Okura Setagaya Tokyo 157-8535
TEL
03-3416-0181
Homepage URL
fujino-a@ncchd.go.jp
Sponsor or person
Institute
National center for child health and development
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
PB3170031
Org. issuing International ID_1
Ministry of Health, Labour and Welfare
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立成育医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 10 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 19 | Day |
Last modified on
| 2018 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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