• US researchers have made another potentially key advance toward adult stem celltherapies for a host of diseases. But don’t bank on it just yet. 

   

• A stem-cell therapy for Crohn’s diseaseis in fast-track clinical trials. If it works as hoped, it could reduce the need for surgery that many Crohn’s patients eventually have to undergo. 

   

• Another study adds convincingly to the evidence that stem cell therapy to repair damaged heart muscleworks, and that “changes the entire game.” 

   

• A trial of a stem cell therapy for a deadly childhood brain disease is getting under way in the US. If successful, and if the ethics of using cells from aborted or miscarried fetuses do not again trump the ethics of saving real children from slow, hideous deaths, the trial has the potential to lead to cures for other neurodegenerative diseases and to validate the very exciting regenerative approach to medicine. 

   

• Umbilical cords are a key source of stem cells able to treat a growing list of medical conditions by helping the body to regenerate damaged tissue. Recent legislation creating a US National Cord Blood Bank should spur research and therapies in this very exciting area.

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What effect will the Hwang Woo-suk affair have on stem cell research?

According to the Washington Post:

…. The scandal also has delivered a body blow to stem cell science, a field of research born just seven years ago that, despite ethical concerns because of its reliance on human embryos, has generated great public enthusiasm. Stem cells, which can become any kind of tissue, show promise for the treatment of conditions including Parkinson’s disease, diabetes and spinal cord injuries.

“Unfortunately, the damage Hwang did can’t be undone,” said Robert Lanza of Advanced Cell Technology in Worcester, Mass., a company that had been racing to make the first customized stem cells but found its venture capital cut off when the Korean team announced its success. “It can’t be undone for us, and it can’t be undone for the thousands of people who may die in the future because this research has been unnecessarily held up while [Hwang] played his games and traveled around the world like a rock star.”

The Associated Press also saw doom and gloom:

…. The latest news was one more disappointment to the scientific world, which had viewed Hwang’s achievements as holding great promise for treating people with a variety of ailments, from spinal cord injuries to Parkinson’s disease.

“It’s a stain on the honor and integrity of the whole field,” said Dr. Robert Lanza of Advanced Cell Technology. “It has sent a lot of scientists on a wild goose chase and down false paths.”

“The bottom line is that it’s a major disaster to our whole field because the expectations were so high and now we are back to square one,” said stem cell scientist Joseph Itskovitz, director of the department of obstetrics and gynecology at Rambam Medical Center in Haifa, Israel.

But the Chicago Tribune is less depressed:

…. U.S. scientists interviewed Thursday said the impact of the fraud is temporary and it will not derail research into treatments based on adult and embryonic stem cells.

Moreover, despite the negative publicity the fabrication brings to a high-profile field, the fact that Hwang’s colleagues ultimately detected the fraud proves science still has effective self-policing powers, they said.

“Actually the scientific process was validated,” said Dr. John Kessler, a stem cell researcher at the Northwestern University Feinberg School of Medicine. “He was a fraud and we now recognize it, and it was his fellow scientists who blew the whistle.”

…. [S]cientists in the field said it is only a matter of time before someone succeeds where Hwang failed.

“It’s discouraging to see something of this sort happen, but it really shouldn’t in the long run have any effect on stem cell research and stem cell biology,” Kessler said. “It doesn’t affect the extraordinary progress we’ve made in all these areas, including the study of embryonic stem cells.”

University of Chicago geneticist Janet Rowley, a member of the President’s Council on Bioethics, said the South Korean affair could have a negative impact on stem cell research in the U.S. if critics are able to argue that scientists in the field are not following ethical standards.

“As far as we know this fraud is limited to the Korean group,” she said. “It’s easy for people who choose to tar people with the same brush.”

But the scandal may also have an energizing effect on scientists who had thought they were trailing Korea in embryonic stem cell research, Rowley said.

“Some scientists here are going to try harder to do this cloning work because instead of being as far behind as they thought they might be, they may well be making good progress in this very difficult area of research,” she said.

Adult vs. Embryo

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University of Louisville researchers have coaxed bone marrow stem cells from adult mice to change into brain, nerve, heart, and pancreatic cells, reports Laura Unger in the Louisville Courier-Journal. The “VSEL” (Very Small Embryonic-Like) stem cells were first proposed in 2004 and were thought to be very rare and difficult to grow in a laboratory. The new breakthrough is in showing that VSELs can indeed be lab-grown and made to differentiate, and are therefore an adult “counterpart for embryonic stem cells [that] could negate the ethical concerns” over embryonic stem cell research and lead to treatments for a host of human diseases.

The research team’s next step is to replicate the experiment with similar cells identified in adult humans. If that works, the discovery goes from “very important” to “incredibly important, . . . [and] transforming,” Unger writes, quoting a cancer researcher. As always, however, there remain major issues to be resolved before the research translates to treatments, which “are most likely many years off,” she says. A leading bioethicist told Unger: “Place your bets on all forms of research right now. It’s too soon to say that adult stem cells can do what embryonic cells do.”

