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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034566
Receipt No. 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

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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
Email 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
Email fujino-a@ncchd.go.jp

Sponsor
Institute National center for child health and development
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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