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Catholic response to stem cells – Featured Today …

Posted: October 14, 2017 at 2:14 am

By Paul NagourneyCatholic Online

"It is better for one man to die for the people than for the whole nation to be destroyed ?" these words of Caiphas, aimed at convincing Pilate to Crucify Jesus, reflect the same issues wrongly posed by the popular media to the people of today. "Is it acceptable to kill human life of a fetus, so that others may benefit?"

Much discussion is occurring regarding the use of stem cells. As with any scientific discussion that enters the public domain, mass misinformation and exaggeration of facts is occurring, so that the faithful are cornered into the position to ask themselves whether stem cell research reflects the will of God, or whether this is a deception of the evil one, aimed at desanctification of human life. The Holy Fathers of the Church teach us that the "devil may appear as an angel of light ", could stem cells be one of these situations in which something is given to us that appears life promoting but really is a dangerous trap?

What are stem cells?

In order for us to understand the issues involved, and what exactly stem cells are, we are forced to take a quick lesson into the science of stem cells. A stem cell is a cell whose purpose is to generate new cells while having the ability to make copies of itself. Everyone has stem cells inside of them. For example, blood is made from stem cells in the bone marrow, after your skin is injured healing occurs because of stem cells in the skin, even after a stroke, although to a small extend, new brain cells are made from stem cells that are found in the brain. The younger an organism is, the more potent the stem cells are. For example, stem cells in a young person are found in higher numbers and have a higher ability to repair damaged tissue as compared to stem cells in an older person. So far there is nothing controversial, right? Right. The stem cells in the developed human can not make another human from scratch. They can make human tissues that are useful for repairing the human body, but they can not make a whole new human. They are not a new human life, but an extension of an existing life. These are adult stem cells.

The problems started when scientists wanted to analyze the earliest stem cell. Since stem cells from children are theoretically more potent than from adults, stem cells from embryos should be even more potent. According to this reasoning, the first cell in the development of a human life, the fertilized egg, is the most potent stem cell. Embryonic stem cells are made from the fertilized egg. They are essentially copies of the fertilized egg that can reproduce in the laboratory. These cells, because of their potential to create a completely new human, are considered by the Catholic Church a human life, and accordingly their manipulation is a sin . What is more disturbing is the horrendous desecration of human life that routinely occurs with these cells for the purposes of "research"...research that has little to do with advancement of human health. We will discuss two abominable acts that are routinely performed in the name of "science" which call to God for punishment. Two acts that are so horrendous that any God-fearing person who respects human life should be disgusted upon hearing about.

Desecration of human life: Worse than 'just' killing

We learn from the Bible and the traditions of the Holy Fathers that God hates unnatural acts. Acts such as homosexuality have led to destruction of Sodom and Gomorrah. Furthermore, we learn from the Bible that acts that defile the dignity of the human such as bestiality are also vile and punishable. So we know that embryonic stem cell research is condemned by the Church because it involves destruction of human life. But how many of us know the other side of embryonic stem cell research? The side that cries to the Heavens begging punishment? The dark side of embryonic stem cell research that conceptually is a "sin against the Holy Spirit " and accordingly is unforgivable?

The first is the generation of mangled human life in the test-tube called "embryoid bodies". In the same way that the fertilized egg after implanting into the mother's womb starts to develop into different tissues, the embryonic stem cell, when placed under "non-adherent" conditions starts to form layers of disorganized tissues. These include brain tissue, pancreatic tissue, and virtually any tissue that is found in the adult . This disorganized monstrosity, literally, a mangled human in a bottle, is subsequently broken down into specific cells, and the cells are then used for experimentation. If we as Christians really believe that life starts with the fertilized egg, and that we are "made in God's image", then is it not revolting to purposely transform the beauty of God into the disorder of the devil? Is not the devil described as "the king of chaos?."

The second terrible act performed in the name of science is the injection of these human lives into animals that lack an immune system. In the study of embryonic stem cells, researchers want to mimic what it would be like to administer an embryonic stem cell in a human, but since they are not allowed to do this, they administer the cells into mice that are genetically engineered not to have an immune response, this way the mice accept the human embryonic stem cells. One may ask, what happens when these human embryonic stem cells are administered into mice. If the cells have not been manipulated, they usually form a type of cancer called a teratoma . This human cancer in the mouse can be seen as the human tissue undergoing a state of disorganization, similar to that found in the embryoid body which we discussed above. If we as Christians really believe that embryonic stem cells are a human life, then why on earth would we allow for human life to be mixed with animals at a cellular level?

Medical problems with embryonic stem cells

Individuals not sharing respect for human life will answer the question posed by Caiphas, the same way that Caiphas answered it: "it is better for one life to be sacrificed in order for many lives to be saved". So let us examine the scenario in which we put aside our beliefs and ask ourselves whether embryonic stem cells actually have the potential to benefit humanity. The answer is a resounding "no". We will explain three fundamental points that demonstrate in a black and white manner that embryonic stem cells from a scientific point of view are not therapeutically useful, nor will be in the foreseeable future.

1. Embryonic stem cells cause cancer. The actual definition of an embryonic stem cell is based on its ability to cause the teratoma type of cancer in the mouse. Now what exactly is a teratoma? The word "teratoma" comes from Greek, which means "monstrous tumor ." This type of cancer occurs rarely in humans and is fatal if not surgically excised before spreading. Defendants of embryonic stem cell research tell us that teratomas will not occur if embryonic stem cells are used in medicine, since it is not embryonic stem cells that are given to people, but embryonic stem cells made into specific tissues that the patient needs. The problem with this argument is that biology is not perfect. Even if conceptually in 10 years it is possible to make, for example functioning liver cells from embryonic stem cells, how will it be possible to purify 100% only the newly generated liver cells and no left over cancer cells? It only takes one single cancer cell to cause a tumor to form. To this point, the defenders of embryonic stem cells will tell us that even if a tumor cell is left over, it will be rejected by the immune system. This is not correct since teratomas possess mechanisms to "hide" from the immune system, whereas normal tissue does not. An example of this is a mouse study in which teratomas developed and were not rejected, while the few embryonic stem cells that did differentiate into heart tissue were rejected by the animal .

2. It is not possible to generate equivalent of human adult tissues from embryonic stem cells. The embryonic stem cell represents the fertilized egg. It has the same immaturity as the fertilized egg. During normal development it takes numerous biological processes occur for a cell to "grow up" from the immature state of the fertilized egg to the maturity of, say a heart cell in a 63 year old person with heart disease. Since the embryonic stem cells are so immature, it is nave to think that by exposing the cells to certain chemicals we can "accelerate" their maturation from processes that take decades to the timespan of days. For example, embryonic stem cells treated with specific chemicals can mature into what resembles heart cells. These cells even beat in the test-tube ! However, these cells are not true heart cells since a lot of the properties of an adult heart cell are not possessed by these "accelerated maturity" cells. Accordingly, to date, no real tissue equivalent has been generated by embryonic stem cells.

