clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer

clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer - Churaumi Study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026506

Enrollment

Registered

2017-05-01

Start date

2017-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Case with esophageal stricture following ESD treatment for early esophageal cancer

Interventions

Oral mucosa and peripheral blood are collected from the patient, an oral mucosa epithelial cell sheet is prepared from the collected oral mucosa and peripheral blood, and transplanted to a laceration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients aged 20 years or older. 2) Patients with esophageal stenosis that occurred after ESD treatment for early esophageal cancer. 3) Patients whose main organ function is kept as a rule as below (data within 1 month before registration). Leukocyte count >= 4,000 <= 10,000 Platelet count >= 100,000 Serum AST (GOT) and ALT (GPT) <= 100 Serum total bilirubin <= 2.0 Serum creatinine <= 2.0 In the above, the inspection standard value of the currently practiced esophageal regeneration cell sheet trial was adopted. However, if it is considered that the reason for not satisfying the above is based on the original disease, it can be selected according to the judgment of the research representative.

Exclusion criteria

Exclusion criteria: 1) Patients with complications of poor control (Heart disease, liver disease, kidney disease, cerebral infarction, etc.). 2)Patients with pregnancy, lactating women and possibility (intention) of pregnancy. 3)A patient with a history of serious drug allergy. 4)Patients infected with infectious diseases (hepatitis B, hepatitis C, HIV, HTLV-1, syphilis). 5)A patient who has a disease in the oral mucosa at the tissue collection site and is unable to collect it. 6)Other patients who are deemed inappropriate by the research representative.

Design outcomes

Primary

Measure	Time frame
Safety of Oral Mucosal Epithelial Cell Sheet	—

Secondary

Measure	Time frame
Preventive effect of esophageal narrowing by oral mucosal epithelial cell sheet transplantation	—

Countries

Japan

Contacts

Public ContactAtsushi Ochiai

Tomishiro Central Hospital Advanced Medical Research Center

ochiai.tomishirocentaral.hp@gmail.com098-850-3811

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026