Britain gives scientists permission to genetically modify human embryos

By Rachel Feltman February 1

 On Monday, Britain's Human Fertilisation and Embryology Authority greenlighted experiments that will attempt to edit the genes of human embryos. The work, which will be the world's first officially approved use of public funding for human-genome editing, is to be led by The Francis Crick Institute's Kathy Niakan.

The news comes less than a year after the first reports of human-gene editing — published by Chinese scientists in the journal Protein and Cell — using the fantastic and at times troubling technology known as CRISPR. By harnessing an ancient defense mechanism built into bacteria, CRISPR allows scientists to target, delete and replace specific genes. It has been used extensively in other organisms, but research in humans has been slow.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

Scientists stumble across unknown stem-cell type

‘Region-selective’ pluripotent cells raise possibility of growing human organs in animals.

Sara Reardon

06 May 2015

 A newly discovered type of stem cell could help provide a model for early human development — and, eventually, allow human organs to be grown in large animals such as pigs or cows for research or therapeutic purposes.

Juan Carlos Izpisua Belmonte, a developmental biologist at the Salk Institute for Biological Studies in La Jolla, California, and his colleagues stumbled across a previously unknown variety of pluripotent cell — which can give rise to any type of tissue — while attempting to graft human pluripotent stem cells into mouse embryos.

Scientists previously knew about two other types of pluripotent stem cells, but growing them in large numbers or guiding them to mature into specific types of adult cells has proven difficult. Writing in Nature, Izpisua Belmonte and his colleagues report a type of pluripotent cell that is easier to grow in vitro and grafts into an embryo when injected into the right spot. They call them region-selective pluripotent stem cells (rsPSCs).

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

U.S. to study whether to use genome sequencing for newborns

By Mark Johnson of the Journal Sentinel

The U.S. government has launched a $25 million program to explore the possibility of using whole genome sequencing for newborn babies, a development with the potential to transform American health care.

The five-year research program will involve reading the entire genetic scripts of some 2,000 newborns, a step that could someday lead to vast troves of electronic medical records describing the details of every person's health from day one.

Genetics experts have long discussed this futuristic possibility, but the idea came under serious discussion at the National Institutes of Health about two years ago in the wake of Nic Volker's sequencing and treatment by the Medical College of Wisconsin and Children's Hospital of Wisconsin.

Volker was 4 years old in 2009 when doctors read his genetic script and traced the cause of his disease to a single error in the sequence of 3.2 billion chemical bases. As a result of the diagnosis, Volker received an umbilical cord blood transplant that appears to have saved his life.

"We could each see that this was something looming over the horizon," said Eric D. Green, director of the National Human Genome Research Institute, whose group is collaborating with the National Institute of Child Health and Human Development on the newborn genome sequencing program.

Under the program, researchers at four institutions around the country will examine the benefits and risks of sequencing babies, looking at the accuracy and cost of the tests and the effect they would have on parents and doctors. Their efforts represent a first step into a complex world of new medical possibilities.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

Cloning Breakthrough Highlights An Alternative Source For Stem Cells

The recent breakthrough in human cloning announced by scientists at Oregon Health and Science University brings to light an alternative source of pluripotent stem cells that may now get more attention.

Altered Nuclear Transfer (ANT), like Somatic Cell Nuclear Transfer (cloning), utilizes the nucleus of a somatic cell, to swap into that of a human egg in order ultimately to generate patient specific pluripotent stem cells.

But in the ANT process, scientists alter the nuclear make-up of the cell or the egg prior to transfer, ensuring that no viable human embryo is possible even in principle from the get-go.

The resulting organism can generate robust pluripotent stem cells, like embryonic stem cells, but without the ethical implications that accompany the creation and destruction of human embryos involved in the SCNT process.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

You Don't "Own" Your Own Genes

RESEARCHERS RAISE ALARM ABOUT LOSS OF INDIVIDUAL "GENOMIC LIBERTY" DUE TO GENE PATENTS THAT MAY IMPACT THE ERA OF PERSONALIZED MEDICINE

NEW YORK (March 25, 2013) — Humans don't "own" their own genes, the cellular chemicals that define who they are and what diseases they might be at risk for. Through more than 40,000 patents on DNA molecules, companies have essentially claimed the entire human genome for profit, report two researchers who analyzed the patents on human DNA. Their study, published March 25 in the journal Genome Medicine, raises an alarm about the loss of individual "genomic liberty."

In their new analysis, the research team examined two types of patented DNA sequences: long and short fragments. They discovered that 41 percent of the human genome is covered by longer DNA patents that often cover whole genes. They also found that, because many genes share similar sequences within their genetic structure, if all of the "short sequence" patents were allowed in aggregate, they could account for 100 percent of the genome.

