In this clinical trial collaboration, GWOXIwas responsible for the manufacturing process, final product release, and the packaging and shipping of stem cell preparations to a local institution in Vietnam for storage until use. The crucial cold chain logistics were not only a key factor in ensuring product quality and safety but also a limiting factor for international stem cell product treatments. The trial results validated the feasibility of using GWOXI's Taiwan-manufactured stem cell preparations as off-the-shelf allogeneic products in Vietnam, marking a first step for the company in future international collaborations and product exports.
Clinical Trial and Preliminary Results
According to the announcement from GWOXI Stem Cell Corp., the clinical trial, titled "Evaluation of the Safety of Adipose-Derived Mesenchymal Stem Cell Transplantation for Type 1 Diabetes Mellitus" (ClinicalTrials.gov ID: NCT05308836), was conducted by Vietnam's renowned Vinmec Research Institute of Stem Cell and Gene Technology (VRISG). The stem cell preparations were provided by GWOXI Stem Cell Corp.. The purpose of this study was to evaluate the safety of intravenously (IV) administered adipose mesenchymal stem cells (AD-MSCs) in 10 patients with Type 1 diabetes (T1D).
For the primary endpoint, no trial-related serious adverse events (SAEs) occurred during the 6-month follow-up period after the subjects received the GXIPC1® intravenous injection. In addition, one treatment-related adverse event (AE) occurred and was resolved. The results of the study show that the adipose mesenchymal stem cell transplant treatment for Type 1 diabetes is safe. The study also observed five secondary indicators: insulin dose, hemoglobin A1c (HbA1c), fasting blood glucose (FPG), C-peptide levels, and blood insulin. The insulin dose showed a statistically significant decrease of 32.34% (P value = 0.014) compared to the baseline screening dose (26.9 ± 21.9 IU/Day), with the dose dropping to 18.2 ± 23.9 IU/Day at the 3-month mark after treatment. While the other secondary indicators showed a downward trend, they did not reach a statistically significant difference. The trial results will be beneficial for the clinical design and development of the next phase of the drug.
According to statistics from the International Diabetes Federation (IDF), the global diabetes population was 537 million in 2021, and is projected to rise to 783 million by 2045. The medical costs for treating diabetes are also increasing year by year, from $966 billion in 2021 to an estimated $1.05 trillion in 2045. An IDF survey indicates that Vietnam is one of the Asian countries with a higher incidence of diabetes. The number of people with diabetes in Vietnam has doubled in the past decade, with IDF statistics showing that approximately 3.994 million adults are currently living with the disease. This highlights that diabetes poses a serious health threat and economic burden both in Vietnam and globally, while also representing a potential market for diabetes drugs and treatments.
VRISG is part of the Vinmec Healthcare System, the largest medical entity under Vietnam's Vingroup conglomerate. The system oversees three major areas: healthcare, research, and education. It has obtained accreditation from the Joint Commission International (JCI), confirming that its medical services have reached a world-class standard. Integrating dozens of hospitals and employing over 500 doctors, the Vinmec Healthcare System is a leading local medical institution and an international organization with extensive experience in cross-border collaboration.