Dr. Sara Vasconcelos in the laboratory at Toronto General Hospital on May 11.Christopher Katsarov/The Globe and Mail

When Sara Vasconcelos talks about her work, it sounds as if shes in the restoration business. But instead of repairing damaged buildings, the researcher at Torontos University Health Network wants to fix damaged hearts by using stem cells to rebuild cardiovascular tissue.

Now, Dr. Vasconcelos is one step closer to achieving that goal with a $3-million grant from the Stem Cell Network, a Canadian research funding organization. Her effort is one of 32 projects across the country that rose to the top in a competition for in the largest outlay of federal funding for regenerative medicine in 20 years.

On Thursday, the Ottawa-based network announced a total of $19.5-million in awards, which together with matching funds from various partners, will translate into $42-million for research and clinical trials over the next three years. The funding will enable the work of more than 400 scientists, clinicians and trainees, the organization said.

Its a big step, said Dr. Vasconcelos, who said she will use her award to build on preliminary findings obtained using rats. She will next work with pig hearts, which offer a much closer analogue to the human organ.

While doing so, she also hopes to overcome a barrier that has stood in the path of those who are trying to repair hearts using cardiomyocytes heart tissue cells that are grown from embryonic stem cells. The problem is that the replacement cells wither away if they are not nourished and kept alive by blood vessels.

As part of her project Dr. Vasconcelos aims to use a technique in which small sections of microscopic blood vessels are harvested from human fat and implanted along with the heart cells.

The microvessels that are like Lego pieces, she said. You can put a whole bunch of them in with the stem cell-derived cardiomyocytes and they will connect to each other and connect to the host vessels that carry blood.

With her grant secured, Dr. Vasconcelos said she is assembling the team that will test the method on pig hearts later this year. Ultimately, her goal is to develop the technique into a therapy that can restore cardiac function in human patients following a heart attack, she said.

Among the other projects to win funding are some that are already heading for clinical studies. That includes a large study led by Guy Sauvageau, a hematologist at Maisonneuve-Rosemont Hospital in Montreal, that involves developing engineered blood stem cells to treat leukemia.

Working with a group of clinical sites in the U.S., Dr. Sauvageau and his team have already had success at treating patients with leukemia who relapse. The new project will involve introducing genetical engineered stem cells into people who are better able to withstand cancer treatment and facilitate recovery.

Between 10,000 and 20,000 patients a year would benefit from this kind of therapy, Dr. Sauvageau said.

In the future, he added, the study could open the door to teaching the body to continually produce and replenish its own cancer-killing immune cells rather than having those cells created externally and infused in a form of treatment know as CAR T-cell therapy.

As part of another of the funded projects, David Thompson at the Vancouver Coastal Health Research Institute will conduct clinical trials for one of the worlds first genetically engineered cell replacement therapies for type 1 diabetes.

Dr. Sara Vasconcelos points to an image of vascular tissue in the laboratory at Toronto General Hospital where they engineer cell and tissue regeneration.Christopher Katsarov/The Globe and Mail

The diversity of the projects highlights the increasing prominence of stem cells in multiple domains of health research, an area where Canada has a long track record of success ever since University of Toronto researchers James Till and Ernest McCullough established the existence of stem cells cells which can differentiate into more specialized types in bone marrow in 1961.

Tania Bubela, dean of health sciences at Simon Fraser University in Burnaby, B.C., said the kind of funding the Stem Cell Network provides helps bridge a crucial gap between fundamental laboratory research and proven therapies for patients.

What weve realized over time is that where you get public sector investments to close the funding gap is exactly in that translational space from preclinical into early stage clinical trials, Dr. Bubela said. Once you have that proof that things are going to work and that they can be taken up by the health system, thats when venture capital starts to get interested.

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Heart, cancer and diabetes projects among winners of funding boost for stem cell therapies - The Globe and Mail

Cardiac Stem Cells Comments Off on Heart, cancer and diabetes projects among winners of funding boost for stem cell therapies – The Globe and Mail | May 13th, 2022

Lab animalshave been an essential part of life-altering and lifesaving scientific research and discovery. But a growing number of scientists are calling for an end to their use, and pushing for new methods that can better replicate human biology instead.

Among them is biomedical researcher Dr. Charu Chandrasekera. She'sthe founder and executive director of the Canadian Centre for Alternatives to Animal Methods at the University of Windsor. Here is part of her conversation with Quirks & Quarks host Bob McDonald.

Animal testing historically has been considered a regrettable necessity in the quest to save human lives. Why do you think this is not the case?

Animals have played an integral role in science over the past century or more, to the point where we have made them the gold standard for human biology. And therein lies the problem.

Over 90 per centof drugs tested to be safe and effective in animals, fail in human clinical trials. And even the ones that make it through, they can still be withdrawn or receiveblack box warnings due to unpredicted side effects in humans. And it's not just the drugs that fail, but the drugs that we missed,like the drugs that never made it to human clinical trials because they had some irrelevant side effects in animals. They could very well been safe in humans.So we've likely missed out on many life saving, history altering medications.

Why would a drug work in an animal but not in a human?

Well, there's a very simple answer to that. We humans, we are not 70-kilogram versionsof mice, rats, guinea pigs, rabbits, cats, dogs, sheep or monkeys. We're human. We're separated by hundreds of millions of years of evolution from some of these laboratory animal species.

And it's not only just the species' differences, but there are also so many issues with the way we conduct this research. We have to induce disease by either doing surgical modifications, giving them a high-fat diet. So dietary modifications, genetic modifications, take out a gene, put in a gene, or chemically destroy their pancreas, for example, to create diabetic models. So when you're doing these experimental modifications in these animals, you're really not recreating the human disease. You are creating a version of a human disease.

What motivated you to go from doing animal research in your lab to trying to end the practice altogether?

It was the scientific failures combined with the ethical standards that I was not happy with. So I worked with animal models of heart failure. And while I was doing all these studies, my dad actually had a heart attack and he required quadruple bypass surgery. And while I was with him at the Halifax Heart Centre, I thought to myself, is the research that I'm doing going to truly help humans like my father and everybody else in this ward?

A few weeks later, when I came back to the lab, I ran into this veteran cardiovascular researcher, and he had worked on receptors similar to the ones that I was working on. And I just looked at him and I said, "Do you think these receptors were activated in my dad's heart during his heart attack?" And his response was, "How the hell would I know? We've never looked at this in the human heart."And for me, that day, it was a profound realization. It was almost like an epiphany. What am I doing this for?

Those are the reasons why we should end animal research. Let's explore some of the solutions. What are some of the alternative methods to animals in research that are being developed?

Recreating human biology in a petri dish is no easy feat. There's no single magical method that can replace all animal testing tomorrow morning. It's really all about context of use, fit for purpose. What is the biological question you're trying to answer, and in what context, and how best can we address that?

So we can use human cells and tissues from cadavers and surgical remains. We can take a diseased heart removed during transplant surgery and bring it back to life in the lab, make it beat again, infused with drugs to study cardiac physiology and cardiac toxicity. We can take just a single human cell and obtain hundreds of data points on human DNA and RNA through multiomics studies. We can engineer human tissue, create miniature organ models like organoids to recapitulated complex diseases using stem cell technologies. The field is just exploding.

Can you give me a list of some of the projects that you're working on at your centreright now?

