Japanease

Oct. 13, 2020

Oct. 13, 2020

jRCTb032200148

Multicenter clinical study on the efficacy and safety with extensive and repeated injections of cultured (human) autologous hair follicle dermal sheath cup cells on male and female pattern hair loss

Multicenter clinical study on the efficacy and safety with extensive and repeated injections of cultured (human) autologous hair follicle dermal sheath cup cells on male and female pattern hair loss

Harada Kazutoshi

Tokyo Medical University Hospital

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

+81-3-3342-6111

kharada@tokyo-med.ac.jp

Harada Kazutoshi

Tokyo Medical University Hospital

6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo

+81-3-3342-6111

kharada@tokyo-med.ac.jp

Oct. 13, 2020

36

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

none

1. Male or female of 20 year old or more with in good health having pattern hair loss involving the vertex area of the scalp.

2. Male subjects with pattern hair loss characterized as type III vertex to type VI on the Norwood Scale, or equivalent type. Female subjects with pattern hair loss characterized as type 3 to type 6 of the Shiseido Scale.

3. Subjects 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. Subjects with willingness to forego the use quasi drug or medical products for hair growth throughout the course of the study.

1. Use of any product (medication or otherwise) which interferes with the hair growth cycle.

2. Any systemic medical treatment or quasi drug for hair growth within six months prior to obtaining the Informed Consent. Or those who underwent hair loss therapies by LED and/or low power output of raiser radiation within six months prior to obtaining the Informed Consent.

3. Presence of any medical condition that influences the hair growth cycle.

4. Infection with viruses such as HBV, HCV, HIV, adult T-cell leukemia, parvovirus or VDS has been confirmed by virological examination and syphilis testing carried out at the time of the screening.

20age old over
No limit

Both

male and female pattern hair loss

1. blood sampling from the subjects.

2. In study subjects, skin sampling from the occipital scalp after local anesthesia and sutures & removals of stiches at the site of sampling will be performed.

3. Injections of S-DSC to subjects.

Based on the global photo assessment, photos will have to be taken at 12 months medications, and will be employed as a primary endpoint. These photos taken following injections of S-DSC will have to be analyzed.

Quantitative analysis by Phototrichogram (hair density etc.)

Recruiting

SHISEIDO CO., LTD.
Applicable
Tokyo Medical University Certified Special Committee for Regenerative Medicine
6-1-1 Shinjuku, Shinjuku-ku, Tokyo

+81-3-5323-2027

regn_irb@tokyo-med.ac.jp
Approval

July. 03, 2020