What Are Myelodysplastic Syndromes and How Are They Treated? – Dana-Farber Cancer Institute

Medically reviewed by David P. Steensma, MD

Myelodysplastic syndromes (MDS) are a group of diseases of the blood and marrow that result in the body being unable to produce enough healthy, mature blood cells.

MDS develops when theblood stem cells found in the bone marrow become injured (i.e., they acquire amutation in the DNA that determines their function) and do not mature intohealthy white blood cells, red blood cells, and platelets. Normally, whiteblood cells work to fight infection, red blood cells carry oxygen, andplatelets help blood clot to stop bleeding. In MDS, cells may be reduced innumber or may not work the way they should. As a result, there are fewerhealthy red blood cells, white blood cells, and platelets.

In addition, a type of immature bone marrow cell called a blast cell can increase in MDS.Fewer than 5% of the marrow cells are blast cells in healthy persons.In some patients with MDS, the blasts increase to 5% or greater.If 20% or more blast cells are present in the marrow, the diagnosis is acute leukemia rather than MDS.

Myelodysplastic syndromes occur mostly in older patients; 75% of patients are more than 65 years old. The disease is very rare in children. Risk factors for MDS include:

There are two major categories of myelodysplastic syndromes.The first is primary or de novo MDS, where an external factor triggering thedisease cannot be identified. In contrast, secondary or therapy-related MDSis developed after use of chemotherapy or radiation for cancer. The term secondary MDS is also used todescribe MDS resulting in children with inborn genetic syndromes.

In about one-third of patients, MDS progresses to a condition known as acute myelogenous leukemia (AML). Secondary or therapy-related MDS, from chemotherapy or radiation, has a higher risk for evolving to AML than primary MDS.

The most common presenting symptom of MDS is fatigue and decreased ability to exercise or to carry on the usual daily activities.Anemia (low red cell count) is present in most patients with MDS; anemia can cause symptoms such as shortness of breath, swelling of the ankles, paleness or other signs and symptoms.

Less common presenting symptoms include bleeding (e.g. nose bleeds or gum bleeding) or easy bruising, due to low platelet counts or platelets that do not work well. Occasionally, patients with low white cells will first be diagnosed after they develop a serious infection MDS is often discovered accidentally during routine blood tests.

At Dana-Farber/Brigham and Womens Cancer Center, adults with MDS are treated in the Hematologic Oncology Treatment Center. For these patients, there are several treatment options.

The only potentially curative approach for MDS is a bone marrow or stem cell transplant, also known as an allogeneic hematopoietic cell transplant, to destroy abnormal cells in bone marrow with chemotherapy or radiotherapy (conditioning) and replace them with healthy cells from a donor.

This approach has many potential serious side effects, including infections or a form of rejection called graft-versus-host disease. Older patients, such as those in their 60s or 70s, are often given a lower dose of radiation or chemotherapy prior to transplant, also known as reduced-intensity conditioning. This therapy may not destroy all bone marrow cells but is enough to allow donor cells to grow in the bone marrow.

Chemotherapy is useful for treating patients with MDS because it treats the entire body, killing abnormal cells and allowing normal ones to grow. A class of low-intensity chemotherapy drugs called hypomethylating agents kill cells that divide rapidly and activate some genes that help cells mature. Using one of these drugs can improve blood counts (sometimes eliminating the need for blood transfusions), lower the number of abnormal cells such as blasts, and lower the chances of getting leukemia.

Side effects include an initial a decrease in blood cell counts, which often later improves as the drug begins to take effect, as well as fever, skin rash, nausea/vomiting, and fatigue. Examples of hypomethylating agents include azacitidine and decitabine.

For patients who have an abnormality of chromosome 5 intheir bone marrow cells and have anemia and do not have increased blasts, apill called lenalidomide may be helpful for improving blood counts. Lenalidomide can cause blood clots or worsenlow white blood count and platelets, and it doesnt work as well for patientswithout a chromosome 5 abnormality.

In rare cases, intensive chemotherapy similar to that givento patients with acute leukemia may be necessary. In certain cases, immune suppressing therapywith anti-thymocyte globulin, cyclosporin, tacrolimus or other drugs may beused.

Supportive therapy involves treating or preventing the symptoms of MDS, rather than treating the MDS directly by trying to eliminate abnormal cells. Supportive therapy can be used alone or with other treatments.