We currently have liver, gut, kidney, lung and blood brain barrier models in development. And we have a number of projects that incorporate these tissues in different configurations to create disease in a dish, and toxicity on a chip. One of the first disease models we're creating is diabetes in a dish, and we're also doing Alzheimer's in a dish. We actually have a project designed specifically to reduce and replace toxicity testing in dogs. And we even have an eco-toxicology project where we're using fish lines to replace toxicity testing on live fish.

This is all based on evidence now. So for some of these methods that we have, we are already seeing that they are able to recapitulate these human responses. We can actually look at the data that we get from using these new technologies and compare them against existing data. But we are also seeing things like new data where we're going back and reevaluating these old drugs that failed in one system and then putting them through a human biology based system. And we're seeing that they are able to predict human biology better.

How hopeful are you that we can make this shift away from using animals in scientific research?

I'm actually very hopeful that we will be able to shift away from this animal-centred paradigm to one where human biology is the gold standard and humans are the quintessential animal model. There are scientific, innovative financial and legislative efforts happening around the world to make this happen.

The goal really is to reduce as much as possible at this point. And even if we needed to use animals, could they become the last resort that you are only using, you know, five rats, for example, for a procedure that required 400 rats before?So because of all of these efforts happening globally, I'm very hopeful.

Produced by Amanda Buckiewicz. This interview has been edited for length and clarity.

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Meet the Canadian researcher determined to take the animals out of lab testing - CBC.ca

Cardiac Stem Cells Comments Off on Meet the Canadian researcher determined to take the animals out of lab testing – CBC.ca | May 13th, 2022

Stem Cell Investig. 2019; 6: 19.

1Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran;

2Department of Clinical Sciences, Faculty of Veterinary Medicine, University of Tabriz, Tabriz, Iran;

2Department of Clinical Sciences, Faculty of Veterinary Medicine, University of Tabriz, Tabriz, Iran;

3Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

1Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran;

2Department of Clinical Sciences, Faculty of Veterinary Medicine, University of Tabriz, Tabriz, Iran;

3Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

Contributions: (I) Conception and design: E Fathi, R Farahzadi; (II) Administrative support: E Fathi, R Farahzadi; (III) Provision of study materials or patients: None; (IV) Collection and assembly of data: R Farahzadi, N Rajabzadeh; (V) Data analysis and interpretation: All authors; (VI) Manuscript writing: All authors; (VII) Final approval of manuscript: All authors.

#These authors contributed equally to this work.

Received 2018 Nov 11; Accepted 2019 Mar 17.

Recent developments in the stem cell biology provided new hopes in treatment of diseases and disorders that yet cannot be treated. Stem cells have the potential to differentiate into various cell types in the body during age. These provide new cells for the body as it grows, and replace specialized cells that are damaged. Since mesenchymal stem cells (MSCs) can be easily harvested from the adipose tissue and can also be cultured and expanded in vitro they have become a good target for tissue regeneration. These cells have been widespread used for cell transplantation in animals and also for clinical trials in humans. The purpose of this review is to provide a summary of our current knowledge regarding the important and types of isolated stem cells from different sources of animal models such as horse, pig, goat, dog, rabbit, cat, rat, mice etc. In this regard, due to the widespread use and lot of attention of MSCs, in this review, we will elaborate on use of MSCs in veterinary medicine as well as in regenerative medicine. Based on the studies in this field, MSCs found wide application in treatment of diseases, such as heart failure, wound healing, tooth regeneration etc.

Keywords: Mesenchymal stem cells (MSCs), animal model, cell-based therapy, regenerative medicine

Stem cells are one of the main cells of the human body that have ability to grow more than 200 types of body cells (1). Stem cells, as non-specialized cells, can be transformed into highly specialized cells in the body (2). In the other words, Stem cells are undifferentiated cells with self-renewal potential, differentiation into several types of cells and excessive proliferation (3). In the past, it was believed that stem cells can only differentiate into mature cells of the same organ. Today, there are many evidences to show that stem cells can differentiate into the other types of cell as well as ectoderm, mesoderm and endoderm. The numbers of stem cells are different in the tissues such as bone marrow, liver, heart, kidney, and etc. (3,4). Over the past 20 years, much attention has been paid to stem cell biology. Therefore, there was a profound increase in the understanding of its characteristics and the therapeutic potential for its application (5). Today, the utilization of these cells in experimental research and cell therapy represents in such disorders including hematological, skin regeneration and heart disease in both human and veterinary medicine (6).The history of stem cells dates back to the 1960s, when Friedenstein and colleagues isolated, cultured and differentiated to osteogenic cell lineage of bone marrow-derived cells from guinea pigs (7). This project created a new perspective on stem cell research. In the following, other researchers discovered that the bone marrow contains fibroblast-like cells with congenic potential in vitro, which were capable of forming colonies (CFU-F) (8). For over 60 years, transplantation of hematopoietic stem cells (HSCs) has been the major curative therapy for several genetic and hematological disorders (9). Almost in 1963, Till and McCulloch described a single progenitor cell type in the bone marrow which expand clonally and give rise to all lineages of hematopoietic cells. This research represented the first characterization of the HSCs (10). Also, the identification of mouse embryonic stem cells (ESCs) in 1981 revolutionized the study of developmental biology, and mice are now used extensively as one of the best option to study stem cell biology in mammals (11). Nevertheless, their application a model, have limitations in the regenerative medicine. But this model, relatively inexpensive and can be easily manipulated genetically (12). Failure to obtain a satisfactory result in the selection of many mouse models, to recapitulate particular human disease phenotypes, has forced researchers to investigate other animal species to be more probably predictive of humans (13). For this purpose, to study the genetic diseases, the pig has been currently determined as one the best option of a large animal model (14).

Stem cells, based on their differentiation ability, are classified into different cell types, including totipotent, pluripotent, multipotent, or unipotent. Also, another classification of these cells are based on the evolutionary stages, including embryonic, fetal, infant or umbilical cord blood and adult stem cells (15). shows an overview of stem cells classifications based on differentiation potency.

An overview of the stem cell classification. Totipotency: after fertilization, embryonic stem cells (ESCs) maintain the ability to form all three germ layers as well as extra-embryonic tissues or placental cells and are termed as totipotent. Pluripotency: these more specialized cells of the blastocyst stage maintain the ability to self-renew and differentiate into the three germ layers and down many lineages but do not form extra-embryonic tissues or placental cells. Multipotency: adult or somatic stem cells are undifferentiated cells found in postnatal tissues. These specialized cells are considered to be multipotent; with very limited ability to self-renew and are committed to lineage species.

Toti-potent cells have the potential for development to any type of cell found in the organism. In the other hand, the capacity of these cells to develop into the three primary germ cell layers of the embryo and into extra-embryonic tissues such as the placenta is remarkable (15).

The pluripotent stem cells are kind of stem cells with the potential for development to approximately all cell types. These cells contain ESCs and cells that are isolated from the mesoderm, endoderm and ectoderm germ layers that are organized in the beginning period of ESC differentiation (15).

The multipotent stem cells have less proliferative potential than the previous two groups and have ability to produce a variety of cells which limited to a germinal layer [such as mesenchymal stem cells (MSCs)] or just a specific cell line (such as HSCs). Adult stem cells are also often in this group. In the word, these cells have the ability to differentiate into a closely related family of cells (15).

