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Archive for the ‘Stem Cell Therapy’ Category

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Despite growing calls to the contrary in many Catholic circles, I took the ALS Ice Bucket challenge earlier today at a Boy Scout Eagle Service project. So, I gather folks might want to know why.

Amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, is a terrible muscular disease in which people lose their skeletal muscle function, including the muscles that help us breathe. It was 75 years ago this summer that Yankee legend, Lou Gehrig, announced his departure from baseball in a speech that has become as iconic as the Iron Horse himself.

A major research and advocacy organization, the ALS Association (ALSA) has been the beneficiary of some $40 million raised in an awareness campaign that has as a simple device people calling out friends and family, challenging them to either give $100 or have ice water dumped on their heads. Many, such as your humble author (with a little frat boy left in him), have elected to do both. The problem for some is that ALSA has been an advocate for embryonic stem cell research, which tears apart a human being in the embryonic stage of development and uses its cells for research purposes. That’s a major hurdle. But now for some facts.

ALSA has said that they have one embryonic stem cell line that has been funded by a private donor, and that work on this line of cells is nearing the end of its lifespan. That’s not hard to believe . Almost nobody pursues embryonic stem cell research anymore. The reason is simple.

They. Just. Don’t. Work.

They are too young, immature, and undifferentiated to control. They grow into tumors. There are too many unknown variables. They are a nightmare that have produced zero return on investment, and for both parties in grant applications, that’s a big, big deal. Labs have been abandoning them like rats jumping from a sinking ship.

Researchers now use induced pluripotent stem cells (iPSC’s), which are generated directly from adult cells. We also now have hundreds of therapeutic uses from adult stem cells. So, embryonic stem cells are yesterday’s failed experiment. Still, that won’t assuage some who are entirely intolerant of any organization that might have ESC’s still in research. For the faithful Catholic this is where the ethical waters get a bit muddy.

The National Catholic Bioethics Center recently weighed in, offering alternative organizations not using ESC’s. That’s fine, but consider that the same organization doesn’t have a moral problem with using vaccines cultured in cell lines derived from aborted fetuses:

Whether immunization with these vaccines is permissible depends upon whether their use involves the Catholic in cooperation with evil. Briefly, formal cooperation arises when an individual shares in the intention or the action of another who does what is wrong. Immoral material cooperation occurs when one who cooperates makes an essential contribution to the circumstances of a wrongdoer’s act. Thus the question about vaccines derived from aborted fetuses concerns whether or not their use involves the Catholic in immoral cooperation with the evil of abortion.

The answer, in short, would appear to be “no.” For it seems impossible for an individual to cooperate with an action that is now completed and exists in the past. Clearly, use of a vaccine in the present does not cause the one who is immunized to share in the immoral intention or action of those who carried out the abortion in the past. Neither does such use provide some circumstance essential to the commission of that past act. Thus use of these vaccines would seem permissible.

The author, Dr. Ted Furton, is from my conversations with him, and my reading of his material, a profoundly good, moral, and decent Catholic man and scholar. His rationale in the case of the vaccines in question can be applied to donating to ALSA, which is winding down its sole line of ESC’s (that have private funding). It’s an old cell line, just as the vaccine culture line is an old cell line. Unlike the vaccine cell line, ALSA’s one ESC line is on a dead end trajectory.

So, what’s really at issue here? Stem cell researchers are licking their wounds after more than a decade of fruitless endeavor. Virtually all recognize that the morally unproblematic ASC’s and iPSC’s are bearing great fruit, thanks to their being more mature and differentiated (hence more easily controlled). Ought we withhold funding from researchers at ALSA whose administrators today pay weak lip service (and no more money) to one of science’s greatest boondoggles?

For what it’s worth, as a Catholic Molecular Biologist who has raged for a decade at this ugly abuse of science, I think it’s more important to fund the research community’s redemption than to rub their collective nose in past sins. ALSA has many great minds on staff. New money goes to morally acceptable research. Like the son in the parable who initially refused his father’s request, they have come about and are now doing what we have called upon them to do for over a decade.

