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his 2006 State of the Union address to prohibit groups have introduced human neural stem cern for the funding agency: chimerizing early
the most egregious abuses of medical research cells or fetal brain tissue into developing rodent embryos, according to Daley, is more con-
including the creation of human animal embryos to assess their capacity to engraft cerning than transplanting cells into adults or
hybrids (Nat. Biotechnol. 24, 487490, 2006). and ultimately repair brain or CNS damage. fetuses; due to their potential for transformation,
What became clear after the days presenta- Chimeras are used to assess the potency of stem chimerizing using pluripotent stem cells is more
tions was that the field is far from creating a cell populations and could potentially provide concerning than using differentiated cells; and
chimera with any significant amount of human- a place to store human germ cells that might chimerizing with nonhuman primates is more
derived cells, calling into question whether poli- be otherwise be lost by chemotherapy. And ethically concerning than doing so with species
tics or process was behind the agencys action. humanized mice, whose immune systems are distantly related to humans. Existing National
NIHs deputy director for science, outreach engineered to be partially human, are used both Academy of Science guidelines, which were set
and policy, Kathy Hudson, standing in for NIH as research tools and as factories for humanized out in 2005 (and later amended in 2009), deal in
director Francis Collins at the conference, as antibody therapeutics, for example in the pro- part with these concerns. They prohibit mixing
well as Carrie Wolinetz, associate director of duction of Sanofis mAb Praluent (anti-PCSK9) human embryonic stem cells with nonhuman
science policy at the NIH, did nothing in their for hypercholesteremia. primate blastocysts, and they do not allow for
public remarks to shed light on the reason Chimeras are not just laboratory freaks but breeding any chimera that might have germ tis-
for the moratorium, the likely outcome of the exist in nature as well. Women who have carried sue derived from human cells. The fear among
researchers is that any new guideline might
extend the prohibition against chimerizing
npg
Whether new regulations would apply roleto identify, review, and fund research in foreknowledge of the October moratorium,
to work by University of Rochesters Steve biomedicine to advance the health of people says Goldman. Members of staff told him
Goldman, who presented at the meeting, was argues for continuing funding in this field. They that they are concerned that the funding
also left hanging. Goldman implants glial pro- also pointed out the existence of several bodies moratorium might presage more regulations.
genitor cells from patients with neuropsychiatric that already oversee research involving chime- They did make it clear that the panel was
disorders into mouse embryos. This work allows ras: the Institution Review Boards (IRBs) for meant as a fact-finding mission, not a forum
him to uncover potential new pathways for research involving human cells and tissues, the to make policy. Summing up the feeling of
intervention as well as create models for study- Stem Cell Review Organizations (SCROs) for researchers is Salks Belmonte. Itis impor-
ing the molecular bases of the pathologies seen studies with stem cells, and the Institutional tant to have guidelines so that researchers
in these patients. Animal Use Committees (IACUCs). have a clear path in thispromising and fast-
Ultimately, the list of unknowns about human Researchers must also, the letter noted, comply moving area, but ablanket ban on funding
chimeras made it clear that fundamental knowl- with federal, state and local laws. this work willslow much-neededprogress in
edge is still needed before this field can move Perhaps most surprising was that NIH basicresearch, he says.
forward to provide therapeutic solutions, partic- staffers at the meeting said that they had no Laura DeFrancesco Senior Editor
ularly in the area of organ replacement. Leading
a discussion at the meeting, Janet Rossant, from Corrections
the Hospital for Sick Children in Toronto, asked
In the December 2015 issue, in the article Predictive biomarkers for checkpoints, first tests approved,
a series of pointed questions: Are there funda- in Table 1, the highest threshold for PD-L1 positivity with the Ventana SP142 diagnostic for immune
mental blocks with interspecies chimeras, given cells was given as 50%; the threshold is 10%. In addition, in Box 1, the name of the company Arcteris
that only chimeras between closely related spe- was misspelled as Arcteries. The errors have been corrected in the HTML and PDF versions of the article.
cies have succeeded so far? What is the ideal cell In the November 2015 issue, in the article Drug makers target ubiquitin proteasome pathway anew,
2016 Nature America, Inc. All rights reserved.
type for engraftment, a pluripotent or fully dif- pevonedistat (TAK-924) was mis-identified as TAK-243, and the synergies referred to were seen in
ferentiated cell or something in between? And preclinical experiments, not in phase 1. The first two sentences in the penultimate paragraph Less
selective, perhaps, is targeting the E1 ubiquitin-activating enzyme. But Takeda is exploring these
of course, even if whole organs were generated
targets in combination with other therapies, having seen what senior scientist Allison Berger describes
in an interspecific chimera, what are the real as striking synergy between an E1 ubiquitin-activating enzyme inhibitor TAK-243, in phase 1, and
prospects of using them in the clinic, given the azacytidine in patients with acute myelogenous leukemia have been replaced with Targeting pathways
complex nature of an organ like a kidney or a linked to ubiquitin-like proteins remains at an early stage, too. Takeda is exploring the potential of
heart, which have continued interaction with pevonedistat (TAK-924), a first-in-class inhibitor of Nedd8 activating enzyme, in several cancers. A
the host even after the organ is formed? combination trial with azacitidine is underway in acute myelogenous leukemia, following what senior
scientist Allison Berger called striking synergy seen in preclinical experiments. The errors have been
In a letter published in Science on the day the
corrected in the HTML and PDF versions of the article.
panel met, researchers from Stanford and the
University of Minnesota pointed out that NIHs
will expand biopharma regulatory approval as well as to initiate follow-up surveys with
research and manufacturing patients taking the drugs. The new rules go into effect in 2017.
with $37 million in funding
over the next eight years. One
key objective is to strengthen
the links between industry and
academia, said minister for
higher education and research
Helene Knutsson.
Map: iStockphoto; Flags: Jelena Zaric/ Hemera/Thinkstock
ZAMBIA
The government VIETNAM
launches its National Beginning this
Biosafety Authority to regulate month, food products
GM organisms and their products containing at least one GM
within Zambia. Policy formulation, INDIA ingredient making up over 5% of
notification and issuing permits for India unveils its National Biotechnology total ingredients must include the
key biosafety matters will include Development Strategy 20152020, which phrase genetically modified on
input from the ministries of higher aims to grow the sector into a $100 billion industry by their labels. Fresh and live GM
education, health, lands, natural 2025. The plan emphasizes a strong infrastructure for plants and animals, unpackaged
resources and environmental R&D in vaccines, genomics, infectious and chronic GM foods, and those produced for
protection as well as the ministry of diseases and crop science, among others, and scientific export only are not subject to the
local government and housing. and technological training for the countrys workforce. requirement.