臨床研究等提出・公開システム

Date of registration	Mar. 31, 2020
Last modified on	Jan. 31, 2025
Trial ID	jRCTb030190278

Scientific Title	Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia and congenital esophageal stenosis (Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia and congenital esophageal stenosis)
Public Title	Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia and congenital esophageal stenosis (Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia and congenital esophageal stenosis)
Manager (representative manager when conducting as a multicenter joint research)	Kasahara Mureo

Contact for Scientific Queries	Name	Yamamoto Yuki
	Affiliation	National center for child health and development
	Address	2-10-1 Okura Setagaya Tokyo
	Telephone	+81-3-3416-0181
	E-mail	yamamoto-yuk@ncchd.go.jp
Contact for Public Queries	Name	Yamamoto Yuki
	Affiliation	National center for child health and development
	Address	2-10-1 Okura Setagaya Tokyo
	Telephone	+81-3-3416-0181
	E-mail	yamamoto-yuk@hcchd.go.jp

Target sample size		8
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patient presents with anastomotic re-stricture after repair of congenital esophageal atresia or congenital esophageal stenosis (2) Patient present with anastomotic re-stricture after five or more balloon dilatation treatments
	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/mm^3, >=10,000/mm^3 (5) Patient's PLT <100,000/mm^3 (6) Patient's AST, ALT >=100 IU/L (7) Patient developed hypersensitivity to pig-derived ingredient or bovine-derived ingredient (8) Patient has a history of drug hypersensitivity (9) Patient has severe complication irrelevant to anastomotic re-stricture
	Age Minimum	5age old over
	Age Maximum	50age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Patient presents with anastomotic re-stricture after repair of EA and CES
Intervention(s)		Transplant autologous oral mucosal epidermal cell sheet endoscopically to the dilated site after endoscopic balloon dilatation
Primary Outcome(s)		Serious adverse events
Secondary Outcome(s)		1. Symptoms related to anastomotic stricture (e.g.: dysphagia), degree of anastomotic stricture 2. Frequency and interval balloon dilatation 3. Assessment by the passage of endoscope through the anastomosis site stricture 4. Adverse events

Anticipated date of first enrollment	Oct. 20, 2018
Actual date of first enrollment	Feb. 22, 2018
Recruitment status	Recruiting

Secondary Sponsor

Secondary Sponsor

Source of Monetary Support	Japan agency for medical research and development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Certified Special Committee for Regenerative Medicine, National center for child health and development
Address	2-10-1 Okura Setagaya, Tokyo
Telephone	+81-3-3416-0181
E-Mail	kenkyu-ncchd@ncchd.go.jp
Approval Status	Approval
Date of approval	Aug. 14, 2017

Plan to share IPD	No
Countries of Recruitment（Except Japan）	none

Secondary ID(s)	PB3170031
Issuing Authority	Ministry of Health, Labour and Welfare

History of Changes

No	Publication date
8	Jan. 31, 2025	(this page)	Changes
7	Jan. 09, 2024	Detail	Changes
6	April. 03, 2023	Detail	Changes
5	Feb. 17, 2023	Detail	Changes
4	Aug. 10, 2022	Detail	Changes
3	Mar. 22, 2022	Detail	Changes
2	May. 07, 2021	Detail	Changes
1	Mar. 31, 2020	Detail

List of change history