UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Mucosal regeneration therapy by autologous intestinal stem cell transplantation to inflammatory bowel disease patients.
Title of the study (Brief title)	Intestinal stem cell transplantation to inflammatory bowel disease patients.
Region	Japan

Condition
Condition	Ulcerative colitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The present study is planned to evaluate the feasibility and safety of autologous intestinal stem cell transplantation for the treatment of refractory ulcers in ulcerative colitis patients.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Safety: Evaluation of adverse events observed from study entry to 52 weeks after autologous intestinal stem cell transplantation.
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Autologous intestinal stem cell transplantation (Single-dose)
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) Acquirement of patient-signed formal approvement at study entry. (2) Age over 20 at study entry. (3) Satisfy the diagnostic criteria for ulcerative colitis. (4) Limited clinical efficacy, reduction of efficacy or intolerance to the following drugs: Corticosteroids, Immunomodulators (tacrolimus, azathioprine, 6-mercaptopurine), and anti-TNF antibodies (infliximab, adalimumab, golimumab). (5) Sustained colonic ulcer (over 5mm diameter) confirmed by colonoscopy performed within 4-weeks from study entry.
Key exclusion criteria	(1) Past history of colectomy. (2) Planning or awaiting colectomy. (3) Satisfies contraindication criteria for colonoscopy. (4) Failure to confirm the presence of un-inflamed region by colonoscopy performed within 4-weeks from study entry. (5) Presence of gastrointestinal dysplasia. (6) Complication of colitis other than ulcerative colitis. (7) Presence of active infection. (8) Poor general condition. (9) Past history or suspected presence of malignancy within 5 years from study entry. (10) Having difficulty in making self-decision due to diseases such as dementia. (11) Pregnant or lactating women, including suspected pregnancy or those anticipating pregnancy. (12) Allergy against Neoveil or Beriplast. (13) Allergy against aprotinin, thrombin, fibrinogen, or polyglycolic acid. (14) Allergy against gentamycin or streptomycin. (15) Under treatment with antithrombotic drugs. (16) Under treatment either with hemocoagulase, epsilon aminocaproic acid, tranexamic acid, or aprotinin. (17) Recommended to be excluded by the study director or other study members.
Target sample size	8

Research contact person
Name of lead principal investigator	Mamoru Watanabe
Organization	Tokyo Medical and Dental University
Division name	Department of Gastroenterology and Hepatology
Address	1-5-45 Yushima, Bunkyou-ku, Tokyo, 113-8519
TEL	03-3813-6111
Email	mamoru.gast@tmd.ac.jp

Public contact
Name of contact person	Ryuichi Okamoto
Organization	Tokyo Medical and Dental University
Division name	Center for Stem Cell and Regenerative Medicine
Address	1-5-45 Yushima, Bunkyou-ku, Tokyo, 113-8519
TEL	03-3813-6111
Homepage URL
Email	rokamoto.gast@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

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	2018 Year 04 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 25 Day
Last modified on	2017 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033766