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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040927
Receipt No. R000046728
Scientific Title Human immune cell-derived iPS cells to establish treatment model of human diseases
Date of disclosure of the study information 2020/06/29
Last modified on 2020/06/28

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Basic information
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
Condition Healthy Volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
Primary outcomes number of established master cell banks
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Chiba 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 RIKEN Center for Integrative Medical Sciences
Name of secondary funder(s)

IRB Contact (For public release)
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
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
2020 Year 06 Month 29 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 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

Progress
Recruitment status No longer recruiting
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
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

Management information
Registered date
2020 Year 06 Month 28 Day
Last modified on
2020 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046728

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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