3. Embryonic stem cells are not compatible with the recipient. Let us imagine that the problem of cancer, and the problem of lack of maturity, has been resolved. A very significant obstacle that few people talk about is the fact that the tissues generated from embryonic stem cells are not compatible with the general population. God has made humans very unique from each other immunologically. This is why recipients of organ transplants are required to take drugs that suppress the immune system. Even if people take immune suppressing drugs, the transplant surgeon will not perform the transplant unless the tissues are immunologically matched. The likelihood of finding immunologically matched organs is between 1in 100,000 to 1 in 10,000,000. At present there are approximately 100 embryonic stem cell lines, which are derived from approximately 100 individuals. Therefore even through using immune suppressive drugs (which are toxic and have many side effects), the ability of embryonic stem cells to be used on a widespread basis is impossible.

Adult stem cells as an alternative

It is sad that with all the media and public attention given to embryonic stem cells, the great promise of adult stem cells is largely forgotten. As we discussed at the beginning of the article, adult stem cells are found in all of our bodies and have the purpose of healing injured tissue. The only problem with adult stem cells is that these cells usually are not found at high enough concentrations at the areas where they are needed. For example, people who have a heart attack or stroke, contain much higher concentrations of stem cells in their blood compared to healthy people. This is because the stem cells start to migrate to the injured tissue in order to heal it but there are not enough of them to cause full healing. If one could increase the number of stem cells in the body then theoretically, one could enhance the ability of the body to heal itself. Indeed, this appears to be possible. Numerous studies have shown that augmentation of this natural process by administration of adult stem cells is highly beneficial to patients with diseases ranging from heart failure , to peripheral artery disease , to Crohn's Disease .

In contrast to embryonic stem cells, which have never been used in people and most likely will not be in the next several years, thousands of patients have benefited from adult stem cells. Unfortunately, in the US, adult stem cells can only be obtained by joining clinical trials, which may be found at the NIH website http://www.clinicaltrials.gov. The only alternative for patients seeking adult stem cell therapy is going outside to US to clinics such as http://www.cellmedicine.com which replicate the procedures used experimentally in the US for select patients that fit the inclusion criteria.

Conclusion: Adult stem cells are the Catholic Christian's response

In today's time of general godlessness and lack of respect for life, it is not only the responsibility, but the obligation, of the Catholic faithful to understand the fundamental difference between embryonic stem cells and adult stem cells. Embryonic stem cell research is associated with not only killing of innocent life, but also obscene desecration of God's Image. Additionally, for the reasons mentioned, embryonic stem cells do not pose a scientific solution to health problems. They are a source of siphoning funds and attention away from real stem cell research that actually helps people's health. Adult stem cells, being part of the body that God gave to us are a great scientific discovery, whose translation into cures for horrible disease should be strongly endorsed by the faithful.

- - -

1 John 11:50. 2 St. John Climacus, The Ladder of Divine Ascent. 3 Reverend Demetrios Demopulos, Ph.D. Ethical Issues in Stem Cell Research, Volume III, Religious Perspectives, National Bioethics Advisory Commission, Rockville, Maryland, June 2000. 4 Matthew 12:31. 5 Kurosawa H. Methods for inducing embryoid body formation: in vitro differentiation system of embryonic stem cells. J Biosci Bioeng. 2007 May;103(5):389-98. 6 Mikkola et al. Distinct differentiation characteristics of individual human embryonic stem cell lines. BMC Dev Biol. 2006 Aug 8;6:40. 7 http://en.wikipedia.org/wiki/Teratoma . 8 Nussbaum et al. Transplantation of undifferentiated murine embryonic stem cells in the heart: teratoma formation and immune response. FASEB J. 2007 May;21(7):1345-57. 9 Abdel-Latif et al. Adult bone marrow-derived cells for cardiac repair: a systematic review and meta-analysis. Arch Intern Med. 2007 May 28;167(10):989-97. 10 Hernandez et al. Autologous bone-marrow mononuclear cell implantation in patients with severe lower limb ischaemia: A comparison of using blood cell separator and Ficoll density gradient centrifugation. Atherosclerosis. 2006 Sep 15; 11 http://www.osiris.com.

Catholic Online http://www.catholic.orgCA, USPaul Nagourney - Author, 661 869-1000

paul.nagourney@gmail.com

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Lung Institute | Stem Cell Treatment for COPD & Emphysema

Posted: October 14, 2017 at 2:03 am

Lung Institute | Stem Cell Treatment for COPD & Emphysema Treatment

Stem Cell Therapy Can Help.

At the Lung Institute, we recognize that all patients have their own stories. While they have chronic lung conditions in common, our patients have had all kinds of careers and hobbies. Whether they enjoy growing plants in the garden, playing a round of golf or creating delicious meals, our patients are unique and deserve treatments unique to them.

At the Lung Institute, we screen each patient thoroughly, focusing on medical history and current condition to encourage only the best-possible treatment results.

Using the natural maintenance capabilities of stem cells, we first withdraw and separate the patients stem cells from their blood or bone marrow. We then reintroduce the stem cells into the body where they come to rest inside the lungs, promoting both natural healing and inflammation reduction.

To learn more about how stem cells work, review our Stem Cell Treatment Basics and discover how stem cell therapy can work to affect your quality of life. Click on the links below to read more about the two treatments we offer.

* All treatments performed at Lung Institute utilize autologous stem cells, meaning those derived from a patient's own body. No fetal or embryonic stem cells are utilized in Lung Institute's procedures. Lung Institute aims to improve patients' quality of life and help them breathe easier through the use of autologous stem cell therapy. To learn more about how stem cells work for lung disease, click here.

All claims made regarding the efficacy of Lung Institute's treatments as they pertain to pulmonary conditions are based solely on anecdotal support collected by Lung Institute. Individual conditions, treatment and outcomes may vary and are not necessarily indicative of future results. Testimonial participation is voluntary. Lung Institute does not pay for or script patient testimonials.

Under current FDA guidelines and regulations 1271.10 and 1271.15, the Lung Institute complies with all necessary requirements for operation. The Lung Institute is firmly in accordance with the conditions set by the FDA for exemption status and conducts itself in full accordance with current guidelines. Any individual who accesses Lung Institute's website for information is encouraged to speak with his or her primary physician for treatment suggestions and conclusive evidence. All information on this site should be used for educational and informational use only.

As required by Texas state law, the Lung Institute Dallas Clinic has received Institutional Review Board (IRB) approval from MaGil IRB, now Chesapeake IRB, which is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP), for research protocols and stem cell procedures. The Lung Institute has implemented these IRB approved standards at all of its clinics nationwide. Approval indicates that we follow rigorous standards for ethics, quality, and protections for human research.

