This study provides the first long term evidence of the safety and feasibility of utilizing a patient's own bone marrow concentrate stem cells to treat severe low back pain

Fort Collins, Colorado (PRWEB) April 03, 2017

Retired orthopedic spine surgeon, Kenneth Pettine, M.D. is excited to release the three year results of his bone marrow stem cell treatment study. Dr. Pettine has been a pioneer in the use of bone marrow concentrate stem cell injections. He was the first surgeon to inject biologics into the human spine as part of an FDA Study in the U.S. almost seven years ago. He has the only U.S. Patent on the method of treating orthopedic and spine pathology with a patient's own stem cells.

This study provides the first long term evidence of the safety and feasibility of utilizing a patient's own bone marrow concentrate stem cells to treat severe low back pain, said Dr. Pettine. Thats terrific news for patients who up until now only had the option of undergoing expensive and invasive back fusion or artificial disc surgery.

Degenerative disc disease is a common back pain diagnosis in the United States and affects millions of patients. The symptoms of the condition can become so painful that patients may be forced to miss work and are prevented from participating in regular daily activities. Treatment is often limited to palliative care such as chiropractic, physical therapy, narcotics, injections or invasive surgical procedures to try to decrease the daily chronic low back pain. Numerous studies have shown surgery improves back pain in the average patient only 40%. Stem Cell therapy improved the average patient 70% with long term follow up.

Dr. Pettines treatment uses a patient's own bone marrow concentrate stem cells to help reduce inflammation in the spine and stimulate the creation of new tissue in the spinal disc to help reverse the effects of the disease. The office procedure is performed with I.V. sedation and usually takes 45 minutes. The study noted that patients who received higher concentrations of stem cells in their injections saw a greater improvement in their back pain.. This three year follow-up research study shows utilizing a patient's own stem cells can provide long-term back pain relief and prevented the need for invasive surgery in 77% of the patients.

If you live in the Northern Colorado area and are experiencing neck or back pain due to degenerative disc disease, you can learn more about Dr. Pettines treatment and research by visiting his website at http://www.KennethPettine.com.

About Dr. Kenneth Pettine Dr. Pettine has been the principal investigator of 18 FDA studies about stem cells and their uses and is considered a pioneer in the field. He founded The Rocky Mountain Associates in Orthopedic Medicine in 1991 to offer patients a non-fusion surgical option for their neck and back pain. He co-invented the FDA-approved Prestige cervical artificial disc and the Maverick Artificial Disc. He is currently focused on the use of Mesenchymal stem cell therapy for patients desiring to avoid orthopedic or spine surgery. You can learn more about the therapy and Dr. Pettine at his website, http://www.KennethPettine.com.

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In what's reported to be a world-first, last Tuesday, a Japanese man received a pioneering retinal cell transplant grown from donor stem cells instead of his own.

Doctors took skin cells from a donor bank and reprogrammed them into induced pluripotent stem (iPS) cells, which can be coaxed to grow into most cell types in the body.

For this procedure, the physicians grew the iPS cells into atype of retinal cell, and then injected them into the retina of the patient's right eye.

The test subject was a man in his 60s who has been living with age-related macular degeneration-a currently incurable eye disease that slowly leads to loss of vision.

If this news sounds somewhat familiar, it's because the same team of Japanese doctors successfully performed a similar transplant in 2014. But in that case, the iPS cells came from the patient's own skin, not from a donor.

The 2014 treatment involved culturing a patient's cells into a thin sheet of retinal pigment epithelium cells, which they transplanted directly under her retina.

One year later, their results showed that the patient's disease had not progressedas it would have without any treatment, and she continues to do well.

But a second case study after the 2014 success never went ahead - the researchers found genetic abnormalities in the iPS cells they had derived from an additional patient's skin. To avoid complications, the doctors fromRIKENand Kobe City Medical Centre General Hospital decided to halt the trial and refine their approach.

Now they are back with a potentially safer technique that uses cells from a donor bank. The patient who received the transplant last week is the first of five approved for a study by Japan's health ministry in February this year. It's important to note that so far this is a safety study - a precursor to a clinical trial.

As team leader Masayo Takahashi from RIKEN told a press conference, we will have to wait and see for several years until we know for sure whether last week's transplant was a complete success - which is the whole point of doing a safety study like this.

"A key challenge in this case is to control rejection. We need to carefully continue treatment," she said.

The patient will be closely observed for a year, and then receive check-ups for three more years. The main things for the team to look out for are rejection of the new retinal cells, and the development of potential abnormalities.

An editorial in Nature praises the team's cautious approach, emphasising that this work with iPS cells could pave a smoother path for other trials in the emerging field of stem cell medicine.

If donor cells turn out to be a viable option in iPS cell procedures, it would be huge for creating more affordable stem cell treatments that anyone can benefit from.

Instead of having to induce stem cells out of each individual patient's samples, doctors could go down the cheaper and quicker route of simply picking a suitable match from a donor bank.

Stem cell treatments such as this new procedure are an extremely promising avenue in medicine, but scientists are right to remain cautious and proceed slowly. Just last month a devastating case report broke the news that three women lost their eyesight by participating in a dodgy stem cell trial.

On the other hand, in 2015, an experimental stem cell treatment showed promise in multiple sclerosis (MS) patients, and just last year, stem cell injections were used to help stroke patients in recovery.

With all these exciting developments, we'll definitely be keeping an eye on further reports from the Japanese team.

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BRADENTON, Fla. By now, the time line for recovery from Tommy John surgery is familiar even to the casual baseball fan. It takes at least a year, usually more. It takes tedious, monotonous work on the part of the player.

Alternatives exist, but until now their use among established major leaguers has been limited if tried at all. This season could provide a referendum on two of them. One surgical procedure could cut the recovery time in half. Another treatment could help a player avoid surgery altogether.

I think it can definitely help the game, right-hander Seth Maness, who had a modified elbow ligament surgery in August, said by phone from spring training in Arizona. But the circumstances have to be right.

Maness had a surgery on his right elbow known as a primary repair or primary brace. The procedure reattaches the elbows ulnar collateral ligament to the bone with collagen-coated Arthrex tape. Los Angeles Angels starter Garrett Richards received a stem cell injection into his right elbow to heal his damaged UCL. So far, its working.

The last thing you want to do is have surgery, and if you do what your body does naturally, thats going to be stronger than any replacement surgery, Richards said, also by phone from spring training in Arizona. I just hope that this further gives guys a little bit of knowledge that you have options.

Neither procedure will replace Tommy John. Stem cells dont work in every case, and if the UCL is torn across the middle of the ligament, it needs to be replaced. The sample size for both is also small. But both provide options involving less recovery time for pitchers whose injuries fit a certain profile.

Maness, 28, spent four seasons pitching out of the St. Louis Cardinals bullpen and signed a minor league contract with the Kansas City Royals in February. Maness ligament had pulled away from the bone rather than tearing across the middle. Instead of needing a full Tommy John surgery, which requires grafting a tendon from the wrist or hamstring into the elbow to replace the UCL and at least a year of recovery, Maness was a candidate for a primary repair.

Really this primary brace technology had been used more widely in Europe, particularly for ligament injuries of the knee and the ankle, said Dr. George Paletta, St. Louis Cardinals head orthopedic surgeon who performed Maness surgery. So the concept or the idea was, OK, its working well there, is there a way to adapt it to the elbow?

Paletta had done roughly 60 primary repairs on amateur pitchers prior to operating on Maness and saw an average recovery time of 6 months. That background helped him establish three criteria he needed a young pitcher, an otherwise healthy ligament and, most importantly,the ligament needed to pull off the bone on one end rather than tear in the middle.

Weve had a lot of experience with ligaments healing directly to bone and we have a good understanding of that timetable, so we knew that by about 12 weeks after surgery, this repair should be pretty well healed and pretty solid at that point, Paletta said.

Cardinals reliever Mitch Harris also had the primary repair, as did a third pitcher with major league experience, according to the St. Louis Post-Dispatch, with whom Maness first discussed the procedure in January. Cardinals non-roster outfielder/pitcher Jordan Schafer had the procedure this month.

The UCL in Richards right elbow had a tear running along the ligament, not across it. He sought second opinions from noted orthopedic surgeons Dr. James Andrews and Dr. Neal ElAttrache.

