UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040034 |
|---|---|
| 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 | 2026/10/07 10:24:43 |
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Basic information
Public title
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Acronym
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Scientific Title
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Scientific Title:Acronym
Study on preparation, efficacy and safety of human adipocytes for gene therapy
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Others
Basic objectives -Others
Safety and efficacy of propagated gene-transduced adipocytes in in vitro and in vivo experiments
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
Type, frequency and extent of adverse events associated with liposuction
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
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Liposuction on healthy donor
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) 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.
Key exclusion criteria
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.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Maezawa |
Organization
Chiba university
Division name
University hospital Division of Diabetes, Metabolism and Endocrinology
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
kyokote@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kuroda |
Organization
Chiba university
Division name
University hospital, Center for Advanced Medicine
Zip code
260-8677
Address
1-8-1 Inohana, Chuo-ku, Chiba
TEL
043-222-7171
Homepage URL
kurodam@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba university
Institute
Department
Personal name
Funding Source
Organization
CellGenTech, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
CellGenTech, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Certified Clinical Research Review Board
Address
1-8-1 Inohana Chuo-ku, Chiba-City, Japan, Chiba
Tel
043-226-2616
prc-jim@chiba-u.jp
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 24 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
26
Results
Twenty 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.
Results date posted
| 2020 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1) Healthy individuals who have provided informed consent to participate in this study, including the provision of adipose tissue obtained via subcutaneous fat aspiration
2) Patients undergoing plastic or cosmetic surgery in whom subcutaneous adipose tissue removal or aspiration is required, and who have provided informed consent to participate in this study
3) Patients with familial LCAT deficiency (FLD) who participate in a clinical trial or a Class I regenerative medicine clinical research study conducted at Chiba University Hospital
Participant flow
1) Provision of information to participants and acquisition of informed consent (assignment of identification numbers)
(Principal Investigator or Sub-Investigator in the Department of Plastic and Reconstructive Surgery or the Department of Diabetes, Metabolism and Endocrinology)
2) Assessment of participant eligibility
(Collection of participant information, blood sampling, and infectious disease testing)
3) Registration of participants who meet the eligibility criteria
4) Collection of adipose tissue (Sub-Investigator in the Department of Plastic and Reconstructive Surgery)
5) Preparation of cells using adipose tissue, and analyses and evaluation related to efficacy and safety
(Department of Diabetes, Metabolism and Endocrinology; researchers at the Center for Advanced Medicine)
(As a collaborative research project with Chiba University, researchers from CellGenTech Inc. and ZACROS Corporation will conduct the study jointly with researchers at the Center for Advanced Medicine)
Adverse events
None
Outcome measures
Preadipocytes will be prepared from adipose tissue obtained from participants using the ceiling culture method. Various genes will be introduced into the preadipocytes, and the functions of the genetically modified cells will be evaluated both in vitro and in vivo (animal studies). Through these analyses, the efficacy and safety of the gene-modified preadipocytes will be assessed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 02 | Day |
Last modified on
| 2026 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045645
