UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Title of the study (Brief title)	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	Akihiro Fujino
Organization	National center for child health and development
Division name	Division of surgery, Department of surgical subspecialties
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	Akihiro Fujino
Organization	National center for child health and development
Division name	Division of surgery, Department of surgical subspecialties
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

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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