Dr. Andrews pretty much told me, Hey Garrett, if you were my son, I would try the stem cell first, Richards said.

Doctors removed stem cells from his pelvis and injected them into his elbow, in hopes the cells would heal the UCL. Stem cells, extracted from bone marrow, are able to develop into multiple different tissues and can promote healing.

It just feels tight. Youre putting fluid into a place that pretty much doesnt have any room for any more fluid, Richards said of the injection. If you can imagine youre just overfilling a certain area with this nice special sauce.

Teams sometimes use platelet-rich plasma injections, where blood is spun in a centrifuge to isolate growth factors Takashi Saitos PRP injection in 2008 was believed to be the first for a major league pitcher, and Masahiro Tanaka also has pitched successfully with a partially torn UCL after PRP treatment but stem cells are less common. Bartolo Colon, soldiering into his 20th major league season at 43 years old, had a stem cell treatment in 2010. Boston Red Sox left-hander Drew Pomeranz had a stem cell injection in his elbow this winter to address lingering soreness.But Pomeranz went on the disabled list Thursday with left forearm flexor strain.

It doesnt always work. Richards teammate, lefty Andrew Heaney, needed Tommy John last summer after stem cells didnt do the trick.

Richards six-week exam showed significant growth. His three-month check showed even more. He reported no issues this spring, his high-90s mph fastball is back and he is on track to open the season in the rotation.

Everything feels great, Richards said. Basically I took the year off, let my arm heal and now Im back doing what I always do. I just feel refreshed.

Bill Brink: bbrink@post-gazette.com and Twitter @BrinkPG.

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Friday, March 31, 2017

By Nicholas Snow

The Rose Mercadante Chemistry Seminar Series is pleased to present a seminar entitled "Improving Blood and Marrow Transplantation" by Dr. Robert Korngold of the John Theurer Cancer Center, Hackensack University Medical Center.

The seminar will be held on Tuesday April 4, 2017 at 5:45 p.m. in the Helen Lerner Amphitheater, McNulty Hall, Science and Technology Center, Seton Hall University.

Dr. Korngold specializes in basic science and translational research in the field of blood and marrow stem cell transplantation. In 1978, he demonstrated in mouse models that mature T cells in donor bone marrow were responsible for causing graft-versus-host disease (GVHD) directed to minor histocompatibility antigens in transplanted recipients. This landmark study had significant impact on the future course of clinical treatment for patients undergoing transplantation from matched sibling or unrelated matched donors. Since then he has devoted his career to studying the immunological mechanisms of GVHD and refining the hematopoietic stem cell transplantation process to avoid disease and allow for enhanced anti-leukemia immune reactivity. He is widely recognized as a leading researcher in his field and as such he has served since 2001 as Editor-in-Chief of the journal Biology of Blood and Marrow Transplantation. Dr. Korngold is an author of 140 research articles, reviews and book chapters.

The Department of Chemistry and Biochemistry offers BS, MS and PhD degrees with specializations in all areas of chemistry. Our unique research environment, including traditional full-time students and part-time students is designed to foster collaborations with industry and colleagues in other disciplines. The Rose Mercadante Seminar Series is named for Rose, our departmental secretary for over 40 years, in honor of our alumni, her "boys and girls".

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March 28, 2017 by Layne Cameron Kristin Parent mapped the structure of the giant Samba virus with MSUs cryo-EM microscope, which is featured on the cover of the journal Viruses. Credit: Michigan State University

In a laboratory at Michigan State University, scientists took a DIY approach to build a retrofitted cryo-electron microscope that allowed them to map a giant Samba virus one of the worlds largest viruses.

If the common cold virus is scaled to the size of a ladder, then the giant Samba virus is bigger than the Washington Monument, said Kristin Parent, assistant professor of biochemistry and molecular biology and co-author of the paper featured on the cover of the journal Viruses. Cryo-EM allowed us to map this virus structure and observe the proteins it uses to enter, or attack, cells.

It seems counterintuitive that bigger organisms are harder to see, but they are when using cryo-electron microscopy. Thats because these microscopes usually are used to look at thin specimens and cant decipher larger organisms to reveal their biological mechanisms. For thick samples, scientists see only dark gray or black blobs instead of seeing the molecular framework.

Cryo-EM allowed Parents team to image the giant Samba virus and understand the structures that allow it to enter an amoeba. Once inside, Samba opens one of its capsid layers and releases its nucleocapsid which carries the genetic cargo that sparks an infection. While Samba isnt known to cause any diseases in humans, its cousin, the mimivirus, may be a culprit for causing some respiratory ailments in humans.

If you scoop up a handful of water from Lake Michigan, you are literally holding more viruses than there are people on the planet, said Parent, who published the paper with Jason Schrad and Eric Young, MSU biochemistry and molecular biology graduate students. While scientists cant study every virus on Earth, the insights we glean from viruses like the giant Samba can help us understand the mechanisms of other viruses in its family, how they thrive and how we can attack them.

As bacteria become more resistant to antibiotics, looking for new ways to fight diseases will continue to grow in importance. Parents lab also studies how bacteria-infecting viruses enter cells using this method, which could potentially lead to new antibacterial treatments. Yet the worlds best cryo-EM microscope costs more than $5 million. Limited by funds but not drive, Parent was able to upgrade an existing microscope at MSU to do cryo-EM one that is a tinkerers dream.

This traditional transmission electron microscope was retrofitted with a cryostage, which keeps viruses frozen in liquid nitrogen while theyre being studied. Parent and her team then added a Direct Electron DE-20 detector, a powerful camera the mighty microscopes piece de resistance.

Parent didnt invent cryo-EM, but establishing it on campus serves as a viable proof-of-concept for MSU, opening the door for many interdisciplinary partnerships. This cutting-edge microscopy has applications across many fields, from those addressing a single protein to others studying entire cells. Virtually anyone studying complex molecular machines can advance their work with this tool, Parent added.

Parent has earned an AAAS Marion Milligan Mason Award for Women in the Chemical Sciences. This award, her paper in Viruses and being the co-author who performed cryo-EM work in a recent Nature Communications paper, lays the groundwork to some day have a more advanced cryo-EM microscope housed at MSU to be able to perform high-resolution structural studies.

Weve done quite a bit with our limited resources, but were primed to do more, Parent said. I think MSU could serve as a cryo-EM center and to increase the prevalence of this technology in the Midwest and beyond.

As one example, scientists from Universidade Federal de Minas Gerais (Brazil) and Universidade Federal do Rio de Janeiro (Brazil) also contributed to this study and benefitted from the technology MSU has to offer.

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Skin stem cells gain traction for skin repair and regeneration ... FinancialsTrend Although a tremendous progress has been made, large full-thickness skin defects are still associated with mortality due to a low availability of donor skin areas. and more »

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Using video microscopy in a living mouse lung, a team of researchers at the Universities of California, San Francisco (UCSF) & Los Angeles (UCLA), has revealed that the lungs play a previously unrecognized role in blood production.

Visualization of resident megakaryocytes in the lungs. Image credit: Emma Lefranais et al, doi: 10.1038/nature21706.

The team, headed by UCSF Professor Mark R. Looney, found that the lungs produced more than half of the platelets blood components required for the clotting that stanches bleeding in the mouse circulation.

In another finding, the team also identified a previously unknown pool of blood stem cells capable of restoring blood production when the stem cells of the bone marrow, previously thought to be the principal site of blood production, are depleted.

This finding definitely suggests a more sophisticated view of the lungs that theyre not just for respiration but also a key partner in formation of crucial aspects of the blood, Prof. Looney said.

What weve observed here in mice strongly suggests the lung may play a key role in blood formation in humans as well.

The study was made possible by a refinement of a technique known as two-photon intravital imaging.

The authors were using this technique to examine interactions between the immune system and circulating platelets in the lungs, using a mouse strain engineered so that platelets emit bright green fluorescence, when they noticed a surprisingly large population of platelet-producing cells called megakaryocytes in the lung vasculature.

When we discovered this massive population of megakaryocytes that appeared to be living in the lung, we realized we had to follow this up, said team member Dr. Emma Lefranais, from the UCSF Department of Medicine.

More detailed imaging sessions soon revealed megakaryocytes in the act of producing more than 10 million platelets per hour within the lung vasculature, suggesting that more than half of a mouses total platelet production occurs in the lung, not the bone marrow, as researchers had long presumed.

