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Stem cell therapy: FDA investigates clinics offering …

Posted: January 10, 2019 at 1:41 pm

Inside Mark Bermans clinic in Rancho Mirage, California, is a sign hes obliged by law to post. It reads Not FDA Approved.

Patients who come here to the California Stem Cell Treatment Center can get treatments for ailments ranging from sports injuries to muscular dystrophy. For upward of $5,000, Berman, a plastic surgeon by training, will remove a small portion of their fat, process it, and inject it back into them.

This is called fat-derived stem cell therapy; the premise is that the stem cells in your fat can jump-start the healing process. The stem cells could be good for repairing everything from Alzheimers to paralysis to neurodegenerative conditions, says Berman. These cells are miraculous for helping heal. We dont have a choice. We have to use them.

The problem is theres not much evidence to back up the claims Berman is making. And its not just him there are more than 100 clinicians in the Cell Surgical Network, a group he co-founded in 2010 to promote the same kind of adult stem cell regenerative medicine he practices. According to a 2017 report by three Food and Drug Administration scientists in the New England Journal of Medicine looking at the benefits and risks of this kind of stem cell therapy, This lack of evidence is worrisome.

Fat-derived stem cells may have a positive effect, says Brad Olwin, a professor of molecular cellular and developmental biology at the University of Colorado Boulder with more than 30 years of experience working with stem cells. They may be beneficial; its clearly a possibility. The problem is the research hasnt been done.

So little evidence exists, in fact, that the Department of Justice, on behalf of the FDA, is suing Bermans clinic as well as a clinic in Florida for experimenting on patients with misleading products. The complaint was filed in May 2018 and the investigation is ongoing, according to the DOJ.

Given the popularity and abundance of these clinics nationwide, the FDA is also taking steps to modernize regulation in the field. But despite these efforts to streamline a path to legitimacy for stem cell clinics, unregulated medical procedures persist, at times leading to patient harm.

Currently, the only stem cell therapy approved by the FDA is a bone marrow transplant that uses pluripotent stem cells to treat cancers of the blood and bone marrow.

But doctors in the Cell Surgical Network have moved ahead with using cells for autoimmune, neurologic, and other serious conditions.

And there is a growing number of cases of adverse effects. In 2016, an elderly woman went blind after receiving an injection of stem cells to treat her macular degeneration. She received the treatment at the Stem Cell Center of Georgia an affiliate of Bermans Cell Surgical Network.

More reports of ill-fated procedures have since surfaced across the country, the worst resulting in kidney failure and paraplegia. In December, the Centers for Disease Control and Prevention reported 12 cases of people who suffered bacterial infections from contaminated stem cell treatments. An investigation traced the infections back to a single provider, Genetech, prompting the FDA to issue a warning letter to the company. FDA Commissioner Scott Gottlieb then issued a public statement reaffirming the agencys intent to regulate unapproved treatments.

Bioethicists are sounding the alarm too. In a recent paper in the journal Perspectives in Biology and Medicine, the University of Minnesotas Leigh Turner examined the marketing claims of 716 stem cell clinics in the United States. Often, he found, they were misleading. What at first glance might appear to be credible and compliant clinical research often is highly problematic, he wrote, adding that the individuals most affected are those who often are already dealing with serious health problems and other challenges.

Despite two years of increased scrutiny from the FDA, clinics continue to recruit new patients. Berman insists that repurposed fat-derived stem cells should not be subject to the same regulations as other treatments, and that FDA guidelines are arbitrary and nonscientific. They are a violation of constitutional rights to your own property.

He noted that after the case of the woman with macular degeneration going blind, his networks clinicians no longer inject fat-derived stem cells into patients eyes. But they continue to offer intravenous (bloodstream) injections. We have virtually three or four adverse events, of very little significance or consequence, says Berman, referring to the patients in his network. But according to the FDA, intravenous injections are associated with higher risk.

Other scientists I spoke with say theyre also worried that intravenous treatments may harm patients. Youre taking cells out of one part of your body, and putting them into another. You have absolutely no control after that, says Olwin. He acknowledges the FDAs efforts to crack down on clinics but suggests that much more can be done. They have limited resources to go after people. But I think its irresponsible for doctors and these clinics to be promoting these things.

Some types of stem cells can indeed give rise to virtually any cell in the body providing a platform for regenerating muscle or even rebuilding organs. Stem cells derived from embryos have this power, called pluripotency, but those obtained from adults do not. In order to acquire pluripotency, adult stem cells must be biologically reprogrammed a feat that, when invented, led to a Nobel Prize. These induced pluripotent stem cells allow doctors to treat challenging illnesses such as leukemia.

