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An Exploratory Study to Evaluate the Safety and Efficacy of Multiple Doses of ADS-01 (Platelet-Like Cells Derived from Human Adipose-Derived Mesenchymal Stem Cell Line) for Refractory Skin Ulcers

A Study to Evaluate the Safety and Efficacy of ADS-01 in Patients with Refractory Skin Ulcers

Obara Hideaki

Keio University, School of Medicine

35, Shinanomachi, Shinjuku-ku, Tokyo

obara.z3@keio.jp

Shimakura Akira

AdipoSeeds, Inc.

Keio University,School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo

+81-3-6822-0325

shimakura@adiposeeds.co.jp

Pending

Nov. 01, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(1) Patients with refractory vascular skin ulcers (ulcers associated with arterial occlusive disease of the lower extremities, lower legs, or feet, or venous stasis ulcers) unresponsive to existing therapies
(2) Patients aged 20 to 85 years at the time of consent acquisition (gender not restricted)
(3) Patients for whom written informed consent has been obtained
(4) Patients who are able to participate in this clinical study from the time of consent acquisition through the final observation date and who are willing to comply with the requirements for participation in this study
(5) Patients with refractory skin ulcers with an area of 0.1 cm^2 or greater but less than 10 cm^2
(6) Patients for whom the ulcer area at 4 weeks prior to enrollment is documented at the study site and for whom improvement in the ulcer is less than 50% after 4 weeks of any standard treatment for skin ulcers

(1) Patients with a skin perfusion pressure (SPP) measurement of less than 20 mmHg in the skin tissue proximal to the ulcer on the target limb
(2) Patients who used Trafermin spray, Alprostadil alfadex ointment, Bucladesine sodium ointment, or Tretinoin tocopheryl ointment within 7 days prior to enrollment (start of this clinical study)
(3) Patients who underwent endovascular treatment, surgical bypass, treatment for varicose veins of the lower extremities or negative pressure wound therapy within 14 days prior to enrollment (start of this clinical study)
(4) Patients receiving continuous oral or injectable steroid hormone therapy or immunosuppressive therapy, with poorly controlled underlying disease and unstable condition
(5) Patients undergoing artificial dialysis
(6) Patients with severe liver disease, kidney disease, heart disease, lung disease, blood disorders, metabolic disorders, or other conditions deemed inappropriate for this study by the principal (or sub-investigator)
(7) Patients with a hemoglobin A1c (HbA1c) level of 9.0% or higher despite medical treatment for diabetes
(8) Patients who experienced myocardial infarction or cerebrovascular disorder within 30 days prior to enrollement (start of this clinical study)
(9) Patients with concurrent malignant tumors or diagnosed with advanced cancer within 5 years prior to case registration
(10) Breastfeeding patients. Patients who are pregnant or may be pregnant. Patients planning to become pregnant by the end of this study.
(11) Patients who participated in another clinical study within 6 months prior to obtaining informed consent
(12) Patients with psychiatric disorders or symptoms deemed to make participation in this study difficult
(13) Patients who have experienced severe allergic reactions to cell products, including blood transfusions
(14) Patients with allergies to animals (cattle)
(15) Patients with allergies to streptomycin sulfate and amphotericin B
(16) Patients with uncontrolled infectious ulcers (Clinical infecion grade 2 or higher) requiring antimicrobial administration for purposes other than infection prevention
(17) Patients with an ulcer being evaluated that is graded as Ulcer Grade 3 or Gangrene Grade 2 or higher according to the WIfI classification
(18) Other patients deemed unsuitable for enrollment by the principal (or sub-investigator)

Both

Refractory skin ulcers

Administer 1.5 x 10^8 cells/cm^2 per application to the same ulcerated area once each at weeks 0, 2 and 4 for a total of three applications (by drip application).

Incidence rate of adverse events

(1) Complete epithelialization rate
(2) Ulcer healing rate (reduction rate)
(3) Distance of wound edge migration
(4) Wound depth
(5) Pain assessment (Numerical Rating Scale; NRS)
(6) Quality of Life assessment (EuroQol 5-dimensions; EQ-5D)
(7) Skin perfusion pressure (SPP)
(8) Laser Doppler blood flow measurement
(9) Ankle-brachial index (ABI)

+81-3-5363-3848

Sept. 03, 2025

+81-3-3454-3311

Sept. 03, 2025

+81-44-233-5521

Sept. 03, 2025

No

none