Furthermore, the study's lead author, Dr. Christopher E. Mason of Weill Cornell Medical College, and the study's co-author, Dr. Jeffrey Rosenfeld, an assistant professor of medicine at the University of Medicine & Dentistry of New Jersey and a member of the High Performance and Research Computing Group, found that short sequences from patents also cover virtually the entire genome — even outside of genes.

Full story

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

U.S. Panel Raps How Agencies Handle Human Research

U.S. government agencies fund thousands of studies on human subjects, but do not have a very good handle on the basic information about that research—possibly putting participants in harm's way, a presidential panel of reviewers has found.

The presidential bioethics commission looked into the current protections for human subjects in a review triggered by evidence of unethical behavior in a 1940s experiment that deliberately infected Guatemalan prison inmates and mental patients with sexually transmitted disease.

The commission earlier this year concluded that U.S. government researchers must have known they were violating ethical standards at the time of the experiment, shortly after World War II. They have also called for a better system to compensate medical research subjects.

Nothing like the horrors of the Guatemala study could take place under U.S. government watch now, the panel said in a report released Thursday.

But the lags in how federal agencies collect and store data about their research involving human subjects offers no assurance that all unnecessary injuries or unethical activity are prevented.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

Pay ban on donor organs doesn't include bone marrow, court says

With marrow now being extracted from the bloodstream, a federal appeals court calls it blood parts, not organ parts.

The new reading of the federal prohibition could attract thousands more donors.

By Carol J. Williams, Los Angeles Times

A federal law banning compensation for organ transplants doesn't extend to bone marrow harvested from a donor's blood, a federal appeals court said Thursday in a ruling that could attract thousands of new donors in a national campaign to save the lives of those afflicted with cancer and genetic disorders.

The 1984 National Organ Transplant Act included bone marrow in its list of "organs and parts thereof" for which donors could face criminal charges and five years in prison for providing them in exchange for money or other "valuable consideration."

Though bone marrow is naturally replenishable, unlike livers, kidneys and other whole organs, its sale was barred because the extraction method used at the time the law was passed was painful and risky for the donor and authorities feared the poor would be induced to submit to the procedure to earn money.

In the last 20 years, though, medical advances have brought about a less intrusive method by which the life-saving marrow stem cells are harvested from a donor's bloodstream in much the same way as blood is drawn at a blood bank. The new process, known as apheresis, filters out excess marrow stem cells that circulate in the bloodstream, as opposed to the surgical extraction method, known as aspiration, which inserts a large needle into the hip bone and siphons out the cells.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

UK scientists call for new agency to oversee experiments mixing human and animal cells

By Associated Press

LONDON — British scientists say a new expert body should be formed to regulate experiments mixing animal and human DNA to make sure no medical or ethical boundaries are crossed.

In a report issued on Friday, scientists at the nation’s Academy of Medical Sciences said a government organization is needed to advise whether certain tests on animals that use human DNA should be pursued.

Full story.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

Presidential Commission on Bioethics Calls for Enhanced Federal Oversight in Emerging Field of Synthetic Biology

Washington, DC – The Presidential Commission for the Study of Bioethical Issues today released its first report—a wide-ranging review of the emerging field of synthetic biology— issuing 18 recommendations including a call for coordinated federal oversight of scientists working in both large institutions and smaller settings.

Full report

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.

Bone-fusion protein raises questions about doctors' financial stakes

Some question whether doctors should be allowed to do clinical trial research involving products that might enrich them or the company they work for.

By John Fauber of the Journal Sentinel

Aug. 28, 2010

In January 2002, a group of Food and Drug Administration advisers met on whether to approve a powerful new biological agent that promised to revolutionize back surgery.

The product was like nothing the burgeoning field of spinal fusion surgery had seen before. If used properly, it essentially turned whatever it touched into bone. This was a good thing if it could be confined to the tiny space between vertebrae, but potentially calamitous if it leaked out.

One of the FDA advisers at the meeting raised a concern about nine of the doctors whose research on the product had been submitted to the FDA: The doctorsall had a financial stake in the product, and their test results with it were nearly twice as good as the doctors who did not have a financial interest.

The concern by the FDA advisory panel member was laughed off with a joke, according to a transcript of the hearing, and the panel ultimately deferred to Medtronic, a company that stood to get billions in sales as the maker of the product known as Infuse.

What has happened since is no laughing matter.

Full stroy.

Please visit our sponsor Gehrke & Associates, SC to learn more about how to enhance and defend your intellectual property.  Thank you.