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HOW DOES STEM CELL THERAPY WORK?: SoCal Regenerative …

Posted: May 5, 2019 at 9:51 pm

Stem cell therapy is becoming an extremely popular medical treatment, with many doctors recommending it and many patients reaping the benefits. Doctors are even recommending stem cell therapyfor medical issues that once seemed as if they had no option for treatment other than surgery.

But how does stem cell therapy work? To help you answer that question, we'regoing to take a look at what stem cell therapy is, how it works and how it could helpyou.

Stem cells are the bodys own repair kit. When you receive an injury, your bodys stem cells rush to the injured area and start the healing process.

But sometimes, your own stem cells cannot get through to the injured area due to the amount of damage from the injury or surgery.

The net result is an injury that never heals properly or an injury that persists and takes a long time to heal.

Modern stem cell therapy techniques harvest stem cells directly from the patient's own body.This is a quick and safe process that only involves the gathering of fat cells --also known as adipose tissue --from a patient, which are loaded with stem cells.

Once the adipose tissuehas been gathered, the stem cells are separated by spinning them in a centrifuge. They are then injectedback into the injured part of the body.It is important not to confuse these types of stem cells with embryonic stem cells.

Stem cell therapy is the process of using the aforementioned cells to help patients' bodies repair damaged tissue. It can either accelerate an otherwise slow healing process or allow the body to heal tissue that would have otherwise remained damaged permanently because stem cells couldn't get to it.

The medical advancements in stem cell therapy have been remarkable for the advancement of non-invasive medical treatments. Instead of opting for surgery, which is usually the only option many doctors present, patients now have safe, natural and effective alternatives for joint disorders and beyond.

It is also possible to combinePRP (Platelet Rich Plasma) Therapywith Stem Cell Therapy, in certain situations, to provide an additional element that helps in the healing process.

Stem cell therapy is being used for a variety of ailments, from virtuallyuntreatablediseasesto joint injuries. Here is a list of a few of the medical problems being successfully treated with stem cell therapy:

There are many other medical issues that stem cell therapy can treat and this list is expanding every single day. For example, one of the newest stem cell therapies issuccessfully treating osteoarthritis.

Despite the advanced nature of stem cell therapy, the process has a surprisingly short lead time. In most cases, a single treatment will only take about four hours. Depending on the injury, other treatments may be performed in conjunction with stem cell therapy, such as PRP.

As with any medical procedure, stem cell therapy does come with risks. However, advances in stem cell treatment have nullified many of the risks. For example, there was once a high level of concern that a patient's immune system would reject stem cells. The fact that stem cells now come directly from the patient's own body make this, in addition to many otherrisks, either negligible or nonexistent.

The biggest risk most patients undergoing stem cell therapy face is aninfection from the removal of adipose tissue or the injection of stem cells.

The recovery time from a stem cell therapy treatment is virtually nonexistent. A stem cell therapy treatment is an outpatient procedure. Other than some minor discomfort at the injection site for a short time after the treatment, patients can returnto work the next day.

This makes stem cell therapy a great treatment alternative for those who are concerned about the long recovery timeassociated with a surgical procedure.

Stem cell therapy usually costs between 20 and 50 percent less than surgery for treatments of the same ailment; this doesn't even account for the need for surgery revisions. The range of cost is between $4,000 and $6,000, depending on your injury.

If you have a medicalissue that you need resolved, then you should seriously consider stem cell therapy as a treatment option. It is much less invasive than most other types of treatments and it allows your body to heal the way that it was meant to.

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HOW DOES STEM CELL THERAPY WORK?: SoCal Regenerative ...

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May 2019 Longevity Medicine

Posted: May 4, 2019 at 2:48 am

Posted: May 2, 2019 at 3:46 pm

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Posted: May 1, 2019 at 8:50 am

Alzheimers disease affects one in three seniors, according to the Alzheimers Association. But that doesnt account for all those impacted by the disease. Cronkite News

Shehad researched Alzheimers disease and its effects on the brain for years, but it wasnt until her own mothers memory began to slip that Dr. Eva Feldman, a University of Michigan neurologist,truly grasped how devastating the disease is.

