Lower Limb Ulcers

 Lower Limb Ulcers

Diabetic patients often suffer from peripheral vascular obstruction or neuropathy, which significantly impairs wound healing at the extremities and leads to "Diabetic Foot Ulcers" (DFU). Statistics indicate that approximately 25% of diabetic patients will encounter this condition in their lifetime, with severe cases potentially leading to amputation.

TWB-103, developed by Transwell Biotech, contains viable human skin fibroblasts that actively secrete multiple growth factors and essential reconstruction proteins to initiate and accelerate wound healing at the cellular level.

The Phase I clinical trial was approved by the TFDA in March 2019, with subject enrollment completed in December 2020. Following a 6-month post-treatment follow-up period, all participant follow-ups were concluded in July 2021. The trial successfully passed the GCP inspection by the Ministry of Health and Welfare (MOHW) in August 2022 and officially received regulatory "approval for completion" in December 2022. These achievements demonstrate that TWB-103 meets the highest regulatory standards for clinical execution quality and data integrity.

Key Clinical Data Highlights:

Safety : No Adverse Events (AE), Serious Adverse Events (SAE), or Suspected Unexpected Serious Adverse Reactions (SUSAR) related to the cell therapy occurred.

Complete Healing Rate : 6 out of 10 subjects achieved complete healing within 12 weeks, remaining stable through the end of the trial.

Wound Reduction : The average wound reduction was 85.5% at the end of treatment and further improved to 90.5% by the end of the study.

Remarkable Case Study : A 95-year-old subject, whose wound had remained unhealed for 7.5 months despite conventional treatment, achieved complete healing in just 21 days after receiving TWB-103 therapy.

Conclusion: Comprehensive data confirms that TWB-103 possesses exceptional clinical potential and value in treating chronic, hard-to-heal wounds.

See Detail in "ClinicalTrial.gov"