Experimental Crohn’s Therapy

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The U.S. Food and Drug Administration has approved fast-track clinical trials of Osiris Therapeutics’ Prochymal, a stem-cell drug treatment thought to reduce inflammation and regenerate damaged tissue, as a treatment for Crohn’s Disease. It is being allowed to go straight to Phase 2 efficacy trials, skipping Phase 1 safety trials. Made from stem cells taken from the bone marrow of adult volunteers, Prochymal is already in fast-track trials as a treatment for Graft Versus Host Disease (a life-threatening complication of bone-marrow transplantation) where it has already been shown to be well-tolerated.

A researcher at Duke University Medical Center where the Prochymal trials will be held told Tricia Bishop of the Baltimore Sun: “There is a constant search for additional therapies for Crohn’s disease. The interesting thing about Prochymal . . . is it looks like it may modify scar tissue formation [which] may ultimately reduce the need for surgery.”

Osiris is also studying whether its stem-cell treatment Chondrogen can regenerate cartilage tissue in the knee, and whether another drug called Provacel can repair tissue damaged by a heart attack.

Heart Therapy Success

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Research presented at the American Heart Association in November 2005 showed nearly twice the improvement in the heart’s pumping ability in patients infused with progenitor cells (a form of stem cell) from their own bone marrow following a heart attack, compared to patients receiving a placebo. There was also less heart enlargement in the bone marrow cell patients, which in turn appeared to lead to reduced incidence of new heart attacks, hospitalization due to heart failure, and deaths. In addition, improved blood flow in the area where the attack occurred suggested that new blood vessels may have been created to nourish the damaged area. Benefits to heart function four months after an attack appeared to be most pronounced in patients with more severe damage to the heart muscle.

“The concept that we can regrow heart muscle cells would be an extraordinary development in the treatment of heart disease,” a leading cardiologist told Bill Berkrot and Ransdell Pierson of Yahoo News. “It changes the entire game.”

Stem Cell Therapy for Batten’s Disease

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Stanford University Medical Center is launching the first ever trial of immature neural cell injection therapy in six children afflicted with Batten disease, “a degenerative malady that renders its young victims blind, speechless and paralyzed before it kills them,” reports Paul Elias of the Associated Press. The injections will be made through holes bored into the patients’ skulls. The hope is that the cells will “engraft” in the brain and begin to produce an enzyme whose absence in Batten’s patients causes the disease.

The trial is causing ethical discussion over the possibility of altering the patient’s personality, and over the fact that some of the cells are derived from aborted fetuses.

Potential of Cord Blood

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Blood extracted from discarded umbilical cords after childbirth is “turning out to be a medical treasure trove,” writes science reporter Ronald Kotulak, in a long and informative article in the Chicago Tribune. As one researcher told him: “Cord blood research is moving us into an era of regenerative medicine where we’re going to be approaching chronic degenerative diseases with ways to repair them by generating new tissues.”

Cord blood is already known to be effective against Krabbe disease, sickle cell disease, childhood leukemia, aplastic anemia, and immunodeficiency diseases, but its benefits appear likely also to extend to heart attack, Parkinson’s disease, stroke, Alzheimer’s disease, muscular dystrophy, diabetes, spinal cord injury, amyotrophic lateral sclerosis, Hurler’s syndrome, Tay-Sachs, Sandhoff, metachromatic leukodystrophy, and adrenoleukodystrophy.

“Using [cord blood] cells to deliver therapies is going to be the next big therapeutic breakthrough in medicine,” said one doctor. Cord blood can cause the bone marrow in a diseased child to produce a new supply of healthy blood containing enzymes whose lack causes the disease. Cord blood stem cells also migrate to the brain and other areas of the body unable to produce the enzymes and proteins needed to build myelin, reduce inflammation, fight infection, and spur growth. Cord blood is also a rich source of regulatory T cells, which will be tested in a planned clinical trial among autoimmune disease patients at the University of Minnesota.

Indeed, cord blood is “so adaptable that some researchers believe it can be administered like penicillin to treat injuries caused by common disorders,” says Kotulak. It can give someone a whole new healthy blood supply, or it can hone in on and repair damage caused by strokes, heart attacks, and other injuries. Animals treated in this way “recover to a degree not possible before.”

More than half of all stem cell transplants in children are now done with cord blood, and the number is growing in adults. To stimulate its collection and use, in December President Bush signed the Stem Cell Therapeutic & Research Act of 2005 authorizing US$79 million in new federal funding for the collection and storage of cord blood units from ethnically-diverse cord blood donors and the establishment of a public cord blood bank network. Such legislation is needed because most of the precious blood is still discarded after birth.