Despite the increasing interest in totipotent and pluripotent stem cells, unipotent stem cells have not received the most attention in research. A unipotent stem cell is a cell that can create cells with only one lineage differentiation. Muscle stem cells are one of the example of this type of cell (15). The word uni is derivative from the Latin word unus meaning one. In adult tissues in comparison with other types of stem cells, these cells have the lowest differentiation potential. The unipotent stem cells could create one cell type, in the other word, these cells do not have the self-renewal property. Furthermore, despite their limited differentiation potential, these cells are still candidates for treatment of various diseases (16).

ESCs are self-renewing cells that derived from the inner cell mass of a blastocyst and give rise to all cells during human development. It is mentioned that these cells, including human embryonic cells, could be used as suitable, promising source for cell transplantation and regenerative medicine because of their unique ability to give rise to all somatic cell lineages (17). In the other words, ESCs, pluripotent cells that can differentiate to form the specialized of the various cell types of the body (18). Also, ESCs capture the imagination because they are immortal and have an almost unlimited developmental potential. Due to the ethical limitation on embryo sampling and culture, these cells are used less in research (19).

HSCs are multipotent cells that give rise to blood cells through the process of hematopoiesis (20). These cells reside in the bone marrow and replenish all adult hematopoietic lineages throughout the lifetime of the human and animal (21). Also, these cells can replenish missing or damaged components of the hematopoietic and immunologic system and can withstand freezing for many years (22).The mammalian hematopoietic system containing more than ten different mature cell types that HSCs are one of the most important members of this. The ability to self-renew and multi-potency is another specific feature of these cells (23).

Adult stem cells, as undifferentiated cells, are found in numerous tissues of the body after embryonic development. These cells multiple by cell division to regenerate damaged tissues (24). Recent studies have been shown that adult stem cells may have the ability to differentiate into cell types from various germ layers. For example, bone marrow stem cells which is derived from mesoderm, can differentiate into cell lineage derived mesoderm and endoderm such as into lung, liver, GI tract, skin, etc. (25). Another example of adult stem cells is neural stem cells (NSCs), which is derived from ectoderm and can be differentiate into another lineage such as mesoderm and endoderm (26). Therapeutic potential of adult stem cells in cell therapy and regenerative medicine has been proven (27).

For the first time in the late 1990s, CSCs were identified by John Dick in acute myeloid diseases. CSCs are cancerous cells that found within tumors or hematological cancers. Also, these cells have the characteristics of normal stem cells and can also give rise to all cell types found in a particular cancer sample (28). There is an increasing evidence supporting the CSCs hypothesis. Normal stem cells in an adult living creature are responsible for the repair and regeneration of damaged as well as aged tissues (29). Many investigations have reported that the capability of a tumor to propagate and proliferate relies on a small cellular subpopulation characterized by stem-like properties, named CSCs (30).

Embryonic connective tissue contains so-called mesenchymes, from which with very close interactions of endoderm and ectoderm all other connective and hematopoietic tissues originate, Whereas, MSCs do not differentiate into hematopoietic cell (31). In 1924, Alexander A. Maxi mow used comprehensive histological detection to identify a singular type of precursor cell within mesenchyme that develops into various types of blood cells (32). In general, MSCs are type of cells with potential of multi-lineage differentiation and self-renewal, which exist in many different kinds of tissues and organs such as adipose tissue, bone marrow, skin, peripheral blood, fallopian tube, cord blood, liver and lung et al. (4,5). Today, stem cells are used for different applications. In addition to using these cells in human therapy such as cell transplantation, cell engraftment etc. The use of stem cells in veterinary medicine has also been considered. The purpose of this review is to provide a summary of our current knowledge regarding the important and types of isolated stem cells from different sources of animal models such as horse, pig, goat, dog, rabbit, cat, rat, mice etc. In this regard, due to the widespread use and lot of attention of MSCs, in this review, we will elaborate on use of MSCs in veterinary medicine.

The isolation method, maintenance and culture condition of MSCs differs from the different tissues, these methods as well as characterization of MSCs described as (36). MSCs could be isolated from the various tissues such as adipose tissue, bone marrow, umbilical cord, amniotic fluid etc. (37).

Diagram for adipose tissue-derived mesenchymal stem cell isolation (3).

Diagram for bone marrow-derived MSCs isolation (33). MSC, mesenchymal stem cell.

Diagram for umbilical cord-derived MSCs isolation (34). MSC, mesenchymal stem cell.

Diagram for isolation of amniotic fluid stem cells (AFSCs) (35).

Diagram for MSCs characterization (35). MSC, mesenchymal stem cell.

The diversity of stem cell or MSCs sources and a wide aspect of potential applications of these cells cause to challenge for selecting an appropriate cell type for cell therapy (38). Various diseases in animals have been treated by cell-based therapy. However, there are immunity concerns regarding cell therapy using stem cells. Improving animal models and selecting suitable methods for engraftment and transplantation could help address these subjects, facilitating eventual use of stem cells in the clinic. Therefore, for this purpose, in this section of this review, we provide an overview of the current as well as previous studies for future development of animal models to facilitate the utilization of stem cells in regenerative medicine (14). Significant progress has been made in stem cells-based regenerative medicine, which enables researchers to treat those diseases which cannot be cured by conventional medicines. The unlimited self-renewal and multi-lineage differentiation potential to other types of cells causes stem cells to be frontier in regenerative medicine (24). More researches in regenerative medicine have been focused on human cells including embryonic as well as adult stem cells or maybe somatic cells. Today there are versions of embryo-derived stem cells that have been reprogrammed from adult cells under the title of pluripotent cells (39). Stem cell therapy has been developed in the last decade. Nevertheless, obstacles including unwanted side effects due to the migration of transplanted cells as well as poor cell survival have remained unresolved. In order to overcome these problems, cell therapy has been introduced using biocompatible and biodegradable biomaterials to reduce cell loss and long-term in vitro retention of stem cells.

Currently in clinical trials, these biomaterials are widely used in drug and cell-delivery systems, regenerative medicine and tissue engineering in which to prevent the long-term survival of foreign substances in the body the release of cells are controlled (40).

Today, the incidence and prevalence of heart failure in human societies is a major and increasing problem that unfortunately has a poor prognosis. For decades, MSCs have been used for cardiovascular regenerative therapy as one of the potential therapeutic agents (41). Dhein et al. [2006] found that autologous bone marrow-derived mesenchymal stem cells (BMSCs) transplantation improves cardiac function in non-ischemic cardiomyopathy in a rabbit model. In one study, Davies et al. [2010] reported that transplantation of cord blood stem cells in ovine model of heart failure, enhanced the function of heart through improvement of right ventricular mass, both systolic and diastolic right heart function (42). In another study, Nagaya et al. [2005] found that MSCs dilated cardiomyopathy (DCM), possibly by inducing angiogenesis and preventing cardial fibrosis. MSCs have a tremendous beneficial effect in cell transplantation including in differentiating cardiomyocytes, vascular endothelial cells, and providing anti-apoptotic as well angiogenic mediators (43). Roura et al. [2015] shown that umbilical cord blood mesenchymal stem cells (UCBMSCs) are envisioned as attractive therapeutic candidates against human disorders progressing with vascular deficit (44). Ammar et al., [2015] compared BMSCs with adipose tissue-derived MSCs (ADSCs). It was demonstrated that both BMSCs and ADSCs were equally effective in mitigating doxorubicin-induced cardiac dysfunction through decreasing collagen deposition and promoting angiogenesis (45).

