The US Food and Drug Administration (FDA) has approved the second human trial of human embryonic stem cells — this one testing cells in people with a progressive form of blindness, the company said yesterday.
Worcester, Massachusetts-based Advanced Cell Technology (ACT) said it would start testing its stem cell-based treatment on 12 patients with Stargardt’s macular dystrophy.
SECOND APPROVAL
It is the second trial of human embryonic stem cells to be approved by the FDA this year.
Last month, Geron Corp enrolled the first patient in its study using the cells in people whose spinal cords have been crushed.
GAMBLE
“It is exciting — a vindication. All this work really came through,” said Robert Lanza, chief medical officer of the company, which has struggled to stay solvent as it gambled on the controversial cells.
Stem cells are the body’s master cells, the source of all other cells.
Proponents of using embryonic stem cells say the field could transform medicine, providing treatments for brain diseases like Parkinson’s, juvenile diabetes or severe injuries.
However, opponents object because to get the cells, someone has to take apart a human embryo.
CHANGE
Last year, the administration of US President Barack Obama overturned the strictest of the limitations on using federal funds for the research, but this summer, two researchers challenged the policy.
A US appeals court has ruled that funding could continue while the government appeals, but grants from the US National Institutes of Health have been frozen and unfrozen as various courts have weighed in.
STARGARDT’S DISEASE
Stargardt’s disease causes progressive vision loss, usually starting in children or young adults 10 to 20 years old, as eye tissue called the retinal pigment epithelium, or RPE, degenerates.
There is currently no treatment for Stargardt’s disease.
ACT has coaxed human embryonic stem cells into becoming RPE cells, which will be infused into patients’ eyes.
BOUNTIFUL SUPPLY
“We can generate a virtually unlimited supply of healthy RPE cells,” Lanza said.
The company uses a unique type of human embryonic stem cell, taken from embryos left over at fertility clinics.
A single cell is removed when the embryo only has about eight cells — a process sometimes used when clinics want to test the embryos of people with genetic diseases to ensure that they are healthy.
CONTROVERSY
In theory, the embryo can continue developing, but in this case ACT has not implanted the embryo.
In the past, the company hoped this method of generating human embryonic stem cells would be less controversial than using an entire embryo.
Lanza said getting FDA approval for the trial was difficult.
“They had us jumping through hoops,” he said.
This was in part because the powerful embryonic cells have the power to give rise to all cell types and can cause teratomas — strange tumors containing a mix of cells.
ONE CELL ONLY
Lanza said the company can find even a single cell that might do this and remove it from the treatment batch.
In addition, he said treating an eye disease offers the opportunity to watch the treatment.
“We can look into the eye in real time and see what is going on,” he said.
APPROVAL PENDING
Research centers at the University of Oregon and University of Massachusetts will begin enrolling patients after their internal Institutional Review Boards approve the trial.
“My guess is that we could start in as soon as two to three months,” Lanza said.
Three experts in the high technology industry have said that US President Donald Trump’s pledge to impose higher tariffs on Taiwanese semiconductors is part of an effort to force Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) to the negotiating table. In a speech to Republicans on Jan. 27, Trump said he intends to impose tariffs on Taiwan to bring chip production to the US. “The incentive is going to be they’re not going to want to pay a 25, 50 or even a 100 percent tax,” he said. Darson Chiu (邱達生), an economics professor at Taichung-based Tunghai University and director-general of
‘LEGACY CHIPS’: Chinese companies have dramatically increased mature chip production capacity, but the West’s drive for secure supply chains offers a lifeline for Taiwan When Powerchip Technology Corp (力晶科技) entered a deal with the eastern Chinese city of Hefei in 2015 to set up a new chip foundry, it hoped the move would help provide better access to the promising Chinese market. However, nine years later, that Chinese foundry, Nexchip Semiconductor Corp (合晶集成), has become one of its biggest rivals in the legacy chip space, leveraging steep discounts after Beijing’s localization call forced Powerchip to give up the once-lucrative business making integrated circuits for Chinese flat panels. Nexchip is among Chinese foundries quickly winning market share in the crucial US$56.3 billion industry of so-called legacy
Taiwan Semiconductor Manufacturing Co (TSMC, 台積電) yesterday held its first board of directors meeting in the US, at which it did not unveil any new US investments despite mounting tariff threats from US President Donald Trump. Trump has threatened to impose 100 percent tariffs on Taiwan-made chips, prompting market speculation that TSMC might consider boosting its chip capacity in the US or ramping up production of advanced chips such as those using a 2-nanometer technology process at its Arizona fabs ahead of schedule. Speculation also swirled that the chipmaker might consider building its own advanced packaging capacity in the US as part
A move by US President Donald Trump to slap a 25 percent tariff on all steel imports is expected to place Taiwan-made steel, which already has a 25 percent tariff, on an equal footing, the Taiwan Steel & Iron Industries Association said yesterday. Speaking with CNA, association chairman Hwang Chien-chih (黃建智) said such an equal footing is expected to boost Taiwan’s competitive edge against other countries in the US market, describing the tariffs as "positive" for Taiwanese steel exporters. On Monday, Trump signed two executive orders imposing the new metal tariffs on imported steel and aluminum with no exceptions and exemptions, effective