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
NCT04689594 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2026-03-27
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
- 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
Sponsors & Collaborators
-
CellSeed Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-04
- Primary Completion
- 2023-12-20
- Completion
- 2023-12-20
Countries
- Japan
Study Locations
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