Stem Cells Whistle up a Windpipe

The story involved a woman named Claudia Castillo, a 30-year-old mother of two from Barcelona, Spain. Castillo's windpipe was badly damaged by long-term tuberculosis. Her left lung had collapsed and she faced the possibility of having the lung removed, a dangerous option that would have severely restricted her quality of life.
But then her doctors decided upon a different, pioneering approach to Claudia's problem: they grew a new windpipe using stem cells. The entire procedure, which included doctors working in three different countries - Spain, Italy and England - was almost too fantastic to believe.
First, the doctors got a windpipe from an organ donor. That windpipe was used as a kind of scaffold upon which the stem cells would be placed and where they would be manipulated to grow a new windpipe.
Of course, stem cell research has been a hot-button political topic for years because much of it has involved the use of embryonic stem cell tissue, which is typically derived from aborted fetuses. But in this procedure, doctors used adult stem cells to grow the new windpipe.
And here's the best part: the stem cells weren't just from any adult; they were from Claudia's own body. The doctors in England took a sample of Claudia's bone marrow from her hip, and after millions of cells had been produced, injected various chemicals to induce the cells to turn into highly specialized cells that would create the new windpipe grown on the scaffolding provided by the donated one.
All of which is very good news, and not just because it avoids the ethical and moral implications that accompany embryonic stem cells. The truly great benefit here is that the new windpipe in Claudia's throat contains her own DNA because it was constructed using her own stem cells. Thus, rejection by the body isn't an issue as it is in typical organ transplants.
By the time her story was published, in mid-November, Claudia was already home and, in her own words, "enjoying life and ... very happy that my illness has been cured."
While the early results are encouraging, the doctors and scientists involved cautioned that this is only a halting first step. But it's a promising step, and some of the doctors voiced real optimism, saying that this technique might even be adapted to other organs. And another said that while it's still years away, one day we may be able to produce organs in the laboratory using a patient's own stem cells, without the need of donor organs to use as templates.
So, as it stands, really significant advancement in growing new organs from stem cells that could cure many of our diseases is still well in the future, if it happens at all. But if does happen, this story - which was barely noticed amidst the political turmoil, economic upheaval and deadly natural disasters of 2008 - may end up being like the little ray of hope that flew out of the Pandora's box of 2008.

The Cruelty of Clinical Trials for Crohn’s Disease

Right now there are millions of individuals whose lives are directly dependent on the rate at which new drugs come to market. I'm one of them. I'm fighting for my life.
To date, half of my intestine has been removed to manage Crohn's disease. Last year, at age 23, I enrolled in a clinical trial for a treatment that could save my life: an adult stem-cell therapy that helps damaged intestinal tissue regenerate from the relentless inflammation and scarring caused by Crohn's.
The sponsor, Osiris Therapeutics, reported that Crohn's patients in the therapy's Phase II trial all experienced clinical improvement after receiving the cells. A Phase III trial for the treatment is now nearing completion, but Food and Drug Administration (FDA) approval could be years away, despite its FDA "fast track" designation.
In accordance with antiquated FDA policies, the Phase III trial is randomized with three groups of patients, and double-blinded, which means neither the doctors nor patients are told what treatment is being administered. One group received full-strength stem cells, another received half-strength, and a third got a placebo (the proverbial "sugar pill"). It appears I got the placebo.
Foregoing all other treatments, I received the four scheduled infusions, and yet my disease progressed with a vengeance. In a matter of weeks, I became dangerously malnourished. I've since been readmitted to the hospital countless times, as my doctors continue to plead with Osiris for information. But Osiris has refused, citing adherence to FDA protocol.
I am now a lab rat. I have no right to know what happened to me in the study, nor do I have a right to try the promising treatment as my health deteriorates. It doesn't have to be this way.
Under the Fifth Amendment's guarantee that "No person shall be deprived of life, liberty or property without due process of law," a critically ill patient should have access to a potentially lifesaving drug that has been deemed safe for human consumption, if the patient agrees to bear the risks involved. But earlier this year, the Supreme Court refused to hear a case on the issue, denying countless patients their right to pursue life.
Thankfully, some members of Congress have stepped in to ensure our rights as patients. In May, Sen. Sam Brownback (R., Kan.) and Rep. Diane Watson (D., Calif.) introduced the Access, Compassion, Care and Ethics for Seriously Ill Patients Act. If passed, this bipartisan legislation will begin to restore the rights of millions of patients by widening access to promising investigational drugs.
Human clinical research is an intricate scientific and moral process, but it does not justify taking immoral advantage of patients. Tragically, FDA and Osiris think it does.
Typical approval protocols almost always guarantee patients taking the placebo access to the actual drug -- at the very least -- after the study has ended. But in what appears to me a deliberate act of cruelty, Osiris hung its patients out to dry without any recourse, refusing to confirm which patient got what. The FDA has endorsed Osiris's decision by enabling it to proceed with the study.
Withholding a potential cure is just as bad -- if not worse -- than the potential death sentence of a serious illness. If patients like myself have the audacity to put their lives on the line for the betterment of science and those in their predicament, their decision should not only be embraced, it should be rewarded.
Furthermore, trials without ethical recourse can lead to inadequate and incomplete data, compromising the integrity of the study. If trial patients are treated like lab rats, they won't feel obliged to cooperate unconditionally and report accurate data -- something the FDA and the drug industry rely on heavily, but have failed to consider.
Everyone agrees it is a fundamental right for patients to dictate their course of treatment with FDA-approved drugs. So why do the rules evaporate at the most critical moment, when the only life-preserving options are highly promising investigational drugs?
Mr. Sofer is a student at the University of California, Berkeley.