Margherita Feldmanwas 88 when she movedin June 2017 to the memory care unit of an assisted living home in Saline. And although her memory loss wasnt as acute as some of the other residents, itswhen the cruelty ofthe disease nowthe sixth-leading cause of death in the United States and the scope of the Americas Alzheimers crisis became clear to her daughter.

I learned more about dementia and Alzheimers disease spending lots of hours in that memory care unit than I did as a long-standing, practicing neurologist, said Dr. Feldman, who is the director of the University of Michigans Program for Neurology Research & Discovery.The people in the memory care unit, some were very violent. Some were very passive. Some were very young with really severe memory loss with early-onset Alzheimers. You could see the whole myriad of presentations and you could understand what an enormously difficult disease that it is for the patient, but also for the families.

Dr. Eva Feldman and her mom, Margherita Feldman, pose together for a photograph in December 2017. Three months later, Margherita Feldman, who had Alzheimers disease, died.(Photo: Feldman family photo)

In her work,but also while visiting with her mom, Dr. Feldman considered theenormityof theAlzheimers problem: About5.8 million Americansnow have the disease, according to thethe Alzheimers Association. That number will climb to at least 13.8 million by 2050,a 138%rise, and as many as 1 in 3 people who live to be 85 in the United States will die with Alzheimers disease.

We are really in an epidemic, Dr. Feldman said, driven largely bybaby boomers (those born between 1946 and 1964), who are growing older and coming to an agewhen the disease most commonly strikes.

Alzheimers disease is a form of dementia. Little is known about specifically what combination of factors causesAlzheimers disease, though scientists saygenetics, lifestyle and environmental exposures most likelyplay into it.

Dr. Rebecca Edelmayer, director of scientific engagement for the Alzheimers Association, explained that three specificbrain changes define the disease:

The most commonly recognized early symptom is a memory problem, said Jennifer Lepard, the president and CEO of the Alzheimers Association Greater MichiganChapter, but the disease doesnt always initially present that way.

Before memory loss, it can even bewhat we would call aneffect on your executive functioning, so itsyour ability to process information, make good decisions on complicated factors, planning, she said.One of the best examples of that is sometimes people begin to have trouble with finances.People who have always paid the bills, run the household budget, all of a sudden cant.

One of the reasons its not always easy to see the memory issues up front isits not always the earliest and most prevalent sign, but also because people that have what are called high cognitive reserves people who have a lot of education, who maybe had done very demanding jobs in the past and really utilized their brain a lot are sometimes very good at hiding symptoms and overcompensating.A lot oftimes, they know theyre having some memory issues and some problems, but they are pretty good at making sure that you dontsee it.

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As the disease progresses, there can be confusion about time and place, difficulty speaking and writing, poor judgment, changes in mood and personality, aggression and agitationand being unable to recognizeloved ones, according to the Alzheimers Association. Eventually, people lose the ability to speak, walk, sit and even to swallow.

Anyone with a brain, when they get older, is at risk of developing Alzheimers, Lepard said.There are a number of people that think, well, it wasntin my family, so Im sure I dont have it. And that is not the case.

Although the majority of people who get Alzheimers disease are 65 and older, Dr. Feldman said its also important tounderstand thatAlzheimers is not a normal part of aging, and it does also sometimes occur inyounger people. About200,000 Americans under the age of 65 have early-onset Alzheimers disease, she said.

Dr. Eva Feldman, a University of Michigan neurologist, professor and director of Michigan Medicines Program for Neurology Research & Discovery.(Photo: Scott C. Soderberg, University of Michigan Photography)

Other risk factors include your family history (especially if a first-degree relative has had Alzheimers disease), type 2 diabetes and obesity, high blood pressure, previous brain trauma, and your APOE-e4 status thisis the first risk gene identified and remains the gene with strongest impact on risk, Dr. Feldman said.

Women, too, are at greater risk. As are people of African American and Latino descent.

