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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

Kengo Yamamoto

Sept. 22, 2023

36

Males and females over 20 years of age in good health diagnosed with male and female pattern hair loss. (1) Gender : 19 male, 19 female (2) Age : 40.4 +/- 10.0 years old (3) Height : 163.8 +/- 7.9cm (4) Body Weight : 62.9 +/- 13.0kg (5) BMI : 23.4 +/- 4.4kg/m2 (6) Stage of pattern hair loss: Male (Norwood-Hamilton scale) Type III vertex: 1 Type IV: 13 Type V: 3 Type VI: 2 Female (Shiseido grade) Grade 3: 10 Grade 4: 5 Grade 5: 3 Grade 6: 1

The number of patients who completed the second administration was set in this study as the objective number of patients, which was 36. Of the 40 cases of consent obtained, of which 38 were eligible and received the first injection, 36 were eligible for the second injection, and 34 were continued to the final observation. The discontinuations after the second injection were due to the subject's own reasons.

Two adverse events that could not be denied being related to this study were recorded: mild pain during injection and folliculitis, both of which were transient and resolved on the same day or within a few weeks. No moderate or severe adverse events or systemic adverse events were observed. In general, there are concerns about adverse events in the treatment of pattern hair loss, such as allergic contact dermatitis from topical agents and libido suppression from oral medications, but the safety profile of this clinical study supports the high safety profile of S-DSC treatment for male and female pattern hair loss.

As for the primary endpoint, 30.0% of participants showed improvement, as judged by two independent physicians in a blinded evaluation. Although this result did not reach the lower limit of 50% of the expected value set for the calculation of the number of cases, since pattern hair loss is progressive, therefore "no change" can be considered as the effect of suppressing the progression of hair loss for 12 months, the efficacy rate of 58.6%, including 28.6% of "unchanged" (suppressed progression), can be considered the efficacy rate. The percentage of improvement in secondary endpoints increased over time, reaching 37.1% after 15 months. In the evaluation of hair thinning areas, there was an increase in several parameters associated with increased hair volume. Self-assessment by the participants showed that 62.9% of them felt the effects, such as increased hair volume. In the stratified analysis, the improvement effect was more pronounced in women and in the group with higher percentage of thicker hair in global photograph assessment, phototrichogram, and participants self-evaluation, suggesting that selecting patients based on specific background factors may improve treatment outcomes in the future.

In this study, two cases of mild side effects were observed at the injection site, but they were transient and no serious side effects were noted. In the primary end point, 30% of the participants showed improvement. In The improvement rate of the secondary evaluation increased to 37.1%, and approximately 63% of the participants felt the effects. These findings suggested that this novel approach with S-DSC is a promising option for the treatment of pattern hair loss for which there are limited treatment.

Sept. 26, 2023

https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.16957

https://jrct.niph.go.jp/latest-detail/jRCTb032200148

Harada Kazutoshi

Tokyo Medical University Hospital

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

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

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.)

Complete

+81-3-5323-2027

July. 03, 2020