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Hormone Replacement Therapy for Menopause – webmd.com

Posted: October 14, 2017 at 2:01 am

If youre looking for relief from menopause symptoms, knowing the pros and cons of hormone replacement therapy (HRT) can help you decide whether its right for you.

HRT (also known as hormone therapy, menopausal hormone therapy, and estrogen replacement therapy) uses female hormones -- estrogen and progesterone -- to treat common symptoms of menopause and aging. Doctors can prescribe it during or after menopause.

After your period stops, your hormone levels fall, causing uncomfortable symptoms like hot flashes and vaginal dryness, and sometimes conditions like osteoporosis. HRT replaces hormones your body no longer makes. Its the most effective treatment for menopause symptoms.

You might think of pregnancy when you think of estrogen. In women of child-bearing age, it gets the uterus ready to receive a fertilized egg. It has other roles, too -- it controls how your body uses calcium, which strengthens bones, and raises good cholesterol in the blood.

If you still have your uterus, taking estrogen without progesterone raises your risk for cancer of the endometrium, the lining of the uterus. Since the cells from the endometrium arent leaving your body during your period any more, they may build up in your uterus and lead to cancer. Progesterone lowers that risk by thinning the lining.

Once you know the hormones that make up HRT, think about which type of HRT you should get:

Estrogen Therapy: Doctors generally suggest a low dose of estrogen for women who have had a hysterectomy, the surgery to remove the uterus. Estrogen comes in different forms. The daily pill and patch are the most popular, but the hormone also is available in a vaginal ring, gel, or spray.

Estrogen/Progesterone/Progestin Hormone Therapy: This is often called combination therapy, since it combines doses of estrogen and progestin, the synthetic form of progesterone. Its meant for women who still have their uterus.

The biggest debate about HRT is whether its risks outweigh its benefits.

In recent years, several studies showed that women taking HRT have a higher risk of breast cancer, heart disease, stroke, and blood clots. The largest study was the Womens Health Initiative (WHI), a 15-year study tracking over 161,800 healthy, postmenopausal women. The study found that women who took the combination therapy had an increased risk of heart disease. The overall risks of long-term use outweighed the benefits, the study showed.

But after that, a handful of studies based on WHI research have focused on the type of therapy, the way its taken, and when treatment started. Those factors can produce different results. One recent study by the Fred Hutchinson Cancer Research Center reveals that antidepressants offer benefits similar to low-dose estrogen without the risks.

With all the conflicting research, its easy to see why HRT can be confusing.

If you have these conditions, you may want to avoid HRT:

HRT comes with side effects. Call your doctor if you have any of these:

Your doctor can help you weigh the pros and cons and suggest choices based on your age, your family's medical history, and your personal medical history.

SOURCES:

Garnet Anderson, PhD, director, public health sciences division, Fred Hutchinson Cancer Research Center, Seattle.

Cleveland Clinic: Hormone Therapy (HT), Understanding Benefits and Risks.

John Hopkins Medicine: Hormone Therapy.

Journal of the American Medical Association, Oct. 2, 2013.

Main Line Health: Estrogen, Progesterone, and Menopause.

JoAnn E. Manson, MD, DrPH, chief, preventative medicine division, department of medicine, Brigham and Womens Hospital, Boston.

National Cancer Institute: Menopausal Hormone Therapy and Cancer Fact Sheet.

National Heart, Lung, and Blood Institute: Womens Health Initiative.

National Institutes of Health: WHI Study Data Confirm Short-Term Heart Disease Risk of Combination Hormone Therapy for Postmenopausal Women.

National Institute on Aging: Hormones and Menopause."

North American Menopause Society: Hormone Therapy for women in 2012.

Office on Womens Health, U.S. Department of Health and Human Services: Menopausal hormone therapy (MHT).

U.S. Preventative Services Task Force: Understanding Task Force Recommendations: Menopausal Hormone Therapy for the Primary Prevention of Chronic Conditions.

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Testosterone Replacement Therapy – webmd.com

Posted: October 14, 2017 at 1:58 am

Testosterone is a hormone produced by the testicles and is responsible for the proper development of male sexual characteristics. Testosterone is also important for maintaining muscle bulk, adequate levels of red blood cells, bone growth, a sense of well-being, and sexual function.

Inadequate production of testosterone is not a common cause of erectile dysfunction; however, when ED does occur due to decreased testosterone production, testosterone replacement therapy may improve the problem.

As a man ages, the amount of testosterone in his body naturally gradually declines. This decline starts after age 30 and continues throughout life. Some causes of low testosterone levels are due to:

Without adequate testosterone, a man may lose his sex drive, experience erectile dysfunction, feel depressed, have a decreased sense of well-being, and have difficulty concentrating.

Low testosterone can cause the following physical changes:

The only accurate way to detect the condition is to have your doctor measure the amount of testosterone in your blood. Because testosterone levels fluctuate throughout the day, several measurements will need to be taken to detect a deficiency. Doctors prefer, if possible, to test levels early in the morning, when testosterone levels are highest.

Note: Testosterone should only be used by men who have clinical signs and symptoms AND medically documented low testosterone levels.

Testosterone deficiency can be treated by:

Each of these options provides adequate levels of hormone replacement; however, they all have different advantages and disadvantages. Talk to your doctor to see which approach is right for you.

Men who have prostate cancer or breast cancer should not take testosterone replacement therapy. Nor should men who have severe urinary tract problems, untreated severe sleep apnea or uncontrolled heart failure. All men considering testosterone replacement therapy should undergo a thorough prostate cancer screening -- a rectal exam and PSA test -- prior to starting this therapy.

In general, testosterone replacement therapy is safe. It is associated with some side effects, including:

Laboratory abnormalities that can occur with hormone replacement include:

If you are taking hormone replacement therapy, regular follow-up appointments with your doctor are important.

Like any other medication, directions for administering testosterone should be followed exactly as your doctor orders. If you are unsure or have any questions about testosterone replacement therapy, ask your doctor.

SOURCE:

Get-Back-On-Track.com.

The Hormone Foundation.

News release, FDA.

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Testosterone Replacement Therapy: Testosterone Injections …

Posted: October 14, 2017 at 1:58 am

Many men with low testosterone report improved energy levels, sex drive, and mood after testosterone treatment. If testosterone is low, why not replace it?

Not so fast. A low testosterone level by itself doesn't need treatment. Testosterone replacement therapy can have side effects, and the long-term risks and benefits aren't known. Only men with symptoms of low testosterone and blood levels that confirm this as the cause of symptoms should consider testosterone replacement. Talking with your doctor is the only way to know if testosterone therapy is right for you.