There are many advantages of small animal models usage in cardiovascular research compared with large animal models. Small model of animals has a short life span, which allow the researchers to follow the natural history of the disease at an accelerated pace. Some advantages and disadvantages are listed in (46).

Despite of the small animal model, large animal models are suitable models for studies of human diseases. Some advantages and disadvantages of using large animal models in a study protocol planning was elaborated in (47).

Chronic wound is one of the most common problem and causes significant distress to patients (48). Among the types of tissues that stem cells derived it, dental tissuederived MSCs provide good sources of cytokines and growth factors that promote wound healing. The results of previous studies showed that stem cells derived deciduous teeth of the horse might be a novel approach for wound care and might be applied in clinical treatment of non-healing wounds (49). However, the treatment with stem cells derived deciduous teeth needs more research to understand the underlying mechanisms of effective growth factors which contribute to the wound healing processes (50). This preliminary investigation suggests that deciduous teeth-derived stem cells have the potential to promote wound healing in rabbit excisional wound models (49). In the another study, Lin et al. [2013] worked on the mouse animal model and showed that ADSCs present a potentially viable matrix for full-thickness defect wound healing (51).

Many studies have been done on dental reconstruction with MSCs. In one study, Khorsand et al. [2013] reported that dental pulp-derived stem cells (DPSCs) could promote periodontal regeneration in canine model. Also, it was shown that canine DPSCs were successfully isolated and had the rapid proliferation and multi-lineage differentiation capacity (52). Other application of dental-derived stem cells is shown in .

Diagram for application of dental stem cell in dentistry/regenerative medicine (53).

As noted above, stem cells have different therapeutic applications and self-renewal capability. These cells can also differentiate into the different cell types. There is now a great hope that stem cells can be used to treat diseases such as Alzheimer, Parkinson and other serious diseases. In stem cell-based therapy, ESCs are essentially targeted to differentiate into functional neural cells. Today, a specific category of stem cells called induced pluripotent stem (iPS) cells are being used and tested to generate functional dopamine neurons for treating Parkinson's disease of a rat animal model. In addition, NSC as well as MSCs are being used in neurodegenerative disorder therapies for Alzheimers disease, Parkinsons disease, and stroke (54). Previous studies have shown that BMSCs could reduce brain amyloid deposition and accelerate the activation of microglia in an acutely induced Alzheimers disease in mouse animal model. Lee et al. [2009] reported that BMSCs can increase the number of activated microglia, which effective therapeutic vehicle to reduce A deposits in AD patients (55). In confirmation of previous study, Liu et al. [2015] showed that transplantation of BMSCs in brain of mouse model of Alzheimers disease cause to decrease in amyloid beta deposition, increase in brain-derived neurotrophic factor (BDNF) levels and improvements in social recognition (56). In addition of BMSCs, NSCs have been proposed as tools for treating neurodegeneration disease because of their capability to create an appropriate cell types which transplanted. kerud et al. [2001] demonstrated that NSCs efficiently express high level of glial cell line-derived neurotrophic factor (GDNF) in vivo, suggesting a use of these cells in the treatment of neurodegenerative disorders, including Parkinsons disease (57). In the following, Venkataramana et al. [2010] transplanted BMSCs into the sub lateral ventricular zones of seven Parkinsons disease patients and reported encouraging results (58).

The human body is fortified with specialized cells named MSCs, which has the ability to self-renew and differentiate into various cell types including, adipocyte, osteocyte, chondrocyte, neurons etc. In addition to mentioned properties, these cells can be easily isolated, safely transplanted to injured sites and have the immune regulatory properties. Numerous in vitro and in vivo studies in animal models have successfully demonstrated the potential of MSCs for various diseases; however, the clinical outcomes are not very encouraging. Based on the studies in the field of stem cells, MSCs find wide application in treatment of diseases, such as heart failure, wound healing, tooth regeneration and etc. In addition, these cells are particularly important in the treatment of the sub-branch neurodegenerative diseases like Alzheimer and Parkinson.

The authors wish to thank staff of the Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Funding: The project described was supported by Grant Number IR.TBZMED.REC.1396.1218 from the Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Conflicts of Interest: The authors have no conflicts of interest to declare.

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Stem cell-based regenerative medicine - PMC

Cardiac Stem Cells Comments Off on Stem cell-based regenerative medicine – PMC | April 29th, 2022

The new report by Expert Market Research titled, Global Stem Cell Market Report and Forecast 2022-2027, gives an in-depth analysis of the globalstem cell market, assessing the market based on its segments like types, treatment types, applications and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

Request a free sample copy in PDF or view the report summary@https://www.expertmarketresearch.com/reports/stem-cell-market/requestsample

The key highlights of the report include:

Market Overview (2017-2027)

The stem cell business is growing due to an increase in activities to use stem cells in regenerative treatments due to their medicinal qualities. The increasing use of human-induced pluripotent stem cells (iPSCs) for the treatment of hereditary cardiac difficulties, neurological illnesses, and genetic diseases such as recessive dystrophic epidermolysis bullosa (RBED) is driving the market forward.

Furthermore, because human-induced pluripotent stem cells (iPSCs) may reverse immunosuppression, they serve as a major source of cells for auto logic stem cell therapy, boosting the industrys expansion. Furthermore, the rising incentives provided by major businesses to deliver breakthrough stem cell therapies, as well as the increased use of modern resources and techniques in research and development activities (R&D), are propelling the stem cell market forward.

Because of increased research and development (R&D) in the United States and Canada, North America accounts for a significant portion of the overall stem cell business. Furthermore, the increased frequency of non-communicable chronic diseases such as cancer and Parkinsons disease, among others, is boosting the use of stem cell therapy, boosting the industrys growth. Furthermore, the regions stronghealthcaresector is improving access to innovative cell therapy treatments, assisting the regional stem cell industrys expansion. Aside from that, due to the rising use of regenerative treatments, the Asia Pacific area is predicted to rise rapidly. Furthermore, rising clinical trials are assisting market expansion due to low labour costs and the availability of raw materials in the region, contributing considerably to overall industry growth.

Industry Definition and Major Segments

A stem cell is a type of cell that has the ability to develop into a variety of cells, including brain cells and muscle cells. It can also help to repairtissuesthat have been injured. Because stem cells have the potential to treat a variety of non-communicable and chronic diseases, including Alzheimers and diabetes, theyre being used in medical and biotechnological research to repair tissue damage caused by diseases.

Explore the full report with the table of contents@https://www.expertmarketresearch.com/reports/stem-cell-market

The major product types of stem cell are:

The market can be broadly categorised on the basis of its treatment types into:

Based on applications, the market is divided into:

The EMR report looks into the regional markets of stem cell-like:

Market Trends

The market is expected to rise due to increased research activity in regenerative medicine and biotechnology to personalise stem cell therapy. The usage of stem cells is predicted to increase as the need for treatment of common disorders, such as age-related macular degeneration (AMD), grows among the growing geriatric population. Due to multiple error bars during research operations, it becomes extremely difficult to characterise cell products because each cell has unique properties. As a result, the integration of cutting-edge technologies such as artificial intelligence (AI), blockchain, and machine learning is accelerating. Artificial intelligence (AI) is being used to analyse images quickly, forecast cell functions, and classify tissues in order to identify cell products, which is expected to boost the market growth.

