A 30-day survey of clinical trial notification to initiate a phase I/II study in Japan to evaluate safety and efficacy for the treatment of intractable skin ulcers was completed
AdipoSeeds, Inc. is developing the drug for the treatment of intractable skin ulcers for the medical use of human adipose tissue-derived stromal cell-derived platelet-like cells (ASCL-PLC). On May 15, 2025, a clinical trial protocol notification was submitted to the Pharmaceuticals and Medical Devices Agency (PMDA) to begin a phase I/II study in Japan to evaluate safety and efficacy. The 30-day survey period was completed on June 14, 2025 .
AdipoSeeds will initiate the clinical trial at an early stage.
As Intractable skin ulcers are developed due to the various underlying diseases such as diabetic ulcers, venous stasis ulcers, arteriosclerosis obliterans, buerger’s disease and collagen disease, treatment for ulcers is needed along with treatment for the underlying disease. Worsening ulceration can lead to a decrease in a patient’s quality of life (QOL) due to functional impairment, an increased risk of lower extremity amputation, and an increased risk of death. Furthermore, the number of patients with intractable skin ulcers is also on the rise due to the increase in the number of patients with the underlying diseases in step with the aging population. Therefore, the development of effective treatments for intractable skin ulcers is desired.