We need to stop pouring cold water on the Ice Bucket Challenge. I plan to donate to ALSA and to earmark the money for research on iPSC’s (kinda redundant, as the ESC line is funded by a sole donor). However, the earmark sends a message, a good message for a good cause.

I hope that it helps to end this dread disease and that we can look back and have ownership in having a part in it all, and having funded moral means to such a good end.

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Recent news that Geron has abruptly pulled out of the embryonic stem cell (ESC) business, after having just begun the only human clinical trials with ESC’s, has been met with deserved rejoicing by the pro-life community. While it certainly is a blow to the ESC movement, it doesn’t necessarily signal the impending implosion of the ESC industry.

Not by a long shot.

While ESC’s are on the ropes, adult stem cells (ASC’s) are being declared the winner in some enthusiastic quarters. This, too, may be a bit premature.

What makes adult stem cell (ASC) therapy so very appealing, compared to ESC’s, is that they are not only free of their embryonic counterpart’s ethical baggage, but that they are for the most part an autologous therapy–being taken from one part of the patient’s body and transferred to another. Being thus free of the tissue compatibility/rejection dimensionality that comes from using cells from another human, ASC’s are the much safer alternative, with scores of clinical applications in use globally.

Paradoxically, the strength of ASC’s autologous nature is also their great difficulty from a business perspective, and one of the main reasons that ESC’s are being pursued by industry. ESC’s are taken from embryos that are destroyed in the process, with the hopes that the biotech company can patent a successful line of cells and perpetuate that line of cells indefinitely in the laboratory. With a perpetually growing and dividing line of cells, it is thought, therapy will be less expensive than the more labor-intensive process of retrieval and processing of the patient’s own cells.

That’s a powerful business model for modern day gold prospectors, and one that will keep ESC’s in the game for quite some time to come. Public support is fueled by politicians like former U.S. Senator and Vice-Presidential candidate, John Edwards, who famously thundered from the campaign trail,

If we do the work that we can do in this country, the work that we will do when John Kerry is president, people like Christopher Reeve will get up out of that wheelchair and walk again.

To be fair to Edwards, it takes a great deal of vision and intestinal fortitude to pursue stem cell therapy of either stripe. It takes bold visionaries with charismatic leadership styles to rally donors and benefactors to underwrite such a vision. Had Edwards qualified his remarks, he wouldn’t have drawn the fire that ensued. So here is that qualification.

To date, Geron’s limited human trial with ESC’s to treat spinal cord injury has not resulted in people getting up and walking, or any other demonstrable recovery of function in paralytics.

In Portugal, Dr. Carlos Lima has had some successes in taking ASC’s from the base of the patient’s brain and transferring them to the site of injury in the spinal cord (olfactory mucosa autografts) and actually getting people walking with various degrees of success. To learn more about this from the Journal of Spinal Cord Medicine, click here.

Where ASC’s stand in spinal cord injury may be likened to the Wright brothers at Kitty Hawk. Yes, we have modest sustained flight for the first time in human history. But we need to get to the level of Charles Linbergh’s trans-Atlantic flight.

That will take some doing.

There were several generations of technology that had to be born, each begetting the next, before the promise of Kitty Hawk became the reality of trans-Atlantic flight. ASC’s and spinal cord injury are on their way, while the ESC fleet remains grounded. It may well be that in time ESC’s will emerge as successful therapies. When that day comes, the therapies will have been built through the abrupt ending of millions of human lives in their embryonic stage of development.

Edwards may yet be proven correct, but such success will come at a terrible price that we will all pay at the civilizational level. To achieve that success will require the deadening of moral sensibilities to accept such high-tech cannibalism: civilization literally consuming their young.

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Image via: vote29.com

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My article in today’s Headline Bistro.