With the rising frequency of cancer and cancer-related research initiatives, blockchain technology is increasingly being used to collect and assimilate data in order to improve access to clinical outcomes and the latest advances. Blockchain can also help with data storage for patients while improving the cost-effectiveness of cord-blood banking for advanced research and development (R&D) purposes. In addition, the use of machine learning techniques to analyse photos and infer the relationship between cellular features is boosting the market growth. The increased interest in understanding cellular processes and identifying critical processes using deep learning is expected to move the stem cell business forward.

Latest News on Global Stem Cell Market@https://www.expertmarketresearch.com/pressrelease/global-stem-cell-market

Key Market Players

The major players in the market are Pluristem Therapeutics Inc., Thermo Fisher Scientific Inc., Cellular Engineering Technologies, Merck KGaA, Becton, Dickinson and Company, and STEMCELL Technologies Inc The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

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Expert Market Research is a leading business intelligence firm, providing custom and syndicated market reports along with consultancy services for our clients. We serve a wide client base ranging from Fortune 1000 companies to small and medium enterprises. Our reports cover over 100 industries across established and emerging markets researched by our skilled analysts who track the latest economic, demographic, trade and market data globally.

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Global Stem Cell Market To Be Driven By Increasing Activities To Use Stem Cells In Regenerative Medicines In The Forecast Period Of 2022-2027 ...

Cardiac Stem Cells Comments Off on Global Stem Cell Market To Be Driven By Increasing Activities To Use Stem Cells In Regenerative Medicines In The Forecast Period Of 2022-2027 … | April 29th, 2022

By Steve Gorman

(Reuters) The first all-private astronaut crew to fly aboard the International Space Station (ISS) headed for splashdown Monday off the coast of Florida, wrapping up a two-week mission that NASA has touted as a landmark in commercial spaceflight.

A SpaceX Crew Dragon capsule carrying the four-man team of Houston-based startup Axiom Space Inc began its return flight about 9 p.m. EDT Sunday (0100 Monday GMT) as it undocked from the space station orbiting about 250 miles (420 km) above Earth.

The Crew Dragon was expected to parachute into the Atlantic around 1 p.m. EDT on Monday (1700 GMT), capping a 16-hour ride home from orbit that had been postponed for several days because of unfavorable weather.

The multinational Axiom team was led by Spanish-born retired NASA astronaut Michael Lopez-Alegria, 63, the companys vice president for business development. His second-in-command was Larry Connor, 72, a technology entrepreneur and aerobatics aviator from Ohio designated the mission pilot.

Joining them as mission specialists were investor-philanthropist and former Israeli fighter pilot Eytan Stibbe, 64, and Canadian businessman and philanthropist Mark Pathy, 52.

Launched from NASAs Kennedy Space Center on April 8, they spent 15 days aboard the space station with the seven regular, government-paid ISS crew members: three American astronauts, a German astronaut and three Russian cosmonauts.

The ISS has hosted several wealthy space tourists from time to time over the years.

But the Axiom quartet was the first all-commercial team ever welcomed to the space station as working astronauts, bringing with them 25 science and biomedical experiments to conduct in orbit. The package included research on brain health, cardiac stem cells, cancer and aging, as well as a technology demonstration to produce optics using the surface tension of fluids in microgravity.

Axiom, NASA and SpaceX have hailed the mission as a milestone in the expansion of privately funded space-based commerce, constituting what industry insiders call the low-Earth orbit economy, or LEO economy for short.

It was the sixth human spaceflight for SpaceX in nearly two years, following four NASA astronaut missions to the ISS and the Inspiration 4 flight in September that sent an all-private crew into Earth orbit for the first time, though not to the space station.

SpaceX, the private rocket company founded by Tesla Inc electric carmaker CEO Elon Musk, has been hired to fly three more Axiom astronaut missions to ISS over the next two years. The price tag for such outings is high.

Axiom charges customers $50 million to $60 million per seat, according to Mo Islam, head of research for the investment firm Republic Capital, which holds stakes in both Axiom and SpaceX.

Axiom also was selected by NASA in 2020 to build a new commercial addition to the space station, which a U.S.-Russian-led consortium of 15 countries has operated for more than two decades. Plans call for the Axiom segment to eventually replace the ISS when the rest of the station is retired around 2030.

(Reporting by Steve Gorman in Los Angeles. Editing by Gerry Doyle)

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First all-private astronaut team aboard space station heads for splashdown - KFGO

Cardiac Stem Cells Comments Off on First all-private astronaut team aboard space station heads for splashdown – KFGO | April 29th, 2022

Newswise April 28, 2022 (BRONX, NY)CAR-T therapy, a form of immunotherapy that revs up T-cells to recognize and destroy cancer cells, has revolutionized the treatment of blood cancers, including certain leukemias, lymphomas, and most recently, multiple myeloma. However, Black and Hispanic people were largely absent from the major clinical trials that led to the U.S. Food and Drug Administration approval of CAR-T cell therapies.

In a study published today in Bone Marrow Transplantation (BMT), investigators at the National Cancer Institute-designated Montefiore Einstein Cancer Center (MECC) report that Black and Hispanic patients had outcomes and side effects following CAR-T treatment that were comparable to their white and Asian counterparts.

Representation in cancer clinical trials is vital to ensuring that treatments are safe and effective for everyone, said Mendel Goldfinger, M.D., co-corresponding author of the paper, a medical oncologist at Montefiore Health System, assistant professor of medicine at Albert Einstein College of Medicine, and member of the MECC Cancer Therapeutics Program. We couldnt have been happier to learn that our patients who identify as Black and Hispanic have the same benefits from CAR-T therapy as white patients. We can only begin to say that a cancer treatment is transformational when these therapies benefit everyone who comes to us for care.

People who identify as Black and Hispanic often have tumor biology, immune system biology, and side effects that are distinct from white people. However, very few minorities were enrolled in the major trials that led the FDA to approve CAR-T cell therapy.

Parity for Black and Hispanic PatientsThe new BMT study evaluated outcomes for 46 participants treated at Montefiore between 2015 and 2021. Seventeen of the participants were Hispanic, 9 were African American, 15 were white, and 5 were Asian.

Among Black and Hispanic patients, 58% achieved a complete response after treatment and 19% achieved a partial response. For white and Asian patients, 70% achieved a complete response and 20% had a partial response, indicating no statistical differences among racial and ethnic backgrounds. Results were similar with respect to major side effects experienced: Approximately 95% of participants in each group had mild to moderate cytokine release syndrome, a common side effect to immunotherapy in which people experience fever and other flu-like symptoms.

Diversifying Cancer Clinical TrialsOur findings demonstrate that we are able to effectively treat people from historically marginalized groups using CAR-T; our hope is that more people from a diverse range of racial and ethnic backgrounds will be included in clinical trials, said co-author Amit Verma, M.B.B.S., associate director of translational science at MECC, director of the division of hemato-oncology at Montefiore and Einstein, and professor of medicine and of developmental and molecular biology at Einstein. Ira Braunschweig, M.D., associate professor of medicine at Einstein and director of Stem Cell Transplantation and Cellular Therapy and clinical program director, Hematologic Malignancies at Montefiore, is also co-corresponding author on the study.

At Montefiore, approximately 80% of clinical trial participants are minorities, compared with the nationwide figure of only 8%.

