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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000002134
Receipt No. R000002415
Scientific Title Immunotherapy with NK cells
Date of disclosure of the study information 2009/07/08
Last modified on 2009/06/29

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Basic information
Public title Immunotherapy with NK cells
Acronym Immunotherapy with NK cells
Scientific Title Immunotherapy with NK cells
Scientific Title:Acronym Immunotherapy with NK cells
Region
Japan Asia(except Japan)

Condition
Condition Clinical study to investigate safety and efficacy on NK cells to health and cancer
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Neurology
Clinical immunology Psychosomatic Internal Medicine Infectious disease
Geriatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Safety,Efficacy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes Antitumor effect
Progression-free survival
Overall survival
QOL
Immunological responses

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 To investigate safety and efficacy on NK cells for human
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
5 years-old <=
Age-upper limit
120 years-old >=
Gender Male and Female
Key inclusion criteria 1.5 years or more
2.performance status is 0-1
3.No serious abnormality in bone marrow, liver and/or
renal functions
Key exclusion criteria 1.Uncontrollable infection
2.Serious cardiac disease
3.Active autoimmune disease
4.Pulmonary fibrosis or interstitial pneumonia, or their history, or predisposition to them
5.Serious drug allergy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name zhang benning
Organization Harbin Medical University
Division name Department of Immunology
Zip code
Address 157 baojian-road,harbin city, china
TEL 86-13030028668
Email

Public contact
Name of contact person
1st name
Middle name
Last name zhang benning
Organization Harbin Medical University
Division name Department of Immunology
Zip code
Address 157 baojian-road, harbin city, china
TEL 86-13030028668
Homepage URL
Email zbn-tky@umin.ac.jp

Sponsor
Institute Kuramae clinic
Institute
Department

Funding Source
Organization Kuramae clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 07 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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
Date of protocol fixation
2007 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 09 Month 01 Day
Date trial data considered complete
2009 Year 09 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 29 Day
Last modified on
2009 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002415

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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