As soon as scientists begin discussing the differences between embryonic stem cells, adult stem cells, induced pluripotent stem cells, and altered nuclear transfer, most non-scientists become overwhelmed by the technicalities and quickly lose their moorings in the ethical and funding debates. This is needless and easily cleared up with a simple analogy.

Imagine one is dining in a family restaurant and there are three different families, each with five children. Family A has children who are engaged in a food fight, screaming, and jumping about.

Family B has children who are generally very well behaved, but are given to bouts of restlessness and need to be spoken to by their parents.

Family C has children who are models of decorum, and who on their own have even taken it upon themselves to quietly clean up some of the mess left by other patrons.

That’s the stem cell war in a nutshell. Family A are the embryonic stem cells, wild and untamed, wreaking havoc everywhere they are introduced. They are beyond the ability of scientists to control, and have created tumors in animals during that phase of testing. There is one clinical trial underway in humans we shall return to in Part II.

Electron Micrograph of Early Embryo on the Head of a Pin

Family B are the induced pluripotent stem (iPS) cells. These are normal body cells such as cheek cells and skin cells that have undergone full adult development and then have been chemically treated to return to a state where they can be redirected to become other types of body cells. The problem with these cells is that they have shown some degree of instability, with a propensity to return to their fully differentiated adult state. More on that in a moment.

Family C are the adult stem cells. These are cells that have undergone a great degree of development from the early embryonic stage of development and have the ability to become certain types of tissue. They are remarkably stable when used, and have repeatedly proven themselves remarkably adaptable in clinical trials and therapeutic application. There are over one hundred therapies using these cells.

Now, back to our analogy. Imagine a reporter from an international news agency such as Reuters comes to the restaurant looking to do a story on children’s manners in restaurants and actually spends 90% of her time interviewing the father of Family A, who makes not one mention of his children’s recklessness and destructiveness, not one mention of the exemplary behavior of the children in Family C, but holds forth on the dire future of the children in Family B whose behavior is merely in need of periodic tweaking.

If that sounds unbalanced and bizarre, that’s the essential structure and trajectory of a recent Reuters article by Julie Steenhuysen, entitled, ANALYSIS-Imperfections Mar Hopes for Reprogrammed Stem Cells. The article may be read here.

The core of the article is built around the father of Family A, Dr. George Daley of the Harvard Stem Cell Institute. This quote from Dr. Daley sums up the art of the dodge by proponents of embryonic stem cell research:

“It has not ever been a scientifically driven argument that iPS cells are a worthy and complete substitute for embryonic stem cells,” Daley said. “Those arguments were always made based on political and religious opposition to embryonic stem cells.”

Yes and no.

It’s true that there are people who find it an abhorrent practice to juice women up with dangerous levels of hormones in order to harvest a clutch of eggs from her, fertilize them in a lab, create new human beings and then tear them apart in their embryonic stages of development for the purpose of benefiting other human beings. So, yes there are those who object on political, religious and ethical grounds to such barbarism.

Dr. Daley makes no mention at all of Family C, the adult stem cells which have over one hundred therapeutic applications. In so doing, he fails to grasp the essential reason why induced pluripotent stem cells were sought after. It’s because biologically, embryonic stem cells are wild and untamable, while adult stem cells have gone through the process of cellular maturation naturally and are remarkably stable. They are also expensive to isolate, which is an economic limitation to their widespread use. Also, as embryonic stem cells come from another person, there is the issue of tissue rejection by the recipient.

iPS cells were developed to take advantage of the stability that comes with being a mature cell, and both the abundance of such cells (i.e. skin cells) and their ease of isolation. The thought has been that a few tweaks could get the cells to revert to an earlier developmental stage, as every cell has an identical set of genetic switches. By resetting the switches in the DNA, we have been able to get these cells to revert to an earlier, embryonic stage of malleability, yet retaining much of their adult stability. Also, as the cells come from the patient, there is no issue of tissue rejection.

