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

ATSUNAGA KATO0 个研究点目标入组 6 人开始时间: 2020年3月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

ATSUNAGA KATO