S.Biomedics said Friday it received the regulatory approval for phase 1/2a clinical trials of the Parkinson's disease cell therapy (A9-DPC), using brain dopamine nerve precursor cells derived from human embryonic stem cells.

This is Asia's first approved clinical trial of a treatment for Parkinson's disease using dopamine cells derived from embryonic stem cells, the company said.

Researchers in the U.S. and Europe are also competing to develop a similar-type Parkinson's disease treatment.

The study will evaluate the safety and efficacy of dopamine neural precursor cell transplantation therapy derived from homogeneous embryonic stem cells in patients who have been diagnosed with Parkinson's disease for more than five years. The trial will take place at Severance Hospital in the first half of this year.

Parkinson's disease is a degenerative brain disease in which 60-70 percent of midbrain dopamine nerve cells die, resulting in Parkinson's disease-related motor symptoms. 

Current treatment for Parkinson's disease includes drug therapy such as levodopa and deep brain stimulation, but the therapeutic effect decreases over time and various side effects appear which this candidate therapy intends to overcome.

S.BioMedics said its cell therapy candidate demonstrated “excellent” results in behavioral tests using a Parkinson's disease monkey model. 

Symptoms of human-like Parkinson's disease, such as tremors, stiffness, and slow motion, improved to a normal level after administration of dopamine neurotransmitters, the company said. Tests using PET-CT also confirmed that new dopamine neurons were regenerated, it added.

"More than 20 years of research have resulted in clinical trial approval. As it has shown excellent effects and safety in preclinical studies, we expect good results in clinical trials so we can give hope to patients," said S.Biomedics CEO Kim Dong-wook.

Cho Myung-soo, head of research at S.Biomedics, added that the company is simultaneously conducting phase 1/2a clinical trials of embryonic stem cell-based spinal cord injury treatment and severe ischemia treatment using 3D cell aggregates and will aim to conquer other incurable diseases.