One supportive therapy option is hematopoietic growth factors. Hematopoietic growth factors are hormone-like substances that occur naturally in the body but can be produced synthetically and given in large doses than the body can make. These growth factors are typically injected subcutaneously (under the skin) to help bone marrow make new blood cells. Erythropoietin (epoetin or darbepoetin) is a growth factor that increases red cells. Less commonly, growth factors filgrastim or pegfilgrastim are used to increase white cells, or growth factors romiplostim or eltrombopag are used to increase platelets. Luspatercept is a new drug that improves red cell growth in certain MDS subtypes.

For patients who have had many red cell transfusions andhave an excess of body iron, iron chelation medications such as deferasirox ordeferoxamine may be used to lower iron levels and prevent injury to bodyorgans.

Transfusions with red cells or platelets as needed andantibiotics to prevent or treat infections are other examples of supportivecare used for MDS.

At Dana-Farber/Boston Childrens Cancer and Blood Disorders Center, children with MDS are treated through the Bone Marrow Failure and Myelodysplastic Syndrome Program. Treatment is similar to adults, including supportive care, except that hematopoietic cell transplant is used more commonly in children.

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What Are Myelodysplastic Syndromes and How Are They Treated? - Dana-Farber Cancer Institute

Selma Blair Says She’s Growing Peach Fuzz On Her Face Amidst MS Treatment Recovery – Women’s Health

Selma Blair has been super open when it comes to sharing about her life with multiple sclerosis. Since her diagnosis in August 2018, she's been raising awareness about MS and how it has affected life for her and her 8-year-old-son son, Arthur. Her Instagram is full of pics and posts documenting her days and treatments (and some fun fashion pics, minus pants), with captions revealing how MS has impacted her body and appearance.

Selma's latest post features a close-up photo of her face, showing she's starting to grow some peach fuzz.

"Face it. I have rather thick and substantial peach fuzz. This is a new development. I also have very small ears. Earlier development. School pick up musings. Carry on. #selfie," she captioned her post.

She's getting lots of love and support from her friends and fans.

"You are gorgeous and that is that ," said one fan.

And many lamenting they have peach fuzz too.

"You should see my peach fuzz!!!," wrote another friend.

While Selma didn't specify the suspected cause of her peach fuzz, she's currently in the midst of recovering from a stem cell treatment for her MS that required her to undergo chemotherapy. She's been open about how these treatments have impacted her vision, and caused insomnia and memory problems, as well as hair loss.

The bright side: Apparently she's already back to rocking school pickup like a boss. Here's hoping Selma's feeling better while she recuperates in LA!

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Selma Blair Says She's Growing Peach Fuzz On Her Face Amidst MS Treatment Recovery - Women's Health

Reassessing What’s Really Important After Relapse – Myasthenia Gravis News

I have started this column many times, but I have had trouble putting my emotions into words. I am trying to digest and cope with how my body is slowly failing me, and I dont know how I feel about it.

If you have been following me, you know that I had a stem cell transplant in January. It was a trial treatment and seemed to put me into complete remission. I was functioning like a normal adult for the first time in more than 15 years. I was able to go to the gym, work a full day, and still have the energy to cook a delicious dinner for my husband. I felt like I had been given a second chance at life, and boy, was I going to grab it with both hands!

Over time, I have noticed that my body is not as responsive as it was immediately following my transplant. I need a nap to make it through the day, and I have not set foot in the gym for more than two months. I began to slur my words again, and I have to be careful not to choke on my food during meals I have already had a few close calls.

I have had to reassess what is important to me. Do I really want that six pack, or do I just want to be able to make it through a day without collapsing in a heap? Do I want to push myself to go to every event and pay for it for up to a week?

I went to see my doctor when things had been going downhill for about a month. We made the decision to begin chemotherapy once again. I am only authorized for three rounds and I have already had two. The side effects of chemo are terrible and I am incapacitated for at least three days after a treatment. But I need that joy of life back.

This relapse has been far more difficult emotionally as I now know what it is like to live a full and healthy life. I know what it is like to do everything possible, and still have energy to entertain friends and family. I am back on antidepressants, and I am coping. I will never give up. Something has to work. Something.

***

Myasthenia Gravis News is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional med

I am a Myasthenia Gravis Warrior, wife, friend, and fur-mum. I love to read, crochet, sleep & find the good in every day. I always try to find the silver lining!

