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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02866019
Other study ID # CLS2702-ESO-01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2016
Est. completion date February 2019

Study information

Verified date February 2019
Source CellSeed Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
CLS2702C/CLS2702D
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])

Locations

Country Name City State
Japan National Cancer Center Hospital Chuo-ku Tokyo
Japan National Cancer Center Hospital East Kashiwa-shi Chiba
Japan Tokyo Women's Medical University Hospital Shinjuku-ku Tokyo

Sponsors (1)

Lead Sponsor Collaborator
CellSeed Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants without stenosis until 8 weeks after endoscopic submucosal dissection (ESD) Up to 8 weeks after ESD
Secondary 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. Up to 24 weeks after ESD
Secondary Number of esophageal balloon dilatations (investigated until wound healing is confirmed) Number of esophageal balloon dilatations will be counted. Up to 24 weeks
Secondary 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.
From day -16 to 24 weeks
Secondary 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. Up to 4 weeks
Secondary QOL assessed by the EORTC QLQ-OG 25 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. Up to 24 weeks
See also
  Status Clinical Trial Phase
Terminated NCT04689594 - A Study to Evaluate the Esophageal Stenosis Inhibition Effects of CLS2702C/CLS2702D After Endoscopic Submucosal Dissection (ESD) in Patients With Superficial Esophageal Cancer in the Steroid Administration Risk Group Phase 3