The symptoms of low testosterone are sometimes obvious, but they also can be subtle. Testosterone levels decline naturally in men as they age over decades. But certain conditions can also lead to an abnormally low level. Symptoms of low testosterone include:

If a man has symptoms of low testosterone and tests show he has an abnormally low testosterone level, a doctor may suggest treatment. For millions of men who have low testosterone levels but no symptoms, no treatment is currently recommended. It is has also not been approved for treating men with low levels because of aging.

Testosterone replacement therapy is available in several forms. All can improve testosterone levels:

Why not a simple testosterone pill? Oral testosterone is available. However, some experts believe oral testosterone can have negative effects on the liver. Using other methods, such as skin patches, gels, orally disintegrating tablets, or injections, bypasses the liver and gets testosterone into the blood directly.

What can you expect from testosterone treatment? It's impossible to predict, because every man is different. Many men report improvement in energy level, sex drive, and quality of erections. Testosterone also increases bone density, muscle mass, and insulin sensitivity in some men.

Men also often report an improvement in mood from testosterone replacement. Whether these effects are barely noticeable, or a major boost, is highly individualized.

Karen Herbst, MD, PhD, an endocrinologist at University of California-San Diego, specializes in testosterone deficiency. She estimates about one in 10 men are "ecstatic" about their response to testosterone therapy, while about the same number "don't notice much." The majority have generally positive, but varying responses to testosterone replacement.

Testosterone replacement therapy side effects most often include rash, itching, or irritation at the site where the testosterone is applied.

However, there is also evidence of an increased risk of heart attack or stroke associated with testosterone use. Experts emphasize that the benefits and risks of long-term testosterone therapy are unknown, because large clinical trials haven't yet been done.

There are a few health conditions that experts believe testosterone therapy can worsen:

It will be years before large clinical trials bring any answers on the long-term benefits and risks of testosterone therapy. As with any medicine, the decision on whether the possible benefits outweigh any risks is up to you and your doctor.

Isn't taking testosterone replacement basically the same as taking steroids, like athletes that "dope"? It's true that anabolic steroids used by some bodybuilders and athletes contain testosterone or chemicals that act like testosterone.

The difference is that doses used in testosterone replacement only achieve physiologic (natural) levels of hormone in the blood. The testosterone forms some athletes use illegally are in much higher doses, and often combined ("stacked") with other substances that boost the overall muscle-building (anabolic) effect.

SOURCES:

Drugs.com: "Androderm Side Effects."

Swerdloff, R. Journal of Clinical Endocrinology & Metabolism, 2000.

Striant.com.

Wilson, J. American Journal of Medicine, 1980.

Bhasin, S. Journal of Clinical Endocrinology and Metabolism, 2006.

Karen Herbst, MD, PhD, assistant professor in medicine, University of California, San Diego.

News release, FDA.

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Genetic Modification in Medicine | gm.org

Posted: October 14, 2017 at 1:57 am

Posted by Ardent Editor on July 23rd, 2007

One of the most promising uses for genetic modification being eyed in the future is on the field of medicine. There are a number of advances already being done in the field of genetic modification that may be able to allow researchers to someday be able to develop a wide range of medicines that will be able to treat a variety of diseases that current medicines may not be able to.

There are many ways that genetic modification can be used in the development of new medicines in the future. One of them is in the production of some human therapeutic proteins which is used to treat a variety of diseases.

Current methods of producing these valuable human proteins are through human cell cultures but that can be very costly. Human proteins can also be purified from the blood, but the process always has the risk of contamination with diseases such as Hepatitis C and the dreaded AIDS. With genetic modification, these human proteins can be produced in the milk of transgenic animals such as sheep, cattle and goats. This way, human proteins can be produced in higher volumes at less cost.

Genetic modification can also be used in producing so-called nutriceuticals. Through this genetic modification can be used in producing milk from genetically modified animals in order to improve its nutritional qualities that may be needed by some special consumers such as those people who have an immune response to ordinary milk or are lactose intolerant. That is just one of the many uses that genetic modification may be able to help the field of medicine in trying to improve the quality of life.

Other ways of using genetic modification in the field of medicine concern organ transplants. In is a known fact to day that organ transplants are not that readily available since supply for healthy organs such as kidneys and hearts are so very scarce considering the demand for it. With the help of genetic modification, the demand for additional organs for possible transplants may be answered.

Genetic modification may be able to fill up the shortfall of human organs for transplants by using transgenic pigs in order to provide the supply of vital organs ideal for human transplants. The pigs can be genetically modified by adding a specific human protein that will be able to coat pig tissues and prevent the immediate rejection of the transplanted organs into humans.

Although genetic modification may have a bright future ahead, concerns still may overshadow its continuous development. There may still be ethical questions that may be brought up in the future concerning the practice of genetic modification. And such questions already have been brought up in genetically modified foods.

And such questions may still require answers that may help assure the public that the use of genetic modification in uplifting the human quality of life is sound as well as safe enough. Public acceptance will readily follow once such questions have been satisfactorily answered.

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Diabetes Symptoms – webmd.com

Posted: October 14, 2017 at 1:52 am

How can you tell if you have diabetes? Most early symptoms are from higher-than-normal levels of glucose, a kind of sugar, in your blood.

The warning signs can be so mild that you don't notice them. That's especially true of type 2 diabetes. Some people don't find out they have it until they get problems from long-term damage caused by the disease.

With type 1 diabetes, the symptoms usually happen quickly, in a matter of days or a few weeks. They're much more severe, too.

Both types of diabetes have some of the same telltale warning signs.

Hunger and fatigue. Your body converts the food you eat into glucose that your cells use for energy. But your cells need insulin to bring the glucose in.

If your body doesn't make enough or any insulin, or if your cells resist the insulin your body makes, the glucose can't get into them and you have no energy. This can make you more hungry and tired than usual.

Peeing more often and being thirstier. The average person usually has to pee between four and seven times in 24 hours, but people with diabetes may go a lot more.

Why? Normally your body reabsorbs glucose as it passes through your kidneys. But when diabetes pushes yourblood sugarup, your kidneys may not be able to bring it all back in. This causes the body to make more urine, and that takes fluids.

You'll have to go more often. You might pee out more, too. Because you're peeing so much, you can get very thirsty. When you drink more, you'll also pee more.

Dry mouth and itchy skin. Because your body is using fluids to make pee, there's less moisture for other things. You could get dehydrated, and your mouth may feel dry. Dry skin can make you itchy.

Blurred vision. Changing fluid levels in your body could make the lenses in your eyes swell up. They change shape and lose their ability to focus.

These tend to show up after your glucose has been high for a long time.

Yeast infections. Both men and women with diabetes can get these. Yeast feeds on glucose, so having plenty around makes it thrive. Infections can grow in any warm, moist fold of skin, including:

Slow-healing sores or cuts. Over time, high blood sugar can affect your blood flow and cause nerve damage that makes it hard for your body to heal wounds.

Pain or numbness in your feet or legs. This is another result of nerve damage.

