A Japanese company is launching stem cell... - Cure Parkinson's
A Japanese company is launching stem cell trial in USA
it’s written in japanese, can’t read it😞
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
I wonder why they are testing in the US? Do you think it’s just to get FDA approval?
the clinical trial is not on clinicaltrials.gov
contact information here
Stem cell treatment in China
stem cell transplant in Japan
good news! The Japanese government approved stem cell therapy for Parkinson's.
doc vs Parkinson’s stem cell trial - Jan 2023 update