Video microscopy experiments also revealed a wide variety of previously overlooked megakaryocyte progenitor cells and blood stem cells sitting quietly outside the lung vasculature estimated at 1 million per mouse lung.

Proposed schema of lung involvement in platelet biogenesis. The role of the lungs in platelet biogenesis is twofold and occurs in two different compartments: (a) platelet production in the lung vasculature; after being released from the bone marrow or the spleen, proplatelets (a1) and megakaryocytes (a2) are retained in the lung vasculature, the first capillary bed encountered by any cell leaving the bone marrow, where proplatelet formation and extension and final platelet release are observed; (b) mature and immature megakaryocytes along with hematopoietic progenitors are found in the lung interstitium; in thrombocytopenic environments, hematopoietic progenitors from the lung migrate and restore bone marrow hematopoietic deficiencies. Image credit: Emma Lefranais et al, doi: 10.1038/nature21706.

The discovery of megakaryocytes and blood stem cells in the lung raised questions about how these cells move back and forth between the lung and bone marrow.

To address these questions, Prof. Looney, Dr. Lefranais and their colleagues conducted a clever set of lung transplant studies.

First, they transplanted lungs from normal donor mice into recipient mice with fluorescent megakaryocytes, and found that fluorescent megakaryocytes from the recipient mice soon began turning up in the lung vasculature.

This suggested that the platelet-producing megakaryocytes in the lung originate in the bone marrow.

In another experiment, the team transplanted lungs with fluorescent megakaryocyte progenitor cells into mutant mice with low platelet counts.

The transplants produced a large burst of fluorescent platelets that quickly restored normal levels, an effect that persisted over several months of observation much longer than the lifespan of individual megakaryocytes or platelets.

This indicated that resident megakaryocyte progenitor cells in the transplanted lungs had become activated by the recipient mouses low platelet counts and had produced healthy new megakaryocyte cells to restore proper platelet production.

Finally, the researchers transplanted healthy lungs in which all cells were fluorescently tagged into mutant mice whose bone marrow lacked normal blood stem cells.

Analysis of the bone marrow of recipient mice showed that fluorescent cells originating from the transplanted lungs soon traveled to the damaged bone marrow and contributed to the production not just of platelets, but of a wide variety of blood cells, including immune cells such as neutrophils, B cells and T cells.

These experiments suggest that the lungs play host to a wide variety of blood progenitor cells and stem cells capable of restocking damaged bone marrow and restoring production of many components of the blood.

To our knowledge this is the first description of blood progenitors resident in the lung, and it raises a lot of questions with clinical relevance for the millions of people who suffer from thrombocytopenia, Prof. Looney said.

The findings were published online March 22, 2017 in the journal Nature.

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Emma Lefranais et al. The lung is a site of platelet biogenesis and a reservoir for haematopoietic progenitors. Nature, published online March 22, 2017; doi: 10.1038/nature21706

This article is based on text provided by the University of California, San Francisco.

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Scientists used stem cells to grow human heart tissue that contracted spontaneously in a petri dish marking progress in the quest to manufacture transplant organs.

A team from the University of Pittsburgh, Pennsylvania, used induced pluripotent stem (iPS) cells generated from human skin cells to create precursor heart cells called MCPs. iPS cells are mature human cells reprogrammed into a versatile, primitive state from which they can be prompted to develop into any kind of cell of the body. The primitive heart cells created in this way were attached to a mouse heart scaffold from which the researchers had removed all mouse heart cells, they wrote in the journal Nature Communications.

The scaffold is a network of non-living tissue composed of proteins and carbohydrates to which cells adhere and grow on. Placed on the 3D scaffold, the precursor cells grew and developed into heart muscle, and after 20 days of blood supply the reconstructed mouse organ began contracting again at the rate of 40 to 50 beats per minute, said a University of Pittsburgh statement.

It is still far from making a whole human heart, added senior researcher Lei Yang. Ways have to be found to make the heart contract strongly enough to pump blood effectively and to rebuild the hearts electrical conduction system. However, we provide a novel resource of cells iPS cell-derived MCPs for future heart tissue engineering, Yang told AFP by email. We hope our study would be used in the future to replace a piece of tissue damaged by a heart attack, or perhaps an entire organ, in patients with heart disease.

According to the World Health Organisation, an estimated 17 million people die of cardiovascular ailments every year, most of them from heart disease. Due to a shortage of donor organs, end-stage heart failure is irreversible, said the study. More than half of patients with heart disease do not benefit from drugs. Heart tissue engineering holds a great promise based on the reconstruction of patient-specific cardiac muscle, the researchers wrote.

Last month, scientists in Japan said they had grown functional human liver tissue from stem cells in a similar process. Creating lab-grown tissue to replenish organs damaged by accident or disease is a Holy Grail for the pioneering field of stem cell research. Until a few years ago, when iPS cells were created, the only way to obtain stem cells was to harvest them from human embryos. This was controversial because it required the destruction of the embryo, a process to which religious conservatives and others object.

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As the Chief Doctor of the Institute of Cell Therapy, Y.V.Gladkikh, MD, PhD, Dr. med. sc. commented: In addition to laboratory success in obtaining the functional cardiac tissue, currently there is evidence of successful implantations of heart valves and blood vessels fragments, grown from stem cells, to patients. And in 2012, the Ministry of Health of Ukraine officially approved method of treatment of critical limbs ischemia with the use of cell preparation Angiostem, developed by the biotechnological laboratory of the Institute of Cell Therapy.

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A stem cell-derived heart muscle cell. Proteins that are important for muscle cell contraction are highlighted in red and green, and cell nuclei are blue. Credit: Joseph C. Wu, M.D., Ph.D., Stanford Cardiovascular Institute

Using human heart cells generated from adult stem cells, researchers have developed an index that may be used to determine how toxic a group of cancer drugs, called tyrosine kinase inhibitors (TKIs), are to human cells. While 26 TKIs are currently used to treat a variety of cancers, some can severely damage patients hearts, causing problems such as an irregular heartbeat or heart failure.

For the study, reported February 15 in Science Translational Medicine, the researchers used stem cell-derived heart cells from 13 volunteers to develop a cardiac safety index that measures the extent to which TKIs kill or alter the function of heart cells. They found that the TKIs' toxicity score on the index was generally consistent with what is known about each drug's heart-related side effects.

This work follows on the heels of an earlier study from the same research team, published in Nature Medicine, in which they assessed the heart cell toxicity of doxorubicin, a chemotherapy drug that also causes heart-related side effects, including heart failure. In that study, the researchers used stem cell-derived heart cells from women with breast cancer to correctly predict how sensitive each womans heart cells were to doxorubicin.

Such tests could ultimately help the pharmaceutical industry identify drugs that cause heart-related side effects earlier in the drug development process and help the Food and Drug Administration (FDA) during the drug review and approval process, said the study's senior author Joseph C. Wu, M.D., Ph.D., director of the Stanford Cardiovascular Institute.

I hope this research will be helpful for individual patients, once we further implement precision medicine approaches, he added.

Ranking Heart Toxicity

To assess the potential risk of heart toxicity for drugs in development, pharmaceutical companies use laboratory tests involving animals (usually rats or mice) or cells from animals or humans that are engineered to artificially express heart-related genes. Drug candidates that appear to have an acceptable balance of benefits and risks typically proceed to testing in human clinical trials.

But there can be biological differences between these existing models and humans, so non-clinical lab tests can have significant limitations, explained Dr. Wu.

Currently, the first time humans are exposed to a new drug is during clinical trials, he said. We think it would be great if you could actually expose patients heart, brain, liver, or kidney cells to a drug in the lab, prior to clinical treatment, allowing researchers to determine whether the drug has any toxic effects.

Dr. Wu, a cardiologist by training, studies toxicities cancer drugs cause in heart cells. Human heart muscle cells (called cardiomyocytes), however, are hard to obtainrequiring risky heart surgery that may be of no direct benefit to the patientand are notoriously difficult to grow in the lab.

As an alternative, researchers have developed a method to produce heart cells from human induced pluripotent stem cells (hiPSCs). hiPSCs are created by genetically engineering normal human skin or blood cells to express four specific genes that induce them to act like stem cells. Chemical treatments can prompt hiPSCs to develop into mature cell types, such as heart muscle cells.

