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

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038051

Enrollment

Registered

2019-09-19

Start date

2017-06-01

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

Esophageal narrowing after ESD

Interventions

Transplant an autologous oral mucosal epithelial cell sheet into the laceration that occurs when balloon dilatation is performed for esophageal stricture

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over 20 years of age. 2) Patients with esophageal stricture that occurred after ESD treatment for early esophageal cancer. 3) In principle, patients whose major organ functions are maintained as follows (Data within one month before registration). White blood cell count > 4,000 / uL, < 10,000 / uL Platelet count > 100,000 / uL Serum AST (GOT) and ALT (GPT) < 100 IU / L Serum total bilirubin < 2.0mg / dL Serum creatinine < 2.0mg / dL However, if it is considered that the reason for not satisfying the above is based on the primary disease, it can be selected at the discretion of the principal investigator. 4) Patients with written consent. 5) For women: Surgery, radiation, or menopause can rule out the possibility of pregnancy, or the use of approved contraceptive methods can reduce the chance of pregnancy from the start of the study to the end of the study.

Exclusion criteria

Exclusion criteria: I) Patients with complications of poor control (Heart disease, liver disease, kidney disease, cerebral infarction, etc.). I) Pregnancy, breastfeeding, and patients with the possibility of pregnancy (will). I) Patients with a history of severe drug allergies. Ii) Patients infected with infectious diseases (hepatitis B, hepatitis C, HIV, HTLV-1, syphilis). I) Patients who have a disease in the oral mucosa of the tissue collection site and cannot be collected. Ii) Other patients who are judged inappropriate by the principal investigator.

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

Advanced Medical Research Center Advanced Medical Research Center

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

Outcome results

None listed

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