Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial… (NCT02866019) | Clinical Trial Compass
CompletedPhase 3
Human (Autologous) Oral Mucosal Cell Sheet Transplantation After ESD in Patients With Superficial Esophageal Cancer
Japan10 participantsStarted 2016-04
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of esophageal epithelial regenerative treatment by the transplantation of the product, CLS2702C, to the esophageal wound site after extensive ESD for superficial esophageal cancer.
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Patients who plan to undergo ESD for the treatment of superficial esophageal cancer
✓. Patients aged ≥20 years at the time of consent
✓. Patients with no clinical metastasis (cN0M0) by cervical to abdominal CT
✓. Patients with an endoscopically diagnosed depth of wall invasion remaining in the epithelium (EP) or lamina propria mucosae (LPM)
✓. Patients with ≥3/4 of circumference and a length of \<8 cm
✓. If the patient has multiple lesions, the circumference of all minor lesions other than the one lesion with the largest circumference (major lesion) must be \<1/2, and the distance between the minor lesions and the major lesion must be 5 cm or more on the major axis.
✓. Patients with squamous cell carcinoma (including high-grade intraepithelial neoplasia) as confirmed by biopsy
✓. Patients whose lesion is confirmed to be localized in the thoracic esophagus (lesions in the cervical esophagus or abdominal esophagus will be excluded). The location of the lesion will be determined by endoscopy.
Exclusion criteria
✕. Patients with cardiac disease (myocardial infarction, unstable angina, and heart failure), renal disease (nephrotic syndrome and kidney failure), or poorly controlled diabetes mellitus
✕. Patients who have an active (within 1 year) malignancy other than esophageal cancer
✕
What they're measuring
1
Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD)
. Patients with active bacterial, fungal, or viral infection
✕. Patients who are being treated with a corticosteroid
✕. Patients with positive HBs antigen, positive HCV antibody, positive HIV antibody, positive HTLV antibody, or positive Treponema pallidum (tested at screening). For patients with positive HBc/HBs antibody, HBV-DNA test will be performed (if the result is negative, the patient will be allowed to enter the study).
✕. Patients with a mental disorder that is difficult to control
✕. Pregnant women, lactating women, and potentially pregnant women
✕. Patients who have participated in another clinical study within 6 months, those who are participating in another clinical study, and those who plan to participate in another clinical study during participation in Study CLS2702-ESO-01