Photo courtesy of the University of Minnesota

MINNEAPOLIS/ST. PAUL A team of biomedical engineering researchers, led by the University of Minnesota, has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack.

The research study was published Apr. 14 inCirculation Research, a journal published by the American Heart Association. Researchers have filed a patent on the discovery.

According to the American Heart Association, heart disease is the No. 1 cause of death in the U.S. killing more than 360,000 people a year. During a heart attack, a person loses blood flow to the heart muscle and that causes cells to die. Our bodies cant replace those heart muscle cells so the body forms scar tissue in that area of the heart, which puts the person at risk for compromised heart function and future heart failure.

In this study, researchers from the University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.

Watch a video of the cells beating on the patch.

Video credit:College of Science and Engineering, UMN

When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries.

Related Article:3D-Printed Guide Helps Regrow Complex Nerves After Injury

This is a significant step forward in treating the No. 1 cause of death in the U.S., said Brenda Ogle, an associate professor of biomedical engineering at the University of Minnesota. We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years.

A team of biomedical engineering researchers has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. Two of the researchers involved are biomedical engineering associate professor Brenda Ogle (right) and PhD student Molly Kupfer (left).Photo credit: Patrick OLeary, University of MinnesotaOgle said that this research is different from previous research in that the patch is modeled after a digital, three-dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue.

We were quite surprised by how well it worked given the complexity of the heart, Ogle said. We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch.

Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart.

The research was funded by the National Science Foundation, National Institutes of Health, University of Minnesota Lillehei Heart Institute, and University of Minnesota Institute for Engineering in Medicine.

In addition to Ogle, other biomedical engineering researchers who were part of the team include Molly E. Kupfer, Jangwook P. Jung, Libang Yang, Patrick Zhang, and Brian T. Freeman from the University of Minnesota; Paul J. Campagnola, Yong Da Sie, Quyen Tran, and Visar Ajeti from the University of Wisconsin-Madison; and Jianyi Zhang, Ling Gao, and Vladimir G. Fast from the University of Alabama,

To read the full research paper entitled Myocardial Tissue Engineering With Cells Derived from Human Induced-Pluripotent Stem Cells and a Native-Like, High-Resolution, 3-Dimensionally Printed Scaffold, visit theCirculation Researchwebsite.

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3D-Printed Patch Can Help Mend a 'Broken' Heart - Lab Manager | News (press release) (blog)

BROOMFIELD, Colo., April 17, 2017 /PRNewswire/ -- "Interventional orthopedics in pain medicine practice" was recently published by Elsevier as a chapter in Techniques in Regional Anesthesia and Pain Management. The chapter, authored by Regenexx founder Christopher J. Centeno, MD examines less invasive ways to treat orthopedic pain and injuries through autologous biologics, such as stem cells and platelet rich plasma (PRP), and the shift from surgical orthopedics to interventional orthopedics.

Interventional orthopedics utilizing advanced technologies, such as ultrasound and X-ray guidance, precise percutaneous injections of autologous biologics, and bone marrow concentrate, (BMC) expand nonsurgical options in the field of orthopedics. Citing the dramatic reduction in cardiac surgery rates since the adoption of the specialty interventional cardiology, the authors reveal, "We are poised on the brink of the same change in orthopedic care." The authors also state, "The field of autologous biologics has the potential to alter the playing field of orthopedic care by allowing percutaneous injections to replace the need for more invasive orthopedic surgeries."

The chapter covers three important tenets in the developing field that will allow Interventional Orthopedics to alter traditional orthopedic care in the future. First is the rapid expansion of injectates (material being injected), such as stem cells and PRP, that can help heal damaged tissue and that can effectively treat musculoskeletal tissues. Second is the precise image-guided placement of those injectates into those damaged tissues. And third is the development of new tools that will advance this regenerative-medicine technology. The chapter also highlights research that supports the use of bone marrow stem cells and the importance of education standards and organization, training, and retraining of physicians to meet these standards.

The full chapter "Interventional orthopedics in pain medicine practice" can be found online at http://www.sciencedirect.com/science/article/pii/S1084208X16300052.

Christopher J. Centeno, MD, is the CEO of Regenexx and an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics. Dr. Centeno maintains an active research-based practice and has multiple publications listed in the US National Library of Medicine.He has also served as editor-in-chief of a medical research journal dedicated to traumatic injury and is one of the few physicians in the world with extensive experience in the culture expansion of and clinical use of adult stem cells to treat orthopedic injuries.

MEDIA CONTACT Mark Testa 155014@email4pr.com (303) 885-9630

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regenexx-network-using-regenerative-medicine-technologies-in-interventional-orthopedics-to-treat-pain-300439851.html

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Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain - Yahoo Finance

April 11, 2017 07:15 ET | Source: Cesca Therapeutics Inc.

RANCHO CORDOVA, Calif., April 11, 2017 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that Dr. Xiaochun (Chris) Xu, Chairman and Interim Chief Executive Officer and Chairman of Boyalife Group, will present an overview of the Companys cardiovascular clinical research program at the 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair, being held April 10-12, 2017 at the Hope Hotel in Shanghai, China.

Details of the presentation are as follows:

Despite recent therapeutic and surgical advances, the effects of peripheral arterial disease, including heart attack and critical limb ischemia (CLI), remain among the worlds leading causes of morbidity and mortality and represent a rapidly escalating public health crisis, noted Dr. Xu. I look forward to presenting a review of our latest findings, including key feasibility study results and an overview of our Phase 3 Critical Limb Ischemia Rapid Stemcell Treatment (CLIRST) trial, which we believe highlight the potential of Cesca Therapeutics proprietary AutoXpress point-of-care platform to deliver autologous cell-based therapies that may represent a new paradigm in patient treatment going forward.