But clinics like Bermans are not using pluripotent stem cells they are using the mesenchymal stem cells found in fat, which are much more limited in function. Arnold Caplan, the fields pioneer who first gave them the stem cell label, recently advocated for renaming them to prevent doctors from claiming that they can cure the blind, make the lame walk, and make old tissue young again.

BrainStorm, a biotechnology company working with mesenchymal cells, recently gained FDA approval to begin clinical trials to treat patients suffering from multiple sclerosis. But to treat the neurological condition, BrainStorm researchers have developed a method to convert the mesenchymal cells into biological factories that release disease-treating proteins. In other words, BrainStorms therapy doesnt involve mesenchymal cells doing the work on their own what some clinics in the Cell Surgical Network claim mesenchymal cells can do.

Outside of the Cell Surgical Network, other clinics are using patients fat-derived cells but making different claims about the treatment.

I dont say Im doing stem cell therapy, says Dr. Joanne Halbrecht, an orthopedic surgeon and founder of Boulder Regenerative Medicine. Her clinic uses patients fat-derived cells to treat orthopedic conditions, injecting them into joints.

Halbrecht avoids the stem cell label because current research does not support claims that these fat-derived cells can turn into cartilage. Instead, she uses patients fat to cushion their joints. According to Olwin and the FDA, such joint injections are significantly lower-risk than intravenous injections.

Berman also administers direct joint injections. But afterward, he tells me, his clinicians also inject the leftover cells into the patients bloodstream. Halbrecht is adamant that this kind of procedure is unproven and unsafe.

Thats definitive. Its not a question, she says. They are completely wrong because there is zero science behind that.

For clinics to prove the safety and efficacy of their fat-derived stem cell treatments to the FDA, they must run rigorous clinical trials.

But some clinicians argue that even if they were interested in clinical trials, getting the FDAs blessing is too daunting. Clinical trials span years and cost millions of dollars. For small, privately owned clinics, this process is unaffordable.

In response, the FDA unveiled a more feasible clinical trial process, better suited to small businesses. Clinics that want to test a specific treatment can now team up on clinical trials and pool their patients, which can save them time and money. Still, the FDA is offering a grace period of up to 36 months for clinics to comply with its guidelines, allowing many to continue operating on patients without doing clinical trials. In the meantime, the FDA is urging patients to do [their] part to stay safe, according to a consumer warning issued in May.

Unfortunately, thats not so easy. Whether or not a clinic is offering an FDA-compliant treatment can be unclear. Some doctors advertise compliance because the device they use to remove and process a patients fat is technically FDA-approved. But if they then advertise their treatment as an FDA-approved stem cell therapy, they risk misleading patients.

Berman has no plans to pursue clinical trials, even with the new streamlined process. He believes his current model of clinical experimentation is adequate. In the so-called safety studies, he treats paying patients with a wide variety of diseases. But according to the recent bioethics report, Turner found that these pay-to-participate studies are poorly designed and unscientific.

In Bermans view, more patients benefit by obtaining cutting-edge treatments faster. But for every revolutionary treatment developed in a lab, there are nine duds and many unpredictable dangers. And unsanctioned clinics cost patients thousands of dollars and are not covered by insurance. Critics argue that it is unethical to charge patients for experimental procedures, as sanctioned clinical trials rarely cost patients anything.

The economic incentives for unsanctioned stem cell clinics are clear. Starting clinical trials would not only reduce patient revenue but also commit clinics to a costly process known to last for years. Shifting blame to the government and research community, Berman assures me that he and his colleagues are not motivated by self-interest. Were the good guys, he says.

In March, the woman blinded by an unsanctioned stem cell treatment filed a lawsuit against Bermans Cell Surgical Network. Bermans site still advertises treatment for macular degeneration with a link to an application.

But tucked away on Bermans website sits a sort of confession that may surprise the many patients who hear him speak with unwavering assurance. The page reads, We do not claim that these treatments work for any listed nor unlisted condition, intended or implied.

Max Levy is a PhD student in chemical and biological engineering at the University of Colorado Boulder and the senior editor of Science Buffs, a graduate student science blog. He writes about health, medicine, and the environment.

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Biology MA | Temple University

Posted: January 9, 2019 at 11:44 am

The Master of Arts in Biology in the College of Science and Technology at Temple emphasizes contemporary coursework for students to gain advanced understanding within the field of modern biology. Students are prepared for professional schools or careers in fields related to the biological sciences. The Biology MA is a part-time or full-time graduate program, and it is tailored for students seeking graduate studies in the biological sciences without experimental research in labs. Compared to the Biology MS, the Biology MA program focuses primarily on coursework and independent research and helpsyou form expertise in one or more areas of biology, such as molecular biology and genetics, among others.

