Unique ID issued by UMIN | UMIN000023343 |
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Receipt number | R000026894 |
Scientific Title | Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia. |
Date of disclosure of the study information | 2016/07/26 |
Last modified on | 2020/06/01 21:16:04 |
Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Clinical research study of autologous DSCC
Clinical study on the efficacy and safety of cultured (human) autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Clinical research study of autologous DSCC
Japan |
Androgenetic alopecia
Dermatology | Adult |
Others
NO
To evaluate the efficacy and safety of human autologous hair follicle dermal sheath cup cells (DSCC) on androgenetic alopecia.
Safety,Efficacy
Phototrichogram of injection site, vital signs, and adverse events until 12 month after injection.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
4
Treatment
Maneuver |
Higher cell concentration
Intermediate cell concentration
Lower cell concentration
Placebo
20 | years-old | <= |
Not applicable |
Male and Female
Patients must meet all the following inclusion criteria to enroll into the study:
1. Male or female of 20 year old or more with in good health having androgenetic alopecia involving the vertex area of the scalp.
2. Males patients with androgenetic alopecia characterized as type III vertex type to type VI on the Norwood Scale. Female patients with androgenetic alopecia characterized as vertex pattern type 3 to type 6 of the Shiseido Scale.
3. Person with willingness to provide written informed consent for participation in the study, to attend all study visits and to complete all procedures required by this protocol.
4. The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation and scars that may confound study results.
5. Person with willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
The presence of any of the following will exclude a subject from study enrolment:
1. Use of any product (medication or otherwise) which interferes with the hair growth cycle.
2. Any systemic medical treatment for hair loss within the last 3 months.
3. Start of contraception treatments of oral contraceptives within the last 3 months.
4. Women who are pregnant or nursing and wish to get pregnant in clinical study period.
5. Presence of any medical condition that influences the hair growth cycle.
6. Infection has been confirmed by virological examination and syphilis testing carried out at the time of the screening.
7. Subjects diagnosed with cancer with or without chemotherapy treatment.
8. Sudden hair loss within the last 3 months unrelated to normal seasonal hair shedding or androgenetic alopecia.
9. Subjects in the process of or having completed surgical correction of hair loss in the past 24 months.
10. History of hypersensitivity has been confirmed by application of local anesthetic.
11. A lot of gray hair of the test areas (areas to be injected).
12 Investigator or the sharing researcher has determined to be inappropriate as a target.
66
1st name | Ryoji |
Middle name | |
Last name | Tsuboi |
Tokyo Medical University Hospital
Department of Dermatology
160-0023
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo, 160-0023, Japan
03-3342-6111
tsuboi@tokyo-med.ac.jp
1st name | Manabu |
Middle name | |
Last name | Takahira |
SRD Co., Ltd
Data Science Department
104-0032
RBM kyobashi Bldg., 3-4-8, Hatchobori, Chuo-ku, Tokyo, 104-0032, Japan
03-5543-0296
m-takahira@cro-srd.co.jp
Tokyo Medical University Hospital
None
Other
Department of Dermatology, Toho University Ohashi Medical Center
Tokyo medical university certified special committee for regenerative medicine
6-1-1 Shinjuku, Shinjuku-ku, Tokyo, Japan
03-3342-6111
Regn_IRB@tokyo-med.ac.jp
NO
2016 | Year | 07 | Month | 26 | Day |
https://www.jaad.org/article/S0190-9622(20)30272-3/abstract
Published
https://www.jaad.org/article/S0190-9622(20)30272-3/abstract
67
Fifty men and 15 women aged 33 to 64 years were injected with DSC cells. Total hair density and cumulative hair diameter at the 300,000 DSC cells injection site was significantly increased compared with the placebo after 6 and 9 months. Men and women showed similar improvements, and there were no serious adverse events.
2020 | Year | 06 | Month | 01 | Day |
2020 | Year | 03 | Month | 05 | Day |
Men and women older than 20 years with MPHL and FPHL.
A total of 67 participants were selected and received biopsies, and 65 participants (50 men and 15 women were injected with autologous DSC cells (FAS). A total of 62 participants completed the 12-month observation period (PPS).
Mild adverse events, such as erythema, swelling, purpura, and small hemorrhages, at the injection sites were observed in 14 cases (45 by sites). Three mild vagal reflexes were seen at the time of injection as systemic adverse events. These local and systemic adverse events were mild and occurred during the injection, after which their disappearance was confirmed.
The difference of total hair density (v.s. Placebo, number/cm2)
6 month: 2.6 [1.1]
9 month: 3.6 [1.1]
The difference of cumulative hair diameter (v.s. Placebo, mm/cm2)
6 month: 0.095 [0.002]
9 month: 0.133 [0.002]
Mean difference [95% WaldCI]
Completed
2016 | Year | 05 | Month | 24 | Day |
2016 | Year | 05 | Month | 31 | Day |
2016 | Year | 07 | Month | 12 | Day |
2019 | Year | 03 | Month | 26 | Day |
2016 | Year | 07 | Month | 26 | Day |
2020 | Year | 06 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026894
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