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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTb030190278

Enrollment

Registered

2020-03-31

Start date

2018-02-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient presents with anastomotic re-stricture after repair of EA and CES

Interventions

Transplant autologous oral mucosal epidermal cell sheet endoscopically to the dilated site after endoscopic balloon dilatation

Eligibility

Sex/Gender

All

Inclusion 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

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 =10,000/mm^3 (5) Patient's PLT =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

Design outcomes

Primary

Measure	Time frame
Serious adverse events	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYuki Yamamoto

National center for child health and development

yamamoto-yuk@hcchd.go.jp+81-3-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026