UMIN-CTR Clinical Trial

Public title

Human immune cell-derived iPS cells to establish treatment model of human diseases

Acronym

Generation of Disease Treatment Model with iPS cells

Scientific Title

Human immune cell-derived iPS cells to establish treatment model of human diseases

Scientific Title:Acronym

Generation of Disease Treatment Model with iPS cells

Region

Japan

Condition

Healthy Volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To establish human NKT cell derived-iPS cells from subjects who met Biological Raw Materials Standards applicable for clinical trials

Basic objectives2

Others

Basic objectives -Others

To establish human NKT cell derived-iPS cells from subjects who met Biological Raw Materials Standards applicable for clinical trials

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

number of established master cell banks

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

60

years-old

>

Gender

Male and Female

Key inclusion criteria

1) Age : Between 20 and 59 years old.
2) Those who agree to take a medical consultation by a doctor
3) Those who agree to take blood tests, including tests on infectious diseases, twice: the second blood test will be conducted after a window period
4) Systolic blood pressure must be between 90 and 160 mmHg, and diastolic blood pressure must be 100 mmHg and less
5) Weight : Male 45kg and above; Female 40kg and above
6) Those who acknowledge to understand the terms and conditions of this study, and sign study participant agreement of their own free will, after receiving sufficient explanation on participation in this study.

Key exclusion criteria

In accordance with the Biological Raw Materials Standards, we exclude subjects who fall into either of the following categories based on medical consultations and/or tests:
1) Those who have a diseases that requires tretments or medications, or is being tested for a suspected disease.
2) Those who have a history of the second degree Vasovagal Reaction and more
3) Those who have a history of the following diseases:
･ Malignant diseases
･ Respiratory diseases (except transient inflammation, and bronchial asthma more than 1 year after cure)
･ Cardiovascular diseases (except cases of congenital heart diseases with no symptoms, untreated, and no screening-detected abnormal ECG)
･ Inflammatory bowel diseases
･ Endocrine diseases (except diabetes which are well controlled only by diet therapy)
･ Renal diseases (except acute nephritis which have been cured)
･ Collagen diseases, and autoimmune diseases
･ Cerebrovascular disorders, and epilepsy
･ Hepatitis (except hepatitis A or D more than 6 months after being cured)
4) Those who have been diagnosed with a genetic disorder or who have a family history of a genetic disorder
5) Those who have received a blood transfusion or an organ transplant, or who have undergone organ donation
6) Those who are currently pregnant, or within 1 year after giving birth
7) Those who have been diagnosed with or are suspected to have transmissible spongiform encephalopathy, dementia, or mental illnesses.
8) Those who have a history of the following infectious diseases:
･ Malaria, Chagas disease, or Toxoplasma gondii infection
･ Tuberculosis within 5 years after being cured
･ Sexually Transmitted Diseases within 1 year after being cured
･ Dengue fever within 1 month after being cured
･ Erythema infectiosum within 6 months after being cured, or an onset of eryhema infectiosum among family members within 1 month
9) Those whose primary doctor consider inappropriate to participate in this study

Target sample size

20

Name of lead principal investigator

1st name	Shinichiro
Middle name
Last name	Motohashi

Organization

Graduate school of Medicine, Chiba University

Division name

Department of Medical Immunology

Zip code

2608670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

TEL

043-222-7171

Email

motohashi@faculty.chiba-u.jp

Name of contact person

1st name	Shinichiro
Middle name
Last name	Motohashi

Organization

Graduate school of Medicine, Chiba University

Division name

Department of Medical Immunology

Zip code

2608670

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

TEL

043-222-7171

Homepage URL

Email

motohashi@faculty.chiba-u.jp

Institute

Chiba 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

RIKEN Center for Integrative Medical Sciences

Name of secondary funder(s)

Organization

Clinical Research Ethics Committee of the Graduate School of Medicine, Chiba University

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

Tel

043-222-7171

Email

motohashi@faculty.chiba-u.jp

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

2020

Year

06

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

20

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

Completed

Date of protocol fixation

2017

Year

09

Month

08

Day

Date of IRB

2017

Year

11

Month

20

Day

Anticipated trial start date

2017

Year

12

Month

01

Day

Last follow-up date

2019

Year

12

Month

18

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Items to examine the eligibility of this study continuation after registration
1) Meet the criteria of liver function, renal function, bone marrow function, and infectious disease tests at a blood test after registration.
2) Meet the criteria of proliferation test of peripheral blood NKT cells
3) Meet the criteria of induction of NKT cell derived-iPS cells
4) Meet all the criteria of infectious tests after the window period
5) Meet the criteria of iPS cell differentiation towards NKT cells
6) Meet the criteria of sterility and virus free test in master cell banking for iPS cells

Registered date

2020

Year

06

Month

28

Day

Last modified on

2020

Year

07

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046728