I have a new Cell Stem Cell piece out today that aims to take stock of today’s stem cell regulatory oversight in the U.S., Japan, and elsewhere including Australia, Canada and India. I use a carrot and stick metaphor for encouraging legit research and taking regulatory action on serious non-compliant activities, respectively. Where is stem cell oversight today? Too much stem cell carrot and not enough stick? Some would probably say too little carrot and too much stick? Given how the stem cell arena can …Read More
The ability of for-profit stem cell clinics to pitch unproven, risky stem cell offerings to patients may soon get much tougher in Australia. The country’s Therapeutic Goods Administration (TGA), which has some similar responsibilities there as the FDA does here in the U.S., announced planned new reforms that’ll put stem cell clinics under more scrutiny and more thorough oversight. Hopefully it’ll in many ways provide patients with more protections. While details remain to be determined, there are four major components to the TGA policy change, which …Read More
New human clinical trials using derivatives of pluripotent stem cells in China for Parkinson’s Disease (PD) have raised expectations and some eyebrows. PD is a neurodegenerative condition, sometimes diagnosed or followed by PET scans such as the one at left, characterized by loss of dopaminergic neurons leading to severe and sometimes life-threatening symptoms.