Unplanned weight loss. If your body can't get energy from your food, it will start burning muscle and fat for energy instead. You may lose weight even though you haven't changed how you eat.

Nausea and vomiting. When your body resorts to burning fat, it makes ketones. These can build up in your blood to dangerous levels, a possibly life-threatening condition called diabetic ketoacidosis. Ketones can make you feel sick to your stomach.

If you're older than 45 or have other risks for diabetes, it's important to get tested. When you spot the condition early, you can avoid nerve damage, heart trouble, and other complications.

As a general rule, call your doctor if you:

SOURCES:

Cleveland Clinic: "Diabetes: Frequently Asked Questions" and "What Is Diabetes?"

University of Michigan Health System: "Type 1 Diabetes."

National Diabetes Information Clearinghouse: "Am I at Risk for Type 2 Diabetes? Taking Steps to Lower Your Risk of Getting Diabetes."

Baylor Scott & White Healthcare: "Urinary Frequency" and "Diabetes and Diabetic Neuropathy Hard-to-Heal Wounds."

Sutter Health: "Question & Answer: Is Sudden Weight Loss a Sign of Diabetes? If So, Why?"

Neithercott, T. Diabetes Forecast, August 2013.

University of Rochester Medical Center: "Diabetic Skin Troubles."

Joslin Diabetes Center: "Diseases of the Eye" and "Diabetic Neuropathy: What You Need to Know."

The Nemours Foundation: "When Blood Sugar Is Too High."

Virginia Mason Medical Center: "Complications."

Carolinas Health System: "Diabetes: Yeast Infections and Diabetes: What You Should Know."

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Transplantation of Mouse Embryonic Stem Cells into the …

Posted: October 14, 2017 at 1:50 am

Animal and surgical procedures

Mongolian gerbils of both genders aged 36months with healthy external ears were used for this study. The animals were born and raised in low-noise environment [median sound level was 40dB sound pressure level (SPL)] at the Animal Research Facility of the Medical University of South Carolina. All aspects of the animal research were conducted in accordance with the guidelines of the local Institutional Animal Care and Use Committee.

Animals were anesthetized with pentobarbital sodium (50mg/kg) and given atropine (0.2mg/kg) to reduce respiratory secretions. Body temperature was maintained between 37C and 38C using a heating pad. Sterile procedures were used to open the bulla and place about 2040l of a 1mM ouabain (Sigma, O-3125) solution in normal saline in the RW niche. After 30min, the ouabain solution was removed by wicking with a small piece of filter paper. The surface of the bulla was fully closed with dental cement, and the incisions were closed with sutures. Postsurgical discomfort was treated with buprenorphine if necessary. The animals allowed to recover for 13days after ouabain exposure before transplantation were designated as the early post-injury (EPI) transplant group, whereas animals allowed to recover for 7days or longer were designated as the late post-injury (LPI) transplant group.

Approaches used for ESC transplantation and the state of differentiation of ESCs after RA neural induction. A Surgical approach to expose the round window (RW) niche of the gerbil cochlea for ESC transplantation. The basilar membrane comprises the translucent zone and is visible through the RW membrane. The bony osseous spiral lamina, the wall of Rosenthals canal (RC), and the central modiolus are located in the opaque zone. Scale bar=500m. B Schematic diagram illustrating three delivery routes of ESCs into: (1) Rosenthals canal, (2) perilymph of scala tympani (ST), (3) and endolymph of scala media (SM). The photograph was modified from a radial paraffin section of the basal turn from a normal young gerbil. Sa stapedial arteria, Sp.L spiral ligament, SV scala vestibuli. Scale bar=100m. C The majority of the cultured ESCs stained for nestin (green). Nuclei were countstained with bis-benzimide (blue). Scale bar=20m.

Surviving ESCs 34weeks after transplant

To suppress rejection of mouse ESCs, gerbils were given daily injection of cyclosporine A (15mg kg1 day1 s.c., Sandoz Pharmaceutical Corp., NJ) starting 1day before surgery and terminating the day before sacrifice. The same dose was given to all animals in this study.

Mouse ESCs were prepared for transplantation from (1) wild-type D3 cells, (2) D3 cells engineered to express enhanced green fluorescent protein (EGFP), or (3) D3 cells modified to over-express bcl2 (D.I. Gottlieb, Washington University, St. Louis, MO). The D3 cell line was isolated from day4 129/Sv blastocysts (Doetschman et al. 1985). The details for EGFP expression and bcl2 gene modification have been described previously (Adams et al. 2003; Wei et al. 2005). The ESC lines were maintained at low passage (<20) with normal karyotype. Cells were passaged, and neural differentiation was induced using the 4/4+ RA induction protocol (Bain et al. 1995; Bain and Gottlieb 1998). Briefly, undifferentiated cells were maintained in T25 flasks in ES cell growth media (ESGM) consisting of Dulbeccos modified Eagle media (with l-glutamine, without pyruvate, Gibco 11965-043) supplemented with 10% fetal bovine serum, 10% new born calf serum, 8.5g/ml guanosine, 8g/ml adenosine, 7.3g/ml cytidine, 7.3g/ml uridine, 2.4g/ml thymidine, 1,000U/ml of leukemia inhibitory factor (LIF, Gibco 13275-011), and 104M -mercaptoethanol.

For neural lineage induction, cells were harvested from the growth flasks by trypsinization with 0.25% trypsin and ethylenediaminetetraacetic acid (EDTA) in Hankss salt solution (Gibco, 15050) for 10min. One quarter of the cells from a T25 flask were seeded into a standard 100-mm bacterial Petri dish in ESC induction medium (ESIM). The ESIM is similar to ESGM, but without LIF and -mercaptoethanol. After 2days, the cell aggregates and the media were removed from the dish, and cells were allowed to settle for 10min in a 15-ml centrifuge tube. The medium was then aspirated and replaced with fresh ESIM. Cells were then returned to the culture dish for an additional 2days. The culture medium was replaced with ESIM containing 5107M RA (all-trans RA, Sigma R-2625), and cells were cultured for an additional 4days before harvesting for transplant. The state of ESC differentiation after RA 4/4+ neural induction was in agreement with the results of previous studies (Meyer et al. 2005; Wei et al. 2005). Although there was heterogeneity among the cell types generated by this protocol, a great majority (76.23.5%) of the cultured ESCs were positive for neuronal precursor and/or immature neuron markers such as nestin (Fig.1C).

