S.BIOMEDICS Concludes Phase 1/2a Parkinson's Disease Cell Therapy Trial with TED-A9 Dopaminergic Progenitors

Feb 29, 2024, S.BIOMEDICS Co., Ltd., a leading company in stem cell therapy, has completed a Phase 1/2a clinical trial involving the transplantation of TED-A9 cells into the brains of 12 Parkinson's disease patients. TED-A9 is a type of high-purity dopaminergic progenitor cell derived from human embryonic stem cells (hESCs) under strict GMP standards. The trial aimed to evaluate the safety and potential efficacy of TED-A9 cell therapy for a period of two years post-transplantation, with an additional three-year safety monitoring period.
The study included patients diagnosed with Parkinson's disease for over five years, who experienced motor complications such as drug wearing-off, freezing of gait, or dyskinesia. Participants ranged in age from 50 to 75 years old and were divided into two groups: a low-dose group receiving 3.15 million cells and a high-dose group receiving 6.30 million cells. The initial phase of the trial involved three patients at a low dose, with no safety concerns reported within three months post-transplantation. This led to the enrollment of additional patients at both low and high doses.
The transplantation procedure was described by Prof. Dong-Wook Kim, the developer of TED-A9 and CTO of S.BIOMEDICS, who targeted three segments of the putamen with cells injected at three points within each track. The clinical trial was conducted at Severance Hospital under the leadership of Prof. Jin-Woo Chang and Prof. Phil-Hyu Lee, with no reported side effects, complications, or adverse reactions following the TED-A9 transplantation.
TED-A9 represents a significant advancement in the field of regenerative medicine, offering a highly purified source of dopamine cells derived from hESCs. S.BIOMEDICS believes that these cells have the potential to restore motor function in Parkinson's patients by replacing dead cells. The company is committed to developing data-driven medicine for Parkinson's disease and sees TED-A9 as a potential fundamental treatment that could surpass current therapies, which only provide temporary symptom relief.
S.BIOMEDICS, established in 2005, is focused on regenerative medicine and currently has seven cell therapy programs in development, targeting non-curable diseases. The company is listed on the Korea Exchange (KOSDAQ: 304360) and is also the founder and controller of S.THEPHARM, a corporation specializing in anti-aging products. More information about the TED-A9 trial can be found at ClinicalTrials.gov (NCT05887466).

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!