As an academic medical center, it is not enough to make novel therapies like CAR-T available, said Susan Green-Lorenzen, R.N. M.S.N., system senior vice president of operations at Montefiore and study co-author. We need to be at the forefront of ensuring that these treatments are effective for the communities we serve this research reflects this commitment.

The study is titled Efficacy and safety of CAR-T cell therapy in minorities. In addition to Drs. Goldfinger, Verma, and Braunschweig and Ms. Green-Lorenzen, other Einstein and Montefiore authors are Astha Thakkar, M.D., Michelly Abreu, N.P., Kith Pradhan, Ph.D., R. Alejandro Sica, M.D., Aditi Shastri, M.D., Noah Kornblum, M.D., Nishi Shah, M.D., M.P.H., Ioannis Mantzaris, M.D., M.S., Kira Gritsman, M.D., Ph.D., Eric Feldman, M.D., and Richard Elkind, P.A.-C.

***

About Albert Einstein College of MedicineAlbert Einstein College of Medicineis one of the nations premier centers for research, medical education and clinical investigation. During the 2021-22 academic year, Einstein is home to 732M.D.students, 190Ph.D.students, 120 students in thecombined M.D./Ph.D. program, and approximately 250postdoctoral research fellows. The College of Medicine has more than 1,900 full-time faculty members located on the main campus and at itsclinical affiliates. In 2021, Einstein received more than $185 million in awards from the National Institutes of Health. This includes the funding of majorresearch centersat Einstein in cancer, aging, intellectual development disorders, diabetes, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership withMontefiore, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. For more information, please visiteinsteinmed.org, read ourblog, followus onTwitter, like us onFacebook,and view us onYouTube.

About Montefiore Health SystemMontefiore Health System is one of New Yorks premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable caretoapproximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 10hospitals, including the Childrens Hospital at Montefiore, Burke Rehabilitation Hospital and more than 200 outpatient ambulatory care sites. The advanced clinical and translational research at its medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation,toits preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive caretopatients and their families. For more information, please visitwww.montefiore.org. Followus onTwitter and Instagram and LinkedIn, or view us onFacebookandYouTube.

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Montefiore Einstein Cancer Center Finds CAR-T Therapy Effective in Black and Hispanic Patients - Newswise

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The change in the prevalence of HHD

At the global level, the prevalence of HHD increased by 137.91% from 7.82 million in 1990 to 19.60 million in 2019 (Fig.1A, Table S1). The prevalence rate went up year by year, while the ASPR was relatively stable (Fig. 1C). The ASPR was 233.77 (95% UI=170.52312.9) per 100,000 population in 2019, which increased slightly compared with that in 1990 with an EAPC of 0.17 (95% UI=0.150.18) (Fig. 1C, Tables S2 and S3). Compared with the ASPR trend of the female subjects (EAPC, 0.28, 95% UI=0.260.30), the trend of the male subjects was more stable during the study period (EAPC, 0.02, 95% UI=0.000.04, Table S3).

The global trend of hypertensive heart disease from 1990 to 2019. The number of prevalence (A), death (D), and DALY (G). The rate of prevalence (B), death (E), and DALY (H). Age-standardized rate of prevalence (C), death (F), and DALY (I). Dashed lines represent 95% uncertainty interval; DALY, disability adjusted life-year

HHD occurred mostly in people aged over 65 (Fig. S1A). We also found that the ASPR increased with age growth for both men and women in 1990 and 2019. The female prevalence rate was much higher than male in people aged over 80 during 2019, yet there was a similar prevalence rate for aged men and women in 1990 (Fig.2).

The gender-specific global prevalence, death, and DALY rate of hypertensive heart disease in 1990 and 2019. The vertical axis represents DALY, death, and prevalence rate (per 100,000 population). DALY, disability adjusted life-year

Among 25 GBD regions, top three regions with the highest prevalence cases were Asia, East Asia, and America. In addition, the three regions with the highest ASPR were East Asia (426.15, 95% UI=306.64574.76), Oceania (344.91, 95% UI=248.54477.87), and Southeast Asia (334.77, 95% UI=244.81451.58) (Table S4). At the national level, China carried the highest HHD prevalence, followed by the United States of America and India (Fig. S2A). The highest ASPR of HHD occurred in Cook Islands, Jordan, Kuwait and Seychelles (Fig. S2C).

A total of 1.16 (95% UI=0.861.28) million people were estimated to experience HHD associated deaths worldwide in 2019, which increased from 0.65 (95% UI=0.530.73) million death cases in 1990 (Table S1). The ASDR in females was 15.05 (95% UI=11.5117.09) per 100,000 population in 2019, which was moderately higher than that in males (14.95, 95% UI=10.3216.75) (Table S2). Although the number of HHD deaths grew up dramatically during 19902019, the trend of death rate was relatively stable and the global ASDR declined with a negative value of EAPC (0.74, 95% UI=-0.92--0.58) (Fig. 1D, E, and F, Table S3). Meanwhile, the male and female ASDR shared a similar trend (EAPC for men, 0.72, 95% UI=-0.95--0.50; EAPC for women, 0.79, 95% UI=-0.93--0.65).

For both men and women, age-specific distribution of death rate remained stable in 1990 and 2019 (Fig. 2). Like HHD prevalence, people aged over 65 were more likely to suffer HHD deaths (Fig. S1B).

At the regional level, Central Sub-Saharan Africa, Eastern Sub-Saharan Africa, North Africa and Middle East had the highest ASDR; Australasia, high-income Asia Pacific and Eastern Europe were the three regions with the lowest ASDR (Table S5). At the national level, China carried the highest HHD death burden, followed by India and the Untied States of America (Fig. S2D). Bulgaria, Afghanistan, and Central African Republic were the three countries with highest ASDR (Fig. S2F).

A total of 21.50 (95% UI=16.4023.90) million DALYs were estimated on a global scale in 2019, and 13.94 (95% UI=11.3115.65) DALYs in 1990 (Table S1). There was a consistent rise in DALY number (Fig. 1G). However, DALY rate declined between 1990 and 2005, then ascended during 20062019 (Fig. 1H). In addition, it shown a persistent decline for the age-standardized DALY rate over the 30years (Fig. 1I).

The age-standardized DALY rate in men was 277.86 (95% UI=199.58311.14) per 100,000 population in 2019, which was higher than that in women (256.81, 95% UI=205.22291.98) (Table S2). The DALY rate distribution for males and females in 2019 was similar to that in 1990 (Fig. 2). In 2019, the age-specific trends of DALY rate attributed to HHD were similar for both sexes.

On the observation of the regions scale, Central Sub-Saharan Africa, Eastern Sub-Saharan Africa, and Oceania were the three regions with the highest age-standardized DALY rates (Table S5). It revealed a considerable national disparity in the burden of HHD. DALY numbers varied more than 10-fold between countries (Fig.3A). China had the highest HHD DALY number, followed by India and Indonesia (Fig. 3D). After adjusting population, Bulgaria, Estonia, and Cook Islands were the three countries with the highest rate of DALYs (Fig. 3B and E). After adjusting for age and population, Afghanistan, Cook Islands, and Central African Republic had the highest age-standardized DALY rates (Fig. 3C and F).