The methods for recording the compound action potential (CAP) response, distortion product otoacoustic emissions (DPOAEs), and endocochlear potential (EP) were similar to those previously described (Lang et al. 2005, 2006). Physiological data were obtained from ESC-implanted ears and a group of untreated ears. The animals were anesthetized as described above and fitted to a head holder in a sound- and vibration-isolated booth. The pinna and surrounding tissue were removed and bulla opened widely. The CAP electrode was placed on the bony rim of the RW niche and an acoustic assembly, including a probe-tube microphone (B&K 4134, Bruel and Kjaer, Norcross, GA) and driver (Beyer DT-48, Beyerdynamic, Farmingdale, NY), was sealed to the bony ear canal with closed-cell foam. Tone pips were calculated in the frequency domain using Tucker Davis Technologies (Alachua, FL) equipment and software. CAP thresholds were obtained visually with an oscilloscope online at half-octave frequencies from 0.5 to 20kHz with tone pips of 1.8-ms total duration with cos2 rise/fall times of 0.55ms. DPOAEs were measured with an Ariel board (Ariel, Canbury, NJ) and CUBeDISP software (Etymotic Research, ELK grove Village, IL). DPOAEs were obtained with an opened bulla after removing the pinna and underlying tissue. The intensity levels of both primaries were fixed at 50dB SPL. Primary tones were swept from f2=4 to 20kHz with f1/f2 ratio of 1.2 and a resolution of 10 points per octave.

EPs were measured with a micropipette filled with 0.2M KCl yielding an impedance of approximately 2030M. The output of the micropipette was tied to an electrometer (World Precision Instruments FD 223) for direct recording of the potential. EP was defined as the voltage difference between scala media and a pool of isotonic saline on the neck muscles. The micropipette was introduced into the scala media via 30- to 50-m holes drilled through the otic capsule of the three cochlear turns. We first measured the EP in the apical turn (T3), followed by the middle turn (T2) and basal turn (T1). This procedure minimizes the trauma of inserting the micropipette into one turn and causing a reduction of the EP in other turns (Schmiedt et al. 2002; Lang et al. 2002).

The inner ears were fixed for 68h with 4% paraformaldehyde and then decalcified with EDTA. Tissues were embedded in PARAPLAST@ for paraffin sectioning. Deparaffinized and rehydrated sections were immersed in blocking solution for 20min and then incubated overnight at 4C with a primary antibody diluted in phosphate-buffered saline (pH7.4). The primary antibodies used in this study were rabbit anti-GFP (1:200, A11122) or mouse anti-GFP (1:100, A11120) (Molecular Probes, Eugene, OR), rat monoclonal antibody to mouse-specific brain membrane (1:50, M2, Developmental Studies Hybridoma Bank, Iowa City, IA), rabbit anti-bcl2 (1:200, sc492) (Santa Cruz, Santa Cruz, CA), anti-mouse CD45R (1:200, sc19597; Santa Cruz), mouse anti-neurofilament 200 (1:200, Clone N52, N0142; Sigma, Atlanta, GA) and mouse anti-glial fibrillary acidic protein (GFAP; 1:200, MAB360; Chemicon, Temecula, CA). An antigen retrieval treatment was used for immunostaining with mouse brain membrane-specific antibody M2.

The antibodies employed in this study have been widely used and are well characterized. The rabbit anti-GFP polyclonal antiserum was raised against GFP isolated directly from the jellyfish, Aequorea victoria, and has been used for detection of native GFP, GFP variants, and most GFP fusion proteins (Chalfie et al. 1994; Senut et al. 2004). No staining was seen when rabbit anti-GFP antibody was applied to tissues from ears injected with wild-type D3 ESCs. The rat monoclonal antibody M2 was raised against a mouse-specific glial and neuronal cell membrane glycoprotein (Lagenaur and Schachner 1981). The M2 antibody recognizes a 45-kDa band in Western blots and has been used widely as a marker to identify mouse neural cells in host tissues after xenogeneic transplantation (Eriksson et al. 2003; Gates et al. 1998). Anti-bcl2 reacts with bcl2 of mouse, rat, and human origin by Western blotting, immunoprecipitation, and immunohistochemistry and does not cross-react with other apoptosis-associated proteins (Thomas-Mudge et al. 2004; Weisleder et al. 2004). This antibody recognizes a single band around 29kDa in Western blots (manufacturers technical information from Santa Cruz). CD45R (RA3-6B2) is a rat monoclonal IgG2a antibody raised against an extracelluar domain of the transmembrane glycoprotein CD45 and is expressed broadly among hematopoietic cells including macrophages and microglia (Bhave et al. 1998). Monoclonal anti-neurofilament 200 reacts with a single 200-kDa band in both alkaline phosphatase dephosphorylated and untreated preparations of rat spinal cord (manufacturers technical information from Sigma) and specifically stains nerve fibers in the inner ear (Lang et al. 2006; Wise et al. 2005). The GFAP monoclonal antibody recognizes a 50-kDa band by immunoblotting (manufacturers technical information from Chemicon) and has been used extensively to label astrocytes and neoplastic cells of glial lineage in the central nervous system (McLendon and Bigner 1994; Kasischke et al. 2006; Ward et al. 2004). Control staining for all primary antibodies included omission or substitution with similar dilutions of non-immune serum of the appropriate species. No specific staining was detected in any of the control experiments.

Secondary antibodies were biotinylated, and binding was detected with fluorescent (FITC)-conjugated avidin D (1:100; Vector, Burlingame, CA). The procedure for detection of a second antigen with double labeling was the same as for the first antigen but substituting Texas red conjugated avidin D (1:100; Vector) for visualization. Nuclei were counterstained with propidium iodide or bis-benzimide.

The sections were examined with either a Zeiss LSM5 Pascal confocal microscope (Carl Zeiss Inc., Jena, Germany) or a Zeiss Axioplan microscope equipped with a 100-W mercury light source. The captured images were processed using Image Pro Plus software (Media Cybernetics, MD), Zeiss LSM Image Browser Version 3,2,0,70 (Carl Zeiss Inc.) and Adobe Photoshop CS.

Five to six sections approximately 50m apart from each other from the mid-modiolar region were used for cell counts. The observed sections included all three cochlear turns and five vestibular organs. The surviving ESCs were identified by direct fluorescent microscopy for GFP or labeling with M2 antibody in combination with the nuclear marker bis-benzimide. All data are reported as meanSEM. Statistical comparisons of the number of surviving ESCs in EPI model compared to in the LPI model as well as the percentage of GFAP-positive ESCs in RC versus the perilymphatic space were obtained using the Students t test (SPSS, Chicago, IL). A value of p<0.05 was considered statistically significant.

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Future Fertility Fix? Egg-Producing Stem Cells Found in …

Posted: October 14, 2017 at 1:47 am

Feb. 26, 2012 -- Scientists say they have found a way to use ovarian stem cells to perhaps one day help infertile women get pregnant -- or add years to a womans reproductive cycle.

In a study published in Nature Medicine, researchers report finding egg-producing stem cells in human ovaries. They also report being able to make some of those ovarian stem cells grow into immature eggs that may someday be useful for reproduction.