The average person with Alzheimers disease will live four to eightyears after diagnosis, said Lepard, and about 40% of that time, the personwill be in the most severe form of the disease, which requires around-the-clock care.

So, if you take a person who lives eight years after diagnosis, for three of those years, that person will be in the most severe aspects of the disease and will need 24-hour care and have lost most of their ability to keep up with the activities required in daily living, Lepard said.

The intensity of care that people need when the disease has progressed that far is often beyond whattheir loved ones can handle, she said. Plus, families quickly see how expensive long-termcare can be. The average cost to Medicare for a single person with dementia in 2018 was $27,244, according to theAlzheimers Association.

Caring for people with Alzheimers disease and other forms of dementiawill cost$290 billion this year alone.But by 2050, that cost is expected to rise to $1.1 trillion annually. Its the most expensive diseasein America with care costing more than cancer and heart disease, the Alzheimers Association reports.

We really see this bankrupting Medicare at some point, Lepard said. When we talk to members of Congress about the situation and why we need to invest in more research, its becausepeople cannot afford long-term care.

Many people, until they are in the situation of needing long-term care, really dont understand how its funded. They think well, if I have Medicare, Im sure its going to cover it all. Thats not really how long-term care is paid for.

The cost goes far beyond dollars and cents, Dr. Feldman said.

Thats a drain like you cant imagine, shesaid.Theres an economic drain, a drain on those individuals ability to work and be productive in society, a medical drain in terms of the cost to take care of the patient. But then, in my mind having lived it and its not quantifiablenecessarily in terms of dollars is the emotional toll that it takes not only on the patient but on the family.

Dr. Eva Feldman is photographed with her parents, George and Margherita Feldman.(Photo: Feldman family photo)

I saw whole families fall apart in that memory care unit. I saw other families come closer together. I think most families take care of their loved one absolutely as long as they can because you see the essential spirit and essence of the person, but theyre missing that one piece, the memory.

It is the loss, really, of the person that you know right in front of your eyes, and to see what that did to wives and husbands was eye-opening to me. It is cruel, and it is very, very difficult as the primary family member to lose the person you know.

Although the number of Americans with the disease isrising,Alzheimers true toll still maybeunderestimated. The Centers for Disease Control and Preventionreports that oftenwhen people with Alzheimers disease die, the cause of death listed on their death certificates may be pneumonia, heart attack or stroke; it sometimes isntnoted that the patient also had Alzheimers disease.

It was very common its getting better now that someone would be in the late stages of Alzheimers disease and their body is not functioning, Lepard said.They would develop pneumonia and die. Did they die because they developed pneumoniaor did they die because they had Alzheimers? Our argument is that they are dying because they had Alzheimers disease.

Jennifer Lepard, president and CEO of the Alzheimers Association Greater Michigan Chapter.(Photo: Alzheimers Association of Greater Michigan)

More and more, it is being put on death certificates if not as the main cause, it might be listed as pneumonia as a result of Alzheimers disease. We are pushing for that, she said, because it creates a more accurate picture of just how huge its reach truly is.

Without an accurate idea of the scope of the problem, health officials and public policy makers are less likely to give it the attention and research dollars needed to find new and better treatments, she said.

The National Institutes of Health allocated $2.3 billion for Alzheimers disease research this year, which is up significantly from the $500 million that was awarded six years ago.

That sounds like a tremendous amount of money, but it is still much less than NIH spends on AIDS, heart disease or cancer, Lepard said. Of course, we do not want less to be spent on those diseases, but we do believe that so much progress has been made on those diseases because they have been investing the research money to do it. Thats our biggest ask.

Although some treatments can helppeople with mild or moderate Alzheimers disease in the short-term, no treatments have yet been discovered that are effective long-term in stoppingbrain degeneration or reversing memory loss. There is no cure for the disease.

Just like every disorder, the more we can understand, the more awareness, and the more governmental input we can have and research dollars, Dr. Feldman said. There are so many unanswered questions and we really do need to continually do active research in this area and try to develop therapeutics.

