13 March, 2026
Donor Site Wounds
Donor Site Wounds
Once skin tissue is compromised, it not only impairs physiological functions but also carries significant risks of pain and infection. For extensive wounds, skin grafting is the standard clinical intervention; however, the "donor site wound" created at the harvest area requires highly efficient care to ensure proper recovery.
TWB-103, developed by Transwell Biotech, contains viable human skin fibroblasts capable of actively secreting a variety of growth factors and cytokines. By providing essential proteins required for tissue reconstruction, it accelerates the healing process at the cellular level. Following years of rigorous design and preclinical validation, TWB-103 received Investigational New Drug (IND) approvals from regulatory authorities in Taiwan, Japan, and the U.S. in 2017. To date, Phase I/II clinical trials for donor site wound treatment have been completed in Taiwan and Japan, demonstrating Transwell Biotech’s world-class R&D capabilities and commitment to international standards.
The Phase I
Phase I of this clinical trial officially commenced enrollment in Taiwan in July 2017, with all eligible subjects completing their clinical treatments by December of the same year. Prior to proceeding to Phase II, and while remaining blinded, the research team conducted a rigorous "Safety Assessment" based on the clinical data collected during Phase I. The results indicated that subjects treated with either TWB-103 or the control drug exhibited no immediate safety concerns, providing preliminary confirmation of the product's safety profile.
The Phase II
The project officially entered Phase II clinical trials in January 2018, with patient enrollment initiated simultaneously across three medical centers in Taiwan and Japan. Subject recruitment was completed in June 2020, followed by a one-year post-treatment follow-up period, which concluded for all participants in June 2021.
In terms of regulatory compliance, the trial successfully passed the GCP (Good Clinical Practice) inspection by the Ministry of Health and Welfare (MOHW) in September 2022 and officially received the MOHW's "approval for completion" in April 2023. This milestone signifies that the R&D project has met the highest regulatory standards for clinical execution quality and data integrity.