At this point, such seed eggs cant be fertilized by sperm. But if scientists are able to entice them to mature and can prove they can be fertilized and grow into embryos -- a feat that has been reported in mice -- it would overturn a long-held scientific belief that women cant make new eggs as they get older.

What it does is really open a door into human reproduction that 10 years ago didnt even exist, says researcher Jonathan L. Tilly, PhD, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital, in Boston.

Outside experts agree. They say the findings could have profound importance for reproductive medicine and aging, allowing doctors not only to restore a womans fertility but also to potentially delay menopause.

I think the significance of this work is like reporting that we found microorganisms on Mars, says Kutluk Oktay, MD, who directs the Division of Reproductive Medicine and the Institute for Fertility Preservation at New York Medical College in Valhalla, N.Y.

Its a proof of principle that they could do it, says David F. Albertini, PhD, director of the Center for Reproductive Sciences at the University of Kansas Medical Center in Kansas City, Kan.

The world wants to know today if were ready to restore fertility in women, whether theyve aged or been treated for cancer or whatever, Albertini says, adding that he doesnt think thats on the horizon. This is an extremely rare event, at best.

The egg-generating stem cells the researchers were able to extract from ovaries were very rare. The researchers only came across one for every 10,000 or so ovarian cells that they counted.

But when they took those cells and implanted them back into human ovarian tissue, they divided and essentially made young eggs.

Tilly says his team stopped short of trying to make one of the eggs functional because for a lot of reasons, as it should be, it is illegal in the U.S. to experimentally fertilize human eggs.

We think the evidence provided clearly indicates that this very unique, newly discovered pool of cells does exist in women, he says.

Its a really exciting result, says Evelyn Telfer, PhD, a cell biology expert at the University of Edinburgh in Scotland.

What weve previously believed is that you dont get new eggs formed during your adult life. This discovery shows that theres the potential for them to be formed, no question about that, Telfer says, but it doesnt actually show that theyre being formed under normal conditions.

Indeed, she notes, experience would suggest otherwise. Women, after all, do lose their fertility as they age.

There are cells there that under certain conditions have the potential to form [eggs]. Thats the really exciting part of this work. And of course they can be used. Theres a practical application, she says.

Telfer has pioneered a technique that allows her to take immature human eggs and turn them into mature, fertilizable eggs outside the body. She has already partnered with Tilly to try to take his seed eggs to the next stage of development. With special government permission, she says, they may even be able to try to experimentally fertilize the eggs.

Its actually opening up a whole new field of research, to define these cells, to characterize these cells, and to use them in a practical way, she says.

Tilly says that by using egg-generating stem cells to make large numbers of viable eggs, doctors might one day be able to cut the expense of in vitro fertilization (IVF), since women would no longer have to go through multiple cycles of treatment to harvest enough eggs to generate a pregnancy.

If Dr. Tilly can reverse the biologic clock or halt it, and start making eggs from stem cells, its fantastic, says Avner Hershlag, MD, chief of the Center for Human Reproduction at North Shore University Hospital in Manhasset, N.Y.

This is the true reproductive emancipation of women, he tells WebMD. You will be free to a) not compromise on who you share your life and share your kids with, and b) like any man, you will have the freedom to develop a full professional life and not have to stop everything because you are having children.

But Hershlag notes that such an advance might still be years away.

For women who are worried theyll run out of time to have children, Hershlag says there is technology available that helps women buy more time to have a baby. Her best bet is actually, right now, to freeze her eggs if she wants to delay reproduction.

SOURCES:

White, Y. Nature Medicine, Feb. 26, 2012.

News release, Massachusetts General Hospital.

Jonathan L. Tilly, PhD, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital;professor, department of obstetrics, gynecology, and reproductive biology, Harvard Medical School, Boston.

Kutluk Oktay, MD, director, Division of Reproductive Medicine and the Institute for Fertility Preservation, New York Medical College, Valhalla, N.Y.

David F. Albertini, PhD, director, Center for Reproductive Sciences, University of Kansas Medical Center, Kansas City, Kan.

Evelyn Telfer, PhD, reader in cell biology, University of Edinburgh, Scotland.

Avner Hershlag, MD, chief, the Center For Human Reproduction, North Shore University Hospital, Manhasset, N.Y.

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Future Fertility Fix? Egg-Producing Stem Cells Found in ...

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FDA Response – U.S. Stem Cell Clinic

Posted: October 14, 2017 at 1:46 am

RE: Warning letter received August 24th, 2017

Dear Mr. Randall Morris,

Please accept this letter as response to the warning letter received August 24th, 2017. In sum, as was previously demonstrated, the US Stem Cell Clinic (USCC) is not utilizing a biological drug product and therefore the regulations of part 210 and 211 (current good manufacturing practices) do not apply. The comments in the provided warning letter are specific to products that are produced in cGMP manufacturing facilities and classified as drugs according to the FDA. This is not something that a medical clinic would be required to follow. USCC is not manufacturing a drug. That being said, in an abundance of caution, US Stem Cell Clinic will immediately switch to 510(k) approved systems to process tissue in clinic such as bone marrow systems and/or fat systems.

Our facility has demonstrated sterile surgical techniques as required by the medical boards. It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures including using individually wrapped disposable sterile supplies, sterile field prep, and more. The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals. As a clinic performing a medical procedure, we have strict and appropriate protocols in place to prevent contamination and breach of sterility. We are following the exact protocols that are utilized at surgical centers and hospitals. As you know, these protocols are very different than what is required for GMP manufacturing facilities. We have never had an incidence of contamination and the statements that were made in your warning letter and press release are misleading and causing irreparable harm.

We have previously described in detail why the FDA has wrongly defined these in clinic procedures as a drug and provided evidence. The evidence and summary is provided below. I would like to specifically call your attention to the fact that according to your current code of federal regulations, same surgical procedure is not subject to the rules for tissue banks which include minimal manipulation and homologous use. We strongly believe that it is a violation of the rights of American citizens to prevent them from seeking alternative care for their conditions as long as it does not violate regulations or the law. Our clinic is not violating the law as it is currently written. There is huge support from government officials and American citizens for stem cell treatmentsagain, while all laws are adhered to as we do. Please refer to just one petition out of many regarding stem cell treatments in clinic with almost 70,000 signatures: https://www.change.org/p/fda-don-t-shut-down-our-access-to-needed-stem-cell-therapy-treatment.

We would also like to address the comment in your warning letter regarding our firm impairing the ability to conduct the inspection. This statement is blatantly false and should be removed from the record. We provided access to every room in the facility and allowed pictures on multiple occasions. We also provided copies of all requested documents including confidential patient information. We are an extremely small firm with only a handful of employees most of which are part time or 1099 contract. As a small firm with limited resources, it is necessary to schedule the access that was required by the investigators in order to prevent permanent damage to our business. We provided abundant time and availability to the inspectors and on several occasions, the inspectors canceled last minute and did not come. At one point, the inspectors came to the office when the office was closed. During this last inspection, we worked with the inspectors for over a month providing hundreds of copies and burned CDs. On several occasions, I requested paper, printer ink and office supplies but did not receive what was requested. This inspection caused undue financial harm to our small firmyet we made our staff and resources available to the investigators at all times. Stating that we prevented or limited access to our company is an apparent attempt to disparage our company and we deem it both unprofessional and an unfair statement.

