Churaumi Study

Phase 1

Suspended

• Conditions: A case with esophageal stricture after ESD treatment for early esophageal cancer

• Registration Number: JPRN-jRCTb070190053
• Lead Sponsor: ATSUNAGA KATO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-23
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 6

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified