A small clinical trial involving 12 patients with Parkinson's disease has reported no safety concerns with a newly developed human stem-cell-based therapy.

The therapy called TED A9 was delivered as a cell transplant injected directly into the brain of the participants as part of a Phase 1/2a clinical trial, which is principally concerned with assessing safety and dosing requirements.

The drug's developer, S.Biomedics, in Seoul, South Korea, claimed in a press release: 'According to Professor Jin-Woo Chang, [the principal investigator of the transplant conducted at Severance Hospital, Seoul,] none of the 12 Parkinson's disease participants had any side effects, complications, or unusual adverse reactions following the transplantation of TED-A9'.

The trial participants were aged between 50 and 75 years old, had been diagnosed with Parkinson's disease for more than five years, and had already motor complications such as freezing of gait or dyskinesia.

To ensure and monitor the safety of the treatment, an initial three patients were injected with a low dose (3.15 million cells) and monitored for three months, before another three patients were treated at high dose (6.3 million cells) and also monitored for three months.

No side effects, complications, or unusual adverse reactions were seen in either group during the three-month assessment period. Therefore, the clinical trial continued by adding three further patients to each of the low-dose and high-dose groups. Again, no safety concerns were seen.

Parkinson's symptoms are caused by the progressive loss of neurons that produce dopamine, a major chemical messenger in the brain. The TED-A9 therapy contains dopaminergic progenitor (precursor) cells, which had themselves been derived in the lab from embryonic stem cells.

The drug developers at S.Biomedics hope that the dopaminergic precursor cells in TED-A9 will treat Parkinson's disease by replacing the mature dopamine-producing nerve cells that are lost in patients.

Professor Dong-Wook Kim, a neurosurgeon and the principal developer of TED-A9, said: 'We have developed a fundamental therapeutic mechanism that directly replaces dopaminergic neurons lost in patients with Parkinson's disease. TED-A9 could represent a fundamental treatment that surpasses current therapies, which only temporarily alleviate the symptoms of Parkinson's disease,'.

The trial is expected to continue until February 2026, allowing safety of the therapy to be monitored for a total of five years. As part of the study, exploratory efficacy will also be examined for two years using clinical measures of motor symptoms and a patient questionnaire of daily life quality.

More Information is available at ClinicalTrials.gov.

More here:
Human stem-cell-based therapy for Parkinson's disease proven safe PET - BioNews