Think of the heart as two tubes, each with an atrium or upper chamber and a lower chamber, the ventricle. The lungs are between the two, and the system is set up so that low oxygen blood does not mix with the blood that is saturated with oxygen.

If there is only one ventricle, the system can’t adapt to increased need for oxygen. Not only is the ability to pump the blood not enough to increase when exercising, excited, or scared – or even growing – but the oxygen-rich blood always mixes with the depleted blood, even on the way to the lungs.

Without surgery, 70% of children die before they turn one year old. Up until now, the corrective surgery has involved using grafts of artificial tubes, that don’t grow, and need to be replaced every so often.

The new technique uses a “bio-absorbable” scaffold on which the patient’s own stem cells are seeded and grown. This new blood vessel is surgically implanted so that the anatomy, and the blood flow, is more like the normal heart. It’s hoped that the new graft will grow with the child and prevent the need for repeat surgeries as the child grows.

In the end, the choice to become the first patient in Dr. Breuer’s study turned on three things, Ms. Irizarry says: the family’s faith in God, their trust in the doctor, and the potential for a natural blood vessel that could possibly help avoid more surgeries. “Before, they were using plastic, now they’re using this special graft that will grow with her,” Ms. Irizarry says.

Angela is the first, so we don’t really know whether the new vessel will grow with her. But there’s evidence from other, similar procedures to build new bladders and other organs.

Unfortunately, the process of getting the new procedures from early trials to use for those 3,000 babies a year is complicated and slow, even with an FDA “exemption:”

Development of the procedure has been painstaking. Dr. Breuer undertook four years of laboratory research after he joined Yale in 2003 before seeking approval from the U.S. Food and Drug Administration in 2007 to test the approach on patients. It took four more years and 3,000 pages of data before he got a greenlight. The study builds on the cases of 25 children and young adults successfully treated in Japan a decade ago with a similar approach.

Dr. Breuer, who holds several patents through Yale related to the technology, expects to implant a tissue-engineered blood vessel in a second patient soon as part of a six-patient study to test the safety of the procedure and determine whether the blood vessels actually grow in the body as a child gets bigger. The hope is that if these patients are treated without a hitch, the procedure may be available under a special FDA humanitarian device exemption, which would allow Yale to charge for it while conducting a larger study.

It’s a shame that it took so long to get the procedure to the first patient, and that many more will have to wait even longer. There must be a way to place judgement before bureaucracy in these cases.

Cross-posted at WingRight.org.

He’s also well known to be an advocate for unethical embryonic stem cells.

Well now, he’s coming back to Texas. For a company that focuses research on adult stem cells!

Press release:

HOUSTON, Feb. 10, 2012 /NEWS.GNOM.ES/ – Celltex Therapeutics Corporation is pleased to announce that Glenn McGee, Ph.D., an internationally respected bioethicist, has joined the firm as president of Ethics and Strategic Initiatives. At Celltex, Dr. McGee’s responsibilities will include ensuring that all of the firm’s work, centered on adult stem cells, will meet the highest ethical standards of the medical and scientific communities.

“We wanted Glenn at Celltex because from the start we have been determined to do things right,” said David Eller, chairman and chief executive officer of Celltex, which is based in Houston, Texas. “Celltex is a leader in adult stem banking and multiplication technology. We already have state-of-the-art technology, and with Glenn, we are assured that we will be using it in the most ethical way possible.”

Dr. McGee, who resigned his position as the John B. Francis Chair at the Center for Practical Bioethics and his role as editor-in-chief of The American Journal of Bioethics in November 2011, was the founder of the publication. Under his leadership, The American Journal of Bioethics became the leading journal in its field. He is now serving in an advisory capacity with the journal until March 1, 2011. (sic)

“I am very excited about being part of Celltex as we bring this enormously promising new technology to the United States,” said Glenn McGee, Ph.D. “We are learning more about adult stem cells every day, and I want Celltex to set the standard for its ethical banking and use.”

 

Edited for spelling, 2/17/12

TIGM starts with frozen embryonic stem (ES) cells — cells taken from the early stage of a mouse embryo — containing the inactivated gene of interest. The ES cells then take six to eight weeks to thaw and expand. A highly-skilled microinjectionist then injects these cells into a protective cavity formed during embryogenesis, called a blastocyst, which is surgically placed in a recipient female mouse’s uterus. Twenty-one days later, the mouse gives birth.

But this litter will not have the mice the scientists desire. The mice from this litter, known as chimeras, contain a mixture of DNA from the mother and the ES cells. These mice then mate with chimeras and this second generation has potential for a mouse that contains the gene of interest from the original ES cells.

Of the mice that are born from this second litter, a maximum of 33 percent may have the same gene as the ES cells, and these are the knockout mice. More often than not, the litter yields no knockout mice, which then requires further mating and more time. (Read more: High-priced mice – The Battalion – Texas A&M.)

