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
Not Applicable
Recruiting
- Conditions
- Patient presents with anastomotic re-stricture after repair of EA and CES
- Registration Number
- JPRN-jRCTb030190278
- Lead Sponsor
- Yamamoto Yuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 7
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method