Gwo Xi Stem Cell’s Diabetes Cell Therapy Product GXIPC1® Receives Phase I Trial Results Approval from Vietnam’s MOH
Gwo Xi Stem Cell (TPEx.: 6704), a leading cell therapy company at Hsinchu Biomedical Science Park in Taiwan, announced that its independently developed, manufactured, and exported diabetes stem cell therapy product GXIPC1® has successfully completed its Phase I clinical trial in Vietnam, officially approved for closure by the Vietnam Ministry of Health (MOH). This marks a significant milestone in the international clinical advancement of Taiwan-made cell therapy products.
The clinical study was conducted at Vinmec Times City International Hospital, representing Vietnam’s first foreign allogeneic stem cell therapy clinical trial. This open-label, single-arm Phase I study aimed to evaluate the safety of GXIPC1® in participants with type 1 diabetes (T1DM).
The results showed no serious adverse events (SAEs) following cell infusion, confirming that GXIPC1® was safe and well-tolerated. Furthermore, daily insulin usage significantly decreased from 26.9 ± 21.9 IU/day at baseline to 18.2 ± 23.9 IU/day at 3 months post-treatment, representing a 32.34% reduction (p value = 0.014). These findings indicate the potential clinical benefit of GXIPC1® in reducing insulin dependence among patients with T1DM.
GXIPC1® is an allogeneic adipose-derived mesenchymal stem cell (ADSC) product manufactured at Gwo Xi Stem Cell’s Taiwan GMP-compliant facility and exported via cold-chain logistics to Vietnam. The trial not only validates the stability and reliability of Taiwan’s cell processing center but also proves the feasibility of “Made in Taiwan, Treated Internationally”, which is a major step forward for Taiwan’s regenerative medicine industry in global clinical and licensing collaboration.
Beyond GXIPC1®, Gwo Xi Stem Cell is advancing its next-generation diabetes stem cell therapy product using its proprietary Nigiro-Med® stem cell activation platform. This innovative technology induces stem cells to acquire insulin-secreting capabilities within 7 days, over four times faster than conventional 30-day differentiation methods.
Key pancreatic β-cell genes (PDX1, ISL1, INS) were shown to be stably expressed, with >90% cell viability, and a 3-fold increase in CD47 expression, indicating both insulin secretion potential and reduced immune rejection risk. The results were published in the peer-reviewed journal Cell Transplantation and the technologies related to the product have been patented in the U.S., China, and Taiwan.
In 2019, Gwo Xi Stem Cell signed an international collaboration memorandum (MoU) with Vinmec Research Institute of Stem Cell and Gene Technology (VIRISG) for stem cell drug development. Photo courtesy of Gwo Xi Stem Cell.
Unlike conventional approaches focused solely on terminal differentiation, Nigiro-Med® prioritizes producing functional stem cells, optimizing both clinical applicability and cost-effectiveness, highlighting Gwo Xi Stem Cell’s innovative approach in regenerative medicine and diabetes therapy.
According to the International Diabetes Federation (IDF), more than 540 million people worldwide are living with diabetes in 2024, a number projected to reach 780 million by 2045, with healthcare expenditures exceeding USD 1 trillion. In Taiwan, more than 2.45 million people suffer from diabetes, posing serious public health and economic challenges. As current treatments (e.g., diet control, medication, and insulin) remain palliative, novel therapeutic strategies are urgently needed.
The ongoing development of GXIPC1® and next-generation therapies by Gwo Xi Stem Cell offers new hope for diabetes patients globally.
Through its PIC/S GMP-compliant facility, Gwo Xi Stem Cell continues to advance the internationalization of Taiwan’s cell therapy products, establishing itself as a global player in the regenerative medicine field.