Global map of the disease burden of hypertensive heart disease (A, DALY number; B, DALY rates; C, Age-standardized DALY rates) and the top 20 countries with disease burden (D, DALY number; E, DALY rates; F, Age-standardized DALY rates)

The drift of HHD-related ASPR, ASDR, and age-standardized DALYs rate among five SDI quintiles were presented in Fig.4. The ASPR of HHD was highest in the middle SDI region, and the lowest in the high SDI region between 1990 and 2019 (Fig. 4A). It was interesting to note that, as opposed to the regions with other SDI, the middle SDI region presented a descending trend of ASPR (EAPC, 0.24, 95% UI=-0.2--0.20) (Table S3). ASDR and age-standardized DALY rate decreased the fastest in the middle SDI region (EAPC, 1.58, 95% UI=-1.98--1.20 for ASDR; EAPC, 1.74, 95% UI=-2.11--1.41 for age-standardized DALY rate) (Table S3, Fig. 4B and C). In the middle SDI region, the trend of ASDR and age-standardized DALY rate presented undulating curves (Fig. 4B and C). Compared with a downward trend for females (EAPC, 0.28, 95% UI=-0.4--0.11), male age-standardized DALY rate showed an upward tendency in the high SDI region (EAPC, 0.34, 95% UI=0.110.57).

The age-standardized prevalence, death, and DALY rate for hypertensive heart disease by different SDI regions, 19902019. ASPR, age-standardized prevalence rate; ASDR, age-standardized death rate; DALY, disability adjusted life-year; SDI, socio-demographic index

ASPR, ASDR, and age-standardized DALY rate of HHD stratified by SDI were shown in Fig.5. ASPR of HHD rose before SDI value of 0.4 and then start to decrease (Fig. 5A). There was a negative and significant Pearsons correlation between HHD disease burden and SDI (r=0.74, 95% CI=-0.77--0.70, p<0.001, for age-standardized DALY rate; r=0.70, 95% CI=-0.74--0.66, p<0.001, for ASDR) (Fig. 5C). The univariate linear regression indicated that many socioeconomic variables (HDI, IHDI, SDI, HAQ, population with at least some secondary education, life expectancy, and physicians per 10,000 people) had a significantly negative correlation with age-standardized DALY rate (all p<0.001, Table1).

The trend in ASPR (A), ASDR (B), age-standardized DALY rate (C) of hypertensive heart disease in 21 regions based on SDI. Expected values are shown as the dark blue line. ASPR, age-standardized prevalence rate; ASDR, age-standardized death rate; DALY, disability adjusted life-year; SDI, socio-demographic index

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Global, regional, and national burden of hypertensive heart disease during 19902019: an analysis of the global burden of disease study 2019 - BMC...

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Inflammation represents one of the leading drivers of disease. Biotech company 180 Life Sciences is developing novel, anti-TNF therapies for treating distinct inflammatory diseases.

DocWire News spoke to James Woody, CEO of 180 Life Sciences, to learn more about the company, its mission, its treatment assets, and current clinical trials its involved in.

*Interview recorded in March 2022.

DocWire News:Can you give us some background on yourself, and the company, 180 Life Sciences?

James Woody:So by background, Im a pediatric immunologist, and in my prior life, I was Chief Scientific Officer of a company called Centocor, which was one of the very early biotech companies. And we were the first ones ever to make a anti-TNF antibody and to test it in patients, and we were able to show that it was remarkably effective in patients with rheumatoid arthritis, Crohns disease and psoriasis and ulcerative colitis. And that actually began the pretty much the whole antibody based biologics industry. We were the first ones to do this with a humanized antibody.

I went on from there to run a pharmaceutical company called Syntex, former Syntex that was after Roche bought it and did that for eight years, we invented a lot of small molecules. And then I went on to start a company in oncology, cancer stem cells. And from there I went over to the dark side and joined a venture capital group and helped start companies for about 10 years and some of them are really successful. Some of them are okay and some crashed and burned, but thats the nature of the business. And then more recently I helped start a couple companies on my own. And then I was approached by the founders of 180 LS to help them out and also to be CEO of their company, so thats how I came to be CEO of 180 Life Sciences.

180 Life Sciences is repurposing anti-TNF for unmet needs. What is anti-TNF?

So in your body, you have lots of protein circulating around in your blood. These tell the body cells what to do, and some of them are called cytokines and cytokines are the ones that kind of tell your immune system what to do. And theres quite a lot of these. And theres some of them that are very good. Theres some of them that are bad actors and one of them is called tumor necrosis factor. It was named that totally by accident because it seemed to eliminate tumors in mice, but thats never been able to be shown in humans, but the name has stuck with it. So tumor necrosis factor is the thing that causes some types of inflammation, if theres an overproduction. For example, in rheumatoid arthritis, its the tumor necrosis factor that drives the destruction of the joints of your fingers and knees and shoulders and everything, so its a destructive cytokine. And what we did is we made a specialized antibody against TNF that binds it up and blocks it and prevents it from causing the inflammation. And that was the basis of infliximab or Remicade that we discovered from Centocor.

What is Dupuytrens disease, how is it characterized?

Dupuytrens Contracture is kind of a chronic disease, but it affects quite a lot of people, maybe 16 or 20 million in the US, same in Europe. It starts out as a small nodule in your palm. And over time, maybe a couple of years, some faster, some slower, it begins to form cords underneath the palm of your hand, it pulls your fingers together and contracts them. Sometimes this is inherited in families and sometimes it just occurs. So what happens is that this nodule starts, and as I said, over time, the fingers become contracted. So theres no therapies for the early stage when the nodules just form, but thats the basis of what were doing, Ill talk about that in a minute.

Later on, after the fingers are already contracted and you have the disability, you cant button your clothes, you cant type with that hand. You cant do many of the things that you like to do with your hand. Theres several therapies that they try. One of them is injecting a collagenase thats partially effective, but they all, about half of those recur. You can try to disrupt these cords with a needle called needle aponeurectomy or alternatively, what happens is you end up going to surgery and they cut these cords out. Ironically, my wife had this and went through a whole year of steroid injections into her hand, finally had to have the surgery. So Im familiar with the process. But thats what happens, and I think people, as soon as the nodule forms, people these days, because they have Dr. Google, can immediately know whats going to happen in the long run, so the information out there is quite impressive.

180 Life Sciences recently completed a Phase 2 study for Dupuytrens. Tell us about the study protocol, the drug used and other updates on the study.

Our colleague in England, Dr. Jagdeep Nanchahal, was able to look at Dupuytrens Contracture and especially the nodules, and through a series of very elegant experiments, he was able to show that the nodule was driven by the TNF, the bad actor. And in this case, the inflammation caused the fibrosis that were talking about, that leads to the finger contracture. And so he was able to work out that if you inject anti-TNF into this nodule, you can impact the course of the disease.

And so he did a very large trial of about 150 patients in the UK and was able to inject anti-TNF into the nodules of their hands. And in that trial, which took over a year, there were three or four injections, but we were able to show that both the primary and secondary endpoints of the trial were met and the endpoints had to do with the size of the nodule, whether it was growing, whether it was shrinking, whether it was harder or whether it was softer or whether the fingers were contracting, all of that, but we met the primary endpoints and the full publication with all the details will be out, hopefully in the next couple of months.

You have another trial planned for Frozen Shoulder. What is Frozen Shoulder, and how will the trial aim to address it?