It seems that some of these cells have a propensity to revert to their adult form. This instability differs from the instability of the embryonic stem cells in one key respect. When an iPS cell reverts to adult form, therapy fails and the cell dies. The difficulty with embryonic cells is that they tend to form tumors, which adds a whole new disease state to the patient.

As the state of the research exists, it is far easier to tweak the behavior of the iPS cell than it is to bring any semblance of order out of the primordial chaos of embryonic stem cells. The difference?

As the human body develops, cells mature under the influence of immediately neighboring and distant cells in the body. We know a small degree of how this happens, and embryonic stem cell research allows us to attempt this in the Petri dish. It is a daunting task to take a few early cells from a young embryo and replicate blindly the phenomenally complex processes of maturation that occur in the context of an integrated organism.

Tweaking the iPS cell is the easier and morally superior approach.

In Part II, where each technology stands in its development and what therapeutic trials and applications each has underway.

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Jesus Healing the Man Born Blind

Referencing his miracles in John 14, Jesus told his Apostles, “Greater works than these will you do.”

And do it is today with adult stem cell therapy. What once required the laying on of hands in so many areas is now routine medical treatment. I suspect that this protocol will become very routine in the next five years. Here is a link to a recent news report of doctors treating the blind with their own stem cells to restore sight. The article is wonderfully written and needs no further explanation here.

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Suppose we woke to the following headline with our morning coffee: Obama Administration to Fund 13 New Experimental HIV Drugs., followed by this secondary header- Activist Groups Outraged at Funding ‘Useless’ Class of Drugs over Proven Entity.

Indeed, suppose the story went on to describe how the President and the Democrats remained wedded to funding a class of drugs whose side-effects were so horrendous in animal research models that use in humans would be unthinkable.

Further suppose that the classes of drugs that have shown dramatic efficacy went underfunded, and were even ridiculed by the President and his fellow travelers. Imagine that states such as California floated $3 Billion bonds to float such useless research into drugs that couldn’t make it out of animal trials over drugs working in human HIV/AIDS patients. Imagine the outrage coming from the scientific and medical communities, from AIDS activists, AIDS patients and their loved ones.

There would be calls for Congressional hearings. There would be protests that would make the HIV protests of the 1980’s look tame by comparison.

Certainly people would wonder why. Why would the federal and state governments obstinately sink tens of billions of dollars into such fruitless research and allow other nations to capitalize on the existing research bearing good fruit?

Absent a mass delusion as an explanation, people would be looking for a smoking gun.

Thus it is with Embryonic Stem Cells (ESC”s) vs. Adult Stem Cells (ASC’s). Thus it has been this week with President Obama. Read it here.

When ESC proponents want to advance funding of these cell lines, they NEVER specify ESC v. ASC. Rather, they throw around the generic term ‘Stem Cells’ when speaking of their promise and current use in therapeutics. Recall that ESC’s are derived from tearing apart a human in its embryonic stage of development. ASC’s are derived from adults.

ESC’s have consistently shown themselves to be uncontrollable, growing wild and forming tumors in animals. They have yet to clear that hurdle before moving into human clinical trials. In India, one physician using ESC’s is purported to have her patients recovering slight function after spinal cord injuries. She will not divulge her methodology, and so remains highly suspect.

ASC’s, in contrast, have over a hundred therapeutic applications, none involving tumor formation. Some of these lack FDA approval and must be obtained overseas. They have been published in peer-reviewed journals.

So why the obstinate refusal to put the bulk of the money into ASC’s?

Abortion.

Obama and Co. cannot afford for people to begin developing sensitivity to the plight of embryonic humans, lest that awakening to the dignity of humans in the embryonic stage spill over into increased consciousness over abortion. That would mean the Democrats losing their central organizing principle, their raison d’etre. Pressing ahead with ESC’s is a buttress to support abortion.

It’s high-tech cannibalism.