Given that we are a medical clinic that does not manufacture drugs, the guidance document that you referenced does not apply to our facility. Instead, USCC is performing a medical procedure wherein tissue is removed from a patient and re-implanted during the same surgical procedure. 21 C.F.R. 1271(b) titled Human Cells, Tissues and Cellular Tissue-Based Products, expressly states, you are not required to comply with the requirements of this part if you are an establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.

The procedure performed at USSC is simply the practice of medicine. Medical practitioners have been performing similar type procedures in clinic for decades including fat, skin, tendon/ligament, vascular, hair and bone grafts, bone marrow transplantation, and blood/plasma transplantation. Please keep in mind that many of these medical procedures may involve non-homologous use of tissue (CABG with vein graft or ileum to replace bladder) or more than minimal manipulation (skin grafts, hair transplants, or bone grafts). But because these are completed by medical practitioners during the same surgical procedure, the practitioners per the exception clause are not required to comply with the requirements of this part (1271) which includes details on products under section 351 vs. 361 PHS Act.

Therefore, the regulatory sections of Part 1271 regarding homologous use or more than minimal manipulation are not applicable to the procedures performed by USSC. To be clear, the purpose of stem cells inside our bodies is to maintain and repair damaged tissue, therefore any application of stem cells to patients would in fact be defined as homologous.

Even if USSC were somehow subject to the regulatory sections of Part 1271, the protocols utilized by USSC would be exempt from the regulations because the procedures practiced at USSC do not involve more than minimal manipulation. Part 1271 Regulations create a regulatory exemption from the manufacturing and labeling requirements that normally apply to drugs and biological products for any HCT/P that is no more than minimally manipulated. See 21C.F.R. 1271.10(a). Minimal manipulation of cells means processing that does not alter the-relevant biologicalcharacteristics. Id. 1271.3(f)(2).

In the procedures performed at USCC, the actual stem cells are not modified or changed in any way but instead separated via centrifugation. Even the collagenase digestion only changes the integrity of the extracellular matrix and does not change the characteristics of the cells themselves. These scientific facts were confirmed by several leading stem cell scientists at the September 2016 FDA hearing.

Medical procedures are already scrutinized and regulated by the state medical boards, legislatures, and agencies. In addition, the doctor patient relationship is protected and physicians take a vow to protect the safety, health and welfare of patients. They are dedicated to serving the interest of the patient and market forces, societal pressures, and administrative demands must not compromise this promise. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of drugs. The FDA does not regulate the practice of medicine or the bodies/tissues of individuals.

This same procedure is currently performed at thousands of clinics throughout the US. Notably, throughout the stem cell field, these clinics and practitioners also maintain that the procedures performed are medical procedures, and that the regulations of part 210 and 211 (current good manufacturing practices) do not apply.

We are aware that many clinics have been visited by the FDA without any actions or warnings letters. At USCC, we are following standard clinical procedures for medical facilities to ensure safety of the patients. This is considered a medical procedure because the tissue is removed from the patient and re-implanted during the same surgical procedure to the same patient (autologous use). The protocols used at our clinic have been well established in publications as both efficacious and safe. Over ten thousand patients have been treated using similar protocols with a strong safety record. Specifically, over 7000 patients have been treated using the exact same laboratory kit that we utilize at USCC.

Bone marrow and blood products are currently being utilized in the clinic in a similar fashion. The only reason bone marrow products are being regulated differently is because they predate the 1976 medical device amendments allowing for a 510k process instead of IND/IDE. There is no scientific or medical reason that fat tissue removed from a patient would be regulated differently than bone marrow or blood, when they are being used for the same purpose. According to recent publications, cells from fat tissue are demonstrating superior clinical results than bone marrow cells. This is most likely due to the fact that the bone marrow contains very high amounts of white blood cells (WBCs) which can cause unnecessary inflammation whereas fat has low amounts of WBCs. Fat tissue, however, may contain up to 500 times more stem cells. The rate of complications from taking a bone marrow aspirate is significantly higher than taking an adipose sample. The cells that are obtained from an adipose sample are separated from the adipocytes and have not been manipulated or changed in any way prior to reintroducing into a patient. According to reports, these therapies do not have the same negative side effects as many of the available drugs on the market.

We are aware that the FDA received comments on the published draft guidelines regarding adipose tissue procedures in clinic. We are also aware that the FDA held a public hearing regarding these topics in September 2016 in which many scientists, physicians and patients expressed support for these therapies. We are able to provide the FDA with any necessary information to demonstrate that this is a medical procedure that is safely done on an outpatient basis. Published results of outcomes to date have been overwhelmingly positive.

If the federal government were to interfere with a persons ability to obtain and utilize their own cells in their body to heal themselves, this could be a gross violation of the constitution. According to the constitution, Americans have a fundamental right to privacy as well as protection from undue government intrusion. Specifically, in the case of Griswold v. Connecticut 381 U.S. 479, 484-486 (1965), the Supreme Court recognized that specific guarantees in the Bill of Rights create zones of privacy to protect certain intimate activities from means which sweep unnecessarily broadly and thereby invade the area of protected freedoms. Regarding bodily integrity, the court ruled that no right is held more sacred, or is more carefully guardedthan the right of every individual to the possession and control of his own person, free from all restraint or interference from others Both Roe v. Wade, 410 U.S. 113 (1973) and Planned Parenthood v. Casey 506 U.S. 833 (1992), protected rights to privacy, autonomy, and personal choice. See also A.L.A. v. West Valley City, 26 F.3d 989, 990 (10th Cir.1994) (There is no dispute that confidential medical information is entitled to constitutional privacy protection.); According to A. Rahman Ford, JD, PhD, Undue infringement by the federal government upon so sacrosanct a right as the bodily integrity of private persons must be viewed as paternalistic, Victorian and an affront to the freedoms inherent in the Constitution itself.

Notwithstanding the aboveand again, in an abundance of cautionit is our sincerest interest to adhere to the FDAs interpretation of the laws and have several specific questions that we would like the FDA to kindly provide answers to:

Our clinic is simply providing medical treatments to consenting patients using cells from their own body during a medical procedure which does not invoke oversight by the federal government. We would like to specifically request a meeting with the FDA commissioner to better explain the procedures that have successfully helped thousands of people.

We look forward to your responses to our questions above. Feel free to contact me if additional information is required.

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FDA Response - U.S. Stem Cell Clinic

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