AdipoSeeds, Inc, a start-up comany to commercialize the technologies developed by Keio University,is pleased to inform that the result of Fist-in-human study of Adipose-tissue devived mesenchymal stem cell line-derived platelet-like cells (ASCL-PLC) [*1] for the treatment of intractable skin ulcer was published in Regenerative Therapy (Volume 30, December 2025, Pages 606-615 [*2], Title: Safety and efficacy of long-shelf-life allogeneic adipose-derived mesenchymal stem cell line-derived platelet-like cells for refractory foot ulcers: A translational preclinical and phase 1/2a study).

 

The study has shown that there is no particular concern about the safety of ASCL-PLC and that there is a certain degree of efficacy, including complete closure of the ulceration by 12 weeks after administration.

 

Based on the results of these studies, we are preparing to initiate phase I/II trials in Japan for the treatment of intractable skin ulcers in ASCL-PLC (Development code: ADS-01) at an early stage. We have already submitted a clinical trial notification to PMDA and have completed a 30-day survey period. We aim to start case registration within 2025.

 

We also have been adopted by the program for strengthening drug discovery venture ecosystem by Japan Agency for Medical Research and Development (AMED) to conduct the above-mentioned clinical trial and we have already achieved the milestones of 1st stage  (from August 2024 to September 2025). Currently, we are submitting the application for advancing to 2nd Stage (October 2025 to September 2026) .

 

We aim not only to improve QOL of patients who are forced to spend a long time on treatment but also to contribute to the improvement of healthcare economics by developing novel treatment methods for intractable skin ulcers which don’t have any effective treatment methods.

 

[About intractable skin ulcers]

Intractable skin ulcers are associated with ischemia caused by impaired arterial blood flow or venous stasis. Ischemic ulcers are typically caused by peripheral arterial disease, diabetes, or vasculitis due to collagen disease. Venous ulcers often develop for patients with varicose veins, or as sequelae of deep vein thrombosis.

 

For intractable skin ulcers caused by ischemia, the treatment for hypertension, diabetes, hyperlipidemia, and hyperuricemia is performed in accordance with the guidelines for treatment of peripheral arterial disease. In addition, antiplatelet drugs are used to improve blood flow. Exercise therapy such as walking and pharmacotherapy such as vasodilators are also given depending on the symptoms, and smokers are instructed to quit smoking. For seriously ill patients, revascularization procedures such as endovascular catheterization and surgical bypass are performed, but these procedures also take time to heal skin ulcers. Furthermore, a high rate of recurrence of skin ulcers has been reported in patients who once healed skin ulcers after revascularization surgery. As a result, there are many patients who fail to improve their skin ulcers after these standard treatments, who do not undergo revascularization surgery depending on the site or extent of the lesion, and who are forced to undergo lower extremity amputation through repeated recurrences of skin ulcers.

 

On the other hand, skin ulcers caused by venous stasis, as well as skin ulcers caused by ischemia, take a long time to treat and have a high recurrence rate.

 

Therefore, it is desirable to develop new treatment methods for these intractable skin ulcers.

 

[About AdipoSeeds].

Our mission is to produce platelet-like cells from human adipose tissue and create a new blood flow. We aim to provide safe and medically applicable platelet products mainly from adipose tissue which is discarded after surgery of liposuction in order to contribute to solve globally accelerating platelet shortages in future aging society. We also aim to create a future where treatment practices involving platelets can be offered safely at a lower cost.

 

In addition, we are working to resolve medical unmet needs in the field of tissue repair and regeneration using platelet-like cells derived from human adipose tissue.

 

[*1] We establish ASCL (Adipose-derived Mesenchymal Stem Cell LIne) to overcome the disadvantages of ASC (adipose-derived mesenchymal stem cells)  and deferenciate ASCL into ASCL-PLC (ASCL-derived Platelet Like Cells)  using our proprietary technology.

 

[*2] A paper on the results of an exploratory trial of mesenchymal stem-cell-derived platelet-like cells (ASCL-PLC) in patients with intractable skin ulcers, conducted in collaboration with Keio University, is available at the following sites.

 

https://www.sciencedirect.com/science/article/pii/S2352320425001749