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IMBRUVICA Treats CLL and SLL Patients Without Chemotherapy – BioSpace

CL Shebley / Shutterstock

"I hadn't been to the doctor for a really long time 'cause I was healthy. So I went for a regular, routine checkup, and he felt a lump on the left side of my jaw. So he sent me for a CT scan, and that's when they discovered tons of nodes all through my upper chest and neck and jaw. After the biopsy results, I was diagnosed with Chronic Lymphocytic Leukemia," tells Tina, an IMBRUVICA patient who described her treatment journey in a moving video.

After experiencing terrible side effects, Tina thought that she may die. "That's the first time I really thought that I might not make it." She went through doctor after doctor, even moving across the country, before eventually attempting chemotherapy. "I stopped them midway, I didn't want to do any more treatments."

Finally, her doctor told her about IMBRUVICA, discussing the potential benefits and risks. Soon after Tina began taking the drug, her doctor was extremely satisfied with her progress, adjusting from a weekly appointment to just once every two months.

IMBRUVICA, or Ibrutinib, is a medication used to treat certain cancers (such as mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrom's macroglobulinemia). Ibrutinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells. Ibrutinib is also used to treat a certain problem that may occur after a stem cell transplant (chronic graft versus host disease). It works by weakening your body's defense system (immune system)."

IMBRUVICA is a once-daily oral therapy, and describes itself as working differently than other treatments such as chemotherapy. "IMBRUVICA works by blocking the activity of a protein called Bruton's tyrosine kinase, or BTK. BTK is a protein involved in communication signals within B cells. By blocking BTK, IMBRUVICA may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs. BTK is also found in normal B cells, so blocking it may cause side effects. A relationship between how IMBRUVICA works and why it helps to treat certain diseases has not been clearly identified."

The FDA greenlit the drug for the 10th time in January of this year, with approval being "based on results from the Phase III iLLUMINATE study that showed the combination treatment significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab in previously untreated CLL/SLL patients who were 65 years or older, or less than 65 years old with coexisting conditions. Trial results showed that patients who were treated with the combination of Imbruvica and Gazyva experienced a 77% reduction in risk of progression or death compared to the chemotherapy arm. AbbVie said the chemotherapy-free, anti-CD20 combination regimen also showed an 85% reduction in risk of progression or death compared to chlorambucil plus obinutuzumab when evaluating PFS in patients with high-risk disease."

Carol Moreno, M.D., Ph.D., Consultant Hematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain, and lead iLLUMINATE investigator quoted that "This latest IMBRUVICA FDA approval gives the healthcare community the first chemotherapy-free, anti-CD20 combination to treat CLL and SLL patients who have not yet started therapy. Also, and importantly, this new treatment combination helps reduce the need for chemotherapy."

IMBRUVICA even offers a YOU&i Support Program, "a personalized program that helps your patients learn about access to IMBRUVICA (ibrutinib), find affordability support options, and sign up for information and resources to support them along their treatment journey." New patients experiencing insurance coverage delays can "receive a free 30-day supply of IMBRUVICA. The free product is offered to eligible patients without any purchase contingency or other obligation." The program includes resources such as a list of specialty pharmacies and distributors, a sample letter of medical necessity, affordability support options, nurse call support, and various other clinical resources.

Tina describes a great change in her quality of life since starting IMBRUVICA to close out her treatment journey video. "My outlook has changed since I started taking IMBRUVICA. I feel that I am much more capable of moving forward and taking care of myself first. It comforts me a great deal to know that my friends and my doctor are totally by my side. They have meant everything to me through this whole process. I am very happy to have IMBRUVICA as my treatment. The advice I give for people who are diagnosed with CLL is do the research, advocate for yourself, and never give up until you find the treatment and the doctor who are right for you."

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IMBRUVICA Treats CLL and SLL Patients Without Chemotherapy - BioSpace

New restrictions put fetal tissue research in the balance – AAMCNews

Fetal tissue has been used in biomedical research for decades, contributing to advances in vaccine development and HIV drug testing. Current research into macular degeneration, multiple sclerosis, spinal cord injuries, and Parkinsons could lead to therapies that could improve the lives of millions of patients. But new federal restrictions on the use of fetal tissue, which become effective Sept. 25, will halt some studies and have a crippling effect on others.

In June, the U.S. Department of Health and Human Services (HHS) announced new rules that discontinue research within the National Institutes of Health (NIH) that involves human fetal tissue from elective abortions and requires that NIH-funded research involving human fetal tissue that is conducted at academic health centers be subject to a lengthy approval process.

