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

JRCT ID: jRCTs043230043

Registered date:23/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: skin ulcer
• Date of first enrollment: 21/07/2023
• Target sample size: 80
• Study type: Interventional
• Intervention(s): For patients who develop skin ulcers, fat stem cell culture supernatant extract is sprayed on the ulcer site.

Outcome(s)

• Primary Outcome: Effective rate determined based on the rate of ulcer reduction from Day 0

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 90age old
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Nakagawa Masahiro
• Source(s) of Monetary Support: TeleBio Inc.