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.
This study is a multicenter, single-arm, open-label study of CLS2702C/D in patients who plan to undergo ESD for superficial esophageal cancer. In this study, the efficacy and safety of CLS2702C (cell sheet) transplanted (applied) to the wound site after ESD using CLS2702D (transplantation device) will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
CLS2702C (cell sheet) will be transplanted to the wound site using CLS2702D (transplantation device) (screening period, 1 month \[4 weeks\]; cell sheet culture period, 0.5 month \[16 days\]; transplantation period, assessment/follow-up period, 6 months \[24 weeks\])
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD)
Time frame: Up to 8 weeks after ESD
Time to wound healing
Wound healing is defined as re-epithelized state with no white coat, erosion, or ulcer in the process of healing. The time to wound healing will be assessed endoscopically.
Time frame: Up to 24 weeks after ESD
Number of esophageal balloon dilatations (investigated until wound healing is confirmed)
Number of esophageal balloon dilatations will be counted.
Time frame: Up to 24 weeks
Number of participants reporting one or more adverse events and product deficiencies
An adverse event is defined as any untoward medical occurrence in a subject who has used the product or received the study treatment, regardless of the causal relationship with the product. An adverse event can therefore be any untoward and unintended sign (including abnormal laboratory finding), symptom, or disease (new disease or worsening of an existing disease) temporally associated with the use of the product or implementation of the study treatment.
Time frame: From day -16 to 24 weeks
Quality of Life (QOL) measured with the EORTC QLQ-C30
The European Organization for Research and Treatment of Cancer QLQ-C30 is a quality-of-life instrument for use in international clinical trials in oncology. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale.
Time frame: Up to 4 weeks
QOL assessed by the EORTC QLQ-OG 25
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EORTC QLQ-OG25 questionnaire is a quality-of-life instrument for use in patients with esophagogastric cancers. The QLQ-OG25 has six scales, dysphagia, eating restrictions, reflux, odynophagia, pain and anxiety.
Time frame: Up to 24 weeks