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Churaumi Study

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTb070190053
Enrollment
6
Registered
2020-03-23
Start date
2018-05-31
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

A case with esophageal stricture after ESD treatment for early esophageal cancer

Interventions

Oral mucosa and peripheral blood are collected from the patient, and an oral mucosal epithelial cell sheet is prepared from the collected oral mucosa and peripheral blood. The prepared cell sheet is t

Sponsors

ATSUNAGA KATOU
Lead Sponsor

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 = 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

MeasureTime frame
Safety of oral mucosal epithelial cell sheet

Secondary

MeasureTime frame
Prevention of esophageal stricture by transplanting oral mucosal epithelial cell sheet

Countries

Japan

Contacts

Public ContactOCHIAI ATSUSHI

Social Medical Corporation Yuaikai Yuuai Medical Cetner

ochiai.tomishirocentral.hp@gmail.com+81-98-850-3811

Outcome results

None listed

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