About the Symposium of Translational Medicine in Stem Cell Myocardial Repair

The 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair brings together more than 650 of the worlds cardiac disease thought leaders to discuss the potential of translational and regenerative medicine in treating myocardial infarction (MI) and cardiac failure. The symposium is co-sponsored by the Shanghai Society for Cell Biology, the Institute of Health Sciences, the Shanghai Cardiovascular Disease Institute, the Guangzhou Institutes of Biomedicine and Health, and the Key Laboratory of Stem Cell Biology, Shanghai.

About Cesca Therapeutics Inc.

Cesca is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. Cesca is an affiliate of the Boyalife Group (http://www.boyalifegroup.com), a China-based industrial-research alliance among top research institutes for stem cell and regenerative medicine.

Forward-Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

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CESCA Therapeutics to Present at the 2017 International Symposium of Translational Medicine in Stem Cell ... - GlobeNewswire (press release)

Scientists have created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack, researchers at University of Minnesota in the US said. During a heart attack, a person loses blood flow to the heart muscle and that causes cells to die.

Our bodies can not replace those heart muscle cells so the body forms scar tissue in that area of the heart, which puts the person at risk for compromised heart function and future heart failure. Researchers used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.

When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries. This is a significant step forward in treating the No 1 cause of death in the US, said Brenda Ogle, an associate professor at the University of Minnesota.

We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years, said Ogle. Ogle said that the research is different from previous ones as the patch is modelled after a digital, three- dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells.

Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue, researchers said. We were quite surprised by how well it worked given the complexity of the heart. We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch, Ogle said.

Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart. The study was published in the journal Circulation Research.

Publish date: April 16, 2017 12:57 pm| Modified date: April 16, 2017 12:57 pm

Tags: 3D-Bioprint, Brenda Ogle, cells, Heart, heart attack, heart failure, Journal Circulation Research, scientists, structural proteins, University of Minnesota

Read more:
Scientists have made a 3D-printed patch that can help heal the damaged heart tissue - Tech2 (blog)

WASHINGTON D.C: Scientists have developed a revolutionary 3D-bioprinted patch that could one day be used to repair damage to the human heart.

The patch can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack.

The researchers from the University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.

When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries.

"This is a significant step forward in treating the No. 1 cause of death in the U.S.," said researcher Brenda Ogle. "We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years."

Ogle said that this research is different from previous research in that the patch is modelled after a digital, three-dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue.

"We were quite surprised by how well it worked given the complexity of the heart," Ogle noted. "We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch."

Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart.

The research study is published in Circulation Research, a journal published by the American Heart Association.

See the article here:
Breakthrough in cardiac health: 3D-printed patch can help mend a 'broken' heart - Economic Times

A team of biomedical engineering researchers, led by the University of Minnesota, has created a revolutionary 3D-bioprinted patch that can help heal scarred heart tissue after a heart attack. The discovery is a major step forward in treating patients with tissue damage after a heart attack.

The research study is published today in Circulation Research, a journal published by the American Heart Association. Researchers have filed a patent on the discovery.

According to the American Heart Association, heart disease is the No. 1 cause of death in the U.S. killing more than 360,000 people a year. During a heart attack, a person loses blood flow to the heart muscle and that causes cells to die. Our bodies cant replace those heart muscle cells so the body forms scar tissue in that area of the heart, which puts the person at risk for compromised heart function and future heart failure.

In this study, researchers from the University of Minnesota-Twin Cities, University of Wisconsin-Madison, and University of Alabama-Birmingham used laser-based 3D-bioprinting techniques to incorporate stem cells derived from adult human heart cells on a matrix that began to grow and beat synchronously in a dish in the lab.

Watch a video of the cells beating on the patch.

When the cell patch was placed on a mouse following a simulated heart attack, the researchers saw significant increase in functional capacity after just four weeks. Since the patch was made from cells and structural proteins native to the heart, it became part of the heart and absorbed into the body, requiring no further surgeries.

This is a significant step forward in treating the No. 1 cause of death in the U.S., said Brenda Ogle, an associate professor of biomedical engineering at the University of Minnesota. We feel that we could scale this up to repair hearts of larger animals and possibly even humans within the next several years.

Ogle said that this research is different from previous research in that the patch is modeled after a digital, three-dimensional scan of the structural proteins of native heart tissue. The digital model is made into a physical structure by 3D printing with proteins native to the heart and further integrating cardiac cell types derived from stem cells. Only with 3D printing of this type can we achieve one micron resolution needed to mimic structures of native heart tissue.

We were quite surprised by how well it worked given the complexity of the heart, Ogle said. We were encouraged to see that the cells had aligned in the scaffold and showed a continuous wave of electrical signal that moved across the patch.

Ogle said they are already beginning the next step to develop a larger patch that they would test on a pig heart, which is similar in size to a human heart.

The research was funded by the National Science Foundation, National Institutes of Health, University of Minnesota Lillehei Heart Institute, and University of Minnesota Institute for Engineering in Medicine.

In addition to Ogle, other biomedical engineering researchers who were part of the team include Molly E. Kupfer, Jangwook P. Jung, Libang Yang, Patrick Zhang, and Brian T. Freeman from the University of Minnesota; Paul J. Campagnola, Yong Da Sie, Quyen Tran, and Visar Ajeti from the University of Wisconsin-Madison; and Jianyi Zhang, Ling Gao, and Vladimir G. Fast from the University of Alabama,

To read the full research paper entitled Myocardial Tissue Engineering With Cells Derived from Human Induced-Pluripotent Stem Cells and a Native-Like, High-Resolution, 3-Dimensionally Printed Scaffold, visit the Circulation Research website.

