Unique ID issued by UMIN | UMIN000040034 |
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Receipt number | R000045645 |
Scientific Title | Study on preparation, efficacy and safety of human adipocytes for gene therapy |
Date of disclosure of the study information | 2020/04/24 |
Last modified on | 2024/04/05 11:52:53 |
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Japan |
Not applicable
Not applicable | Adult |
Others
NO
Gene-transduced adipocytes are propagated using adipose tissue obtained from healthy donors, patients of plastic surgery, and LCAT deficiency patients. The purpose of this study is to evaluate safety and efficacy of the propagated cells and to establish production procedure and quality tests, and the administration procedure.
Others
Safety and efficacy of propagated gene-transduced adipocytes in in vitro and in vivo experiments
Others
Others
Not applicable
Gene-transduced adipocytes are propagated using adipose tissue obtained from healthy donors, patients of plastic surgery, and LCAT deficiency patients. The purpose of this study is to evaluate safety and efficacy of the propagated cells and to establish production procedure and quality tests, and the administration composition for practical use.
Type, frequency and extent of adverse events associated with liposuction
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
Central registration
1
Treatment
Maneuver |
Liposuction on healthy donor
20 | years-old | <= |
Not applicable |
Male and Female
1) Age 20 or older, gender is not required.
2) Prior to the implementation of this study (before preparing the resected subcutaneous tissue fat; the same applies hereinafter). Those who have explained the purpose and contents of this study and obtained their written consent.
3) FLD patients are patients who have agreed to participate in clinical trials or clinical research such as Type I regenerative medicine and undergo liposuction.
1) Those that it is difficult to collect enough adipose tissue or it is difficult to collect adipose tissue necessary for this study
2) Patients with severe liver, kidney, heart, lung disease, etc. who may be complications after surgery
3) Extremely low nutritional status
4) Those whose general condition is extremely deteriorated
5) Pregnant women, lactating women, persons who may be pregnant
6) Patients who received chemotherapeutic agents within 1 year of lipectomy for cancer patients
7) A person who has a serious infection.
Interviews and clinical tests for HBV (hepatitis B), HCV (hepatitis C), HIV (human immunodeficiency), adult T-cell leukemia, and syphilis. For parvovirus B19, cytomegalovirus, and EB virus, conduct clinical tests as needed.
8) FLD patients follow the exclusion criteria of clinical trials or clinical studies of regenerative medicine.
9) Others that the investigator or investigator deems inappropriate based on clinical symptoms, laboratory test items, etc.
40
1st name | Yoshiro |
Middle name | |
Last name | Maezawa |
Chiba university
University hospital Division of Diabetes, Metabolism and Endocrinology
260-8677
1-8-1 Inohana, Chuo-ku, Chiba
043-222-7171
kyokote@faculty.chiba-u.jp
1st name | Masayuki |
Middle name | |
Last name | Kuroda |
Chiba university
University hospital, Center for Advanced Medicine
260-8677
1-8-1 Inohana, Chuo-ku, Chiba
043-222-7171
kurodam@faculty.chiba-u.jp
Chiba university
CellGenTech, Inc.
Profit organization
Japan
CellGenTech, Inc.
Chiba University Certified Clinical Research Review Board
1-8-1 Inohana Chuo-ku, Chiba-City, Japan, Chiba
043-226-2616
prc-jim@chiba-u.jp
NO
千葉大学医学部附属病院
2020 | Year | 04 | Month | 24 | Day |
Unpublished
23
Eighteen cases were newly enrolled in this study.
Five cases obtained re-consent regarding the use of cells collected in past clinical studies (tissue collection was not performed in this study).
The study is ongoing.
2020 | Year | 10 | Month | 02 | Day |
Open public recruiting
2020 | Year | 03 | Month | 10 | Day |
2020 | Year | 03 | Month | 11 | Day |
2020 | Year | 04 | Month | 24 | Day |
2025 | Year | 01 | Month | 31 | Day |
2020 | Year | 04 | Month | 02 | Day |
2024 | Year | 04 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045645
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