UMIN-CTR Clinical Trial

Public title

Mucosal regeneration therapy by autologous intestinal stem cell transplantation to inflammatory bowel disease patients.

Acronym

Intestinal stem cell transplantation to inflammatory bowel disease patients.

Scientific Title

Mucosal regeneration therapy by autologous intestinal stem cell transplantation to inflammatory bowel disease patients.

Scientific Title:Acronym

Intestinal stem cell transplantation to inflammatory bowel disease patients.

Region

Japan

Condition

Ulcerative colitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

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

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Mamoru Watanabe

Organization

Tokyo Medical and Dental University

Division name

Department of Gastroenterology and Hepatology

Zip code

Address

1-5-45 Yushima, Bunkyou-ku, Tokyo, 113-8519

TEL

03-3813-6111

Email

mamoru.gast@tmd.ac.jp

Name of contact person

1st name
Middle name
Last name	Ryuichi Okamoto

Organization

Tokyo Medical and Dental University

Division name

Center for Stem Cell and Regenerative Medicine

Zip code

Address

1-5-45 Yushima, Bunkyou-ku, Tokyo, 113-8519

TEL

03-3813-6111

Homepage URL

Email

rokamoto.gast@tmd.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2018

Year

04

Month

01

Day

Date of IRB

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

Other related information

Registered date

2017

Year

11

Month

25

Day

Last modified on

2017

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033766