Originally posted here:
3D-printed patch can help mend a broken heart - UMN News

Science Daily

'Neuron-reading' nanowires could accelerate development of drugs for neurological diseases Science Daily "We envision that this nanowire technology could be used on stem-cell-derived brain models to identify the most effective drugs for neurological diseases," said Anne Bang, director of cell biology at the Conrad Prebys Center for Chemical Genomics at ... and more »

Continued here:
'Neuron-reading' nanowires could accelerate development of drugs for neurological diseases - Science Daily

Q. Im in doubt regarding myelodysplasia is it multipotent or pluripotent?

A. Thats a great question because it lets us talk about hematopathology (yay!) and also stem cells (which can be confusing unless someone explains some simple stuff).

What is a stem cell? First, lets talk about stem cells. The thing that makes a stem cell a stem cell, at least in my mind, is the ability to self-renew. This means that the stem cell can either divide into two daughter cells which will mature into grown up cells, or (and more commonly) it can give rise to two cells: one that will become a mature cell, and another which retains the capacity to divide again. Its called asymmetric division: instead of giving rise to two of the same cells, you get one regular cell and another stem cell (which can continue this cycle of replication for a long long time).

(Virtually) limitless replication Most cells have a limited number of times that they can divide. This is because the telomeres (little protective DNA sequences) on the end of the chromosomes get a little shorter every time the DNA replicates and eventually they are so short that they cant protect the DNA and the cell is unable to divide. Stem cells and cancer cells have an enzyme called telomerase that replenishes the telomeres, keeping them nice and long so the cell can keep on dividing. Stem cells do eventually die so technically, there are a limited number of cell divisionsbut its a really, really big number. Cancer cells, on the other hand, are often totally immortal they can just keep on dividing and dividing.

Totipotent Another cool thing about stem cells is that they can give rise to many different kinds of cells. Heres where things can get murky. There are stem cells in an embryo which are able to give rise to any of the cell types in the body: hepatocytes, epithelial cells, neurons, cardiac muscle cellseverything. This makes sense: if youre going to grow into a human, you have to have cells that give rise to all the necessary cell types. These stem cells are called totipotent or pluripotent stem cells. Theres a slight difference between the two words: totipotent means that the stem cell can give rise to any and all human tissue cells and it can even give rise to an entire functional human. The only totipotent cells in human development are the fertilized egg and the cells in the next few cell divisions.

Pluripotent After those few cell divisions, the cells become pluripotent. Pluripotent cells are similar to totipotent cells in that they can give rise to any and all human tissue cells. Theyre different, though, because they are not capable of giving rise to an entire organism. On day four of development, the tiny little embryo forms two layers: one that will become the placenta and the other that will become the baby. The cells that will become the baby can give rise to any human tissue type (obviously) but those cells alone cant give rise to the entire organism (because you cant form the baby without the placenta). Slight difference but enough to make a separate term.

Multipotent Another term you should know is multipotent. Multipotent stem cells cannot give rise to any old cell in the body they are restricted to a limited range of cell types. For example, there are multipotent stem cells in the bone marrow that can give rise to red cells, white cells and platelets. They cant give rise to hepatocytes, or any other cell type, though so they are not totipotent or pluripotent.

There are lots of multipotent stem cells in the adult human body. They reside in the bone marrow, skin, muscle, GI tract, endothelium, and mesenchymal tissues. This means that there is a nice source for replacing cells that have died or been sloughed away.

What about myelodsyplasia? So back to your question. Myelodysplasia is a hematopoietic disorder in which cells in the bone marrow grow funny (dysplasia) they might be binucleate, or not have the normal number of granules, or whatever. In addition, some cases have an increase in blasts in the bone marrow but not over 20%, or youd call it an acute leukemia. Some cases transform, eventually, into an acute myeloid leukemia; others just stay the way they are and dont become nasty.

Check out the image above, from a case of myelodysplasia. There is a bizarre, multinucleated erythroblast at 11 oclock (this is called dyserythropoiesis, or disordered red cell growth). There are also two messed-up neutrophils (dysgranulopoiesis) at 4 oclock and 10 oclock the one at 4 oclock has only two nuclear lobes, and both are hypogranular (not enough specific granulation). Theres also an increase in blasts, if this field is representative: theres one in the middle and (probably) one at 5 oclock.

This disorder (actually, its a group of disorders) involves stem cells in the bone marrow. Sometimes only one cell line is involved (red cells, say); other times all three cell lines are involved (red cells, white cells and platelets). Either way, the disorder involves a stem cell, and since the stem cells in the bone marrow are multipotent, it would be correct to say that myelodysplasia is a disorder of multipotent stem cells in the bone marrow. Its kind of redundant, though, because as far as we know, there arent any other kind of stem cells in the bone marrow! But at least you know the answer to your question now.

Read the original post:
Multipotent vs. pluripotent stem cells - Pathology Student

RANCHO CORDOVA, Calif., April 11, 2017 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (KOOL), a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that Dr. Xiaochun (Chris) Xu, Chairman and Interim Chief Executive Officer and Chairman of Boyalife Group, will present an overview of the Companys cardiovascular clinical research program at the 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair, being held April 10-12, 2017 at the Hope Hotel in Shanghai, China.

Details of the presentation are as follows:

Despite recent therapeutic and surgical advances, the effects of peripheral arterial disease, including heart attack and critical limb ischemia (CLI), remain among the worlds leading causes of morbidity and mortality and represent a rapidly escalating public health crisis, noted Dr. Xu. I look forward to presenting a review of our latest findings, including key feasibility study results and an overview of our Phase 3 Critical Limb Ischemia Rapid Stemcell Treatment (CLIRST) trial, which we believe highlight the potential of Cesca Therapeutics proprietary AutoXpress point-of-care platform to deliver autologous cell-based therapies that may represent a new paradigm in patient treatment going forward.

