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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040034

Enrollment

Registered

2020-04-24

Start date

2020-04-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Liposuction on healthy donor

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Type, frequency and extent of adverse events associated with liposuction	—

Countries

Japan

Contacts

Public ContactMasayuki Kuroda

Chiba university University hospital, Center for Advanced Medicine

kurodam@faculty.chiba-u.jp043-222-7171

Outcome results