A large body of research has established that human adult stem cell-derived heart cells, which function and grow in cell culture, can be used as an initial model to screen drug compounds for toxic effects on the heart, said Myrtle Davis, Ph.D., chief of the Toxicology and Pharmacology Branch of NCIs Division of Cancer Treatment and Diagnosis, who was not involved in the studies.

For the Science Translational Medicine study, Dr. Wu and his colleagues set out to determine if a panel of human stem cell-derived heart cells could be used to evaluate the heart toxicity of 21 different FDA-approved TKIs.

They generated hiPSC-derived heart endothelial, fibroblast, and muscle cells from 13 volunteers: 11 healthy individuals and 2 people with kidney cancer who were being treated with a TKI. Using drug concentrations equivalent to what patients receive, the investigators next determined how lethal each TKI was to the heart cells.

They found that several TKIs were very lethal to endothelial, fibroblast, and heart muscle cells from all 13 individuals, while others were more benign.

Stem cell-derived heart muscle cells grown in a dish spontaneously contract as a beating heart does, so the researchers also analyzed the effects of TKIs on the cells beat rate, or contractility. They found that several TKIs altered the cells beat rate before they were killed by the drug treatment. If severe enough, an irregular heartbeat (called an arrhythmia), can disrupt normal heart function.

From these lethality and contractility experiments, the team developed a cardiac safety index, a 0-to-1 scale that identifies how toxic a TKI is to heart cells (with 0 being the most toxic). They then used the index to rank the 21 TKIs. The control treatment scored a 1, while a few TKIs that are labeled by the FDA with boxed warnings for severe heart toxicity scored close to 0.

Safety indices like this one can be very useful during drug discovery, said Dr. Davis, and the applicability of the index developed by Dr. Wu and his colleagues will become clear when they evaluate its performance with more compounds.

And for the safety index to be applicable to more patients, the panel of cells used to develop it would need to be gathered from a sufficiently representative population of people reflecting different ages, races/ethnicities, health statuses, and other characteristics, said Lori Minasian, M.D., deputy director of NCIs Division of Cancer Prevention, who was not involved in either study.

For example, the study did not include cells derived from patients with [pre-existing] cardiac disease, said Dr. Davis.

A Personalized Approach

In addition to their potential application during drug development, Dr. Wu believes that stem cell-derived heart cells could potentially be used to predict toxicity risk for individual patients. He and his colleagues explored this possibility in their Nature Medicine study.

Doxorubicin, used on its own or in combination with other drugs, is an effective treatment for breast cancer and several other types of cancer. Like TKIs, however, it is known to cause heart toxicities, such as arrhythmias and heart failure, in a small proportion of patients. But there has been no way to predict which patients will experience these side effects.

The researchers developed stem cell-derived heart cells from eight women with breast cancer who had been treated with doxorubicinhalf of whom experienced cardiotoxicity from the treatment and half who did not.

In several different lab tests, the heart cells from women who had experienced cardiotoxicity were more sensitive to doxorubicin than those from women who had not. More specifically, in heart cells from women who had experienced cardiotoxicity, doxorubicin treatment caused more severe irregularities in cell contractility, and even low concentrations of the drug killed the cells.

An Improved Model

While the stem cell-derived heart cell model may be an improvement over the current [drug testing] system, its not perfect, said Dr. Minasian. For example, the model does not capture contributions of other organs and cells to the toxic effects of a drug, she explained. The drug may be broken down in the liver, for instance, and side products (called metabolites) may also cause toxic effects.

In addition, the lab-grown stem cell-derived version of someones heart cells are not going to be exactly the same as the cells found in that persons heart, Dr. Wu noted. Nevertheless, they reflect the same genetics and they are pretty good at predicting drug response, he said.

Looking forward, Dr. Minasian said, figuring out how to best use this approach is going to take more work, but being able to better predict human response [to cancer drugs] is important.

The research teams next steps include conducting prospective studies to determine whether they can use a patients stem cell-derived heart cells to potentially predict if that person will develop heart toxicity before they actually receive cancer treatment.

This article has been republished frommaterialsprovided byNCI. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference

Sharma, A., Burridge, P. W., McKeithan, W. L., Serrano, R., Shukla, P., Sayed, N., ... & Matsa, E. (2017). High-throughput screening of tyrosine kinase inhibitor cardiotoxicity with human induced pluripotent stem cells. Science translational medicine, 9(377), eaaf2584.

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Measuring Heart Toxicity of Cancer Drugs - Technology Networks

Cardiac Stem Cells Comments Off on Measuring Heart Toxicity of Cancer Drugs – Technology Networks | March 24th, 2017

A non-surgical treatment that uses a patients own bone marrow stem cells to treat chest pain or angina improved both symptoms and the length of time treated patients could be physically active, according to recent research.

We injected a catalyst molecule that caused bone marrow stem cells to enter the patients blood, then harvested them to re-inject into the patient,said Hadyanto Lim, Ph.D., study senior author.

Thirty minutes after the cell separation procedure finished, the collected stem cells were injected back into the patient through an IV.

Four weeks after receiving the treatment, patients experienced significantly fewer angina-related symptoms, and they were able to exercise at a higher intensity and for a longer period of time.

The studys limitations are the small number of patients and absence of a control group. Because no control group was used, the placebo effect cannot be ruled out, Lim noted.

Although this treatment is currently used to treat some cancers multiple myeloma and lymphoma it will need more investigation before it can be made available to the general public to treat angina, according to Lim.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Hard to treat chest pain may be improved with a patients own stem cells

For more background on the Genetic Literacy Project, read GLP on Wikipedia.

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Injection with own stem cells alleviates chest pains, angina, study finds - Genetic Literacy Project

Bone Marrow Stem Cells Comments Off on Injection with own stem cells alleviates chest pains, angina, study finds – Genetic Literacy Project | March 24th, 2017

Before we get to the therapeutic stuff, here is a reminder of the main problem people with Parkinsons disease face.

Researchers are reasonably sure that the accumulation of a protein called alpha-synuclein is responsible for neurons dying in people with PD. However, there are two competing theories as to how it builds up andspreads,the threshold theoryandthe ascending theory(also called the prion hypothesis). The ascending theory states that alpha-synuclein spreads from cell to cell, infecting cells as the protein moves up through the brain.The threshold theory recently put forward by Dr. Ole Isacson and Dr. Simone Engelender, proposes that alpha-synuclein builds up independently in each affected cell.

Regardless, an improved understanding of exactly how such proteins misfold and clump together is at the heart of the riddle that is Parkinsons as well asa long list of other diseases. Thankfully a number of labs around the world have been working on this sticky problem. Additionally, if anyone wants to help you can do so very easily from any computer, watch this video to learn how.

The ongoing revolution in genetics is playing an increasingly important role in our understanding of the disease while also revealing whyit varies so much from patient to patient. There havebeen dozens of mutations and variants associated so far with the disease. We are just beginning to understand the role our genes play in the development of neurological diseases but an immense amount of progress has been made in the last 15 years since the human genome was sequenced. Now that sequencing costs have plummeted to around a thousand dollars we are on the verge of a new era in medicine that promises to give patients treatments tailored to their specific condition.

Personalized medicine is healthcare based on your unique genetic and molecular blueprint. Each individual has distinct genetic makeup, biomolecule and metabolic profiles, set of gut microbes, and so on. Similarly, there is no one-size-fit-all in healthcare. How you stay healthy or how you are treated for disease should be catered to match your unique profile. Knowledge of your genomics, proteomics, metabolomics, microbiotics, and other bioinformatics allow for the improvement in the quality of life, from disease prevention to therapy best suited to you. (from the Personalized Medicine Initiative in British Columbia.)

A better understanding ofgeneticswill help unlock a cascade of other problems that surround this disease includingmitochondrial dysfunction, lysosomal degradation, neuroinflammation,gut bacteria, andepigenetics, among others. And thankfully there is now a large interconnected global community of researchers working to solve these problems with more resources and better tools than in all of human history combined. This growth in a variety of public and private sector health initiatives across disciplines has lead a growing number of experts to believe that we will make more progress in the next decade than we did in the past century, which is good reason to be hopeful consideringwhat medicine was like a hundred years ago.

This medical revolution will be further bolstered by new and improved imaging techniques.A big part of the problem we still have with this disease is that we cant actually see what is wrong. Every person who has PDhas slightly different symptoms but we dont really know why primarily because we cant accurately see inside patients heads. Soon a new line of imaging techniques will be available that will give surgeons and researchers a much better understanding of what is going on inside the heads of each patient.

