Stem cell treatment for Alzheimer’s progresses
Nature Cell has gained FDA clearance to start phase 1 and phase 2 trials of its stem cell-based treatment for Alzheimer’s disease.
The South Korean biotech company’s AstroStem investigational product harvests stem cells from 10mg of a patient’s own abdominal fat, which is then administered intravenously to the patient.
News of the progress came just ahead of Lilly’s announcement that its Alzheimer’s candidate solanezumab failed in its latest phase 3 trial.
Lilly’s setback has poured more cold water on the beta amyloid hypothesis, which suggests the build of this protein in the brain is the chief culprit for the disease.
There are a number of other products in big pharma pipelines to treat Alzheimer’s, but many depend on the same or similar amyloid targets, such as Biogen’s aducanumab.
However analysts are increasingly pessimistic about their chances of success.
Researchers are therefore looking at alternative ways to target the disease, but the underlying mechanism of the disease is still poorly understood, making drug development in Alzheimer’s a hit-and-miss affair.
Dr. Jeongchan Ra is Nature Cell’s chief executive, and has collaborated with professor Yoohun Suh, a global brain research leader, to isolate the stem cell, which was cultivated with patented technology as an animal model for Alzheimer's disease. The results were published in the well known scientific journal PLoS One.
Production of the approved clinical trial materials will be done by Nature Cell’s sister company RBio Biostar Stem Cell Research Institute (Biostar), which has been developing technology for dementia reduction for more than 10 years.
Nature Cell says the FDA clinical trial approval is the first ever for autologous adipose-derived stem cells. It says Biostar's technology for repeated intravenous administration of stem cells has already been applied more than 3,000 times in the past year to patients with autoimmune diseases who have been approved by Japan's Ministry of Health and Welfare.
The company is also developing the same autologous stem cell treatment for degenerative arthritis.
JontStem's phase 2 clinical trial in the US. It is a great result that affirms the technological developments of the RBio Biostar Stem Cell Research Institute:
Two hospitals in the US will start recruiting patients at the end of this year. Because of the cutting-edge nature of the field, this will mean it is likely to be many years before the drug’s value can be proven and approval gained.