AAMCNews spoke with Lawrence S. B. Goldstein, PhD, distinguished professor at the University of California (UC), San Diego, School of Medicine and founder and former director of the Sanford Stem Cell Clinical Center at UC San Diego Health, about how scientists use fetal tissue and what the new restrictions mean for the future of biomedical research.

For what areas of biomedical research is the use of fetal tissue particularly important?

Cells derived from fetal tissue have been critical in vaccine development. Numerous vaccines have been developed using fetal cells developed by [renowned researcher] Leonard Hayflick and others who followed in his footsteps.

Fetal tissue is also vital to areas of stem cell research because it helps us prove that the cells we've made are actually the cell progenitors of the organs were trying to build or the structures within those organs were trying to build. So fetal tissue is the gold-standard comparison in a variety of areas that use stem cells to make cells or tissues for replacement or research.

Those are the two biggest areas. A third would be the use of so-called humanized mice, where fetal tissue is used to make mice that have completely human blood-forming and immune cell-forming tissues so that drugs can be tested against HIV, for example, or research can be done on a variety of hereditary blood diseases and immune diseases.

What makes fetal tissue unique?

Some have argued that it has better growth potential in culture. But I think the most valuable part is that fetal tissue provides very early organ tissue that can be used for research, so early kidney tissue, early brain tissue, or early immune-forming tissue.

When we use stem cells, sometimes we're not entirely sure we've made pure populations of cells or that we necessarily have made the right kind of cell, so getting at the so-called progenitors of different organs and tissues is vital.

What are some common misconceptions about fetal tissue?

There are two incorrect statements about fetal tissue research. The first is that we know enough about stem cells that appropriate alternatives to fetal tissue can be developed now. The fact is, stem cells can do a lot of things. But there's very clear evidence in the scientific literature and presented at scientific meetings that establish that stem cells are not yet at the point where they can completely replace fetal tissue. In fact, the development of all alternatives using stem cells will require fetal tissue to validate that stem cells have made the right cell types.

The second incorrect statement is that all of these vaccines could have been developed using nonhuman cells, such as monkey cells, and that's also just not true. One of the problems with the use of monkey cells, for example, that's emerged from reviews of the history is that they often carry viruses that are potentially toxic to humans, and the human cells seem to lack those viruses.

[Science magazine journalist] Meredith Wadman, MD, recently wrote a book about the history of vaccine development called The Vaccine Race: Science, Politics, and the Human Costs of Defeating Disease. It's really very clear that fetal tissue was vital to the development and the continued production of vital vaccines that have saved millions and millions of lives. So it's an incorrect statement to say, Oh, we didn't need fetal cells in the development of vaccines. That's also nonsense. The history is clear.

How has fetal tissue made your own research possible?

The best example comes not from my own lab but from work we've done in the Sanford Stem Cell Clinical Center. One of the clinical trials thats ongoing is the use of fetal spinal stem cells to treat spinal cord injury. These cells have provided striking results in rats for spinal cord injury, and they're now in phase one human clinical trials. And a few of the patients seem to be doing better.

This is remarkable because spinal cord injury is an injury for which there's almost no effective treatment, and is unfortunately common, and its victims suffer terribly during their lives. We need more clinical trial data to really ascertain what's going on. We have to continue using these fetal cells in spinal cord injury victims to see if we can truly develop a therapy. But the results are very promising in the early stages.

Which aspects of these new restrictions are going to put the greatest burden on researchers?

One of the big problems is that a very long detailed justification for fetal tissue needs to be provided as part of the research strategy part of the application and NIH limits the number of pages you can have in that part of the application. Not only do you have to provide a lengthy justification for the use of fetal tissue ... it [also] crowds out a lot of the actual scientific part of the application.

A second potential problem is, if you have an existing [NIH Research Project Grant], and you make a discovery that requires some simple experiment with fetal tissue, you can't just go ahead and do it with the NIH funds. You have to write a completely new grant application that needs to go through competitive review and then the HHS ethics review board ... before you can do what is a simple experiment. It will slow down the progress of science in areas that may unexpectedly and appropriately require the use of fetal tissue for some straightforward experiments.

The third problem is the grants will all be exposed to duplicate review in a sense. [A grant will go to] the initial review group, which will review the fetal tissue justification and the science. Then it'll go to the NIH Council. This is all standard so far. But then it goes to the ethics review board of HHS, which in its current description, reviews not only the ethics, but also reviews the scientific justification again. Its completely redundant and a waste of time and it's not going to gain any additional quality of review of the science.