Note the problematic definition the author gives for “blastocyst.” The blastocyst is a stage of life of the embryo. It is the organism, itself.

This is not cloning, either, although the author implies that it is. Cloning is the production of an identical twin of the donor. The embryos produced by making chimeras are not identical to each other, much less an original donor.

Just imagine: the embryonic stem cells must first become germ cells – oocytes or sperm precursors  – in that chimeric embryo. That’s the only cells that will effect the genes of the future baby mice.

The story goes on to explain that, hopefully, there will eventually be a male mouse whose sperm will contain the inactivated gene and which then can be used to impregnate female mice for the production of whole litters without the gene.

This is how ethical science is done, not through the destruction of humans at the embryonic stage.

If a patient’s own neural stem cells can be identified, harvested or used in place, and controlled to develop into cells that replace damaged cells, we may have new treatments for spinal cord injury, Lou Gehrig’s disease, muscular dystrophies, and even strokes.

This is a big “maybe,” but we’re on our way to “using the original container!”

 

In the search for neural stem cells, scientists have been using a few known genes as clues to find candidates deep in the middle of the spinal cord. While some neural stem cells have been discovered there, the newly identified class of spinal cord radial glia run along the edge of the spinal cord, an incredibly convenient location for activating them with minimal secondary damage to help the spinal cord repair during disease or after injury.

“When we first saw known neural stem cell genes appearing in these cells on the edge of the cord, I realized we not only had a brand new cell, but had the capacity to reveal a new gene set that may also guide us to hidden neural stem cells in atypical locations in the brain. I did not expect so many of them to link to human diseases,” Dr. Roskams said.

Identifying these cells and the genes relevant to activate them opens fresh new pathways to explore effective therapies to treat spinal cord injury and several types of neurodegenerative disease.

via New Class of Stem Cell-Like Cells Discovered in Spinal Cord Offers Possibilities for… — SEATTLE, Sept. 15, 2011 /PRNewswire/ –.

The California Institute for Regenerative Medicine (CIRM), the state stem cell agency, today approved research planning grants for five UC Davis Health System teams that are working to develop human clinical trials to treat illnesses such as Huntington’s disease, vascular disease, osteoporosis, HIV/AIDS and airway disease in children. The awards are specifically designed to support collaborative research that will bring potential therapies to the Food and Drug Administration for approval within four years.

“These grants are extremely important to California and to the field of regenerative medicine,” said Jan Nolta, professor of internal medicine and director of the UC Davis Institute for Regenerative Cures. “They enable our teams of scientists and clinicians to plan stem cell clinical trials that will offer treatments to patients who currently have few if any other medical options.”

Stem cells offer the unique potential to restore tissue and repair damage caused by injury or disease. Developing new therapies can normally take 12 or more years. CIRM funding helps advance the most promising approaches for early phase clinical trials. Today’s grants, which range from $71,000 to $110,000, are the first in a two-step process toward applying for full research awards that will be available early next year and worth up to $20 million each.

Known as Disease Team Therapy Development Awards, the grants went to UC Davis stem cell research teams working on five different health disorders

via CIRM approves stem cell research planning grants for five UC Davis teams.

“The world’s first clinical trial of brain stem cells to treat stroke has recorded no adverse effects to date, BBC News has reported. The BBC website reports that research using stem cells to treat strokes “is set to move to its next phase” after independent assessors approved continuation of the trial of the experimental treatment. So far the therapy has been tested on three patients left disabled by strokes.”

via Stroke stem cell trial gets extended – Health News – NHS Choices.

The problem  is that the cells were harvested from the brains of  12 week old aborted fetuses. The researchers at the University of Glascow, Scotland, working with the company, “ReNeuron,” harvested the cells, manipulated them with genes to induce them to become immortal stem cells that will divide infinitely and now have what appears to an endless supply of proprietary cells for future research and treatments of stroke victims.

The abortions were not done for the purpose of harvesting the cells, but there is still a problem with determining whether or not we would be complicit with the original abortion and making  future abortions seem more acceptable (since parents might be told that  “some good” could come from using the dead child’s tissues), if we approve or use the cells.

Traditional formal ethics weighs several conditions to decide whether knowledge and treatments are licit or ethical when using human tissues derived from cadavers. Simply put, the questions are whether the killing done for the purpose of harvesting research material, how many steps are between the decision to kill and the decision to use the tissues , would using the treatment encourage more killing,  how great is the benefit from the treatment and are there alternatives available?

And then, there’s what has been called the “yuck factor.”

The current ethics community ignores most of these questions, having settled on a common theme of utilitarianism, or “the greatest good for the greatest number.”  Otherwise known as “might makes right:” because the powerful, the ones with the lawyers and the degrees decides what is “good.” And who to count or who not to count as human enough to have the right not to be killed. Frankly, this is no different than deciding that the one with the biggest guns and most soldiers may enslave and kill – especially kill – anyone who gets in their way.

