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Autologous Cell Sheets Transplantation After ESD in the Esophagus

NCT02455648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-10-24

No results posted yet for this study

Summary

Healing of mucosal defects after endoscopic mucosal resection in the oesophagus is prone to result in varying degrees of stenosis, especially if the resected area is large and/or circumferential. A new technique was described where autologous cells from the patients own oral mucosa are harvested and cultures on proprietary membranes (coated, temperature sensitive). These membranes, coined cell sheets, are used to cover the mucosal defects.

Conditions

  • Barrett Esophagus

Interventions

PROCEDURE

ESD/EMR plus Cell Sheet

Patients receive ESD/EMR plus CellSheet: Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane ("Cell Sheet") that are inserted 2 weeks later on the occasion of the ESD or EMR

PROCEDURE

ESD/EMR

only ESD/EMR: Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane ("Cell Sheet") but NOT used for insertion in the patient during/after ESD/EMR two weeks later

Sponsors & Collaborators

  • Matthias Löhr

    lead OTHER

Principal Investigators

  • Magnus Nilsson, MD PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-03-25
Completion
2018-03-25

Countries

  • Sweden

Study Locations

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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 NCT02455648 on ClinicalTrials.gov