Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia
Not Applicable
Recruiting
- Conditions
- Congenital esophageal atresia
- Registration Number
- JPRN-UMIN000034566
- Lead Sponsor
- ational center for child health and development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serious adverse events
- Secondary Outcome Measures
Name Time Method Symptoms related to anastomotic stricture (e.g.: dysphagia), degree of anastomotic stricture, cell sheet engraftment, frequency of balloon dilatation, adverse events