Clinical trial of autologous oral mucosal epidermal cell sheet transplantation in patients with anastomotic re-stricture after repair of congenital esophageal atresia

Conditions

Congenital esophageal atresia

Yasushi Fuchimoto, Yuki Yamamoto, Akihiro Fujino, Naoki Shimojima, Akihiro Yoneda et al. (14 authors)

Scientific Reports2026-06-01

Evaluation of safety and efficacy of autologous oral mucosa-derived epithelial cell sheet transplantation for prevention of anastomotic restenosis in congenital esophageal atresia and congenital esophageal stenosis.

Fujino A, Fuchimoto Y, Mori T, Kano M, Yamada Y, Ohno M, Baba Y, Isogawa N, Arai K, Yoshioka T, Abe M, Kanai N, Takagi R, Maeda M, Umezawa A.

2023-04-137 citations

10.1186/s13287-023-03321-8

First-in-human autologous oral mucosal epithelial sheet transplantation to prevent anastomotic re-stenosis in congenital esophageal atresia.

Fujino A, Fuchimoto Y, Baba Y, Isogawa N, Iwata T, Arai K, Abe M, Kanai N, Takagi R, Maeda M, Umezawa A.

2022-01-2814 citations

10.1186/s13287-022-02710-9

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 (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 <10.0 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

Design outcomes

Primary

Measure	Time frame
Serious adverse events	—

Secondary

Measure	Time frame
Symptoms related to anastomotic stricture (e.g.: dysphagia), degree of anastomotic stricture, cell sheet engraftment, frequency of balloon dilatation, adverse events	—

Countries

Japan

Contacts

Public ContactAkihiro Fujino

National center for child health and development Division of surgery, Department of surgical subspecialties

fujino-a@ncchd.go.jp03-3416-0181

Outcome results

None listed