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Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial Esophageal Cancer

NCT02866019 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-03-07

No results posted yet for this study

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.

Conditions

  • Superficial Esophageal Cancer

Interventions

DEVICE

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 \[16 days\]; transplantation period, assessment/follow-up period, 6 months \[24 weeks\])

Sponsors & Collaborators

  • CellSeed Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-02-28
Completion
2019-02-28

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866019 on ClinicalTrials.gov