What do you foresee as the impact of these restrictions on early career scientists?

There's been some discussion of whether or not trainees supported by NIH training grants can participate in fetal tissue research. I'd say that the current situation is that it's murky. Many of us think that the way NIH has described which kinds of grants can use fetal tissue precludes trainees, such as graduate students and postdocs. NIH has countered, but I don't think the situation is so clear given how it's written.

If I were an investigator with a graduate student on an NIH training grant, I sure wouldn't let them work with fetal tissue, given how unclear the rules are and concerns about being audited and told that we did something inappropriate. That's not something I would be prepared to risk. We effectively preclude trainees supported by NIH training grants or research fellowships from participating in fetal tissue research and learning how to do it appropriately from their mentors.

Why should the academic medicine community be concerned about these new restrictions?

A very important goal of biomedical research is to develop new medical therapies as rapidly as possible for patients who suffer from terrible diseases. When we place these restrictions on important areas of research, we slow down the hunt for understanding and the development of new therapies for the patients of physicians, both in academic health centers and out in the regular community.

This interview has been edited for clarity and length.

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New restrictions put fetal tissue research in the balance - AAMCNews

‘I’ve Been Duped’: Disabled Veteran Says He Spent Thousands at Health Center With No Improvement – NBC Southern California

Stephanie Burnette reached out to us after our first I-Team report about an expensive nerve treatment marketed to seniors. She says she and her husband still owe thousands of dollars for treatment they say didn't work for them.

While she and her husband both have neuropathy, Carlos Dominguez does not. This was confirmed by his neurologist in June and again in August.

But after his visit to Superior Health Centers in Aug. 2019, Dominguez says he didn't know what to think.

"They tell me they're going to put me through treatment to cure me," he said.

The disabled veteran says he was drawn to Superior Health Centers by an invitation offering a free dinner and the promise of stem cell treatments.

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"That's what I keep hearing is going to help people who have arthritis, which is what I have in my knee," Dominguez said of stem cells.

To his surprise, he says they also told him he had the debilitating nerve condition called neuropathy and Superior Health warned of dire consequences.

"He told me that later on you could basically have an amputation whether it be your toes or your feet ... so how are you feeling? Of course I'm scared," he said.

Dominguez said Superior Health bombarded him with paperwork he showed us the documents and pointed out more than a dozen places he had to initial and sign.

"They keep shoving one after another after another. They don't even give you a chance to stop and you know, get your thoughts straight."

When it was all said and done, Dominguez had signed up for 2 1/2 months treatment at a cost of $15,602.

The financing was arranged by Superior Health and none of the treatment costs were covered by insurance. Dominguez's neurologist confirmed after his visit with Superior that he does not have neuropathy.

And what about the promise of stem cells? Dominguez showed us a document which says Superior Health uses "human umbilical cord tissue."

"The tissuehas no stem cells or anything that could play any role in regenerating damaged organs or tissues or anything," Kevin McCormack, a spokesman for California Institute for Regenerative Medicine said.

Chiropractic Company Accused of Scamming Patients

CIRM is the state agency that funds stem cell research. McCormack warns many clinics are making big promises with no scientific proof.

"Long term it doesn't work, it doesn't repair the damage, it doesn't restore functions. It doesn't do anything. The only thing it improves is the bank account of these clinics," he said.

Chiropractor Philip Straw first came to the NBCLA I-Team's attention when viewers reached out to our investigative unit with complaints about the neuropathy treatment they received from Optimal Health/Straw Chiropractic. The I-Team started asking questions late last year. We were told in January that the business was closing its doors, but they appear to have reopened as Superior Health Centers where Carlos went.

For example, Straw is seen in television commercials advertising neuropathy treatment. When we've called the number displayed on the commercial, it connects to Superior Health Centers.

NBCLA has tried unsuccessfully to reach Straw and an attorney for Superior Health for comment.

More Patients Come Forward After Chiropractic Investigation

But in a previously issued statement, the attorney wrote:

"Philip Straw is neither practicing at the facility nor is he a professional tenant of Superior Health Centers ... While patients acknowledge that there is no guaranty that they will improve from the treatment, many patients report significant improvement."

When Dominguez heard patient Michele Botts in our first I-Team report, he said her words resonated with him.