The “Wrong” Cure

Adult stem cells get the shaft.

By Wesley J. Smith

Copied from google blogs today - yet another example of how the public are being denied access to the wonders of adult stem cell therapy. Shame on you Larry King.

Members of the liberal media elite have become rather choosy when it comes to advocating stem-cell cures for degenerative medical conditions. To these commentators, cures using adult stem cells just aren't the "right" cures. For stem-cell therapy to really count, it has to come from embryos. Indeed, even the most astonishing research advances using adult cells are ignored by these arbiters of public policy as if they never happened. And since liberal elites dominate public discourse in the stem-cell debate, the American people remain generally unaware of these astonishing scientific advances.

No media personality epitomizes the elite liberal media mindset more than CNN's Larry King. It thus came as no surprise that King cared nothing about adult-stem-cell research breakthroughs when the noted artist, evangelist, and disability-rights activist Joni Eareckson Tada raised the issue in an August interview.

Tada has been quadriplegic since breaking her back in a diving accident at age 17. In recent years, she has become an outspoken opponent of human cloning and of federally funded embryonic-stem-cell research. It was in this context that Tada accepted King's offer to introduce her to Christopher Reeve, the paralyzed former movie star who has become the world's most famous advocate for using human cloning and embryonic stem cells to find cures:

King: He [Reeve] thinks he's going to walk.

Tada: That may very well happen using incredible therapies...using adult stem cell research. It is absolutely amazing what is happening. Dr. Carlos Lima in Lisbon, Portugal, has helped restore bladder and muscle control to people with paralysis using stem cells from their own nasal tissue.

Take a moment and think about what Tada told King. Paralyzed people with serious spinal injuries like those afflicting Tada and Reeve have regained feeling in their bodies using adult-tissue therapies. Assuming that King was unaware of these advances — always a good assumption, given that King prides himself on not preparing for interviews — he should have been thunderstruck by this big news. Tada's assertion should have prompted an immediate follow-up question demanding more details. Had King done this, Tada might have then told him that one of the paralyzed women treated by Dr. Lima with her own olfactory tissue had recently appeared before a Senate subcommittee and presented videos of herself walking with braces!

But King never even attempted to follow up. Indeed, he wasn't the least bit curious about the tremendous news that human patients with serious spinal-cord injury may be able to walk again if these early human trials using adult tissue pan out. Instead, almost reflexively, he promoted embryonic-stem-cell research, stating, "Everyone says it will be faster if embryonic is also used. Nancy Reagan is going to campaign strongly for that."

Tada told King patiently that she opposes embryonic-stem-cell research, in part because she advocates channeling scarce resources "into [adult] therapies which have the most promise, which are the most effective." She then told King about the dangers associated with embryonic stem cells of which he might be unaware, such as tissue rejection and tumors.

King shrugged this off, asserting that problems always happen in the beginning of research studies. "That's true," Tada acknowledged. And then she tried again to get King to just hear how far adult-tissue research has already advanced. "Right now," she said, "incredible therapies" are happening "with their own stem cells, whether dental pulp or nasal tissues, or bone-marrow tissues."

For a second time in two minutes Tada had presented King with the opportunity to provide his audience with a wonderful educational opportunity. Had he followed up, even skeptically, by demanding that Tada give examples of these incredible breakthroughs, she could have told him about human heart patients who have already benefited from treatment with their own bone marrow or blood stem cells. She could have given great hope to people with Parkinson's disease by describing the successes already achieved treating patients with adult cells and their derivatives. Perhaps she would have mentioned the wonderful news that in an early human trial, a patient with multiple sclerosis so advanced that he experienced bouts of blindness appears to have been put into almost total remission using his own stem cells.

