KYOTO – Japanese researchers are aiming to commence clinical research as early as next year using induced pluripotent stem cells to help control the progress of Parkinson’s disease, a member of the team said.
It would be the second such clinical research, following an effort conducted by the government-backed Riken scientific research institute using iPS cells for the retinal regeneration.
The team including Jun Takahashi, a professor at Kyoto University’s Center for iPS Cell Research and Application, is moving toward conducting the clinical research after developing a method to generate human iPS cell-derived dopaminergic neural progenitor cells to lessen the symptoms of the disease.
Parkinson’s disease is a progressive neurological disorder linked to a drop in dopamine production in the brain that causes limb shaking and stiffness. There is currently no treatment to stop the drop in dopamine.
“We found a method that brings us closer to clinical research,” Takahashi said Thursday.
The plan is to file an application for clinical research in early 2015 and begin actual work later in the year, Takahashi said.
The team will first submit an application regarding the planned clinical research to a third-party panel, which will be set up by Kyoto University to assess the safety of the research.
The researchers will then submit the details of their plan to the Health, Labor and Welfare Ministry for consideration by an expert panel. The health minister’s approval will be required for the clinical research.
It will take about a month to select patients, around six months for cells to be created, and about three further months to check the safety of the cells, according to Takahashi.
The team’s clinical research will target six patients, with 10 million or more cells being cultured without animal-derived substances, which are at risk of being infectious. The cells will then be transplanted to the patients’ brains.
Afterward, the team will observe for a year whether tumors form, Takahashi said, adding the team hopes patients in serious condition and in need of nursing care will be able to move around, while others will become less dependent on medicines.