In addition, there are some immense ongoing collaborations such as theEuropean human brain projectand theU.S. brain initiativethat are trying to do for the brain what the human genome project did for our understanding of the genome. If successful it will give researchers unprecedented insight into how our minds are pieced together.

Then there are the new therapies themselves.

Levadopa For 50 years now this wonder drug has brought relief to millions. Of course, problems still persist, namely in getting it past that stubborn blood brain barrier and making sure a more steady supply is delivered to reduce on/off fluctuations. To get around some of those problems we now havepatches, slow release and extended release capsules, as well asintestinal pumps that deliver a steady flow of the drug directly into the intestines. Of course this drug is not an ideal solution as there are nasty side effects that come from long term use, predominantly dyskenisia which gives people the motor control of a blob of jelly, but for now, it is still the best stop-gap solution we have.

Deep Brain Stimulation This science-fiction wonder has become the undisputed Queen of modern treatments. It has already proven itself to be a miracle worker, re-animating hundreds of thousands with its electric wizardry. It too is steadily improving, from John Palfermans book,Brain Storms,Instead of implanting devices that simply deliver a continuous electrical stimulation, they are developing technologies that deliver stimulating jolts only when required. ..The idea is to design DBS so that the system can monitor the electrical activity in the basal ganglia, and when it detects an abnormal signal, it can respond automatically with an appropriate stimulation. A smart device

New Drugs There is along list of promising drugs that are already in clinical trial.Some of these drugs have the potential to not only offer symptomatic relief but hit the holy grail that is actual disease modifying therapies.

Neuromodulation techniques A number of novelneuromodulation techniques are being tested for clinical use. The most prevalent is called transcranialmagnetic stimulation in which magnets are attached to the outside of patients headsthat send a focused electric current deep into the target areas of the brain. Already an approved therapy for depression, TMS is now being tried in PD.

Immunotherapies The relatively recent identification of alpha-synuclein as playing a key role in disease formation has lead researchers to believe that we may be able to harness the bodies immune system to stop the protein from clumping while also mitigating the bodies natural inflammatory responses that damages neurons.

Pharmacogenetics The genetic revolutionhas spurred the development of a relatively new field of pharmacology called pharmacogenetics. Eventually, instead of making one drug for everybody, we will be able to tailor drugs to better fit each persons unique condition.

Stem Cell Therapies Though there were a series of trials in the 90s that had mixed results, recently a number of labs around the world have begun reexamining the therapeutic potential of stem cells. This is thanks in part to the 2007 discovery of anew type of stem cell called IPS cells which allow researchers to grow fully functioning stem cells from patients own skin cells. This has opened the door to a new set of therapies while also giving us better disease models. Since those first trials we have also made a series of other advances in our understanding of how to use stem cells which has lead to somestunning results in trials on other apes. Some labsare hoping to push forward with human trials starting at the end of this year.

Gene Modification Therapies As discussed earlier, the field of genetics is blowing up and one of the biggest benefits to society that will come from it is a new set of therapies called gene modification therapies.The most popular one today is called CRISPR, a technique that already allows researchers to cut and paste genetic code, changing the genome of living organisms. A number of articles have come out touting these kind of gene-editing techniques as the future of medicine. This first use ofCRISPRwas in a lung cancer patient in Chinalast fall, but it is also being used to help us understand neurodegenerative disordersincludingParkinsons disease.

Direct Programming In conjunction with gene therapy, direct programming is believed to bethe final solution to the problem of neurodegeneration. It is a subset of the new field of synthetic biologythatwill eventually allow us to change cell types in living organisms. For example, inpeople with Parkinsons disease we will be able toreprogram other healthy cells in the affected area, such as glial cells or astrocytes, and directly turn them into dopamine-producing cells.

When it comes right down to it, the reason why we have not been able to cure a lot of the diseases that are still with us today, such as neurodegeneration or cancer, is that there are an incredible number of factors to consider when trying to treat them, possibly too many for any human, or even any group of humans, to make sense of. But there might be a solution to this problem as we are now figuring out ways to export more and more of our intellectual abilities into computers. Already computers have become as good ashumans at diagnosing certain conditions, and astaggering number of healthcare companieshave now invested heavily in applyingartificial intelligence to the medical industry.This, along with further advances in nanotechnology,has a lot of potentialin helping us understand diseases such as Parkinsons and may reveal novel insights into how to treat them.

As you can see, there is plenty in the pipeline. While there may not be any magic bullet, there is no doubt that we will continue to see improvements in the treatment of Parkinsons disease that will benefit millions. While it is important to remain skeptical of all the promises being made, there is very good reason to believe that afflictions such as Parkinsons disease may one day be a thing of the past.

More here:
We're About to Enter a New Era in Parkinson's Disease Treatments - Futurism

IPS Cell Therapy Comments Off on We’re About to Enter a New Era in Parkinson’s Disease Treatments – Futurism | March 24th, 2017

Published: March 22 2017

Stanford University School of Medicine researchers grew heart muscle cells and used them, along with CRISPR, to predict whether a patient would benefit or experience bad side effects to specific therapeutic drugs

What would it mean to pathology groups if they could grow heart cells that mimicked a cardiac patients own cells? What if clinical laboratories could determine in vitro, using grown cells, if specific patients would have positive or negative reactions to specific heart drugs before they were prescribed the drug? How would that impact the pathology and medical laboratory industries?

We may soon know. Researchers at Stanford University School of Medicine (Stanford) have begun to answer these questions.

May Be Feasible for Clinical Laboratories to Use Pluripotent Stem Cells for Assays

In a Stanford press release, researchers stated that induced pluripotent stem cells (iPS cells), coupled with CRISPRtechnology, could be used to determine:

1) Whether a patient would benefit from a specific therapeutic drug; and

2) The likelihood that the patient might have a negative reaction or bad side effect from that drug.

Thirty percent of drugs in clinical trials are eventually withdrawn due to safety concerns, which often involve adverse cardiac effects. This study shows that these cells serve as a functional readout to predict how a patients heart might respond to particular drug treatments and identify those who should avoid certain treatments, said Joseph Wu, MD, PhD, in the Stanford press release. Wu is Director of Stanfords Cardiovascular Institute and a Professor of Cardiovascular Medicine and Radiology.

The researchers believe their discovery could become a form of diagnostic and prognostic testing performed by pathologists and clinical laboratories if it passes further clinical trials.

Heart Muscle Made from Stem Cells, Study Advances Precision Medicine

The iPS cells are stem cells created in a lab, usually from a persons skin sample, and then induced into becoming cells from other parts of the body. Heart muscle cells made from iPS cells mirror the expression patterns of key genes in the donors native heart tissue. This means the cells can be leveraged to predict a patients likelihood of experiencing drug-related heart damage, according to the Stanford release.

The Stanford study also advanced precision medicine. It combined genetics, large-scale data research, and individualized testing to determine the best treatments for patients, noted an article in United Press International (UPI).

Researchers were motivated by a need to understand individual susceptibility to drug-induced cardiotoxicity, to improve patient safety, and to prevent drug attrition, according to the Stanford study, which was published in the research journal Cell Stem Cell.

Human iPS cells enable the study of pharmacological and toxicological responses in patient-specific cardiomyocytes and may serve as preclinical platforms for precision medicine, the authors noted in the study summary.

Furthermore, the researchers idea could have implications for medical conditions beyond cardiomyopathy, noted an article in LabRoots.

Cardiomyopathy is a disease of the heart muscle that affects millions of people worldwide each year.

Joseph Wu, MD, PhD (above left), and Elena Matsa, PhD (above right), both with Stanford University School of Medicine, led a team of researchers who published a study involving CRISPR that suggests heart muscle cells made from induced pluripotent stem cells (iPS cells) could be used to identify cardiac patients who could benefit from or who could be damaged by certain cardiac medications. (Photo credits: Stanford University.)

Testing Tissues in the Stanford University Research Lab

Heres how the research progressed, according to the Stanford press release:

Matsa, Wu, and their colleagues created heart muscle cells, or cardiomyocytes, from iPS cells taken from seven people not known to be genetically predisposed to cardiac problems;

They sequenced the RNA molecules made by the heart muscle cells to learn which proteins the cells were making, and by how much;

They then compared the results within individualslooking at the gene expression patterns of cardiomyocytes derived from several batches of iPS cells from each personas well as among all seven study subjects.

