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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040034
Receipt No. 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 2021/10/05

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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 Koutaro
Middle name
Last name Yokote
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
Email 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
Email kurodam@faculty.chiba-u.jp

Sponsor
Institute Chiba university
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 10
Results Five 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 test 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
Participant flow
Adverse events
Outcome measures
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
2021 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045645

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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