At the 2023 Taiwan Medical Technology Expo expert seminar, Hualien Tzu Chi Hospital and GWOXI Stem Cell shared the Phase II clinical trial results of “Applications of Adipose-Derived Stem Cells in Disease Treatment—A Case Study of the Chronic Stroke Stem Cell Drug SiYiYou”. Director Lin Xin-Rong noted that after six months of follow-up, some participants improved on the Barthel Index from severe dependency to moderate dependency, and their scores on the NIH Stroke Scale (NIHSS) improved significantly to mild severity. Some participants were even able to stand. GWOXI Stem Cell R&D General Manager Lin Po-Cheng added that, based on these preliminary efficacy results, the drug will continue to advance toward market approval.
Hualien Tzu Chi Hospital has been actively involved in various stem cell therapy developments. Since 2017, under the commission of GWOXI Stem Cell, the hospital has conducted “Autologous Adipose-Derived Stem Cell (ADSC) Brain Transplantation for Chronic Stroke”. Stroke patients received autologous ADSCs that were isolated, purified, and expanded in culture, and the cells were implanted into the stroke lesion using stereotactic brain localization techniques. The Phase I clinical trial demonstrated both safety and efficacy, showing improvements in patients’ mobility. The trial results have also been published in a medical journal.
The team subsequently initiated a Phase II clinical trial in 2019, primarily recruiting participants aged 45 to 85 years who had suffered a stroke more than six months prior. The trial aimed to evaluate the efficacy and safety of GXNPC1 injections in chronic stroke patients. Results showed no serious adverse events. In the high-dose group, patients’ NIHSS scores improved by an average of 1.2 points by week 2, with continued improvement reaching an average of 2.7 points by week 24. Moreover, 89% of patients demonstrated neurological function improvements following treatment.
Director Lin Xin-Rong noted that among the participants, there was a 73-year-old patient who had suffered two strokes, with the most recent occurring over 18 months ago. At baseline, the patient was classified as severely dependent on the Barthel Index and moderate-to-severe on the NIHSS. After receiving the GXNPC1 stem cell drug injected into the stroke lesion and being followed for six months, the patient’s Barthel Index improved to moderate dependence, the NIHSS score significantly improved to mild, and the patient progressed to being able to stand independently and care for themselves without assistance. Director Lin expressed hope that in the upcoming Phase III clinical trial, the treatment could help more patients regain dignity and improve their quality of life.
General Manager Lin Po-Cheng stated that the clinical trial results showed participants made significant progress within six months, which greatly encouraged the team to move forward to the next phase of clinical trials. The upcoming trial is currently being planned and is expected to expand enrollment, including a broader range of chronic stroke patients, to further confirm the effectiveness of the GXNPC1 stem cell drug in improving neurological function.
General Manager Lin Po-Cheng also stated that GXNPC1 (Si-Yi-You) already has a comprehensive patent portfolio covering countries in Asia and the Americas. In addition, GXNPC1 has received multiple prestigious awards, including the National Drug Science and Technology Development Award, the Taipei Biotechnology Award, and the National Innovation Award, making it a highly regarded investigational drug.
At the Hualien Tzu Chi Hospital booth during the Taiwan Medical Technology Expo, GWOXI Stem Cells attracted numerous families of stroke patients seeking information on clinical trials and treatment options. During the expert lecture on December 2, the session was completely full, drawing many professionals as well as members of the public concerned about chronic stroke.