"I go, oh boy. I've been duped. That's the first thing I thought ... I've been taken," he said.

Taken for thousands of dollars and left, he says, with no improvement and no hope.

Dominguez never received any stem cell treatments. Instead, he says he told Superior Health he wanted out of his contract and cleared of his financial obligation. He says Superior has not agreed to that.

Consumers can contact the California Chiropractic Examiners Board online here or call 916-263-5355 to speak with someone.

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'I've Been Duped': Disabled Veteran Says He Spent Thousands at Health Center With No Improvement - NBC Southern California

New Research Suggests a Cure for HIV Could be on the Horizon – BioSpace

Modern retroviral therapies have done a good job of turning HIV/AIDS into a treatable chronic illness, but except in a few rare experimental cases using stem cell transplants, there is no cure. Cure, in this case, meaning that the HIV virus is completely eradicated in the patient. Retroviral therapies cause the virus to become inactive, but they still remain in the body and may potentially reactivate if treatment ends.

Researchers at the University of California, San Diego (UCSD) School of Medicine have now identified a key switch that has the potential to eliminate dormant HIV reservoirs. They published their research in the journal mBio.

This is one of the key switches that the HIV field has been searching for three decades to find, said Tariq Rana, professor of pediatrics and genetics at UCSF. The most exciting part of this discovery has not been seen before. By genetically modifying a long noncoding RNA, we prevent HIV recurrence in T-cells and microglia upon cessation of antiretroviral treatment, suggesting that we have a potential therapeutic target to eradicate HIV and AIDS.

Rana and fellow researchers utilized genome-wide expression analysis of long noncoding RNA (lncRNA) in specialized immune cells called macrophages that had been infected with HIV. Macrophages promote inflammation, stimulate the immune system and remove foreign matter. Usually, lncRNAs dont behave the way other RNAs do, which is to say, RNAs deliver DNA codes for proteins. The lncRNAs are involved in controlling which genes are switched on or off in a cell.

The researchers focused on a single lncRNA called HIV-1 Enhanced LncRNA (HEAL) that is found in higher amounts in HIV patients. The researchers believe this is a recently emerged gene that regulates HIV replication in immune cells, including macrophages, microglia and T-cells.

They ran experiments that silenced HEAL or removed it using CRISPR-Cas9 gene editing, which resulted in HIV no longer recurring when antiretroviral treatment was halted. The researchers expect to continue to confirm the data in animal models.

Our results suggest that HEAL plays a critical role in HIV pathogenesis, Rana said. Further studies are needed to explain the mechanism that leads to HEAL expression after an individual is infected by HIV, but this finding could be exploited as a therapeutic target.

This appears to be a major finding, but there have been others recently as well. In August, researchers from the University of Texas Medical Branch at Galveston discovered that the protein BRD4 has a significant role in regulating the production of new copies of the HIV gene. The research group, led by Haitao Hu, assistant professor of microbiology and immunology, designed, synthesized and studied several small molecules to selectively program BRD4 to suppress HIV. They then picked a lead compound, ZL-580, which significantly delayed the reactivation of dormant HIV after antiretroviral therapy was halted.

Like the research published by the UCSD team, this appears to have the potential to be a drug therapy to eradicate the virus, or at least better deal with resistant strains of the disease.

HIV still affects about 37 million people worldwide and approximately 1 million people die annually from HIV-related causes. Treatment typically involves a cocktail of antiretroviral therapy which HIV patients take their entire lives.

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New Research Suggests a Cure for HIV Could be on the Horizon - BioSpace

iSpecimen Increases Global Access to Hematopoietic Stem and Immune Cells – Business Wire

LEXINGTON, Mass.--(BUSINESS WIRE)--Devoted to supporting life science researchers who urgently pursue breakthroughs, iSpecimen today announced it has partnered with new providers of diseased and healthy hematologic tissue to offer one of the industrys largest, most integrated networks of donors and collection sites available while addressing proliferating demand for hematopoietic stem and immune cell products.

Now, researchers can readily access cells with highly specific characteristics through the iSpecimen Marketplace, an online platform that increases access to human biospecimens from specific patients and healthy donors that can provide them.

iSpecimen continues to expand its partner network around the world, enabling researchers to efficiently procure bone marrow aspirate, peripheral blood mononuclear cells (normal and mobilized), and whole bloodall with corresponding donor profile/clinical data from healthy and diseased donors. Researchers today increasingly use these types of tissue and cell products in their work to develop stem cell therapies, immunotherapies, vaccines, diagnostics, new treatments for infectious and autoimmune diseases, and in cell-based assays to advance drug discovery and preclinical development.

