S.BIOMEDICS Reports Promising 12-Month Data for Parkinson's Cell Therapy A9-DPC in Phase 1/2a Trial
核心洞察
S.BIOMEDICS (搜索) announced positive 12-month results from its Phase 1/2a trial of A9-DPC cell therapy for Parkinson's disease (搜索), showing favorable safety profile with no tumorigenesis or immune reactions observed.
The study demonstrated significant motor function improvements, with MDS-UPDRS Part III scores decreasing by 12.7 points in low-dose and 15.5 points in high-dose groups compared to baseline.
Brain imaging revealed increased dopamine transporter (搜索) signals that correlated with clinical improvements, providing mechanistic evidence for the therapy's effectiveness in restoring neural connectivity.
S.BIOMEDICS (搜索) has reported encouraging 12-month results from its Phase 1/2a clinical trial evaluating A9-DPC cell therapy for Parkinson's disease (搜索), demonstrating both favorable safety and efficacy outcomes in 12 participants. The data, announced in July 2025, represents a significant milestone in the development of stem cell-based treatments for neurodegenerative disorders.
Trial Design and Patient Population
The Phase 1/2a clinical trial enrolled 12 participants diagnosed with Parkinson's disease (搜索) for more than 5 years who exhibited motor complications including wearing off, freezing of gait, or dyskinesia. Participants ranged from 50 to 75 years old and were divided equally into two dosing groups: a low-dose cohort receiving 3.15 million cells and a high-dose cohort receiving 6.30 million cells. The final participant received treatment in February 2024.
A9-DPC, also known as TED-A9, consists of high-purity ventral midbrain dopaminergic progenitor cells derived from human embryonic stem cells under rigorous GMP conditions. Through stereotactic surgical procedures, these cells were transplanted bilaterally into three segments of the putamen (搜索): anterior, middle, and posterior sections, with three tracks per putamen.
Safety Profile Remains Favorable
At 12 months post-transplantation, the therapy demonstrated a favorable safety profile with no treatment-emergent adverse events related to the transplanted cells reported. Critically, no tumorigenesis, overgrowth of transplanted cells, ectopic cell migration, or immune-mediated inflammation was observed. Most treatment-emergent adverse events were mild to moderate, with one participant experiencing an asymptomatic mild hemorrhage but no neurological abnormalities or other serious side effects.
Significant Motor Function Improvements
The trial showed substantial clinical improvements across multiple assessment scales. The MDS-UPDRS Part III (off) score, a standard scale for assessing motor symptom severity in Parkinson's disease (搜索), demonstrated mean decreases of 12.7 points in the low-dose group and 15.5 points in the high-dose group at 12 months compared to baseline. The MDS-UPDRS Total (off) score showed even greater improvements of 29.0 points and 34.7 points in the low- and high-dose groups, respectively.
Disease severity improvements were further evidenced by changes in the Hoehn and Yahr stage. Low-dose recipients improved from stage 3.7 to 2.7 on average, while high-dose recipients demonstrated greater improvement from stage 3.8 to 2.2. Additional positive outcomes were observed in the Non-Motor Symptoms Scale, with scores improving by 31.7 points in the low-dose group and 35.8 points in the high-dose group.
Mechanistic Evidence Through Brain Imaging
[18F]FP-CIT PET imaging provided crucial mechanistic evidence for the therapy's effectiveness. The imaging showed an overall increase in putamen (搜索) dopamine transporter (搜索) (DAT) signals, with greater increases observed in the high-dose group. Notably, there was a statistically significant correlation between improvements in MDS-UPDRS Part III (off) scores and increased DAT signal in the posterior dorsal putamen, supporting the hypothesis of synaptic restoration through engrafted cells.
Prof. Dong-Wook Kim of Yonsei University College of Medicine and CTO of S.BIOMEDICS (搜索) commented on the findings: "Our data show a consistent positive trend throughout the study period, demonstrating the favorable safety and efficacy profiles. Importantly, increased DAT signals on PET imaging correlated with the observed behavioral recovery, which is very promising in terms of the mechanism of A9-DPC through neuroimaging."
Competitive Positioning in Cell Therapy Landscape
The results were presented at the 2025 ISSCR Annual Meeting in Hong Kong, where S.BIOMEDICS (搜索) highlighted the clarity and clinical reliability of their treatment mechanism. The company presented what they described as the first significant association between improved behavior after dopamine cell transplantation and brain dopamine imaging data based on 18FP-CIT-PET in the entire group of transplant patients.
According to the company, other international teams attempting Parkinson's disease (搜索) clinical trials using embryonic stem cells or induced pluripotent stem cells do not present clear associations between behavioral improvements and brain dopamine imaging data for all transplant patients, or only show correlations in some patients.
Future Development Plans
The primary objective of the Phase 1/2a trial is to evaluate safety and exploratory efficacy for up to two years post-transplantation, with safety follow-up continuing for an additional three years. S.BIOMEDICS (搜索) plans to continue presenting additional data from their ongoing study as it progresses.
The company, established in 2005, is advancing seven cell therapy programs targeting intractable diseases, with several lead candidates now in clinical development. Beyond A9-DPC for Parkinson's disease (搜索), the company is also developing TED-N for spinal cord injury and FECS-Ad for critical limb ischemia.