Unique ID issued by UMIN | UMIN000020246 |
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Receipt number | R000023374 |
Scientific Title | Safety evaluation of the preemptive immune-cell therapy against cancer |
Date of disclosure of the study information | 2015/12/21 |
Last modified on | 2020/03/19 18:26:34 |
Safety evaluation of the preemptive immune-cell therapy against cancer
Safety evaluation of the preemptive immune-cell therapy against cancer
Safety evaluation of the preemptive immune-cell therapy against cancer
Safety evaluation of the preemptive immune-cell therapy against cancer
Japan |
Malignant tumor
Not applicable | Adult |
Others
NO
The aim of this study is to evaluate the safety, immunological response, and subject satisfaction of the preemptive immune-cell therapy against cancer.
Safety
The defined safety*, immunological response**, and subject satisfaction*** set is analyzed and evaluated annually according to the Act on the Safety of Regenerative Medicine.
* : severity, date, frequency, duration, incidence rate and attribution of adverse events
** : immunological status measured by flow cytometry and blood test
*** : subject satisfaction of the preemptive immune-cell therapy against cancer
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Prevention
Maneuver |
Alpha beta T cell therapy
Gamma delta T cell therapy
NK (Natural Killer) cell therapy
40 | years-old | <= |
Not applicable |
Male and Female
A subject MUST:
1) Have risk factors for cancer and desire for receiving the preemptive immune-cell therapy.
2) Be > 40 of age when obtaining the informed consent.
3) Provide written informed consent.
4) Be determined to be appropriate by the doctor in charge.
A subject MUST NOT:
1) Be diagnosed with cancer.
2) Desire to receive the immune-cell therapy for the treatment of any allergic disease.
3) Be HIV or HTLV-1 positive
4) Be an allotransplant recipient.
5) Have a history or sign of interstitial pneumonia.
6) Have an active autoimmune disease.
7) Be a female who is pregnant, nursing, or of childbearing potential.
8) Be determined to be inappropriate by the doctor in charge.
A subject 70 years of age and above must be carefully considered for the risk of an autoimmune disease to enroll in this study.
100
1st name | Shigenori |
Middle name | |
Last name | Goto |
KOUSHIKAI,Non-profitmedicalcorporation
Seta Clinic Tokyo
101-0062
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
03-5280-0086
goto@j-immunother.com
1st name | Eri |
Middle name | |
Last name | Oguma |
KOUSHIKAI,Non-profitmedicalcorporation
Center for Clinical Trials and Research
101-0062
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
03-5244-5751
citeg@j-immunother.com
KOUSHIKAI,Non-profitmedicalcorporation
None
Self funding
01.Seta Clinic Tokyo
02.TouTou
03.Kitaosaka Medical Clinic
04.Fukuoka Medical Clinic
05.LSI Sapporo Clinic
06.TKC Tokyo clinic
Seta Clinic Group Certified Committee for Regenerative Medicine
3F New Surugadai Bldg.2-1-45 Kandasurugadai, Chiyoda-ku Tokyo, 101-0062 JAPAN
03-5244-5751
ccrm@j-immunother.com
NO
jRCTc030190259 - jRCTc030190261
jRCT (Japan Registry Clinical Trials)
01.瀬田クリニック東京 (東京都)
02.よろず医療相談蕩蕩(東京都)
03.北大阪メディカルクリニック(大阪府)
04.福岡メディカルクリニック(福岡県)
05.LSI札幌クリニック(北海道)
06.TKC東京クリニック(東京都)
2015 | Year | 12 | Month | 21 | Day |
Unpublished
Terminated
2015 | Year | 11 | Month | 01 | Day |
2015 | Year | 12 | Month | 10 | Day |
2015 | Year | 12 | Month | 21 | Day |
2025 | Year | 12 | Month | 21 | Day |
This is a paid study.
Transition to jRCT (Japan Registry Clinical Trials).
2015 | Year | 12 | Month | 17 | Day |
2020 | Year | 03 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023374
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