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Effectiveness assessment of autologous adipose tissue derived stromal vascular fraction(SVF) on alopecia

Status Approved

  • First Submitted Date

    2020/12/24

  • Registered Date

    2021/02/09

  • Last Updated Date

    2021/01/25

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005880
    Unique Protocol ID P01-202012-11-005
    Public/Brief Title Innovative method of Alopecia treatment by using adipose-derived stromal vascular fraction (SVF) cells
    Scientific Title Effectiveness assessment of autologous adipose tissue derived stromal vascular fraction(SVF) on alopecia
    Acronym ESVFA
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number P01-202012-11-005
    Approval Date 2020-12-22
    Institutional Review Board Name Korea National Institute For Bioethics Polycy (KNIFBP)
    Institutional Review Board Address 113, Namdaemun-ro, Jung-gu, Seoul, Republic of Korea
    Institutional Review Board Telephone 02-737-8959
    Data Monitoring Committee
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Sung ILL Chung
    Title representive
    Telephone +82-64-743-6668
    Affiliation TOP Cell Plastic Surgery
    Address 161, Yeonbuk-ro, Jeju-si, Jeju-do, Republic of Korea
    Contact Person for Public Queries
    Name Sung ILL Chung
    Title representive
    Telephone +82-64-743-6668
    Affiliation TOP Cell Plastic Surgery
    Address 161, Yeonbuk-ro, Jeju-si, Jeju-do, Republic of Korea
    Contact Person for Updating Information
    Name Do Ha Kim
    Title cordinator
    Telephone +82-64-743-6668
    Affiliation TOP Cell Plastic Surgery
    Address 161, Yeonbuk-ro, Jeju-si, Jeju-do, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-02-17 Anticipated
    Target Number of Participant 20
    Primary Completion Date 2021-03-03 , Anticipated
    Study Completion Date 2021-03-03 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study TOP Cell Plastic Surgery
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-02-17 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name TOP Cell Plastic Surgery
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name TOP Cell Plastic Surgery
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Androgenetic alopecia (AGA) is characterized by progressive reduction of hair density on the scalp through gradual conversion of terminal hairs into vellus hairs. Stromal vascular fraction (SVF) cells harvested from fat cells are one of the latest breakthroughs in the aesthetic field. This study aimed to present clinical cases for the treatment of alopecia areata by transplantation of SVF into the scalp.To evaluate the efficacy of the use of the stromal vascular fraction (SVF) in androgenetic alopecia patients(age range 20-65,-grade I to V), who are suffering from AGA, have been treated with a single injection of autologous SVF in the upper scalp. Autologous SVF was generated and characterized before the injection of 7-8 × 106 cells into the scalp of the patient. Hair regeneration was assessed by three clinical tests: hair skin quality, hair thickness, and hair density at 3 and 6 months post-injection and compared to pre-injection results.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Prospective  
    Target Number of Participant 20
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Healthy patients (age range 20-65 years; grade I to V), who are suffering from AGA

    Cohort/Group Description

    patients (age range 20-65 years; 10 men, 10 women, grade I to V), who are suffering from AGA, have been treated with a single injection of autologous SVF in the upper scalp. Autologous SVF was generated and characterized before the injection of 7-8 × 106 cells into the scalp of the patient. Hair regeneration was assessed by three clinical tests: hair skin quality, hair thickness, and hair density at 3 and 6 months post-injection and compared to pre-injection results.Follow-up for hair evaluation was based on the hair cycles and was performed 1, 3 and 6 months after injection, using Aroma Smart Wizard system (ASW200, Aram Huvis, Seoul, Korea).
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    1. Male and female volunteers aged 20-65 years in good health and diagnosed with android type alopecia
    Sampling Method
    simple random sampling
    Condition(s)/Problem(s) * (L00-L99)Diseases of the skin and subcutaneous tissue 
       (L64.9)Androgenic alopecia, unspecified 

    MeSH Heading Alopecia Tree Number(s) C17.800.329.937.122 C23.300.035 Unique IDD000505 RDF Unique Identifierhttp://id.nlm.nih.gov/mesh/D000505 Scope NoteAbsence of hair from areas where it is normally present. Entry Term(s) Alopecia Cicatrisata Alopecia, Androgenetic Alopecia, Male Pattern Androgenetic Alopecia Androgenic Alopecia Baldness Baldness, Male Pattern Female Pattern Baldness Hair Loss Male Pattern Baldness Pattern Baldness Pseudopelade NLM Classification #WR 460 Date Established 1966/01/01 Date of Entry 1999/01/01 Revision Date2016/02/26
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~65Year

    Description

    1. Male and female patients with androgenic alopecia
    2. Age of 20-65 years, provide written informed consent and comply with the study requirements
    3. Norwood-Hamilton grades I-V
    4. Active hair loss within last 12 months
    5. No clinically significant disease or abnormal laboratory results at the time of screening visit
    6. Patient has adequate abdominal or other subcutaneous adipose tissue accessible by syringe-based lipoharvest
    7. For women of child-bearing potential: negative pregnancy test at screening visit
    Exclusion Criteria
    1. Patients with inflammation, infection, malignancy, allegoric disease, autoimmune disease, pregnancy, diabetes and on current anticoagulant therapy.
    2. Subject who has previously failed or has been deemed nonresponsive to a previous experimental hair loss treatment, prior surgery in the treatment area and subject who has a sensitive, irritated, or abraded scalp area
    3. Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator
    4. Any disease or condition (medical or surgical) that in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk
    Healthy Volunteers Yes
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Alopecia grede, Hair density, Hair thickness
    Timepoint
    before treatment and after 1, 3, and 6 months after treatment
    Secondary Outcome(s) 1
    Outcome
    scalp status, keratin of scalp, scalp sensitivity, scalp sebum, hair pore status, and cuticle status
    Timepoint
    before treatment and after 1, 3, and 6 months after treatment
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 6
    Way of Sharing Available on Request
    (tjkl1012@naver.com)
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