As a result of thecurriculum's emphasis oncoursework, youll develop the analytical thinking skills necessary for biological research and literature review. Interdisciplinary coursework includes

All Biology MA students produce a written, nonresearch literature thesis in the final year ofthe masters program. Youll become proficient in researching, investigating and interpreting primary scientific literature. Graduates are able to writeauthoritative, critical and in-depth scientific reviews.

Although much of your time in the Biology MA program will be spent in class, youll have access to the Department of Biologys centers and institutes, including the Center for Biodiversity, the Institute for Contemporary Molecular Science and the Sbarro Health Research Organization.

Learn more about the College of Science and Technologys centers, facilities and institutes.

To earn the Biology MA, students must successfully complete the degrees culminating event, which is the masters nonresearch literature thesis. This is an original research study that presents a problem in the biological sciences based on a rigorous review of literature in the biological sciences, as well as demonstrates a students advanced knowledge of research methods and mastery of the primary area of interest.

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Biology MA | Temple University

Recommendation and review posted by G. Smith is worth $435 USD – Immortality …

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Biotechnology Graduate Program | Department of Molecular …

Posted: January 8, 2019 at 5:45 am

The Biotechnology graduate program offers Masters (Sc.M. & A.M.) and Ph.D. degrees and is designed for students interested in a range of topics related to the field of biotechnology including drug & gene delivery, drug discovery and cell therapy. Faculty have active research in one or more of these three areas. The educational objectives of the program are to promote an understanding of: 1.) the designs and materials used in novel cell and drug delivery systems; 2.) the molecular, cellular and animal sciences of drug discovery & drug development; and 3.) the development and testing of cell-based therapies for the treatment of diseases. We also offer courses on the business and management of biotechnology.

Ph.D. Application Deadline: First week in January

Ph.D. Recruitment Day: TBD

External Masters Application Deadlines: November 15 (Spring start) and April 15 (Fall start)

For general information about graduate programs at Brown, visit the following websites: Graduate School, Applying to Brown, and Financial Support.

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What Are Examples of Biotechnology? |

Posted: January 8, 2019 at 5:45 am

Some examples of biotechnology include human gene therapy, genetically modifying plants and changing the genes of bacteria. Biotechnology helps improve crops so they produce more, healthier produce. It also helps fight human diseases.

Biotechnology is generally involved in changing the genes of a an organism to get the desired result. It affects the most people through genetically modified crops. Genetic modification of crops started thousands of years ago through selective breeding for preferred traits, but with the advances in technology in the modern day, scientists are able to directly manipulate genes. These plants produce higher quality food at a higher rate, and are often resistant to pests and diseases, which helps feed larger amounts of people for a lower price on less land.

Biotechnology more directly helps humans with gene therapy and the modification of bacteria to produce insulin for patients with diabetes. Gene therapy can help reduce or remove the effects of a disease, such as cancer or AIDS, but is still mostly in research and development. This type of therapy is still promising and has had good results in testing phases. Modified bacteria cells that produce insulin as they age helps treat and control the effects of diabetes in humans over time.

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Online Biotechnology Bachelor’s Degree | UMUC

Posted: January 8, 2019 at 5:45 am

In addition to the general education requirements and the major, minor, and elective requirements, the overall requirements listed below apply to all bachelor's degrees.

Double majors: You can earn a dual major upon completion of all requirements for both majors, including the required minimum number of credits for each major and all related requirements for both majors. The same class cannot be used to fulfill requirements for more than one major. Certain restrictions (including use of credit and acceptable combinations of majors) apply for double majors. You cannot major in two programs with excessive overlap of required coursework. Contact an admissions advisor before selecting a double major.

Second bachelor's degree: To earn a second bachelor's degree, you must complete at least 30 credits through UMUC after completing the first degree. The combined credit in both degrees must add up to at least 150 credits. You must complete all requirements for the major. All prerequisites apply. If any of these requirements were satisfied in the previous degree, the remainder necessary to complete the minimum 30 credits of new classes should be satisfied with classes related to your major. You may not earn a second bachelor's degree in general studies and may not obtain a second associate's degree within the second bachelor's degree. Contact an admissions advisor before pursuing a second bachelor's degree.

Electives: Electives can be taken in any academic discipline. No more than 21 credits can consist of vocational or technical credit. Pass/fail credit, up to a maximum of 18 credits, can be applied toward electives only.

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