TED-A9 Cell Therapy Trial for Parkinson's Disease Successfully Concludes

In a significant advancement for treating Parkinson's disease, S.BIOMEDICS Co., Ltd. has announced the successful completion of a Phase 1/2a clinical trial involving the transplantation of a novel cell therapy, TED-A9. This therapy, derived from human embryonic stem cells (hESCs), was administered to 12 patients diagnosed with Parkinson's disease for over five years who exhibited motor complications.

The trial was meticulously conducted with participants ranging in age from 50 to 75 years. TED-A9 was divided into two dosage groups: a low-dose group receiving 3.15 million cells and a high-dose group receiving 6.30 million cells. The transplantation process was carried out without any reported issues, as explained by Prof. Dong-Wook Kim, the developer of TED-A9 and Chief Technology Officer of S.BIOMEDICS.

The primary goal of the trial was to evaluate the safety and preliminary efficacy of TED-A9 transplantation over a two-year period post-transplant. Safety monitoring will continue for an additional three years, extending the total observation period to five years. Initially, a cohort of three patients was enrolled to assess initial safety, including dose-limiting toxicity (DLT) evaluation, over a period of up to three months post-transplantation. With no safety concerns, the trial expanded to include additional patients in both the low-dose and high-dose groups.

The transplantation targeted specific segments of the putamen, with cells injected at precise points, as detailed by Prof. Kim. The clinical trial was led by Prof. Jin-Woo Chang, a neurosurgeon, and Prof. Phil-Hyu Lee, a neurologist, both of whom reported no side effects, complications, or unusual adverse reactions in the participants following the TED-A9 transplantation.

TED-A9 represents a breakthrough in the field of regenerative medicine, offering a highly purified source of dopamine cells derived from hESCs. S.BIOMEDICS is optimistic about the potential of these cells to restore motor function in Parkinson's disease patients by replacing the dead cells.

Prof. Kim emphasized the company's commitment to developing data-driven medicine for Parkinson’s disease, highlighting TED-A9 as a fundamental treatment that could potentially surpass current therapies, which only provide temporary symptom relief.

S.BIOMEDICS, founded in 2005, is a leading force in stem cell therapy, focusing on regenerative medicine and data-driven biology. The company is developing several cell therapy programs aimed at treating non-curable diseases, with TED-A9 being one of its flagship programs currently in the clinical stage.