Among them, Dr. Feldman said, is whether the disease could be treated earlier before symptoms develop with lifestyle changes,immunotherapy or a vaccine.

The scientists in Dr. Feldmans lab areworking to develop a breakthrough treatment using enhanced lines of human neural stem cells to reduce the buildup of amyloid plaquesto improve memory and learning deficits.

We recently received a grant from the National Institute on Aging to determine exactly how these stem cells impact (Alzheimers disease) and improve memory, she said.

She is fascinated, too, by thepower of music to stir remembrancesin people who have Alzheimers disease.

My mother was born and raised in Italy, and toward the end, she wasnt really speaking a great deal, Dr. Feldman said.Shed speak to me and have conversations, but she was definitely declining.

Margherita Feldman holds her children, Eva and George, on her lap for this passport photo.(Photo: Feldman family photo)

One evening, Dr. Feldman recalledtakingher mother to a sing-along at the assisted living center. A musiciansang many old-fashioned, well-known songs like A Bicycle Built for Two.

Since my mom didnt grow up here as much in her early life, she didnt know some of the songs the other residents knew, she said. But then, the guystarted singing a song in Italian. My moms eyes lit up, and she sang the entire song with him. And I looked at her, and she gave me a big smile, and then she kind of went back into herself, and the memory faded once again.

I saw that many times with music among the other residents. So, you know, its very interesting how music activates the mind. There are still parts of the brain that are working, and a lot of them still have their essential personalities. They just lost their memories.There are so many unanswered questions.

Margherita Feldman was 18 when this photograph of her sitting on a bench in Italy after World War II.(Photo: Feldman family photo)

Dr. Feldman, whose mother died in March 2018, said its hard to pinpoint what is most important moving forward.

As a doctor, I will tell you that early diagnosis, lifestyle intervention (diet/exercise), ensuring optimal care, safety and quality of life for the patient is the most important thing, she said.As my mothers daughter, I will tell you that remembering that the person affected may have lost their memory, but not their spirit, or some would say, their soul.

Contact Kristen Jordan Shamus: 313-222-5997 or [email protected]. Follow her on Twitter @kristenshamus.

The Alzheimers Associationis running the largest clinical trial of its kind in the U.S.to better to understand the best lifestyle interventions for people at risk for developing Alzheimers disease, said Dr. Rebecca Edelmayer, director of scientific engagement for the Alzheimers Association.

Called the U.S. Pointer Study, the association is recruiting 2,000 people ages 60-79 from diverse backgrounds to examine howbetter management of cardiovascular health factors,nutrition, exercise and social and cognitive stimulation can have has an effect on Alzheimers disease.

At this point, there have not been large enough trials to really understand in detail what the best recommendation in terms of modifiable risk factors should be for individuals living at risk of cognitive decline as we age, she said.

To learn more about whether you or someone you know might be a candidate for the U.S. Pointer Study or other Alzheimers disease clinical trials, go to:https://trialmatch.alz.org

Read or Share this story: https://www.freep.com/story/news/local/michigan/2019/04/30/alzheimers-disease-rates-rising-baby-boomers/3539418002/

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May 2019 Longevity Medicine

Recommendation and review posted by G. Smith

Pharmacogenomics FAQ | NHGRI

Posted: May 2, 2019 at 7:48 pm

Much research is underway to understand how genomic information can be used to develop more personalized and cost-effective strategies for using drugs to improve human health.

In 2007, the FDA revised the label on the common blood-thinning drug warfarin (Coumadin) to explain that a person's genetic makeup might influence response to the drug. Some doctors have since begun using genetic information to adjust warfarin dosage. Still, more research is needed to conclusively determine whether warfarin dosing that includes genetic information is better than the current trial-and-error approach.

The FDA also is considering genetic testing for another blood-thinner, clopidogrel bisulfate (Plavix), used to prevent dangerous blood clots. Researchers have found that Plavix may not work well in people with a certain genetic variant.