But King's viewing audience was not allowed to learn any of this, because King did not inquire. Instead, he demanded to know who is harmed by embryonic-stem-cell research and asked whether she would agree to debate Christopher Reeve. Then, it was quickly on to other matters. Clearly, for King, stem-cell medical advances only count if they come from embryonic sources.

King is not alone in this incredibly myopic approach to the stem-cell debate. Other elite liberal commentators are just as narrow in their views about adult-stem-cell research. For example, Laura Bush's recent defense of her husband's stem-cell policy sent several elite liberal commentators into apoplectic orbit. Cynthia Tucker's August 13 syndicated column, "Bush's Policy on Stem-Cell Research Has No Good Defense," was especially nasty — and typically ignorant of the current state of the science.

Charging that only religious extremism stands in the way of stem-cell advances, Tucker accused the president of limiting research "that could...lead to cures for Parkinson's, multiple sclerosis and even some cancers. Some of those cures could be decades away. But we can't get there until we get started."

Tucker either didn't take the time to discover, or doesn't care, that we are already well under way to finding such cures! As stated above, human patients with the very diseases Tucker mentioned have already benefited from adult-tissue therapies. Animal studies have advanced even further. For example, mice with advanced-stage juvenile diabetes have been cured with adult cell therapies. Yet instead of embracing these advances, Tucker complained, "I certainly don't understand a 21st-century superpower that devotes billions to building smart bombs to destroy life efficiently but refuses to fund the research that could save or enhance the lives of millions of its citizens."

Ignorance, thy name is Tucker. Apparently she is unaware that the federal government poured more than $200 million into adult-stem-cell research and about $25 million into embryonic-stem-cell research in 2003. In addition, private investors have abundantly invested in adult-stem-cell research, while generally shunning embryonic and human cloning research, largely because adult therapies are so much closer to fruition than embryonic approaches.

Apparently, Tucker would put her political views before the current state of the science and reverse this funding ratio. But this would be most unwise. It could delay bringing regenerative cures to the American people by diverting resources away from adult-cell cures already in early human trials and toward embryonic research that can't even be done safely in humans — a point made by Joni Eareckson Tada that bounced off Larry King's forehead.

Amazingly, the ideological fervor in favor of using nascent human life in stem-cell treatments is so intense that it prevents even liberal media elites who suffer from these diseases from embracing emerging treatments that use adult cells. Michael Kinsley, the editorial page editor of the Los Angeles Times, is a puzzling case in point. Kinsley has Parkinson's. One would think he would be extremely interested in the successful experiment involving fellow Parkinson's patient Dennis Turner, who five years ago received an 83 percent reversal of his symptoms after a treatment using his own brain stem cells. Kinsley should also find great hope in the results of another human trial in which five Parkinson's patients, treated with a natural body chemical known as glial cell-line-derived neurotrophic factor (GDNF), improved so significantly that three regained their senses of taste and smell.

But Kinsley is blind to this wonderful news. In a diatribe against Laura Bush and the president, Kinsley claimed that "stem cell research has been drastically slowed" by the president's stem-cell policy (again, apparently, the only real stem-cell research is embryonic-stem-cell research). Working himself into a blind rage, Kinsley accused President Bush of "ensuring there is no hope at all" for people like him who suffer from Parkinson's disease — a statement exhibiting sheer indifference to the very facts that hold out true hope for Kinsley's own health problems.

Media opponents of President Bush's stem-cell policy often accuse the president of deciding science questions based on religious beliefs. But they are the ones whose ideological predilections and personal antipathy for political opponents are making them incapable of appreciating the evidence. As the old saying goes, none are so blind as those who will not see.