About the Symposium of Translational Medicine in Stem Cell Myocardial Repair

The 2017 International Symposium of Translational Medicine in Stem Cell Myocardial Repair brings together more than 650 of the worlds cardiac disease thought leaders to discuss the potential of translational and regenerative medicine in treating myocardial infarction (MI) and cardiac failure. The symposium is co-sponsored by the Shanghai Society for Cell Biology, the Institute of Health Sciences, the Shanghai Cardiovascular Disease Institute, the Guangzhou Institutes of Biomedicine and Health, and the Key Laboratory of Stem Cell Biology, Shanghai.

About Cesca Therapeutics Inc.

Cesca is engaged in the research, development, and commercialization of cellular therapies and delivery systems for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapeutics. Cesca is an affiliate of the Boyalife Group (http://www.boyalifegroup.com), a China-based industrial-research alliance among top research institutes for stem cell and regenerative medicine.

Forward-Looking Statement

The statements contained herein may include statements of future expectations and other forward-looking statements that are based on managements current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

More:
CESCA Therapeutics to Present at the 2017 International Symposium of Translational Medicine in Stem Cell ... - Yahoo Finance

April 10, 2017 06:00 ET | Source: Mesoblast Limited

NEW YORK and MELBOURNE, Australia, April 10, 2017 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO) (ASX:MSB) today announced that thePhase 3 trial ofits allogeneic mesenchymal precursor cell (MPC) product candidate MPC-150-IM in patients with moderate to advanced chronic heart failure (CHF)was successful in thepre-specified interim futility analysisof the efficacy endpoint in the trial's first 270 patients. It is expected that the trial will enroll in total approximately 600 patients. After notifying the Company of the interim analysis results, thetrials Independent Data Monitoring Committee (IDMC) additionally stated that they had no safety concerns relating to MPC-150-IM and formally recommended that the trial should continue as planned.

Dr. Emerson C. Perin,Director, Research in Cardiovascular Medicine and Medical Director, Stem Cell Center at the Texas Heart Institute, and a lead investigator on the ongoing Phase 3 trial said: "It is very pleasingto see that thislarge and rigorously conducted Phase 3 trialof Mesoblast's cell therapy was successful in the pre-specified interim futility analysis for the trial's efficacy endpoint in the first 270 patients. Advancedheart failure is a very serious and life-threatening disease, and there is an urgent need to develop a safe and effective new therapy for these patients that may halt or reverse disease progression and prevent the high associated mortality.

Mesoblast Chief Executive Silviu Itescucommented: Passing this interim futility analysis for MPC-150-IM is an important milestone for Mesoblast and our cardiovascular disease program. This validates our strategy and our prioritization of this valuable program.

This ongoing double-blinded randomized (1:1) trial is currently being conducted across multiple study sites in the United States and Canada.It is evaluating MPC-150-IM in adult patients with moderate to advanced New York Heart Association (NYHA) Class II/III chronic heart failure with left ventricular systolic dysfunction. The trials primary efficacy endpoint is a comparison of recurrent non-fatal heart failure-related major adverse cardiac events (HF-MACE) in moderate to advanced CHF patients receiving either MPC-150-IM by catheter injection into the damaged left ventricular heart muscle or sham control. A Joint Frailty Model is the statistical method that evaluates multiplenon-fatal heart failure-relatedevents per patient (such as repeated hospitalizations for decompensated heart failure) while accounting for increased likelihood of a terminal cardiac event (such as death, implantation of a mechanical heart assist device or a heart transplant) for patients with multiple non-fatal heart failure events. In line with best practice for blinded Phase 3 clinical trials, the interim analysis data are only reviewed by the IDMC. Mesoblast, the United States Food and Drug Administration (FDA), and trial investigators are blinded to grouped safety and efficacy data for the ongoing trial as well as the numerical results of this interim analysis.

About Mesoblasts MPC-150-IM Cardiovascular Program MPC-150-IM is Mesoblast's lead allogeneic, cell-based product candidate for the treatment of moderate to advanced chronic heart failure (CHF) due to left ventricular systolic dysfunction.

In Phase 2 results, a single injection of MPC-150-IM into the myocardium of patients with moderate to advanced chronic heart failure prevented any HF related hospitalizations or cardiac deaths over three years of follow-up.1 Nonclinical studies showed that intramyocardial administration of MPCs in animal models of heart failure improved cardiac function and attenuated pathological ventricular remodelling. These effects were attributable, at least in part, to MPC secretion of biomolecules that stimulate reparative processes in the failing heart including new blood vessel formation, cardiac muscle cell survival, and reduction in tissue fibrosis.

MPC-150-IM is also being studied in a Phase 2b trial in 159 patients with NYHA Class IV end-stage heart failure patients in conjunction with implantation of a left ventricular assist device (LVAD).A major objective of this trial, which is being sponsored by the United States National Institutes of Health (NIH), is to assess the ability of MPC-150-IM to help wean patients from a LVAD dependent existence for survival (so-called bridge to recovery).

Additionally, the FDA recently cleared the commencement of a 24-patient trial which is being sponsored by Bostons Childrens Hospital. This study combines Mesoblast's proprietary allogeneic MPC-150-IM product with corrective heart surgery in children under the age of 5 with hypoplastic left heart syndrome.