They also investigated how the cardiomyocytes from each person responded to increasing amounts of two drugs: Rosiglitazone (marketed as Avandia by GlaxoSmithKline), which is sometimes used to treat Type 2 diabetes; and Tacrolimus (marketed as Prograf by Astellas Pharma), which serves as an immunosuppressant to inhibit the rejection of transplanted organs. Each of the two drugs has been associated with adverse cardiac effects in some people, but it has not been possible to predict which patients will experience heart damage.

Gene expression patterns of the iPS cell-derived cardiomyocytes from each individual patient correlated very well, said Elena Matsa, PhD, Stanford Instructor, Cardiovascular Institute, and the studys lead author. But there was marked variability among the seven people, particularly in genes involved in metabolism and stress responses. In fact, one of our subjects exhibited a very abnormal expression of genes in a key metabolic pathway.

Gene Editing Reveals Drug Response Information

Enter the Clustered Regularly Interspaced Short Palindromic Repeats, or CRISPR (pronounced crisper), gene editing technology. CRISPR technology has advanced the study and practice of genetic medicine.

Researchers could not pinpoint a specific gene mutation responsible for abnormal cardiomyocyte response. But they did identify a metabolic pathway that influenced Rosiglitazones response.

They corrected the abnormality using CRISPR-Cas9 (a simplified version of the CRISPR/Cas system). This genome editing technique enables researchers to edit parts of the genome by removing or changing in some manner the DNAsequence, according to yourgenome, an information website dedicated solely to DNA, genes, and genomes.

The results? The Stanford researchers reported boosting a gene expression in the pathway, restoring normal function, and prompting a response to Rosiglitazone that was consistent to that of the other subjects cardiomyocytes.

Clinical Laboratories Become Even More Integral to Cardiac Diagnosis and Treatment

Can iPS-derived cardiomyocytes reliably replicate human heart tissue? Researchers were not sure. So, they created iPS cells from another three people who had heart biopsies or transplants. They then compared the cells made in the clinical laboratory with the gene native cells and found that they were similar in many significant ways.

In the end, cardiomyocytes derived from human iPS cells correlated with patient participants in the Stanford study. And, most importantly, the study revealed a potential ability to test drugs for adverse reactions and improve treatment for millions of people with cardiomyopathy. Should additional research confirm these findings, it could provide medical laboratories with a new approach to improving diagnosis and therapeutic selection for patients with heart disease.

Donna Marie Pocius

Related Information:

Heart Muscle Grown from Stem Cells May Help Doctors Test Treatments

Heart Muscle Made from Stem Cells Aids Precision Cardiovascular Medicine

Transcriptome Profiling of Patient-Specific Human iPSC-Cardiomyocytes Predicts Individual Drug Safety and Efficacy Responses in Vitro

Heart Stem Cells for Individualized Medicine in Cardiology

Stem Cells Create Faithful Replicas of Native Tissues, According to Stanford Study

CRISPR/Cas9 and Targeted Genome Editing: A New Era in Molecular Biology

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Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific ... - DARKDaily.com - Laboratory...

Cardiac Stem Cells Comments Off on Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific … – DARKDaily.com – Laboratory… | March 22nd, 2017

Spinal cord injuries are among the most dramatic and devastating of all injuries, in part because they stem from traumatic accidents but also because there are very few treatment options.

While medical advances have been made in the areas of injury management and improved long-term functioning, for those dealing with spinal cord injuries the sad truth is that researchers have yet to come up with a cure for paralysis.

Victims of spinal cord injuries are left facing a lifelong disability, one that comes not only with a range of personal burdens but which also extracts its toll on the healthcare system studies have shown that the lifetime economic burden of spinal cord injuries in Canada ranges between $1.5 to $3.0 million per individual.

Yet cell therapies represent one area of current research that appears likely to deliver positive results. According to a new study from researchers with the University Health Network and the University of Toronto, the neuroregenerative potential of this approach is promising.

Cell therapy, which in general refers to any procedure involving the implantation of cells, comes in different guises in spinal cord research, depending on the type of cells employed. Clinical research is already being performed using stem cells, which have the ability to self-renew and to differentiate into a variety of specialized cells, and glial cells, which support neural functioning.

The aim in both cases is to introduce the new cells so as to encourage regrowth of nerve fibres where they have been severed and thereby restore nerve function, a seemingly impossible task, since along with the structural damage caused by spinal cord injury comes a series of secondary events such as scarring and inflammation which, although normal bodily repair processes, can effectively impede the chances at regrowth and reconnection of neural networks.

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Reviewing the current state of affairs in spinal cord research, the researchers find that cell therapies, especially those that combine more than one approach, are showing promise but need further study and clinical trials. While combinatorial treatments using cell-coupling, trophic factors, biomaterials, and rehabilitation, may help to improve stem cell effectiveness among a heterogeneous patient population, there is still much research required to optimize their application, say the studys authors.

The researchers found that in early clinical trials, for example, cell therapies have shown modest improvements connected to functional recovery, yet they say that the results are encouraging and that even slight enhancements in sensation and function for those dealing with spinal cord injuries are often quite meaningful. It is clear that a lot remains to be understood in the translation of stem cell therapies, say the studys authors. However, given the significant strides in laboratory work, we should not lose sight of their potential.

The new research is published in the journal Expert Opinion on Biological Therapy.

The primary causes of spinal cord injuries are motor vehicle accidents and unintentional falls, each accounting for a little over 40 per cent of spinal cord injuries. According to Spinal Cord Injury Ontario, there are 1,500 new spinal cord injuries each year and a total of 86,000 Canadians currently living with spinal cord injuries.

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Stem cell therapy shows promise in treating spinal cord injuries ... - Cantech Letter

Spinal Cord Stem Cells Comments Off on Stem cell therapy shows promise in treating spinal cord injuries … – Cantech Letter | March 22nd, 2017

March 13, 2017 02:00 ET | Source: TiGenix NV

multilang-release

PRESS RELEASE REGULATED INFORMATION INSIDE INFORMATION

TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction

Leuven (BELGIUM) - March 13, 2017, 07:00h CET - TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing novel therapeutics from its two proprietary platforms of donor-derived expanded adipose derived stem cells (eASC) and donor-derived expanded cardiac stem cells (AlloCSCs), today announced top-line one-year results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSCs in acute myocardial infarction (AMI).

CAREMI is the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI. Importantly, the trial is the first cardiac stem cell study to integrate a highly discriminatory magnetic resonance imaging (MRI) strategy to select patients at increased risk of heart failure and late adverse outcomes. CAREMI was not powered to establish efficacy therefore no conclusion can be drawn on the secondary efficacy end-points.

The main findings of this study are:

"This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left ventricular dysfunction," commented Professor Fernndez-Avils, Head of the Department of Cardiology at the Hospital General Universitario Gregorio Maran in Madrid (Spain), principal investigator on the trial in Spain. "It is especially encouraging that no cardiac or immunological side effects were observed."

"This is the first study in which we have used a state of the art comprehensive MRI analysis to include patients with a large myocardial infarction in an innovative cell therapy protocol," said Professor Janssens, Head of the Department of Cardiovascular Diseases, University Hospital, Leuven (Belgium), and principal investigator on the trial in Belgium. "Serial MRI analysis and extensive immunological profiling will allow us to further explore the encouraging signals we observed in cell treated patients with the worst MRI signature. These findings offer an exciting prospect for targeted follow-up studies in these high-risk patients."

"Besides confirming the long term safety of the treatment these results suggest interesting opportunities in populations with high unmet medical need," said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. "We look forward to working with our advisors to analyze the data in depth and determine the best way forward with AlloCSC-01 during the second half of this year."

Full data results from the CAREMI study will be presented at an upcoming medical congress.

###

For more information

Claudia D'Augusta Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels and Nasdaq: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development: Cx601 in Phase III for the treatment of complex perianal fistulas in Crohn's disease patients; Cx611 which has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, has concluded a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

About AlloCSC-01

AlloCSC-01 is a cellular product consisting of adult expanded allogeneic cardiac stem cells isolated from the right atrial appendages of donors, and expanded in vitro. Pre-clinical data has shown evidence of the strong cardio-protective and immune-regulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-01 has cardio-reparative potential by activating endogenous regenerative pathways and by promoting the formation of new cardiac tissue. In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration.

