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
CRIS Registration Number |
KCT0005880 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Single | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | TOP Cell Plastic Surgery |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | TOP Cell Plastic Surgery |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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). |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | 1. Male and female volunteers aged 20-65 years in good health and diagnosed with android type alopecia |
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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 |
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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 |
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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)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Alopecia grede, Hair density, Hair thickness |
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Timepoint | before treatment and after 1, 3, and 6 months after treatment |
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Secondary Outcome(s) 1 | ||
Outcome | scalp status, keratin of scalp, scalp sensitivity, scalp sebum, hair pore status, and cuticle status |
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Timepoint | before treatment and after 1, 3, and 6 months after treatment |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2022. 6 |
Way of Sharing | Available on Request
(tjkl1012@naver.com) |
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