Alzheimer’s disease is a kind of dementia, a gradual progression of progressive deterioration of cognitive function including memory, which gradually develops with age. Alzheimer’s Dementia affects about 30 million people worldwide and 500,000 people in Korea. Alzheimer’s disease has been on a steady growth trend due to aging of the population.
Alzheimer's disease Non-Clinical Test Result
As a result, learning and memory skills were restored, especially number of amyloid-dysplastic has decreased.
These findings have shown that the injection of AstroStem significantly improves the deterioration of memory capacity seen in Alzheimer’s animal models and also has the effect of restoring neuropathological phenomena
Ongoing Clinical Trials
i. Phase 1/2 Clinical trial in the U.S.
A clinical trial to compare the safety and efficacy of 10 times of AstroStem in patients with Alzheimer’s disease in the United States was approved by the US FDA in November 2016, The hospital began clinical trials in April 2017.
ii. Phase 1/2a Clinical trial in Korea
We are preparing a clinical trial to compare the safety and efficacy of 10 times of AstroStem in patients with Alzheimer’s disease in Korea.
Patent composition for promoting stability of stem cells – has a patent for a composition capable of promoting the stability of stem cells containing mesenchymal stem cell cultures and bases.
i. Nonclinical safety study
SCID mouse 10 times a dose of intravenous 13 weekly repeated dose toxicity test was conducted, but no abnormality was confirmed.
ii. Clinical safety sutdy
Eight men with spinal cord injury over 12 months underwent intravitreal injection of hAdMSC 4×108 and followed up for 3 months. None of the patients had serious adverse events related to hAdMSC. We confirmed that hAdMSCs are safe for administration and do not induce tumor development.
Approved by Ministry of Health, Labor and Welfare of Japan
AstroStem was approved for regenerative medical treatment for autoimmune disease from Japan Health and Welfare Ministry in 2015, and is currently being treated at a local hospital in Japan.