About Chronic Heart Failure In 2016, more than 15 million patients in the seven major global pharmaceutical markets are estimated to have been diagnosed with CHF.2 Prevalence is expected to grow 46% by 2030 in the United States alone, affecting more than 8 million Americans.3 CHF is a progressive disease and is classified in relation to the severity of the symptoms experienced by the patient. The most commonly used classification system was established by the NYHA and ranges from Class I (mild) to Class IV or end stage (severe). Approximately half of people who develop heart failure die within 5 years of diagnosis.4 Patients with late NYHA Class II or Class III CHF continue to represent a significant unmet medical need despite recent advances in new therapies. CHF causes severe economic, social, and personal costs. In the United States, it is estimated that CHF results in direct costs of $60.2 billion annually when identified as a primary diagnosis and $115 billion as part of a disease milieu.5

1.Perin EC, Borow KM, Silva GV, et al. A phase II dose-escalation study of allogeneic mesenchymal precursor cells in patients with ischemic or nonischemic heart failure. Circ Res. 2015; 117:576-84

2.GlobalData-PharmaPoint (2016): Heart Failure-Global Drug Forecast and Market Analysis to 2025

3.AHA Statistical Update Heart Disease and Stroke Statistics-(2017). Circulation. 2017;131:00-00. DOI: 10.1161/CIR.0000000000000485

4.Mozzafarian D, Benjamin EJ, Go AS, et al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics2016 update: a report from the American Heart Association. Circulation. 2016;133:e38-e360

5.A Re-Evaluation of the Costs of Heart Failure and its Implications for Allocation of Health Resources in the United States. Voigt J. Clinl.Cardiol. 37, 5, 312-321 (2014)

About Mesoblast Mesoblast Limited (Nasdaq:MESO) (ASX:MSB)is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblasts allogeneic, off-the-shelf cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

Forward-Looking Statements This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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The rest is here:
Successful Interim Analysis of Efficacy Endpoint in Mesoblast's Phase 3 Trial for Chronic Heart Failure - GlobeNewswire (press release)

A team of scientists from the University of California, Los Angeles has been able to synthesize an artificial thymus, a human organ that is important to the bodys immune system. An artificial thymus, they say, could produce necessary cancer-fighting T-cells for the body.

On demand.

T-cells, of course, are white blood cells which naturally fight diseases that develop in or infect the body. These T-cells are artificial, though, so they would have to be engineered to target specific forms of cancer, in order to be effective. Still, if this is manageable, then it could provide scientists and health practitioners with additional natural defensesalbeit, bionicfor attacking disease.

The thymus rests in front of the heart. It uses stem cells from the blood to make immune-boosting T-cells, which literally circulate throughout the body to specifically target things that dont belong. In this case, the thymus would create T-cells that could seek out specific cancerous growths without jeopardizing the health of existing tissue.

For the study, the Japanese researchers looked at 27 patients who had received transplants form stem cells that had been taken from their own thigh muscles. These patients showed no sign of any major complications; most patients also showed significant improvement with their symptoms.

Research team member Gay Crooks comments, We know that the key to creating a consistent and safe supply of cancer-fighting T-cells would be to control the process in a way that deactivates all T-cell receptors in the transplanted cells, except for the cancer-fighting receptors. It is important, of course, to take stem cells from the patient who needs them because the body is likely to reject any foreign stem cells (and their byproducts). Apparently, they have been at this study for more than two decades but, unfortunately, the researchers acknowledge that past attempts only showed modest results. From these results, though, they were able to devise a method for producing sheets of muscle stem cells which could then be attached to the inner layer of the sac (which encloses the heart). These stem cells will stimulate healing through the production of chemicals which encourage cardiac regeneration, though the stem cells, themselves, do not survive in the long term.

The results of this study have been published in the scientific journal Nature Methods.

Read more:
Can An Artificial Thymus, Made from Stem Cells, Pump Out Enough T-Cells To Fight Cancer? - Dispatch Tribunal

A stem cell treatment for heart failure patients is safe and shows early signs of effectiveness, according to a study published Wednesday.

The study was conducted by Japanese researchers in 27 patients, who received transplants of stem cells taken from their own thigh muscles. There were no major complications, and most patients showed considerable improvement in their symptoms.

The study was published in the open-access Journal of the American Heart Association. Dr Yoshiki Sawa of Osaka University Graduate School of Medicine was the senior author. It can be found at j.mp/stemheart.

However, two San Diego cardiologists who do stem cell research on heart disease cautioned that similar clinical trials have shown promise over the years, only to fail at the end for various reasons. There is no approved stem cell therapy for heart failure.

So while the trial itself appears to be well-conducted, the researchers are very far from actually proving their treatment is effective, said Dr. Richard Schatz of Scripps Health and Dr. Eric Adler of UC San Diego School of Medicine.

For one thing, the trial was small, they said, and larger trials are where the most rigorous scientific evaluations are made.

These early trials have looked beneficial in the past, Adler said. When we do the larger trials, the results are more equivocal.

Adler said the signs of efficacy in this trial are modest. For example, the change in ejection fraction, a measurement of efficiency in pumping blood, rose from 27 percent to 30 percent in 15 of the 27 patients. Their heart failure was associated with a lack of blood flow, or ischemia. The remaining non-ischemic patients actually had a slight decline.

The entire field of stem cell and regenerative therapy for heart disease has been a disappointment to date, Schatz said.

Weve been at it for 20 years now, and we dont have a product or a positive (late-stage) trial, so that tells you pretty much everything you need to know, he said. Its not for lack of trying or billions of dollars invested. Its just very, very difficult.

The cardiac field has had more success with other technologies, such as cardiac stents. Schatz is the co-inventor of the first stent.

In the study, the researchers acknowledge that previous attempts had only been modestly effective. They devised a method of producing sheets of muscle stem cells and attaching them to the inner layer of the sac that encloses the heart, a layer that rests directly on the heart surface.

The stem cell sheets stimulate healing by producing chemicals that stimulate cardiac regeneration, the study said. The cells themselves dont survive in the long term, but by the time they die they have served their purpose.

Loss of function

Heart failure is a progressive disease in which the heart gradually loses its ability to pump blood. This can be triggered by a heart attack or any other cause that damages the heart muscle.