About CAREMI

The CAREMI trial comprised two consecutive phases: an open-label dose-escalation phase (n=6) and a 2:1 randomized, double-blind, placebo-controlled phase (n=49). The objective of this clinical trial is to evaluate the safety and the efficacy of the cardiac stem cells product AlloCSC-01 in the acute phase of ischemic heart disease. The primary safety endpoint are all-cause mortality within 30 days and percentage of patients with major adverse cardiac events (MACE) within 30 days after treatment. MACE is a broader safety endpoint that covers all-cause mortality as well as new AMI, hospitalization due to heart failure, sustained ventricular tachycardia, ventricular fibrillation and stroke. Secondary safety endpoints include percentage of patients with MACE at 6 and 12 months after treatment, all-cause mortality at 12 months after treatment and percentage of patients with AE during the study. Secondary efficacy include MRI parameters (evolution of infarct size and evolution of biomechanical parameters) and clinical parameters (including the 6 minute walking test and the New York Heart Association scale). The CAREMI study has been conducted at the Hospital General Universitario Gregorio Maraon, Madrid, UZ Leuven, Hospital de Navarra, Hospital Clnico Universitario de Valladolid, Hospital Universitario de Donostia, Hospital Universitario de Salamanca, Hospital Clnico Universitario de Valencia, and Hospital Virgen de la Victoria de Mlaga. The CAREMI trial has benefitted from the support of the CARE-MI consortium (Grant Number 242038, http://www.caremiproject.eu/) funded by the Seventh Framework Programme of the European Commission under the coordination of the Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the participation of research institutions and companies from nine EU countries.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company's expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

Related Articles

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TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction - GlobeNewswire (press release)

Cardiac Stem Cells Comments Off on TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction – GlobeNewswire (press release) | March 19th, 2017

It's a long road ahead for Madalayna Ducharme after her stem cell transplant Friday.

The seven-month-old baby was diagnosed with malignant infantile osteopetrosis, which stunts growth, impairs vision and hearing and if untreated can be fatal.

The girl's family put out a plea in January to try to find a stem cell donor.

It took a few months, with 1,300 people attending swab events and a match was found.

The family posted on Facebook that The best agreed upon opportunity/match for us after many tests and consultations is our son Henrik.

The 2-year-old Henrik had a bone marrow harvest Friday. The family says he had surgery to remove bone marrow from both hips. Madalyna later received her brother's bone marrow in the form of a blood transfusion.

Doctors told the family the surgery went well.

Henrik has since been discharged and is recovering at the Ronald Mcdonald House.

For Madalayna, it's a matter of wait and see to find out if the marrow going into her bones will work as her own.

It will take between 14 and 27 days before doctors can tell if the transfusion was successful.

In the Facebook post, the family thanked everyone for their thoughts and prayers and asked people to continue to think about the family.

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Baby's stem cell transplant goes well, doctors say - CTV News

Bone Marrow Stem Cells Comments Off on Baby’s stem cell transplant goes well, doctors say – CTV News | March 19th, 2017

Three women suffering from a degenerative eye condition were blindedlikely permanentlyin a clinical trial for stem cell therapy, according to a report published Wednesday in the New England Journal of Medicine.

The women, who were all between the ages of 72 and 88, had a common medical condition called age-related macular degeneration, in which cells in the retina begin to die off, resulting in spotty or blurred vision. Researchers suspected stem cells derived from the patient's own body could regenerate some of the cells lost to the disease. So in the clinical trial, which was conducted in 2015, researchers removed some blood and fat from participants' anesthetized abdomens, treated the cells in a standardized way to make them revert to stem cells, then injected into their eyes. They were instructed to use an eyedrops antibiotic for a few days. The three patients had found the trial listed on the government web site clinicaltrials.gov, and had each paid $5,000 for the procedure. The informed consent form listed that blindness was possible as a result of the procedure.

MoreIt's Shockingly Easy To Buy Unregulated Stem Cell Treatments

A few days after the patients received the injected stem cells, the participants ended up in the hospital with vision loss, detached retinas, and hemorrhage. The patients lost vision; subsequent checkups led doctors to conclude that they would likely never regain their sight.

Despite the fact that the participants found the procedure on clinicaltrials.gov, the informed consent forms do not mention that it is in fact a clinical trial. "The patients paid for a procedure that had never been studied in a clinical trial, lacked sufficient safety data, and was performed in both eyes on the same day," the study authors write. Injecting something experimental into both eyes is both not safe and not typical, they continue.

Recently researchers have been testing lots of different medical uses for stem cells, from treating multiple sclerosis to spinal cord injuries. With the passage of the 21st Century Cures Act in December, Congress cleared the way for faster regulatory approval for promising treatments based on stem cells. At least 13 clinical trials were registered to treat AMD alone as of November 2016, the article authors write.

But anecdotes like these bolster those who counsel restraint when it comes to stem cells. "Although numerous stem-cell therapies for medical disorders are being investigated at research institutions with appropriate regulatory oversight, many stem-cell clinics are treating patients with little oversight and with no proof of efficacy," the article authors write.

Jeffrey Goldberg, a professor of ophthalmology at Stanford University and one of the authors of the article, calls this a "call to awareness for patients, physicians and regulatory agencies of the risks of this kind of minimally regulated, patient-funded research," according to a press release.

The post Three Women Blinded In Stem Cell Clinical Trial appeared first on Vocativ.

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3 women blinded in stem cell clinical trial - AOL

Spinal Cord Stem Cells Comments Off on 3 women blinded in stem cell clinical trial – AOL | March 18th, 2017

I just read a concerning paper about an experimental stem cell treatment for children with autism.

The authors are Himanshu Bansal and colleagues of India. The senior author, Prasad S Koka, is the Editor-in-Chief of the Journal of Stem Cells where the paper appeared, which raises questions about whether the manuscript received a thorough peer review. Koka is actually an author on all five of the research papers published in that issue of the journal. But thats a minor issue compared to the content of the paper.

Bansal et al. describe a procedure in which they extracted fluid from the bone marrow of each child. This fluid (bone marrow aspirate) was treated in the laboratory to purify the stem cells within, and then injected into the childs spinal canal. The whole operation took place under general anaesthesia. 10 autistic children aged 4-12 were treated.

I found this pretty shocking. An invasive procedure involving general anaesthesia should only be performed if its medically justified especially in children as young as 4! Bansal et al. provide no scientific explanation for why they thought this treatment was suitable for these patients. They vaguely name immunological and neural dysregulation believed to underlie autism as the target of the cells.

For what its worth, the results showed a slight improvement in autism symptoms after the treatment. However, there was no control group, so placebo effects are likely, and were told that the patients were also given speech therapy, occupational therapy and psychological intervention which might account for the benefits.

So who gave the green light to this project? Well, remarkably, Bansal et al.s paper contains no information about which ethics committee reviewed and approved the study. I dont know about the laws in India, but in the UK or the USA, conducting even the most benign research without the proper ethical approval is serious misconduct. Most journals absolutely wont publish medical research without an ethics statement.

The paper also contains no mention of conflicts of interest another thing that most medical journals require. I believe that financial conflicts of interest are likely to exist in this case because Bansal gives his affiliations as Mother Cell, his own private venture, and RegennMed, who sell various stem cell treatments.

Overall, to say that this paper is ethically questionable is an understatement, and it would have been rejected by any real journal.

This isnt Dr Himanshu Bansals first foray into the amazing world of dodgy stem-cells. He briefly made headlines around the globe last year when he announced his ReAnima project to bring a brain dead woman back to life (with stem cells). Indian authorities eventually blocked his resurrection attempt. Theres some more interesting dirt on Bansal on this forum.

This is also not the worlds first stem cells for autism trial. For example, Duke University launched a $40 million trial in 2014. The treatment in that trial was a blood infusion, so it was pretty non-invasive: no bone marrow, spinal needles, or general anaesthesia. However, critics argue that its pure speculation to think that stem cells would help in autism. Then again, the same could be said about a great many stem cell therapies.

