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 |
Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia
Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Autologous epidermal cell sheet transplantation for anastomotic re-stricture after repair of congenital esophageal atresia
Japan |
Congenital esophageal atresia
Gastrointestinal surgery | Pediatrics |
Others
NO
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
Safety,Efficacy
Exploratory
Not applicable
Serious adverse events
Symptoms related to anastomotic stricture (e.g.: dysphagia), degree of anastomotic stricture, cell sheet engraftment, frequency of balloon dilatation, adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Other |
Transplant autologous oral mucosal epidermal cell sheet endoscopically to the dilated site after endoscopic balloon dilatation
1 | years-old | <= |
18 | years-old | > |
Male and Female
(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
(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
5
1st name | |
Middle name | |
Last name | Akihiro Fujino |
National center for child health and development
Division of surgery, Department of surgical subspecialties
2-10-1 Okura Setagaya Tokyo 157-8535
03-3416-0181
fujino-a@ncchd.go.jp
1st name | |
Middle name | |
Last name | Akihiro Fujino |
National center for child health and development
Division of surgery, Department of surgical subspecialties
2-10-1 Okura Setagaya Tokyo 157-8535
03-3416-0181
fujino-a@ncchd.go.jp
National center for child health and development
Japan agency for medical research and development
Government offices of other countries
Japan
Ministry of Health, Labour and Welfare
YES
PB3170031
Ministry of Health, Labour and Welfare
国立成育医療研究センター(東京都)
2018 | Year | 10 | Month | 20 | Day |
Unpublished
Open public recruiting
2017 | Year | 07 | Month | 19 | Day |
2017 | Year | 11 | Month | 06 | Day |
2019 | Year | 03 | Month | 31 | Day |
2018 | Year | 10 | Month | 19 | Day |
2018 | Year | 10 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039393