NCT04689594

A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group

A Phase III, Multicenter, Open-label Study to Evaluate the Esophageal Stenosis Inhibition Effects and Safety of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: CellSeed Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial esophageal cancer in the steroid administration risk group.

Conditions

• Superficial Esophageal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	CLS2702C/CLS2702D	CLS2702C (cell sheet) will be transplanted to the wound site using CLS2702D (transplantation device) (screening period, 1 month \[4 weeks\]; cell sheet culture period, 0.5 month; transplantation and assessment period, 6 months \[24 weeks\]); follow-up period, 6 months \[24 weeks\]) Other Names: •Human (autologous) oral mucosal cell sheet •Transplantation device

Timeline

• Start date: 2021-02-04
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2020-12-30
• Last updated: 2026-03-27

Locations

1 site across 1 country: Japan