It’s also already obsolete. Recently, we’ve been able to take skin cells from a patient and induce them into an ESC-like state. These are called Induced Pluripotent Stem Cells (iPSC’s). These have the advantage of being from the patients themselves, with no risk of tissue rejection. They are abundant, easy to obtain, easy to induce to pluripotency. Why not fund these instead?

Abortion.

Abortion has poisoned the body politic. It has claimed 52 million lives in the US since 1973. It has ruined countless millions of women’s lives, and now it is corrupting science.

Where are the denunciations of this wastefulness from the scientific and medical communities? Would this be allowed to stand if it were our HIV analogy instead? Not likely.

Abortion destroys everything it touches. That’s a good thing, as it will force us to eventually seek less recourse to it because of the wastefulness it unleashes on any society evil enough to seek its embrace.

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Image via servitokss.com

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Human embryo having one cell suctioned off (R).

Why, in the face of hundreds of extant therapeutic applications from Adult Stem Cells (ASC), would researchers wish to pursue embryo-destructive research when Embryonic Stem Cells (ESC) haven’t made it out of animal trials because of their tumor-forming propensities?

As a Molecular Biologist, I am asked this question frequently by pro-lifers. Though I am adamantly opposed to embryo-destructive research, I’ll answer for them.

The answer is simple: They just want to know. Period. End of story.

A common misperception about scientists is that all of us are oriented toward therapeutic discoveries. Not so.

Many scientists are indeed oriented toward therapeutic applications, a great many are not. They practice basic research. That is, research with the sole purpose of discovering how things work. These are the ‘pure’ scientists, not oriented toward a given or serviceable outcome. Knowledge simply for the sake of knowledge.

Don’t knock it. It’s vital. Therapeutic advances grow out of the body of basic scientific research. In my graduate studies in molecular microbiology, I discovered quite by accident a whole new dimension of E. coli’s cellular physiology. It was genuinely exciting stuff for a new researcher, to unlock the secrets of nature through the rigorous and diligent application of the scientific method. It turns out that my discovery has all sorts of food safety and medical applications as well. Having presented the research at conferences, a few papers on it should get published this year.

Even if my work had no practical application, it is extremely gratifying to be able to offer the scientific community another piece of the puzzle. I am a basic researcher at heart. In the lab I live for this stuff.

So it’s not difficult to understand other molecular and developmental biologists who have the burning desire to know exactly how we are made in the womb. As a scientist who has studied developmental biology in grad school, I share that burning desire to know the awesome complexity and intricacy of the developmental process. It’s fascinating material.

As a Catholic Christian I’m not willing to kill babies in order to find out. Therein lies the dilemma.

Consider the picture with this post. Absent a Christian anthropology, it’s not hard to see where many of my peers do not consider the early embryo a human person. Without the eyes of faith guided by reason, all one sees is a clump of cells. We know, however, from work done on other animals that developmental pathways become extremely complex once one moves away from the simple cluster of cells seen here, and into the more advanced stages of growth and development

In the wiring-up of the nervous system, cells from the tail end of the spinal cord secrete chemicals that diffuse to the brain end of the spinal cord, inducing nerve cells to grow in that direction. Along the way the projection of the growing nerve cell, called the growth cone, is guided by molecules on the surface of other cells. This is precisely the developmental stage that will be needed to glean the information necessary in spinal cord injury repair therapeutics.

What will we do when we have deduced the answers at the simpler level of development, but now require an organism with a developing nervous system, the point where spinal cord injury repair can be tested? Having proceeded so far down this path, what rationale will be called upon for scientists to stop so much closer to potential therapies? The scientific community won’t hear of it. And really, at that point why should they? The principle that all human life is sacred will have long-since been compromised into obscurity. All we’ll be left with is an argument over the details. Dogs fighting over the carcasses of our own young.