When damaged heart muscle is replaced with scar tissue, as often happens, the heart loses pumping capacity. It becomes overstressed, and its output of blood declines. This limits the patients ability to engage in intensive physical activity. In advanced cases, patients may become bedridden.

Existing treatments include drugs and LVAD units, which take over some of the hearts function to relieve stress. Some drugs may help the heart work more efficiently, but none have been shown to improve heart failure by actually regenerating lost heart muscle.

Stem cell therapy is tested in patients who havent responded well to other treatments. Trials have been and are being conducted in San Diego area hospitals.

Scripps Health has been testing a cardiac stem cell therapy from Los Angeles-based Capricor. The cells, taken from donor hearts, are injected into the coronary artery, where they are expected to settle in the heart and encourage regrowth.

UC San Diego is testing a heart failure therapy from Teva Pharmaceutical Industries. It consists of bone marrow derived mesenchymal precursor cells. These can give rise to several different cell types, including muscle cells.

And many other trials are going on throughout the country and internationally.

Adler and Schatz said theres reason for optimism in the long run, as technologies improve.

Just because the other trials have been negative doesnt mean this technique wont be beneficial, Adler said. Its just too early to tell.

That said, Schatz emphasized that the nature of the three-phase clinical trial process means that the show-stoppers for a treatment typically appear late.

Tighter standards needed

Clean trials trials where we all agree that this is the patient population we want to look at, are needed, he said.

For example, heart failure comes in two types, he said. Ischemic heart failure is caused by heart attacks and blocked arteries, which impede blood flow. Non-ischemic heart failure can be caused by damage from diseases, such as a virus.

Non-ischemics can be younger people, in their 20s and 30s, while the ischemic patients are older. Mixing those patient groups in a single trial is a mistake, he said.

Theyre different animals, Schatz said.

Another pitfall is failing to screen carefully enough to enroll only patients likely to benefit, Schatz said.

You can have a patient who has chest pain, and coronary disease just incidentally, he said.

His shoulder or chest pain is from a virus. So he goes into the trial and gets a placebo injection in his arm of cortisone, and his arm pain goes away. And because hes in that placebo group, hes counted as a success the pain went away. It has nothing to do with his heart. Thats an extreme example, but we actually saw that happen.

In a failed gene therapy trial for heart disease, some patients apparently had received the injection in the wrong location, missing the heart muscle, Schatz said.

You assume they got the gene, but they didnt, Schatz said. The study was negative, and thats why I think it was negative.

Such errors dont show up in Phase 1 trials, Adler and Schatz said, because theyre focused on evaluating safety. And these early trials dont have many patients, there arent enough to comfortably determine the therapy is really effective.

By the last stage of the trial, these sources of error have often been identified and trial standards have tightened up. And thats when the faulty assumptions made early appear as the trial ends in failure.

Despite those forbidding hurdles, Adler said research should continue.

This disease is killing a lot of people. Theres not going to be enough hearts to go around for transplant. Theres six million Americans with heart failure, and theres 2,000 heart transplants a year. So coming up with novel regenerative cell-based therapy is something were still excited about.

bradley.fikes@sduniontribune.com

(619) 293-1020

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Study: heart failure stem cell therapy safe, shows early signs of effectiveness - The San Diego Union-Tribune

TiGenix reports 2016 full year results | P&T Community P&T Community PRESS RELEASERegulated informationinsider information TiGenix reports 2016 full year results (Conference call and webcast today at 13:00 CEST) and more »

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Science Daily

How cells react to injury from open-heart surgery: Research ... Science Daily Investigators have learned how cardiac muscle cells react to a certain type of injury that can be caused by open-heart surgery. The findings point to a new ... and more »

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How cells react to injury from open-heart surgery: Research ... - Science Daily

The U.S. Food and Drug Administration (FDA) has approved a new study that will test the efficacy of a stem cell technique used on children suffering from congenital heart disease.

The study is being hosted by Boston Childrens Hospital and Mesoblast Limited, a regenerative medicine company based in Australia. Their 24-patient trial will test the efficacy of Mesoblasts proprietary allogenic mesenchymal precursor cells (MPCs) in a corrective heart surgery on children under the age of 5 that suffer from hypoplastic left heart syndrome (HLHS), according to an April 3 press release.

The new technique is designed to save more patients with HLHS because current treatment is not always effective. Right now physicians generally perform a single, ventricle palliation, which results in the patient using only the right ventricle to the support the hearts entire circulation. However, the treatment is usually only a temporary fix because the right ventricle will eventually tire out, putting the patient at an increased risk for sudden cardiac arrest.

In the randomized, controlled trial, researchers will inject Mesoblasts MPC-150-IM into the left ventricle during surgical recruitment procedures, which should improve ventricular mass and function and ultimately lead to a higher likelihood of biventricular conversion.

The objective of combining Boston Children Hospitals expertise in pioneering surgical approaches to treating hypoplastic heart syndrome with the regenerative potential of our lead cardiovascular product, MPC-150-IM, is to develop a highly innovative treatment for this complex congenital condition as well as other serious and life-threatening cardiac diseases in children, said Kenneth Brow, the senior clinical development executive and head of cardiovascular diseases at Mesoblast, in a statement.

More:
Researchers will use stem cell therapy to grow heart muscle in new study - Cardiovascular Business

Albany, NY (SBWIRE) 04/04/2017 Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

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Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Read Complete Report @ https://www.tmrresearch.com/stem-cell-therapy-market

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

About TMR Research TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

Our savvy custom-built reports span a gamut of industries such as pharmaceuticals, chemicals and metals, food and beverages, and technology and media, among others. With actionable insights uncovered through in-depth research of the market, we try to bring about game-changing success for our clients.

