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Clinical research for autologous-cultured epithelium sheet transplantation for vitiligo vulgaris (Autologous-cultured epithelium sheet for vitiligo vulgaris)

Autologous-cultured epithelium sheet for vitiligo vulgaris (Cultured epithelium for vitiligo vulgaris)

Nakamura Daisuke

Mar. 04, 2024

1

50 years old, male, vitiligo vulgaris appeared approximately 7 years ago.

During the period, autologous cultured epidermal cell sheets were transplanted to one case.

No serious adverse events were observed during the observation period. Three months after transplantation, itching at the transplant site was observed, but this itching was associated with wound healing and became mild during the post-observation period.

Primary endpoint:The number of serious adverse events was 0. Secondary endpoints:There was a slight increase in mean melanin levels at the transplant site 6 months after transplantation.

One subject was transplanted with autologous cultured epidermal cell sheets and no serious adverse events were observed. The validity of the evaluation method and evaluation points of this regenerative medicine technology could be confirmed, and a certain amount of useful information could be collected for future clinical research. The transplanted cases are being followed up and will continue to be followed up.

July. 03, 2024

https://jrct.mhlw.go.jp/latest-detail/jRCTb030200129

Nishikawa Ayaka

Shonan Beauty Clinic, Shinjuku

24F Shinjuku I-land Tower, 6-5-1 Nishishinjuku, Shinjuku-ku, Tokyo

mimura@sbc.or.jp

Mimura Daisuke

Shonan Beauty Clinic, Shinjuku

12F Shinjuku I-land tower, 6-5-1 Nishishinjuku, Shinjuku-ku,Tokyo

+81-50-5865-5944

mimura@sbc.or.jp

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1)Patients who are over 20 years old and obtain consent in writing.
(2) Patients with a diagnosis of vitiligo vulgaris who have little or no effect on at least a few standard treatments
(3) Patients with stable vitiligo that has not progressed within the past year and does not show obvious Koebner phenomenon

(1) Patients being treated for autoimmune diseases
(2) Patients who are systemically administered steroids (corticosteroids)
(3) Patients with skin malignancy, patients with suspected skin malignancy, or patients with a history of skin malignancy less than 5 years
(4) Pregnant women, lactating women, patients who may be pregnant, patients who wish to become pregnant during the study period
(5) Patients with severe heart disease
(6) Patients with severe liver disease
(7) End stage renal failure
(8) Patients with severe blood coagulation disorder
(9) Person with active infection
(10) Persons with mental illness
(11) HCV antibody, HBs antigen, HTLV-1 virus antibody or HIV antibody positive
(12) Patients with allergic symptoms in cattle and mice
(13)Patients with vitiligo area that cannot be covered with Specific Cell Products to be transplanted
(14)Other patients who are determined to be inappropriate for participation in this study by the person in charge

Both

Vitiligo vulgaris

Transplantation of processed (autologous-cultured epithelium sheet) cells

Number of occurrences of serious adverse events

Evaluate below contents,
Successive observation of transplantation site
Healing satisfaction survey
Pain
Transplant site infection

Complete

+81-86-235-6503

July. 14, 2020