Bansal H, Verma P, Agrawal A, Leon J, Sundell IB, Koka PS. (2016). A Short Study Report on Bone Marrow Aspirate Concentrate Cell Therapy in Ten South Asian Indian Patients with Autism Journal of Stem Cells, 11 (1)

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Unethical Stem Cell Therapy for Autism In India? - Discover Magazine (blog)

Bone Marrow Stem Cells Comments Off on Unethical Stem Cell Therapy for Autism In India? – Discover Magazine (blog) | March 18th, 2017

Buffalo, NY (Scicasts) A discovery, several years in the making, by a University at Buffalo research team has proven that adult skin cells can be converted into neural crest cells (a type of stem cell) without any genetic modification, and that these stem cells can yield other cells that are present in the spinal cord and the brain.

The practical implications could be very significant, from studying genetic diseases in a dish to generating possible regenerative cures from the patient's own cells.

"It's actually quite remarkable that it happens," says Dr. Stelios T. Andreadis, professor and chair of UB's Department of Chemical and Biological Engineering, who recently published a paper on the results in the journal Stem Cells.

The identity of the cells was further confirmed by lineage tracing experiments, where the reprogrammed cells were implanted in chicken embryos and acted just as neural crest cells do.

Stem cells have been derived from adult cells before, but not without adding genes to alter the cells. The new process yields neural crest cells without addition of foreign genetic material. The reprogrammed neural crest cells can become smooth muscle cells, melanocytes, Schwann cells or neurons.

"In medical applications this has tremendous potential because you can always get a skin biopsy," Andreadis says. "We can grow the cells to large numbers and reprogram them, without genetic modification. So, autologous cells derived from the patient can be used to treat devastating neurogenic diseases that are currently hampered by the lack of easily accessible cell sources."

The process can also be used to model disease. Skin cells from a person with a genetic disease of the nervous system can be reprogrammed into neural crest cells. These cells will have the disease-causing mutation in their chromosomes, but the genes that cause the mutation are not expressed in the skin. The genes are likely to be expressed when cells differentiate into neural crest lineages, such as neurons or Schwann cells, thereby enabling researchers to study the disease in a dish. This is similar to induced pluripotent stem cells, but without genetic modification or reprogramming to the pluripotent state.

The discovery was a gradual process, Andreadis says, as successive experiments kept leading to something new. "It was one step at a time. It was a very challenging task that took almost five years and involved a wide range of expertise and collaborators to bring it to fruition," Andreadis says. Collaborators include Dr. Gabriella Popescu, professor in the Department of Biochemistry in the Jacobs School of Medicine and Biomedical Sciences at UB; Dr. Song Liu, vice chair of biostatistics and bioinformatics at Roswell Park Cancer Institute and a research associate professor in biostatistics UB's School of Public Health and Health Professions; and Dr. Marianne Bronner, professor of biology and biological engineering, California Institute of Technology.

Andreadis credits the persistence of his then-PhD student, Vivek K. Bajpai, for sticking with it.

"He is an excellent and persistent student," Andreadis says. "Most students would have given up." Andreadis also credits a seed grant from UB's office of the Vice President for Research and Economic Development's IMPACT program that enabled part of the work.

The work recently received a $1.7 million National Institutes of Health grant to delve into the mechanisms that occur as the cells reprogram, and to employ the cells for treating the Parkinson's-like symptoms in a mouse model of hypomyelinating disease.

"This work has the potential to provide a novel source of abundant, easily accessible and autologous cells for treatment of devastating neurodegenerative diseases. We are excited about this discovery and its potential impact and are grateful to NIH for the opportunity to pursue it further," Andreadis said.

Article adapted from a University at Buffalo news release.

Publication: Reprogramming Postnatal Human Epidermal Keratinocytes Toward Functional Neural Crest Fates. Stelios T. Andreadis et al. Stem Cells (2017): Click here to view.

Link:
Study Yields Neural Crest Cells from Adult Skin Cells Without Genetic Modification - Scicasts (press release) (blog)

Skin Stem Cells Comments Off on Study Yields Neural Crest Cells from Adult Skin Cells Without Genetic Modification – Scicasts (press release) (blog) | March 18th, 2017

ScienceBlog.com (blog)

Science in Focus: Creating Neurons from Skin Cells to Understand Autism ScienceBlog.com (blog) Studying brain disorders is complicated for many reasons, not the least being the ethics of obtaining living neurons. To overcome that obstacle, UC San Francisco postdoc Aditi Deshpande, PhD, is starting with skin cells. Thanks to developments in stem ... and more »

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Science in Focus: Creating Neurons from Skin Cells to Understand Autism - ScienceBlog.com (blog)

Skin Stem Cells Comments Off on Science in Focus: Creating Neurons from Skin Cells to Understand Autism – ScienceBlog.com (blog) | March 15th, 2017

March 15, 2017 Credit: Universit du Luxembourg

Stem cells are unspecialised cells that can develop into any type of cell in the human body. So far, however, scientists only partially understand how the body controls the fate of these all-rounders, and what factors decide whether a stem cell will differentiate, for example, into a blood, liver or nerve cell. Researchers from the Luxembourg Centre for Systems Biomedicine (LCSB) of the University of Luxembourg and an international team have now identified an ingenious mechanism by which the body orchestrates the regeneration of red and white blood cells from progenitor cells. "This finding can help us to improve stem cell therapy in future," says Dr. Alexander Skupin, head of the "Integrative Cell Signalling" group of LCSB.

Although all cells in an organism carry the same genetic blueprints the same DNA some of them act as blood or bone cells, for example, while others function as nerve or skin cells. Researchers already understand quite well how individual cells work. But how an organism is able to create such a diversity of cells from the same genetic template and how it manages to relocate them to wherever they are needed in the body is still largely unknown. In order to learn more about this process, Alexander Skupin and his team treated blood stem cells from mice with growth hormones and then watched closely how these progenitor cells behaved during their differentiation into white or red blood cells. The researchers observed that the cells' transformation does not occur in linear, targeted fashion, but rather more opportunistically. Each progenitor cell adapts to the needs of its environment and integrates itself into the body where new cells are needed. "So, it is not as though the cell takes a ticket at the beginning of its differentiation and then travels straight to its destination. Rather, it gets off frequently to look around and see which line is best to take," Alexander Skupin explains.

By this clever mechanism, a multicellular organism can adapt the regrowth of new cells to its current needs. "Before progenitor cells differentiate once and for all, they first lose their stem cell character and then check, as it were, which cell line is currently in demand. Only then do they develop into the cell type that best suits their characteristics and which prevails in their environment," Alexander Skupin says. The researcher likens this step to a game of roulette, where the different types of cells can be thought of as the differently numbered slots in the roulette wheel that catch the ball. "When the cells lose their stem cell character, they are quasi thrown into the roulette wheel, where they first bounce around aimlessly. Only when they have found the right environment do the cells then drop into that niche like the roulette ball falling into a numbered slot and differentiate definitively." This way, the body can orchestrate its cell regeneration and at the same time prevent stem cells from being misdirected too early. "Even if a cell takes a wrong turn, it is ultimately sorted out again if its characteristics are unsuitable for the niche, or slot, it has landed in," says Skupin.

With their study, Alexander Skupin and his team have shown for the first time that a progenitor cell's fate is not clearly predetermined and does not follow a straight line. "This observation contradicts the current doctrine that stem cells are programmed to follow a certain lineage from the beginning," Alexander Skupin says. The researcher is furthermore convinced that the processes are similar for other progenitor cells. "In the lab, we have observed the same differentiation pattern in so-called iPS cells, or induced pluripotent stem cells, which can transform into many different types of cells."

This knowledge can help the researchers to improve the effectiveness of therapies in future. Stem cell therapy involves administering a patient his or her own body's stem cells in order to replace other cells that have died as a result of an affliction such as Parkinson's disease. While this promising treatment method has been intensively researched over many years, there has so far been only limited practical success in endogenous stem cell therapy. It is also highly controversial, since it is frequently accompanied by severe side effects and it cannot be ruled out that some cells might degenerate and lead to cancer. "Because we now have a better understanding of how the body influences the direction in which stem cells differentiate, we can hopefully control this process better in future," Alexander Skupin concludes.

Explore further: Genetic factors control regenerative properties of blood-forming stem cells

More information: Mitra Mojtahedi et al. Cell Fate Decision as High-Dimensional Critical State Transition, PLOS Biology (2016). DOI: 10.1371/journal.pbio.2000640

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Researchers decipher how the body controls stem cells - Phys.Org

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