臨床研究等提出・公開システム

Efficacy and Safety of Adipose Stem Cell Culture Supernatant Extract for Skin Ulcers

Efficacy and Safety of Adipose Stem Cell Culture Supernatant Extract for Skin Ulcers

Nakagawa Masahiro

Hamamatsu University Hospital

1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka

nakagawa@hama-med.ac.jp

Takiguchi Tetsuya

Hamamatsu University Hospital

1-20-1,Handayama,Chuo-ku,Hamamatsu,Shizuoka

+81-53-435-2798

takiguchi@hama-med.ac.jp

Recruiting

June. 23, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. men and women between 18 and 90 years of age
2. patients with various types of skin ulcers (excluding head and face)
3. patients with skin ulcers with a maximum diameter of 1 cm or more but less than 9 cm
4. patients whose consent to participate in this study has been obtained by signing a consent form by the patient or a proxy.

1. patients with vasculitic ulcers
2. patients requiring inpatient treatment for ulcers
3. patients with severe anemia or thrombocytopenia
4. patients with infection at the site of ulcer and tendency to exacerbation
5. patients with malignant tumors at the ulcer site
6. patients requiring surgical procedures such as amputation or skin grafting (not including debridement)
7. patients receiving continuous oral or injectable steroid hormone therapy
8. patients with severely impaired nutritional status
9. patients undergoing dialysis or immunosuppression
10. who has a history of allergy to adipose stem cell culture supernatant extract
11. patients who have been deemed unsuitable by the principal investigator or a subinvestigator

Both

skin ulcer

For patients who develop skin ulcers, fat stem cell culture supernatant extract is sprayed on the ulcer site.

Effective rate determined based on the rate of ulcer reduction from Day 0

1. size of ulcer
2. depth of the ulcer
3. ulcer characteristics (granulation, coloration of granulation, bleeding tendency, drainage, necrotic tissue, redness, pain)

+81-53-435-2680

May. 30, 2023

No

none