A Japanese company is launching stem cell trial in USA

[Farooqji]

sumitomo-pharma.co.jp/news/...

[Caa11]

it’s written in japanese, can’t read it😞

[JayPwP in reply to Caa11]

Sumitomo Pharma Innovation today, healthier tomorrowsClick here to print (PDF/187KB)

March 28, 2024

Research and Development

Announcement of start of corporate clinical trial for "Parkinson's disease treatment using iPS cell-derived dopaminergic neural progenitor cells" in the United States

Sumitomo Pharma Co., Ltd. (Headquarters: Osaka City, President and CEO: Hiroshi Nomura) is conducting a corporate clinical trial (hereinafter referred to as the "Clinical Trial") regarding the treatment of Parkinson's disease (hereinafter referred to as the "Treatment") using iPS cell-derived dopaminergic neural progenitor cells. We are pleased to announce that we filed an IND application ( Investigative New Drug Application ) with the U.S. Food and Drug Administration ( FDA ) in February 2024 , and that the FDA has recently completed a 30 -day investigation and are now ready to begin this clinical trial. To do. Please note that frozen cells will be used in this clinical trial.

Regarding this treatment, an investigator-initiated clinical trial using unfrozen products will begin in the United States in November 2023 at the University of California , San Diego. Additionally, in Japan, an investigator-initiated clinical trial using unfrozen products was conducted at Kyoto University Hospital since 2018 .

This clinical trial is our first U.S. clinical trial using differentiated cells derived from allogeneic iPS cells in our regenerative and cell therapy business, which we are focusing on. It will be a big step.

[Summary of this clinical trial]

Test cell DSP-1083 Dopaminergic neural progenitor cells derived from allogeneic iPS cells (frozen product)

development stage Phase 1/2

subject parkinson's disease

Clinical trial design

(target number of cases)

Multicenter, double-blind, randomized study

(dozens of patients: administration observation group and sham observation group)

Main endpoint Safety: Frequency and severity of adverse events

Secondary endpoints

(effectiveness) Motor symptom evaluation, etc.

Clinical trial conductor Sumitomo Pharma America, Inc. (our U.S. subsidiary)

*The start of investigator-initiated clinical trials in the United States will be disclosed on December 26 , 2023 . sumitomo-pharma.co.jp/news/...

For your reference

parkinson's disease

In Parkinson's disease, the dopamine content in the striatum decreases markedly due to the degeneration and loss of dopamine neurons in the brain, resulting in an imbalance in the functioning of the basal ganglia neural circuits that control the brain's motor functions. It is a chronic progressive neurodegenerative disease that is thought to cause motor symptoms.

The four main motor symptoms characteristic of Parkinson's disease are tremor, muscle rigidity, bradykinesia, and impaired postural reflexes. Motor symptoms often begin with tremor, followed by bradykinesia and muscle rigidity, and progress slowly from one upper or lower limb to the other. As the condition progresses further, postural reflex disorders may appear, causing postural instability. In this way, motor symptoms spread from the extremities to the trunk and progress slowly, but in addition to motor symptoms, non-motor symptoms such as autonomic nervous symptoms, psychiatric symptoms, and sleep disorders are also observed.

dopaminergic neural progenitor cells

Dopamine is a neurotransmitter that is produced within dopamine neurons. Parkinson's disease is caused by the progressive loss of dopaminergic neurons and decreased dopamine production. Dopamine neuron progenitor cells are cells that are about to differentiate into dopamine neurons. Research using Parkinson's disease model animals has revealed that mature dopamine neurons can be efficiently engrafted in the brain by transplanting dopamine neuron progenitor cells.

iPS cells (induced pluripotent stem cells)

Cells obtained by artificially reprogramming somatic cells by gene transfer, protein transfer, drug treatment, etc., or cells generated by the division of such cells, which have the property of differentiating into endodermal, mesodermal, and ectoderm cells. It also maintains the ability to self-replicate.

that's all

[Caa11 in reply to JayPwP]

Thank you so much !

[Smittybear7]

is there a translation in English?

[jocelyng in reply to Smittybear7]

See above.

[janers]

I wonder why they are testing in the US? Do you think it’s just to get FDA approval?

[Farooqji in reply to janers]

FDA approval has already been obtained

[Boscoejean]

the clinical trial is not on clinicaltrials.gov

contact information here

sumitomo-pharma.com/inquiry/