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For patients and their families

Parkinson's disease research

The following answers are based on information available as of January 5, 2024.

The term "clinical trial" refers to the iPS cell-based therapy for Parkinson’s disease conducted at Kyoto University Hospital.


Q

Which patients will participate in the clinical trial?

A

Eligibility is given to patients diagnosed with Parkinson’s disease and who also meet the following criteria.

・Drug treatment does not adequately control symptoms

・Are between 50 and 69 years old at the time of consent

・Show signs of on-off phenomenon

・Score stage 3 or higher on the Hoehn and Yahr scale in the off phase

・Score stage 3 or lower on the Hoehn and Yahr scale in the on phase

・Responds well to L-dopa administration

* Note that patient recruitment is now complete.

Q

How many patients will participant in the trial?

A

In total, 7 patients are expected to participate.

Q

Where will the trial be conducted?

A

All patients will be treated at the Kyoto University Hospital.

Q

How long will patients be admitted to the hospital?

A

Approximately one month.

Q

How long will patients be observed after the cell transplant? How often will patients need to visit or be admitted to the hospital?

A

The follow-up period is two years. Initially, patients will visit the hospital monthly, but that will be reduced to every two months eventually. Patients will also be admitted 5 times during this two-year window. Follow-up will also be done after the trial ends.

Q

How long are the hospital stays for the transplantation and follow-up observations?

A

The hospital stay will be 1 month for the transplantation and 1 week for the follow-up observations.

Q

How can I apply to participate as a patient?

A

The clinical trial is no longer recruiting patients.

Q

What type of surgery will be done?

A

Approximately 5 million neural progenitor cells differentiated from iPS cells will be transplanted into both the left and right putamen by stereotactic surgery.

Q

Can deep brain stimulation (DBS) be combined with DBS?

A

Patients who have undergone DBS are not eligible for this clinical trial, but we expect the two treatments can be combined in the future.

Q

When will the cell transplantation be available to all patients?

A

The use of the cell transplantation as an approved treatment will depend on the results of the clinical trial and cannot be predicted at this time.

Q

If this cell transplantation treatment becomes mainstream, will it be eligible for insurance subsidies?

A

It is expected to be eligible for insurance subsidies.

Q

What is the current status of the clinical trial?

A

For the clinical trial that started in 2018, we completed cell transplants for a total of 7 patients as planned by the end of 2021, and the monitoring of the patients after the cell transplantation also finished at the end of 2023.

At present, no serious safety concerns have been raised. We will analyze the data in 2024 and publish the results in a scientific paper and other forms.

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