Editor's NOTE:

Apart from the fact that embryonic stem cell research  (ESCR) is immoral, the testing on humans in this case would appear to be premature in that no testing has been done to date on primates. The documented creation of malignant tumors in animals is extremely worrisome and the possibility of tumor creation in primates should have been studied before subjecting humans to testing.

--Dr. J. Hubert


First tests for stem cell therapy are near

By Rob Stein
Washington Post
Sunday, August 29, 2010; 6:14 PM

Even as supporters of human embryonic stem cell research are reeling from last week's sudden cutoff of federal funding, another portentous landmark is quietly approaching: the world's first attempt to carefully test the cells in people.

Scientists are poised to inject cells created from embryonic stem cells into some patients with a progressive form of blindness and others with devastating spinal cord injuries. That's a welcome step for researchers eager to move from the laboratory to the clinic and for patients hoping for cures. But beyond being loathsome to those with moral objections to any research using cells from human embryos, the tests are worrying many proponents: Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry.

"We desperately need to know how these cells are going to perform in the human setting," said John Gearhart, a stem cell pioneer at the University of Pennsylvania. "But are we transplanting cells that are going to cause tumors? Will they stay where you put them and do what you want them to do?"

Supporters of these privately funded, government-sanctioned tests, including patients' advocates, bioethicists and officials at the companies sponsoring them, are confident that research has been exhaustively vetted. The Food and Drug Administration has demanded extensive experiments in the laboratory and on animals to provide evidence that the cells are safe enough to test in people and hold great promise.

"We're very optimistic," said Thomas B. Okarma, president and chief executive of Geron Corp. of Menlo Park, Calif., which after years of delay received a green light in July from the FDA to study patients partially paralyzed by spinal cord injuries. "If we're right, we'll revolutionize the treatment of many chronic diseases."

But some researchers fear that the stakes jumped even higher with the federal judge's decision blocking federal funding. If patients are hurt by the cells - or even if there's no hint the cells help - that could be a devastating blow just as scientists are scrambling for funding from private foundations and benefactors. They cite the case of Jesse Gelsinger, whose 1999 death from a gene therapy experiment set that once highly touted field back years.

"There's a lot of angst around these trials," said Evan Y. Snyder, director of the stem cell program at the Sanford-Burnham Medical Research Institute in San Diego. "There's going to be this perception that if the cells do not perform well, the entire field will be illegitimate."

Most of the apprehension focuses on the Geron trial. Safety worries - most prominently fears that the cells could cause tumors - prompted the FDA to repeatedly demand additional data from Geron, including most recently assurance cysts that developed in mice injected with the cells posed no threat.

"We jumped through a lot of hoops to convince a lot of audiences," Okarma said. No one wants another Jesse Gelsinger."

While Geron eventually hopes to test the cells on many patients the first trial will involve 10 partially paralyzed by a spinal cord injury in the previous one to two weeks. Surgeons will inject the first patient with about 2 million "oligodendrocyte progenitor cells," created from embryonic stem cells, in the hopes the cells will form a restorative coating around the damaged spinal cord. In tests in hundreds of rats, partially paralyzed animals walked.

The trial is designed primarily to ensure the cells are safe. But researchers will look for signs that the therapy restores sensation or enables patients to regain movement.

"If we were able to do that, it would be a phenomenally positive result," Okarma said. MORE...

____________

Editor's NOTE:

Here is the follow-on piece.

Dr. J. Hubert

First patient treated in stem cell study

By Rob Stein
Washington Post
October 11, 2010; 9:06 AM ET

The first patient has been treated with human embryonic stem cells in the first study authorized by the Food and Drug Administration to test the controversial therapy.

A patient who was partially paralyzed by a spinal cord injury had millions of embryonic stem cells injected into the site of the damage, according to an announcement early Monday by the Geron Corp. of Menlo Park, Calif., which is sponsoring the groundbreaking study.

The patient was treated at the Shepherd Center, a 132-bed hospital in Atlanta that specializes in spinal cord and brain injuries, Geron said. The hospital is one of seven sites participating in the study, which is primarily aimed at testing whether the therapy is safe. Doctors will, however, also conduct a series of specially designed tests to see whether the treatment helps the patients. No additional information about the first patient was released.

With U.S. stem cell treatments limited, some patients have tried other countries. Experimental stem cell treatments offered in China are luring American patients such as 9-year-old Kara Anderson, whose parents took her around the world to help treat her cerebral palsy.

The study marks a milestone in stem cell research, which is considered one of the most promising developments in medical research in decades but has been fraught with controversy.

The announcement comes as the future of federal funding for embryonic stem cell research remains in doubt. A federal judge ruled in August that the Obama administration's more permissive policy for funding the research violated a federal law prohibiting taxpayer money being used for research that involves the destruction of human embryos. The Justice Department is appealing.

Lack of Moral Clarity on Embryonic Stem Cell Research Continues: Debate Stalled in Courts

Appeals court lifts ban on stem cell funding

By Rob Stein
The Washington Post
September 9, 2010; 12:20 PM ET

An appeals court Thursday lifted a temporary injunction barring the federal government from funding research involving human embryonic stem cell research.

A three-judge panel of the U.S. Circuit Court of Appeals for the District of Columbia granted a request from the Justice Department to stay an injunction issued Aug. 23 blocking the funding. In a major victory for supporters of the research, the court said the Obama administration could resume funding the research pending a full appeal of the case.

U.S. District Judge Royce C. Lamberth, ruling in a lawsuit filed by two researchers working on alternatives to the cells, said the funding violated a federal rule that prohibits federal tax money from being used for research that involves the destruction of human embryos.

Here's an excerpt from Thursday's order:

O R D E R
Upon consideration of the emergency motion for stay pending appeal and for
immediate administrative stay, it is
ORDERED that the district court's August 23, 2010 order be stayed pending
further order of the court. The purpose of this administrative stay is to give the court sufficient opportunity to consider the merits of the emergency motion for stay and should not be construed in any way as a ruling on the merits of that motion. See D.C. Circuit Handbook of Practice and Internal Procedures 33 (2010). It is
FURTHER ORDERED that appellees file a response to the emergency motion
by September 14, 2010, at 4:00 p.m. The appellants may file a reply by 4:00 p.m. on September 20, 2010. The parties are directed to hand-deliver the paper copies of their submissions to the court by the time and date due.

The original decision was hailed by opponents of the research, who argue it is immoral to destroy human embryos. But it was condemned by supporters and advocates for patients, who said it was a major setback for one of the most promising areas of biomedical research.

In response to the order, the National Institutes of Health announced it was suspending consideration of any new grants for such research. Any researchers who had already received funding could continue their work, but their grants would not be renewed when they come up for routine review, the NIH said. As a result, hundreds of scientists around the country are scrambling to try to figure out how they are going to continue their research.

The Justice Department asked that the injunction be lifted as it appeals the decision, arguing the halt to the funding was causing irreparable harm to researchers, the federal government and patients hoping for cures.

Thursday's decision was hailed by supporters of the research.

"We are very pleased that the Court of Appeals has stayed the preliminary injunction. It is crucial that federal funding for human embryonic stem cell research be restored permanently and this stay is a step in that direction," said Lisa Hughes, president of the Coalition for the Advancement of Medical Research, a coalition of patient advocacy groups, scientists and research organizations that has lobbied for the funding. "While this issue continues to be argued in the courts, we call on Congress to move swiftly to resolve this issue and secure the future of this important biomedical research."