Utah’s new stem cell law undermines FDA’s authority
The state of Utah has just enacted a law permitting patients to receive medical treatments using placental stem cells without formal approval by the United States' federal regulatory...
Australia’s first human challenge trials centre opens
Australia's first clinical trial unit specifically commissioned to conduct human challenge trials, or controlled human infection model (CHIM), Doherty Clinical Trials (DCT) Ltd, was recently opened...
FDA approves first gene-editing therapy
The Food and Drug Administration (FDA) recently approved Casgevy (exagamglogene autotemcel), the first cell-based gene-editing therapy to utilise the CRISPR/Cas9 system (CRISPR) in history, to treat transfusion-dependent...
Consumers should beware of stem cell treatments for Covid-19
A recent analysis has identified 38 companies offering so-called stem cell treatments and exosome treatments for preventing as well as treating COVID. These interventions are...
China’s revised regulation on human genome editing: the good news and the bad news
Remember the scandalous revelation of the world's first births of genome-modified twins (Lulu and Nana) by Dr He Jiankui in 2018? Recently, China revised its regulation...
Third global summit on human genome editing: Moving on after the He experiment
The much anticipated Third International Summit on Human Genome Editing was held in London earlier this month to explore the advances of the science, challenges...
Regulating dodgy stem cell clinics: FDA is appealing against ruling
The US Food and Drug Administration (FDA) has decided to appeal a surprising decision after it lost a case it was fighting against a California...
California court creates regulatory uncertainty over the FDA regulation of stem cell therapies
In a recent lawsuit brought by the Food and Drug Administration (FDA), a California judge entered a judgment in favour of the California Stem Cell...
Washington state sues ‘snake oil’ stem cell clinic
A Seattle based stem cell company, US Stemology, is being sued for deceptively marketing and selling stem cell therapies for a cure-all for dozens of...
Class action over unproven stem cell treatment settled for US$3.65 million
San Diego-based StemGenex, a now-bankrupt stem cell clinic, has to pay out US$3.65 million to its former patients for ineffective stem cell treatments. The complaint,...
Are human challenge studies for Covid ethical?
Researchers at Oxford University, in the UK, are seeking volunteers to participate in human challenge studies. These are carefully controlled experiments which involve deliberately infecting...
The CRISPR babies: the story unfolds
Remember the shocking announcement of the first births of genome modified twins (Lulu and Nana) globally? In an article in Nature Biotechnology, we learn a...