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Stem Cell Therapy Market Detailed Study Analysis and Forecast by 2025 - MilTech

Eddie Marks is the pioneer in the University of Delaware Department of Medical Laboratory Sciences. Hes the first Ph.D. graduate in program history.

Having completed a professional masters degree in business/biotechnology at UD, Marks jumped at the opportunity of a fledging Ph.D. in the medical sciences program. Of course, Marks was interested in the programs core courses like statistics, immunology and physiology, but the department also granted the aspiring researcher a great deal of independence.

There is a lot of freedom to be able to choose, which is what I really liked coming in, explained Marks, who researches how adult bone narrow stem cells can treat heart attacks. I took a biology ethics course and a materials science course, which, by learning some of the engineering, really helped to further my research.

With a microbiology background, Marks was used to growing cells and working under a microscope, which eased his translation into the field. He was motivated by his adviser Arun Kumar, who also took an interdisciplinary route. Kumar took an organic chemistry background and applied it to nanomedicine. As a masters students, Marks was tapped to work on a stem cell project with Kumar. He took the preliminary data and worked on turning the stem cells into tissue types.

But research is far from Marks only talent. Elsevier Health reached out to Kumar about a book on thymosins, a protein class with diverse biological activities. Kumar and Marks had used one of these thymosin proteins specific to the heart thymosin beta-4 to turn stem cells into heart tissue. So the pair drafted a book chapter on how this protein helps heal our most vital internal organ.

We looked at [the proteins] role in development as the heart is growing, its natural effects after a heart attack, how the protein gets released and how we and other researchers use it to attempt to heal the heart after certain cardiac events, said Marks.

Earlier this month, Marks successfully defended his dissertation Adult Human Bone Marrow Mesenchymal Stem Celled Primed for the Repair of Damaged Cardiac Tissue after Myocardial Infarction. Half of the numbered chapters of the dissertation were published or are currently under review in scientific journals. Each of the six chapters of the dissertation is a paper to be published.

With his Ph.D. in hand, Marks is headed to private industry, which could mean consulting or science writing.

I want to be client-facing and help an array of companies.

Combining the time spent on the masters and Ph.D. program, Marks completed the two degrees in only five and a half years. Around the country, the typical student finishes similar programs between six and eight years time. He credits the department for the unique program design and streamlined process.

The department is very connected to the hospital [Christiana Care] and has a good reputation at the University, said Marks. The faculty knows every group from biology to engineering to the Life Science Research Facility and down to STAR Campus. There are connections everywhere. My dissertation committee had incredibly varied areas of expertise and that would not happen without Medical Laboratory Sciences.

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First Ph.D. recipient - UDaily

Early efforts to harness the potential of stem cells for treating disease were largely focused on regeneration and the ability to repair tissues in the body through cell therapies. However, as technologies have advanced, the focus is shifting to using stem cells in drug discovery applications, such as compound screening, toxicity testing, target identification, and disease modelling. Professor Christine Mummery, from the University of Leiden tells us more and explains why stem cells are particularly suited to these applications.

Why use stem cells?

What is it that makes stem cells such an attractive option for drug discovery studies? One of the main reasons is that they make a much better model of human disease and drug reactions than animal models. As Professor Christine Mummery explains, many commonly used animal models such as mice do not accurately reflect some of the workings of cells and processes in the human body, having different immune systems and characteristics, such as heart rate, for example. This can result in problems with drugs falling down in clinical trials after showing promising results in earlier animal studies.

Using more relevant models provides not only financial savings by highlighting issues earlier in the drug discovery pipeline, but also helps efforts to reduce the number of animals used in research.

Stem cells in toxicity testing

A vital part of determining a drugs safety is assessing its cardiac toxicity. This refers to the side effects a drug can have on the functioning of the heart, such as causing arrhythmias and sudden death. As well as ensuring the safety of a drug, however, there is also a need to not unduly constrain drug development. Improvements in assay design and the implementation of the Comprehensive in Vitro Proarrhythmia Assays (CiPA) are helping to find a balance in this area.

Professor Christine Mummery tells us more about the problem of cardiotoxicity and how stem cell models and CiPA can help.

Stem cells can also play a role in testing the systemic toxicity of drugs. As Dr Glyn Stacey from NIBSC explains, pluripotent stem cell lines are increasingly being used to develop new assays that enable earlier identification of drugs that can have chronic effects on the body.

Endogenous activation of stem cells A novel and promising area of currently developing research is the ability to drive regeneration endogenously using small molecules. As Professor Angela Russell from the University of Oxford describes in the following video, we might not need to rely on using stem cells themselves, but rather small molecule therapeutics that can promote repair in damaged tissues. Circumventing the need for cells could have huge benefits for both the patient and drug developers.

What are some of the hurdles?

Stem cells certainly provide numerous opportunities to accelerate the drug discovery field, but challenges do remain.

A fundamental issue faced by all researchers in this field is ensuring the quality of the cells used. As Dr Glyn Stacey explains, a good level of quality control needs to be maintained throughout, to ensure that cells have not been contaminated or mixed up with another cell line.

Understanding signalling pathways and knowing which growth factors to add to push cells to develop into progenitor cells can also present challenges to researchers developing stem cell based screening assays. Producing sufficient numbers of relevant cell types to conduct a screen is another problem commonly faced.

The final hurdle is translation to the clinic, which relies on proving the safety of a treatment, and ensuring that it does not give rise to secondary conditions. In the case of Professor Angela Russells work, this involves taking careful steps to select compounds that act through correct pathways that wont increase the risk of cancer developing.

What does the future hold?

The roles that stem cells play in the drug discovery process are likely to continue to increase, as developments in technology enable the creation of a wider range of cells and assays. A move towards using cells with greater maturity and models that incorporate a combination of different cell types, enabling the study of interactions between cells is on the horizon. These combinations of cells will teach us a lot about drug discovery and disease, says Professor Christine Mummery.