Precision orders are simple, centralized and efficient

Using the iSpecimen Marketplace, researchers gain centralized, single-source access to a vast and growing population of healthy donors and patients (e.g., solid and liquid tumors, autoimmune, and numerous other diseases) with hematopoietic and immune cell phenotypes that match their particular research study criteria. Moreover, the Specimen Marketplace enables researchers to conveniently select from a comprehensive list of donor attributes, specify exclusion criteria, request a quote, and order banked or prospectively collected specimens online. By centralizing specimen procurement through the Marketplace, researchers can save precious time and human resources via a single source of procurement, order management, contracting, compliance and data access.

Unparalleled online selection, customization, compliance and order management experiences

iSpecimen also announced today it has upgraded the iSpecimen Marketplace experience for hematopoietic and immune cell customers, enabling a uniquely convenient and customizable online product selection experience. Now, researchers can easily refine their specimen selections involving numerous parameters such as HLA type (low and high resolution), blood type, body mass index, ethnicity, race, age, and gender. The iSpecimen Marketplace also offers the industrys most comprehensive donor screening capability, permitting researchers to select the required scope of infectious disease testing such as CMV, hepatitis (B&C), HIV, West Nile Virus, syphilis, Chagas, and more.

The iSpecimen Marketplace incorporates a range of unique order management features into the hematopoietic and immune cell procurement experience, allowing researchers to centrally manage multiple quotes, orders, shipments, and invoices across a large partner network. Customers and partners can expect to see ongoing enhancements to the iSpecimen Marketplace, designed to continuously increase biospecimen access and improve key aspects of the biospecimen procurement journey.

As with any human biospecimen collection, iSpecimen ensures that cells are collected in accordance with U.S. Health and Human Services regulations as well as HIPAA guidelines. Biospecimens are also collected under iSpecimens IRB protocol with informed consent or under partners IRB/IEC protocols with informed consent, both of which have been reviewed and approved by iSpecimens compliance team.

Hematopoietic stem and immune cells are used in some of the newest and most exciting medical science occurring today, said Wayne Vaz, Vice President of Growth and Corporate Development. There is a clear market trend towards increasing supply chain efficiency while maintaining a high level of regulatory compliance, data integrity, product selection, speed, and scalability. With the iSpecimen Marketplace, everything is in one place online, streamlining the procurement of specimens much like popular websites do for flights, cars and hotels.

To learn more or to search iSpecimen hematopoietic stem and immune cell products, visit iSpecimen Marketplace. Login simply requires an email.

About iSpecimenHeadquartered in Lexington, MA, iSpecimen is the marketplace for human biospecimens, providing researchers with the specimens they need from the patients they want. The privately held company has developed the iSpecimen Marketplace, an online platform connecting healthcare organizations that have access to patients and specimens with the scientists who need them. Proprietary cloud-based technology enables researchers to intuitively search for specimens and patients across a federated partner network of hospitals, labs, biobanks, blood centers, and other healthcare organizations. Researchers easily and compliantly gain access to specimens to drive scientific discovery. Partner sites gain an opportunity to contribute to biomedical discovery as well as their bottom line. Ultimately, healthcare advances for all. For more information about iSpecimen, please visit iSpecimen.com.

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iSpecimen Increases Global Access to Hematopoietic Stem and Immune Cells - Business Wire

Alternative medical treatments and compassionate use – Lexology

Patients who are beyond treatment under the standards of conventional medicine often seek help from alternative medical treatments; however, these methods pose not only medical risks for patients, but also legal risks for doctors.

Facts

A surgeon with qualifications in vascular, heart and thorax surgery treated seriously ill patients using an innovative method. The patients suffered from morbus Parkinson, multiple sclerosis, various forms of myatrophy and paralysis, traumatic spinal cord injuries, macular degenerations or psychiatric impairments such as autism. All of the patients were beyond treatment under the standards of conventional medicine. The surgeon treated them with stem cell therapy.

First-instance and appeal decisions

In April 2014 the Viennese Administrative Authority fined the surgeon under Section 49(1) of the Act on the Medical Profession for failing to observe patient welfare namely, for not evaluating the side effects and counterindications of using stem cell therapy to treat the abovementioned conditions.