Cancer is another very active area of pharmacogenomic research. Studies have found that the chemotherapy drugs, gefitinib (Iressa) and erlotinib (Tarceva), work much better in lung cancer patients whose tumors have a certain genetic change. On the other hand, research has shown that the chemotherapy drugs cetuximab (Erbitux) and panitumumab (Vecitibix) do not work very well in the 40 percent of colon cancer patients whose tumors have a particular genetic change.

Pharmacogenomics may also help to quickly identify the best drugs to treat people with certain mental health disorders. For example, while some patients with depression respond to the first drug they are given, many do not, and doctors have to try another drug. Because each drug takes weeks to take its full effect, patients' depression may grow worse during the time spent searching for a drug that helps.

Recently, researchers identified genetic variations that influence the response of depressed people to citalopram (Celexa), which belongs to a widely used class of antidepressant drugs called selective serotonin re-uptake inhibitors (SSRIs). Clinical trials are now underway to learn whether genetic tests that predict SSRI response can improve patients' outcomes.

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Pharmacogenomics FAQ | NHGRI

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Framework for the Regulation of Regenerative Medicine Products

Posted: May 1, 2019 at 4:49 pm

The U.S. Food and Drug Administration has published two final guidance documents that are part of a comprehensive policy framework to address how the agency plans to support and expedite the development of regenerative medicine products, including human cells, tissues, and cellular and tissue-based products (HCT/Ps). These guidance documents build upon FDAs risk-based, flexible regulatory framework, and underscore the agencys commitment to help bring new and innovative treatment options to patients.

The final guidance documents are:

The final guidance on minimal manipulation and homologous use are intended to provide clarity in the determination of whether HCT/Ps are subject to FDAs premarket review requirements. The final guidance on the same surgical procedure exception is intended to provide clarity as to whether an establishment may qualify for an exception from the requirements under Part 1271 by meeting the exception in 21 CFR 1271.15(b).

The FDA is also publishing two new draft guidances, which are intended to aid in the effort to bring innovative, safe, and effective products to patients as efficiently as possible:

The draft guidance on expedited programs describes several programs, such as Fast Track designation and Breakthrough Therapy designation, that are available to sponsors of regenerative medicine therapies, and information about the requirements for, and benefits of, the new RMAT designation program that was created by the 21st Century Cures Act. The draft device guidance, which FDA is publishing as required by section 3034 of the 21st Century Cures Act, provides the agencys current thinking about concepts related to the evaluation of devices used in the recovery, isolation and delivery of RMATs.

04/26/2019

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Framework for the Regulation of Regenerative Medicine Products

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Gene therapy reverses rare immune disorder | National …

Posted: May 1, 2019 at 4:48 pm

April 30, 2019

Children born with a rare genetic disorder called X-linked severe combined immunodeficiency (X-SCID) dont have a functioning immune system. As a result, they cant fight off infections. Without treatment, an infant with X-SCID will usually die within the first year or two of life.

The best option for treatment of newly diagnosed infants with X-SCID has been stem-cell transplantation from a genetically matched sibling. But less than a quarter of children with X-SCID have a matched donor available. For those without a matched donor, standard treatment has been a half-matched bone marrow transplant from a parent. But most infants receiving this type of transplant only have part of their immune system, called T lymphocytes, restored. These infants will need lifelong injections of protective antibodies. In addition, as they grow into young adulthood, they may have chronic medical problems that affect growth, nutrition, and quality of life.

To develop a better approach to fix the immune systems of children with X-SCID, researchers have used gene therapy to alter patients own blood stem cells. An engineered virus brings a healthy copy of the gene into the stem cells to replace the mutated gene that causes the disease.

Early results from trials of gene therapy for X-SCID resulted in life-saving correction of T lymphocytes. But similar to bone marrow transplant from a parent, the immune restoration was incomplete. In addition, in those first gene therapy studies, almosta third of the children developed leukemia. The approach accidentally stimulated cells to grow uncontrollably. In later studies, improved design of the engineered virus didnt cause cancer, but also didnt fully restore a healthy immune system.

