UMIN-CTR Clinical Trial

Basic information
Public title	clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Acronym	churaumi study
Scientific Title	clinical study of the autologous oral mucosal epithelial cell sheets in preventing formation of strictures after endoscopic submucosal dissection for esophageal cancer
Scientific Title:Acronym	churaumi study
Region	Japan

Condition
Condition	Esophageal narrowing after ESD
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The safety of transplanting an autologous oral mucosal epithelial cell sheet for the laceration that occurs when the balloon dilation is performed against esophageal stricture after ESD treatment for early esophageal cancer and its effectiveness for prevention of esophageal constriction
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety of Oral Mucosal Epithelial Cell Sheet
Key secondary outcomes	Preventive effect of esophageal narrowing by oral mucosal epithelial cell sheet transplantation

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Transplant an autologous oral mucosal epithelial cell sheet into the laceration that occurs when balloon dilatation is performed for esophageal stricture
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients over 20 years of age. 2) Patients with esophageal stricture that occurred after ESD treatment for early esophageal cancer. 3) In principle, patients whose major organ functions are maintained as follows (Data within one month before registration). White blood cell count > 4,000 / uL, < 10,000 / uL Platelet count > 100,000 / uL Serum AST (GOT) and ALT (GPT) < 100 IU / L Serum total bilirubin < 2.0mg / dL Serum creatinine < 2.0mg / dL However, if it is considered that the reason for not satisfying the above is based on the primary disease, it can be selected at the discretion of the principal investigator. 4) Patients with written consent. 5) For women: Surgery, radiation, or menopause can rule out the possibility of pregnancy, or the use of approved contraceptive methods can reduce the chance of pregnancy from the start of the study to the end of the study.
Key exclusion criteria	I) Patients with complications of poor control (Heart disease, liver disease, kidney disease, cerebral infarction, etc.). I) Pregnancy, breastfeeding, and patients with the possibility of pregnancy (will). I) Patients with a history of severe drug allergies. Ii) Patients infected with infectious diseases (hepatitis B, hepatitis C, HIV, HTLV-1, syphilis). I) Patients who have a disease in the oral mucosa of the tissue collection site and cannot be collected. Ii) Other patients who are judged inappropriate by the principal investigator.
Target sample size	6

Research contact person
Name of lead principal investigator	1st name Atsunaga Middle name Last name Katou
Organization	Gastroenterology
Division name	Gastroenterology
Zip code	9010243
Address	25 ueda tomidusuku-shi okinawa
TEL	098-850-3811
Email	akatou@yuuai.or.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Ochiai
Organization	Advanced Medical Research Center
Division name	Advanced Medical Research Center
Zip code	9010243
Address	25 ueda tomidusuku-shi okinawa
TEL	098-850-3811
Homepage URL
Email	ochiai.tomishirocentral.hp@gmail.com

Sponsor
Institute	okinawa prefecture
Institute
Department

Funding Source
Organization	okinawa prefecture
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kyushu University Specific Regenerative Medicine Committee
Address	3-1-1 umade higasiku hukuoka-city
Tel	092-642-5082
Email	byshasiwatas@jimu.kyushuu.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 03 Month 11 Day
Date of IRB	2017 Year 03 Month 07 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 19 Day
Last modified on	2019 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030434