Clinical trial · Interventional
Autologous Cell Sheets Transplantation After ESD in the Esophagus
Transplantation of Autologous Cell Sheets After Endoscopic Submucosal Dissection (ESD) for Early Adenocarcinoma of the Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD/EMR | Procedure | — | UNRESOLVED |
| ESD/EMR plus Cell Sheet | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ESD/EMR plus Cell Sheet
- description
- Patients receive both mucosal buccal biopsy and insertion of cell sheets during/after ESD/EMR
- interventionNames
- Procedure: ESD/EMR plus Cell Sheet
- type
- SHAM_COMPARATOR
- label
- ESD/EMR
- description
- patients receive both mucosal biopsy but no placement of cell sheets during/after ESD
- interventionNames
- Procedure: ESD/EMR
Primary outcomes (1)
- measure
- Post-operative stenosis
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Barrets esophagus, histologically confirmed, or early oesophageal cancer (both squamous and adeno) Exclusion Criteria: * no consent can be given * prior ESD/EMR
References
Publications (1)
- RESULTJonas E, Sjoqvist S, Elbe P, Kanai N, Enger J, Haas SL, Mohkles-Barakat A, Okano T, Takagi R, Ohki T, Yamamoto M, Kondo M, Markland K, Lim ML, Yamato M, Nilsson M, Permert J, Blomberg P, Lohr JM. Transplantation of tissue-engineered cell sheets for stricture prevention after endoscopic submucosal dissection of the oesophagus. United European Gastroenterol J. 2016 Dec;4(6):741-753. doi: 10.1177/2050640616631205. Epub 2016 Feb 19. PMID 28408991