In 2010, Dr. Harry Malech of NIHs National Institute of Allergy and Infectious Diseases (NIAID) and Dr. Brian Sorrentino of St. Jude Childrens Research Hospital reported a new and safer version of gene therapy for X-SCID. They designed a harmless engineered virus (called a lentivector) that could deliver genes into cells without activating other genes that can cause cancer. Before the altered stem cells were returned to their bodies, patients were given low doses of the chemotherapy drug busulfan. This made it easier for the new stem cells to grow in the bone marrow. In young adults and children treated at the NIH Clinical Center, the new therapy proved to be both safe and effective at restoring the full range of immune functions.

Based on this work, a team led by Dr. Ewelina Mamcarz of St. Jude Childrens Research Hospital began treatment in 2015 of newly diagnosed infants with X-SCID using the lentivector and busulfan. The work was funded in part by NHLBI. The team described the treatment of eight infants with the disorder on April 18, 2019, in the New England Journal of Medicine.

By 3 to 4 months after infusion of the repaired stem cells, 7 of the 8 infants had normal levels of multiple types of immune cells in their blood. The last infant required a second stem-cell infusion, after which his immune-cell levels rose to a normal range.

The infants new immune systems were able to fight off infections that the researchers had detected before the gene therapy. Four of the eight discontinued immune-system boosting medications that theyd previously needed. Of those four, three developed antibodies in response to vaccination, indicating a fully functional immune system.

A year and a half after gene therapy, all children were healthy and growing normally.

The broad scope of immune function that our gene therapy approach has restored to infants with X-SCID as well as to older children and young adults in our continuing study at NIH is unprecedented, Malech says.

The researchers will continue to follow the participants over time. They plan to track how the childrens immune systems develop and look for any late side effects.

References:Lentiviral Gene Therapy Combined with Low-Dose Busulfan in Infants with SCID-X1. Mamcarz E, Zhou S, Lockey T, Abdelsamed H, Cross SJ, Kang G, Ma Z, Condori J, Dowdy J, Triplett B, Li C, Maron G, Aldave Becerra JC, Church JA, Dokmeci E, Love JT, da Matta Ain AC, van der Watt H, Tang X, Janssen W, Ryu BY, De Ravin SS, Weiss MJ, Youngblood B, Long-Boyle JR, Gottschalk S, Meagher MM, Malech HL, Puck JM, Cowan MJ, Sorrentino BP. N Engl J Med. 2019 Apr 18;380(16):1525-1534. doi: 10.1056/NEJMoa1815408. PMID: 30995372.

Funding:NIHs National Institute of Allergy and Infectious Diseases (NIAID); National Heart, Lung, and Blood Institute (NHLBI); and National Cancer Institute (NCI); American Lebanese Syrian Associated Charities; California Institute of Regenerative Medicine; and Assisi Foundation of Memphis.

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Gene therapy reverses rare immune disorder | National ...

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Genetic Medicine | List of High Impact Articles | PPts …

Posted: May 1, 2019 at 4:47 pm

Genetic medicine is the integration and application of genomic technologies allows biomedical researchers and clinicians to collect data from large study population and to understand disease and genetic bases of drug response. It includes genome structure, functional genomics, epigenomics, genome scale population genomics, systems analysis, pharmacogenomics and proteomics. The Division of Genetic Medicine provides an academic environment enabling researchers to explore new relationships between disease susceptibility and human genetics. The Division of Genetic Medicine was established to host both research and clinical research programs focused on the genetic basis of health and disease. Equipped with state-of-the-art research tools and facilities, our faculty members are advancing knowledge of the common genetic determinants of cancer, congenital neuropathies, and heart disease.

Related Journals of Genetic Medicine

Cellular & Molecular Medicine, Translational Biomedicine, Biochemistry & Molecular Biology Journal, Cellular & Molecular Medicine, Electronic Journal of Biology, Molecular Enzymology and Drug Targets, Journal of Applied Genetics, Journal of Medical Genetics, Genetics in Medicine, Journal of Anti-Aging Medicine, Reproductive Medicine and Biology, Romanian journal of internal medicine

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Genetic Medicine | List of High Impact Articles | PPts ...

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