Stem Cells may end the need for heart transplants

British scientists have developed a new technique that can rebuild a severely damaged heart, and one day, might replace the need for transplantation.
Researchers at Imperial College London revealed that stem cell heart surgery can help repair damaged hearts using progenitor cells derived from patients’ own cardiac muscle.
They have discovered a way to extract, grow in the laboratory and then graft on a patient’s own muscle-building cells which then can be used to patch up the heart and increase its pumping power
Moreover, it can increase the quality of life for people who suffer a heart attack.
“This could transform the care for patients who have had heart attacks or have heart disease,” the Telegraph quoted Dr Nicholas Boon, President of the British Cardiovascular Society as saying.
“Because the cell therapy uses a patient’s own cells, it negates the risks or complications associated with other treatment options such as rejection linked to transplantation,” Boon added.
Researchers led by American Professor Michael Schneider have discovered a way to rejuvenate hearts using specialist versions of heart stem cells - known as “progenitor” cells - found in small quantities in human hearts.
The research team isolated the special cells from human hearts and cloned them in the lab. They then used a proprietary, non-toxic technique to multiply them.
The technique was found to be effective in trials conducted using mouse model and it did lead to the formation of new heart tissue.
“It’s very exciting - and we could be doing human trials within three years,” said Professor Schneider.
“This is pretty cutting edge stuff, in an ideal world, we could have a situation where patients with heart disease have their disease reversed as healthy tissue grows back.
“We hope that at the very least this will make the lives of those suffering from heart disease easier - allow them to get up stairs and do more things in their daily lives.
“The more ambitious hope is that will eventually keep people out of hospital and make them live longer,” he added. (ANI)

Vatican issues major new bioethics document

Associated Press

VATICAN CITY (AP) — The Vatican raised its opposition to embryonic stem cell research, the morning-after pill, in vitro fertilization and human cloning to a new level Friday in a major new document on bioethics.

But in the document, the Vatican also said it approved of some forms of gene therapy and encouraged stem cell research using adult cells. And it said parents could in good conscience inoculate their children with vaccines produced with cells derived from aborted fetuses.

The Vatican's Congregation for the Doctrine of the Faith issued "The Dignity of a Person" to answer bioethical questions that have emerged in the two decades since its last such document was published.

With it, the Vatican has essentially confirmed in a single, authoritative instruction the opinions of the Pontifical Academy for Life, a Vatican advisory body that has debated these issues for years.

The Vatican's overall position is formed by its belief that human life begins at conception, and must be afforded all the consequent respect and dignity from that moment on. The Vatican also holds that human life should be created through intercourse between husband and wife, not in a petri dish.

As a result, the Vatican said it opposed the morning-after pill, even if it doesn't cause an abortion, because an abortion was "intended." In the use of drugs such as RU-486, which causes the elimination of the embryo once it is implanted, the "sin of abortion" is committed; their use is thus "gravely immoral."

The Vatican also said it opposed in vitro fertilization because it involves separating conception from the "conjugal act" and often results in the destruction of embryos. The Vatican supports, however, techniques that help couples overcome obstacles to getting pregnant.

In the document, the Vatican elaborated on a host of issues surrounding assisted fertility, saying it:

_Opposed the selective reduction of embryos often used in in vitro procedures since it essentially is abortion.

_Opposed pre-implantation diagnosis of embryos since it may be followed by the destruction of those embryos deemed defective or otherwise undesirable.

_Opposed freezing embryos, since it is "incompatible with the respect owed to human embryos" and also means they were created in vitro.

It said that, while freezing eggs is not in itself immoral, it becomes unacceptable when it occurs for the sake of artificial procreation.

The Vatican lauded as "praiseworthy" the suggestion by some to let infertile couples "adopt" the thousands of frozen embryos that have been produced in vitro over the years. But it said such adoptions present a host of medical, psychological and legal problems.

The instruction also weighed in on research involving stem cells, cloning and gene therapy.

The Vatican stressed that it fully supported research involving adult stem cells. But it said obtaining stem cells from a living embryo, even for the sake of effective therapies, was "gravely illicit."

It said gene therapy on regular cells in the body other than reproductive ones was in principle morally licit since it sought to "restore the normal genetic configuration of the patient or to counter damage caused by genetic anomalies."

But it said that cell therapy which seeks to correct genetic defects with the aim of transmitting the therapy onto offspring was more problematic.

"Because the risks connected to any genetic manipulation are considerable and as yet not fully controllable, in the present state of research, it is not morally permissible to act in a way that may cause harm to the resulting progeny," the document said.

In the document, the Vatican also:

_Repeated its opposition to human cloning for both medical therapies and reproduction. Such techniques could result in an individual being subjected to a form of "biological slavery from which it would be difficult to free himself."

_Said parents could in good conscience use a vaccine for their children that was developed using cell lines from an "illicit origin." Religious groups in the United States have pressed the Vatican to issue a statement concerning the morality of using vaccines developed using cell lines derived from aborted fetuses.

"Grave reasons may be morally proportionate to justify the use of such 'biological material,'" the instruction said, adding that the parents would have to make known their disagreement with the way the vaccines were developed and press for alternatives.

But the document was very strong in stressing that researchers using such material were in a different position and had a greater degree of responsibility. It said they had a moral duty to remove themselves from the "evil aspects" of the original, illicit act — even if they and their institutions had nothing to do with it.