All interviews from Stem Cells in Drug Discovery 2017 can be found here.

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Stem Cells in Drug Discovery - Technology Networks

SOUTH SAN FRANCISCO, CA--(Marketwired - March 29, 2017) - VistaGen Therapeutics Inc. (VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today that the European Patent Office (EPO) has issued a Notice of Intention to Grant the Company's European Patent Application for AV-101, its oral CNS prodrug candidate in Phase 2 development for major depressive disorder (MDD). The granted claims covering multiple dosage forms of AV-101, treatment of depression and reduction of dyskinesias associated with L-DOPA treatment of Parkinson's disease will be in effect until at least January 2034.

"We are extremely pleased to receive the EPO's notice of intention to grant significant CNS-related patent claims for AV-101, another substantial step forward in our plan to secure a broad spectrum of intellectual property protection for AV-101 covering multiple CNS indications," stated Shawn Singh, Chief Executive Officer of VistaGen.

About AV-101

AV-101 (4-CI-KYN) is an oral CNS prodrug candidate in Phase 2 development in the U.S. as a new generation treatment for major depressive disorder (MDD). AV-101 also has broad potential utility in several other CNS disorders, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases, such as Parkinson's disease and Huntington's disease.

AV-101 is currently being evaluated in a Phase 2 monotherapy study in MDD, a study being fully funded by the U.S. National Institute of Mental Health (NIMH) and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH, as Principal Investigator.

VistaGen is preparing to advance AV-101 into a 180-patient, U.S. multi-center, Phase 2 adjunctive treatment study in MDD patients with an inadequate response to standard FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator.

About VistaGen

VistaGen Therapeutics, Inc. (VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen's lead CNS product candidate, AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development for major depressive disorder (MDD). AV-101's mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company's Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including chronic neuropathic pain, epilepsy, Parkinson's disease and Huntington's disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit.

VistaStem Therapeutics is VistaGen's wholly owned subsidiary focused on applying human pluripotent stem cell technology, internally and with collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. In December 2016, VistaGen exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.

Read More

For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH's Phase 2 (monotherapy) and/or the Company's planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen's filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC's website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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VistaGen Therapeutics Receives European Patent Office Notice of Intention to Grant European Patent for AV-101 - Yahoo Finance

Next wave of innovation and discovery

Over the past 70 years, new surgical techniques and medical therapies, some of which were developed at the Stanford School of Medicine and Packard Childrens, have evolved and greatly improved outcomes for children with almost every type ofcongenital heart disease.

Heart defects that were once universally fatal can now be surgically improved. As patients born with heart disease survive longer, there are now more adults than children in the United States with congenital heart disease. However, further advancements are still needed to ensure a healthier future for patients, many of whom continue to face a compromised quality of life and require subsequent surgeries.

Surgical intervention can repair, but it rarely can truly cure, said pediatric heart surgeonFrank Hanley, MD, who is also the Lawrence Crowley, MD, Endowed Professor in Child Health at the School of Medicine and executive director of the Betty Irene Moore Childrens Heart Center. Children who have received complex surgical intervention to repair a cardiac abnormality require careful monitoring and specialized care throughout their life span. We imagine a day when a child born with a poorly working aortic valve, rather than undergoing multiple open-heart operations throughout his lifetime, instead receives a replacement valve engineered from his own stem cells. Dr. and Mrs. Moores gift comes at a critical juncture enabling us to advance beyond surgical repair to the discovery of transformational treatments and interventions and, ultimately, to true cures.

The center has an overall survival rate of 98 percent. Beyond survival alone, the goal is now to ensure an excellent overall outcome from normal brain function for even the most fragile patients, to the ability for children to perform well in school and to exercise and enjoy an active life into adulthood.

We are committed to providingbabies and children with heart disease and their families with the happiest, healthiest lives possible, from the early identification of problems, to expert intervention, and finally to a lifetime of care and support, saidStephen Roth, MD, MPH, chief of pediatriccardiologyand director of the Betty Irene Moore Childrens Heart Center.

Dr. and Mrs. Moores incredible gift will not only bolster our clinical capabilities for children and families receiving care now in the Betty Irene Moore Childrens Heart Center, it will also accelerate basic and translational research by Stanford Medicine faculty and scientists to develop more precise techniques to predict, prevent and cure, said Lloyd Minor, MD, dean of the School of Medicine. When it comes to achieving precision health, we must think as big as we can not just about treating disease, but about making and keeping people healthy and nowhere is this more true than in children.

In 2017, Packard Childrens will complete its major expansion, becoming the most technologically advanced, family-friendly and environmentally sustainable childrens hospital in the nation. The Moores gift will enable the Childrens Heart Center to expand its state-of-the-art clinical and research facilities, train the future leaders of cardiovascular medicine and surgery, and improve the field of pediatric cardiology and pediatric cardiovascular surgery through innovative research. In addition, the center will expand its clinical facilities, including a newly designed outpatient center.

Packard Childrens established the Childrens Heart Center in 2001 to focus more expertise and resources on congenital heart disease, the most common type of birth defect worldwide. Each year, approximately 40,000 children in the United States are born with heart defects, and an additional 25,000 children develop some kind of acquired heart disease.

The center has gained recognition as a national and international destination program for several highly specialized surgical procedures, and is also a full-service cardiology program that cares for patients with all forms of cardiovascular conditions. Under the leadership of Hanley and Roth, the center receives more than 25,000 patient visits annually and performs 80 to 90 percent of all cardiac surgical care for children in northern and central California.

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$50 million gift to Packard Children's Hospital will advance care ... - Stanford Medical Center Report