I want to know these answers as much as the fiercest proponent of ESC research. I’m just not willing to sell out the innocent for my answers. If I don’t get them here, I’ll have eternity to get them from The Source.

In this battle over ESC and ASC, we do well to lobby lawmakers on where the entire source of therapeutic benefits resides, namely ASC’s. It’s even more important to educate the public in this regard. We also need to understand the lobby of university researchers who have a very different motive for this research. Money is also a major issue. When funding is set aside for a given line of inquiry, cash-strapped departments line up like refugees at an oasis in the desert. Promises of potential therapeutic applications are added to research funding proposals to gussy them up.

For the college, it’s the money. For the basic researcher it’s the money, the knowledge, and publications. For the applied researcher it’s the cure. For the politician, it’s cynically using the scientific community to lay down a noble-looking smokescreen in order to protect abortion by treating embryos as fungible laboratory substrate.

Joycelyn Elders, former Surgeon General under President Clinton, once famously declared:

“We really need to get over this love affair with the fetus and start worrying about children.”

In truth, America is just beginning a love affair with the fetus through advanced imaging systems. Had we a love affair with the fetus, abortion would be illegal, and there would be no debate over embryo-destructive research.

It seems that pro-choice politicians have seized upon embryo-destructive research as the means to realize Elder’s fondest desire.

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Normal Red Blood Cell (R) Sickle Cell (L)

Another milestone for Adult Stem Cell Therapy, from the National Institutes of Health

Photo: Getty Images

“A modified blood adult stem-cell transplant regimen has effectively reversed sickle cell disease in 9 of 10 adults who had been severely affected by the disease, according to results of a National Institutes of Health study in the Dec. 10 issue of the New England Journal of Medicine. The trial was conducted at the NIH Clinical Center in Bethesda, Md., by NIH researchers at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Heart, Lung and Blood Institute (NHLBI), and the National Institute of Allergy and Infectious Diseases.”

Sickle Cell disease affects mainly Africa-Americans in this country, with about 70,000-80,000 cases existing. Sickle cell afflicts roughly 1 out of every 500 live births in this community.

Because of a structural/biochemical anomaly, when affected red blood cells (rbc’s) lose oxygen, the red blood cells sickle in shape and become sticky, clumping in small blood vessels. A host of complications arise, leading to premature death. More here.

Adult blood stem cells, present in bone marrow, are transplanted into the bones of children whose own marrow has been destroyed using chemotherapy. The child then produces a whole new healthy source of rbc’s, as well as a whole new immune system with no chance at tissue rejection. This can’t be done in adults, who have already suffered too much organ damage.

Adults receive adult stem cells that are matched to their human leukocyte antigens (HLA), the unique identifying proteins on cell surfaces used by the body to determine what is that person’s cell and what is a potential pathogen. The closest HLA matches are family members. Interestingly in these adults treated, there was no sign of tissue rejection, and the disease was effectively reversed in 9 of 10 subjects.

That’s awesome news! No need for embryo-destructive research.

More from the study:

“One of the main obstacles in treating a larger number of African-Americans with sickle cell disease is the relative lack of an available HLA-matched donor. Dr. Tisdale explained, ‘Most white Americans can easily find a matched donor in the unrelated bone marrow or cord blood registries; yet when we screened a number of the people in our trial who were without an HLA-matched sibling donor, we could not find a compatible unrelated donor.'”

Now for some inconvenient truth.

There are ways to increase the available pool of donors in the African-American community.

1. Bank cord blood at birth using medicaid money for mothers who have limited means. It’s cost-effective in the long term.

2. Stop the abortions. African-Americans make up 12% of the population and have 37% of the abortions. This represents an enormous pool of potential donors being selected against every year.

3. With illegitimacy approaching 70% and too many families being comprised of siblings with different fathers, it’s harder to find HLA matches within families. A return to stable family paradigms makes good medical sense as well as good moral sense. Good morality is good medicine.

Adult stem cells continue to steamroll their embryonic counterparts.

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