On 30 July, Kyoto University Hospital announced that it will begin a series of physician-initiated clinical trials for the treatment of Parkinson's disease using dopaminergic progenitors, which will be generated from induced pluripotent stem (iPS) cells. The trials will begin on 1 August, and has been designed in partnership with the University's Center for iPS Cell Research and Application (CiRA). Formal notification was submitted to the Pharmaceutical and Medical Devices Agency (PMDA) on 4 June 2018.
The project will be led by KyotoU Hospital Professor Ryosuke Takahashi, and involve the Hospital's three departments — Neurology, Neurosurgery, and Diagnostic Imaging and Nuclear Medicine — as well as a CiRA team headed by Principal Investigator Professor Jun Takahashi.
The team is committed to ensuring the safety and adequacy of the clinical procedures, with the goal of making the new, iPS cell-based treatment available to patients as soon as possible.
Clinical trial details
CiRA's stockpiled iPS cells (iPS Cell Stock for Regenerative Medicine) will be used to generate dopaminergic progenitors, which will then be transplanted into the brains of seven patients (allogeneic transplantation). To minimize the risk of immune rejection, the subjects will be treated with tacrolimus, an immunosuppressant commonly used following organ transplantation.
- Target condition
- Participation opportunities
Those interested in taking part are advised to visit the following webpage (in Japanese, open until 30 September 2018 ):
- Kyoto University Hospital: "About the physician-initiated clinical trials for Parkinson's disease"
- CiRA: "Announcement of physician-initiated clinical trials for Parkinson's disease"