Yes, Frozen Shoulder is another kind of inflammatory condition where fibrosis forms in the shoulder. And it initially starts out as being extremely painful. And that goes on for several months and then eventually the pain subsides, but the shoulder becomes totally immobile. And eventually you have to have surgery to remove the fibrotic tissues. Interestingly enough, this occurs more common in patients with diabetes, but about half of those patients also have Dupuytrens. And so we think that the fibrosis in the Dupuytrens and the fibrosis in the shoulder is the same mechanism. And so Dr. Nanchahal will be injecting anti-TNF into the shoulder very early, as soon as the pain is evident, then hell try to inject anti-TNF and maybe relieve the pain and also the formation of the fibrosis, so that one can avoid the surgery, which is actually quite expensive. And also, theres quite a long course of physical therapy after the surgery, so its something youd like to avoid. And so were trying to treat patients both with Dupuytrens and Frozen Shoulder before the disability develops.

A third program, which is soon to be clinical, is anti-TNF for post-operative cognition delirium or POCD. Tell me about POCD, and the preliminary research that led the team to pursue this indication?

We know that now that theyre doing fairly aggressive surgery in older patients, either hip replacements or emergency hip corrections or CABG procedure, coronary artery bypass graft, or cardiac surgery, that a fair percentage of these people after the surgery, just have a foggy brain. And the fog goes on for some time and we call it postoperative cognitive dementia, as the technical term. And in some patients, maybe 15 or 20%, it doesnt go away. And they end up in nursing homes and they actually dont live very long after that. And so our colleagues in the UK, Dr. Nanchahal and Dr. Feldmann and his colleagues, have shown that during the surgery, any kind of aggressive surgery, that TNF is released from the tissue damage, and the TNF goes to the brain and opens it up and lets inflammatory cells get into the area of the brain thats where your cognitive areas are, and so that leads to the dementia.

And in the past, theyve thought this all had to do with the anesthesia, but we think its the TNF thats actually causing this dementia going forward. And so were actually going to do a trial in patients that are having their hip repaired that are older, and were going to administer one dose of anti-TNF just before the surgery starts with a view towards preventing the dementia going forward. So this will be a long trial, but if it works, itll be something that everybody who goes into major surgery would want to have. So its another exciting opportunity for 180 LS and our investigators.

180 Life Sciences recently announced licensing of a compound called HMGB1. Tell us more about HMGB1 and the companys plans for it.

The company is also working on other areas of fibrosis, not just Dupuytrens Contracture and Frozen Shoulder, but other areas like liver fibrosis, which occurs with NASH. And we are working on ways to prevent that as well, much like were working on Dupuytrens and Frozen Shoulder. The fibrosis in the liver is really hard to reverse, and there are no real agents that do that, but theres a lot of people trying different things. Now what the HMGB-1 does, it doesnt change the fibrosis, but once the fibrosis is stopped, it could help the liver cells to regenerate. So this is kind of a regenerative medicine. It makes the tissues regenerate, whether its heart or whether its liver or whether its lung or whatever. And so its going to be used after the fibrosis is stopped. And so thats kind of what were interested in. And were just getting that program off the ground and making the initial compounds to do our testing.

Any closing thoughts?

Well, Id like to talk about our team. The company was founded by Dr. Mark Feldmann, who was the one, he was the original person who figured out that TNF was causing the joint destruction and arthritis, and with he and I and others, that actually did the very first trials ever. And this was done in patients with wheelchairs, and they actually got up out of their wheelchairs and walked around. It was a phenomenal moment. We had no idea it would work that well. And some of them actually did a pirouette down some stairs. We have videos of this. So its kind of like The Awakening movie where they gave them the L-DOPA and they all woke up. Well, in this case, they got up out of their wheelchairs and theres no patients in wheelchairs with rheumatoid arthritis in the whole world because of that drug, and the ones that followed on.

The current Humira from AbbVie is the preferred one. But the whole idea and concept, we started back then. Other founders, Dr. Larry Steinman, he and Mark put 180 LS together. And he developed Tysabri, the very first drug to help MS patients. And it was another phenomenal discovery that he made. And hes also working on MS and other areas. But so we have the leaders in inflammation as the people who actually founded the company. So its a pleasure to work with them. Ive been acquainted with them off and on for the past, maybe 25 years, so working with them again is a real pleasure.

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James Woody, CEO of 180 Life Sciences: Developing New Therapies to Treat Inflammatory Diseases - DocWire News

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SUNNYVALE, Calif., April 12, 2022 (GLOBE NEWSWIRE) -- BioCardia, Inc.[Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for BCDA-04, a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). This allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

The first part of the clinical trial will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to Phase II in a randomized study in adult patients recovering from ARDS due to COVID-19. "This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies," said Ian McNiece, Ph.D., BioCardias Chief Scientific Officer. "After IV delivery, the cells migrate to the lungs for local therapeutic benefit. We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation in the lungs. Our goal is to help recovering patients with ARDS due to COVID-19 recover faster and more fully, while avoiding longer term respiratory issues."

"In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA's acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system," said Peter Altman, Ph.D., Chief Executive Officer. "Our off the shelf MSC platform may have significant advantages over others in clinical development for multiple indications because the MSCs express the biologically important NK1 receptor which binds Substance P. Our in-house clinical cell manufacturing is also expected to be an important strategic asset that enables rapid and cost-effective development."

About ARDS

Acute respiratory distress syndrome (ARDS) occurs when fluid builds up in the tiny, elastic air sacs (alveoli) in the lungs. The fluid keeps the lungs from filling with enough air, which means less oxygen reaches the bloodstream. This deprives organs of the oxygen they need to function. ARDS typically occurs in people who are already critically ill or who have significant injuries. Severe shortness of breath the main symptom of ARDS usually develops within a few hours to a few days after the precipitating injury or infection. Many people who develop ARDS don't survive. The risk of death increases with age and severity of illness. Of the people who do survive ARDS, some recover completely while others experience lasting damage to their lungs1. Based on preliminary clinical reports on COVID-19, respiratory failure complicated by ARDs is the leading cause of death for COVID-19 patients.2 Despite multiple clinical studies, no pharmacological treatments have proven effective for ARDS.3, 4

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is developing cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP autologous and NK1R+ allogeneic cell therapies are the Companys biotherapeutic platforms that enable four product candidates in clinical development. The CardiAMP Cell Therapy Heart Failure Trial investigational product has been granted Breakthrough designation by the FDA, has CMS reimbursement, and is supported financially by the Maryland Stem Cell Research Fund. The CardiAMP Chronic Myocardial Ischemia Trial also has CMS reimbursement. For more information visit:www.BioCardia.com.

FORWARD LOOKING STATEMENTS

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, initiation of our BCDA-04 clinical trial, and the mechanism of action and ease of administration of our NK1R+ MSC therapy.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardias Form 10-K filed with the Securities and Exchange Commission on March 29, 2022, under the caption titled Risk Factors. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

_________________________________________________________________________________________________________

Media Contact:Anne Laluc, MarketingEmail:alaluc@BioCardia.comPhone: 650-226-0120

Investor Contact:David McClung, Chief Financial OfficerEmail:dmcclung@BioCardia.comPhone: 650-226-0120

(1)MayoClinic.Org

(2)Rajagopal K, Keller SP, Akkanti B, et al. Advanced pulmonary and cardiac support of COVID-19 patients, emerging recommendations from ASAIOa living working document. Circ Heart Fail. 2020 May;13(5).

(3)Thompson BT, Chambers RC, Liu KD (2017) Acute respiratory distress syndrome. N Engl J Med 377(19):19041905.

(4)3. Group RC, Horby P, