UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016964 |
|---|---|
| Receipt number | R000019605 |
| Scientific Title | Study for infrastructure development for manufacturing of disease-specific iPS cell. |
| Date of disclosure of the study information | 2015/03/30 |
| Last modified on | 2015/03/30 07:39:35 |
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Basic information
Public title
Study for infrastructure development for manufacturing of disease-specific iPS cell.
Acronym
NHO-iPS-Study1
Scientific Title
Study for infrastructure development for manufacturing of disease-specific iPS cell.
Scientific Title:Acronym
NHO-iPS-Study1
Region
| Japan |
Condition
Condition
Designated intractable diseases
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Disease-specific iPS cell banking infrastructure development
Basic objectives2
Others
Basic objectives -Others
Amassment of blood samples and clinical data of patients having designated intractable diseases, for iPS cells
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of designated intractable diseases for iPS cells
Key secondary outcomes
Each number of patients of designated intractable diseases for iPS cells
Base
Study type
Observational
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Designated intractable diseases determined by the Committee for study for infrastructure development for manufacturing of disease-specific iPS cell.
2. Participants are accepted regardless of age and gender.
3. Written informed consent or assent with written proxy informed consent.
Key exclusion criteria
1. HBV carrier (HBsAb+)
2. HCV-Ab+ patient
3. HIV-infected patient, HTLV-1-infected patient
4. Unauthorized person by Principal Investigator or the Commiittee
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuru Kawai |
Organization
National Hospital Organization
Higashisaitama Hospital
Division name
Hospital Director
Zip code
Address
4147 Kurohama Hasuda-shi, Saitama, 349-0196, JAPAN
TEL
(+81)-48-768-1161
iPS@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nao Tsuchida |
Organization
National Hospital Organization Headquaters
Division name
Clinical Research Center
Zip code
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo, 152-8621, JAPAN
TEL
(+81)-3-5712-5087
Homepage URL
iPS@hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Center for iPS Cell Research and Application
Name of secondary funder(s)
MEXT(Japan)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構東埼玉病院等（埼玉）、（National Hospital Organization Higashisaitama Hospita (Saitama) etc.）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 30 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