In July 2015 the Viennese Administrative Tribunal(1) partly confirmed this decision. The tribunal ruled that potential health risks cannot be withheld from patients.

Supreme Administrative Court decision

On appeal, the Supreme Administrative Court(2) overruled the Viennese Administrative Tribunal's decision. The court held that the administrative tribunal had accused the surgeon of regularly using autologous stem cell therapy as a new treatment, even though clinical studies had yet to determine its benefits and risks.

According to the court, stem cells fall within the definition of medicinal products under Section 1 of the Medicinal Products Act.(3) The court could therefore revert to the doctrine and precedents on the off-label use of medicinal products. In its view, the tribunal had not shown that the treatment was clearly prohibited. Further, without a prohibition on the off-label use of medicinal products with marketing authorisation, such a prohibition cannot be based on the Medicinal Products Act. Therefore, an infringement of "compliance with existing rules according to sec 49 (1) Act on the Medical Profession" was not obvious.

The use of medicinal products or treatments that have not been clinically evaluated in terms of benefit-risk ratio for certain (new) indications is referred to as 'compassionate use'. The Declaration of Helsinki on ethical principles for medical research involving human subjects states as follows:

Unproven interventions in clinical practice

37. In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician's judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

According to legal literature, compassionate use is a deviation from medical standards in special treatment situations, either because the standard is unhelpful or no standard for the special treatment is available. Unlike clinical studies, it refers to individual cases and not to a clinical sample.

Under Section 49(1) of the Medical Profession Act physicians must observe the rules of medical science; however, these rules are only guidelines with respect to patient welfare insofar as it is possible to go beyond conventional medicine. Therefore, Section 49(1) does not prohibit compassionate use for patients who are beyond therapy under conventional medicine if they are comprehensively informed and the compassionate use makes objective sense.(4)

There is no legal definition of 'compassionate use' and no Supreme Court precedents in this regard. On 13 February 1956 the German Federal Court ruled(5) that a method of treatment is a clinical study and not a compassionate use if the method is applied not primarily in the interests of treating a patient, but in the interest of scientific research. A new method of treatment may be applied if the responsible medical evaluation and comparison of the expected benefits and risks of the new method with the standard treatment under consideration justify its application.(6)

New methods may be used only on patients who are fully informed that said methods imply unknown risks. Further, patients must be able to evaluate and consent to (or not) said risks.(7)

In the case at hand, all of the surgeon's patients were beyond treatment such that, according to the medical standard, no successful cure could be expected at the time of the treatment.

The Viennese Administrative Tribunal failed to establish that the applied treatment had posed a danger to the patients; rather, it stated only that health risks cannot be excluded without clinical studies. The tribunal reproached the applicant for integrating the method of treatment into regular clinical operations. Compassionate use that is legitimate in individual cases becomes illegitimate if it is adopted in regular clinical operations, as it becomes a regular treatment with an unverified method. This further implies that the person administering the treatment has applied it in multiple cases. It is unclear whether the application of a new therapy on a larger number of patients excludes the qualification of the treatment as compassionate use.

Insofar as the Viennese Administrative Tribunal questioned the surgeon's claim to have evaluated the risks of stem cell therapy in each case, the tribunal lacked evidence to evaluate the types of risk that would prohibit compassionate use. Further, the tribunal failed to establish the circumstances and specific patient information that would prohibit compassionate use. Therefore, the Supreme Administrative Court set aside the Viennese Administrative Tribunal's decision.

Comment

The Supreme Administrative Court's decision appears to favour a liberal approach to new therapies and compassionate use and enhances the possibilities for developing new therapies and alternative medicines in future. However, patient welfare remains paramount for qualifying a new method as compassionate use.

Endnotes

(1) VGW-001/047/26739/2014-28.

(2) 24 April 2019, RA 2015/11/0113.

(3) Kopecky, Stammzellenforschung in sterreich, 2008, 269.

(4) Resch and Wallner, Handbuch Medizinrecht (second edition), 2015, 222.

(5) III ZR 175/54.

(6) German Federal Court of Justice, 13 June 2006, VI ZR 323/04.

(7) German Federal Court of Justice, 13 June 2006, VI ZR 323/04 and Federal Court of Justice, 27 March 2007, VI ZR 55/05.

This article was first published by the International Law Office, a premium online legal update service for major companies and law firms worldwide.Register for a free subscription.

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