The good news is that research using adult stem cells and cells from umbilical cord blood are also being used in human trials.

I received an e-mail from the American Defense Fund concerning the lawsuit against the State of Arizona by Planned Parenthood over a law to protect those of us in medicine who have consciences.

The ruling overturned a two year old injunction that prevented quite a few limitations placed on abortion in the State, including informed consent, parental consent, and the requirement that doctors, not nurses, perform abortions as well as the conscience issue.

Over the last decade, there have been several deliberate attacks against the right of medical professionals to obey our consciences and to refuse to provide services that we do not believe are “medical care.”

More at WingRight.org

“The Blood & Tissue Center generated $140.1 million in revenue last year, according to its annual report.”

and,

GenCure is “filling a niche for a very high-growth industry and at the same time fulfilling another mission — treating patients,” Badylak said in an interview. “The field has grown so fast that the need for source material has exceeded the supply.”

GenCure currently only processes human tissue, but Fisk said it is exploring the possibility of processing pig tissue for transplantation in humans.

BioMed SA, which promotes San Antonio’s heath care and bioscience industries, earlier this year created a regenerative medicine committee to encourage collaboration among local officials working in the field. Fisk is a committee member.

“Regenerative medicine is a very dynamic, emerging field of medicine,” said Ann Stevens, BioMed SA’s president. “The Blood & Tissue Center is positioned to be an important player in that arena.”

More:

South Texas Blood & Tissue Center is jumping into the field of regenerative medicine.

Through a new subsidiary called GenCure, the nonprofit group is focusing on providing tissue and cells for use in the treatment of patients and for clinical research.

GenCure expands the Blood & Tissue Center’s life-saving mission to include assisting in the replacement of missing or injured muscle tissue and aiding in the treatment of various diseases.

“We are uniquely different. Other blood centers do not have this diversification,” said Mary Beth Fisk, the Blood & Tissue Center’s interim president and chief operating officer.

GenCure actually was formed last year to capitalize on the regenerative-medicine aspects of the center’s Texas Cord Blood Bank, its Marrow Donor Program of South and Central Texas, and its Tissue Services unit, which collects donated human tissue. GenCure, also a nonprofit, employs about 75 people.

via S.A. blood center enters a new realm in the field of regenerative medicine | Investor Stemcell.

I love being out in the sun if it’s not too hot. Could it be that my brain reacts the same way it would to desert?

This is an interesting study comparing the activity of the brain when people who like to tan indoors are exposed to UV light and when the tanning beds didn’t expose them to UV.

How Tanning Changes the Brain – NYTimes.com.

 

A study in 2005 did show that a large proportion of sunbathers met the psychiatric definition of a substance abuse disorder, based on their answers to a variation of a test often used to help diagnose alcohol addiction.

But Dr. Adinoff and his colleagues decided to go a step further. They recruited a small group of people from tanning salons who said that they liked to tan at least three times a week and that maintaining a tan was important to them. The frequent tanners agreed to be injected with a radioisotope that allowed researchers to monitor how tanning affected their brain activity.

On one occasion, the study subjects experienced a normal tanning session. But on another occasion, the researchers used a special filter that blocked only the UV light, although the tanners weren’t told of the change.

Brain images later showed that during regular tanning sessions, when the study subjects were exposed to UV rays, several key areas of the brain lighted up. Among those areas were the dorsal striatum, the left anterior insula and part of the orbitofrontal cortex – all areas that have been implicated in addiction. But when the UV light was filtered out, those areas of the brain showed far less activity.

The researchers also found evidence that the tanners appeared to know — on a subconscious level, at least — when they had undergone sham tanning sessions and not received their usual dose of UV rays. The tanners, questioned after each session, expressed less desire to tan after the real sessions, indicating they had gotten their fill. But on days when the tanners were unknowingly deprived of the UV rays, their desire to tan after the session remained as high as it was before the session began.

“They all liked the session where they got the real UV light,” said Dr. Adinoff. “There was some way people were able to tell when they were getting the real UV light and when they were not.”

“How much alcohol does it take to get intoxicated?

“Many people figure a few beers at a ballgame or a couple of glasses of wine with dinner won’t put them over the legal limit for driving. But how alcohol affects people is highly individual, with a number of factors in the mix.”

via Alcohol Math: Who Gets Drunk and Why – WSJ.com.

The WSJ evidently changed the title when sharing via “Press This.” (A plug in from WordPress.com.)

There is this wonderful comment from Psalms 104:14-15:  He causeth the grass to grow for the cattle, And herb for the service of man; That he may bring forth food out of the earth,  And wine that maketh glad the heart of man, And oil to make his face to shine, And bread that strengtheneth man’s heart.

Of course, David never drove a car. Be careful out there, y’all!