AdipoSeeds has been advancing  the development of human adipose tissue-derived platelet-like cells (ASCL-PLC, Development Code: ADS-01) for the treatment of intractable skin ulcer with getting a subsidy from Japan Agency for Medical reserach and Development (AMED) since AMED has accepted our program of  “Development of human adipocyte-derived platelet-like cells (ASCL-PLC) for the treatment of intractable skin ulcers as a product for allogeneic regenerative medicine”  in the “Drug Discovery Venture Ecosystem Enhancement Project” in fiscal 2024.

 

The interim assessment of AMED resulted in an assessment of the “Stage Gate Passed”, which determined the provision of a subsidy for the next stage  between October 2025 and September 2026.

 

Our progress in the previsous stage has been evaluaed effective based on the following reasons [*1]:

(1) We has already submitted a clinical trial inisitation notification to Pharmaceuticals and Medical Devices Agency (PMDA)  and a 30-day survey period also has been completed as planeed.

(2) Technical transfer relating to the manufacture of investigating product and a toxicological test (GLP test)  have been progressing smoothly.

(3) Medical institutions conducting a clinical trial have been selected.

 

In developing the treatment of intractable skin ulcer using human adipose tissue-derived platelet-like cells (ASCL-PLC), the investigator-led study was conducted at Keio University Hospital. The results are presented in Regenerative Therapy(Volume 30, December 2025, Pages 606-615) [*2]. There are no particular concerns regarding the safety of ASCL-PLC, and it has been shown that the ulcers were completely closed by 12 weeks after administration, indicating the certain efficacy of ASCL-PLC.

 

We are now preparing to promptly initiate a phase I/II trial of ADS-01 for the treatment of itractable skin ulcer in Japan.

 

(*1) Interim assessment (stage-gated assessment) from AMED is available at:

 

Interim Assesemnt of AMED （only in Japansese)

 

(*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.

 

Regenerative Therapy(Volume 30, December 2025, Pages 606-615