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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008046
Receipt No. R000009476
Scientific Title Clinical prospective study to investigate efficacy of NK cell therapy for malignant tumors.
Date of disclosure of the study information 2012/05/28
Last modified on 2013/05/31

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Basic information
Public title Clinical prospective study to investigate efficacy of NK cell therapy for malignant tumors.
Acronym Clinical prospective study to investigate efficacy of NK cell therapy for malignant tumors.
Scientific Title Clinical prospective study to investigate efficacy of NK cell therapy for malignant tumors.
Scientific Title:Acronym Clinical prospective study to investigate efficacy of NK cell therapy for malignant tumors.
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obsterics and gynecology Dermatology Oto-rhino-laryngology
Urology Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the stability of NK cell culture technology, and investigate efficacy of NK cell therapy for malignant tumors.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To examine the stability of NK cell culture technology and explore improvement factors of NK cell cultivation.
Key secondary outcomes Safety
Immunological responses
Efficacy

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 NK cells are injected on day0, day14, day28, day42, day56, day70.
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with histologically confirmed malignant tumors.
(2) Performance Status is 0-2.
(3) No serious abnormality in bone marrow, liver, and renal functions.
(4) Informed consent has been obtained.
Key exclusion criteria Patients who have:
(1) Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them;
(2) Serious drug allergy;
(3) Positive for HIV or HTLV-1;
(4) Active autoimmune disease;
(5) Continuous systemic administration of steroids;
(6) Other cancers;
(7) Active infections;
(8) Pregnant or lactating;
(9) T cell, NK cell lymphoma and leukemia;
(10) Serious cardiac disease;
(11) Any reason why, in the opinion of the investigator, the patient should not participate.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kamigaki
Organization Seta Clinic Group
Division name Clinical reserch center
Zip code
Address 8F Kokoro to Karada no genki pulaza Bld. 3-6-5 Iidabashi, Chiyoda-ku Tokyo, 102-0072 JAPAN
TEL 03-5215-0086
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Ibe
Organization Seta Clinic Group
Division name Clinical research center
Zip code
Address 8F Kokoro to Karada no genki pulaza Bld. 3-6-5 Iidabashi, Chiyoda-ku Tokyo, 102-0072 JAPAN
TEL 03-5215-0086
Homepage URL
Email scrc@j-immunother.com

Sponsor
Institute Seta Clinic Group
Institute
Department

Funding Source
Organization Medinet Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 瀬田クリニックグループ

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 28 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 Completed
Date of protocol fixation
2012 Year 05 Month 11 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2013 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 05 Month 28 Day
Last modified on
2013 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009476

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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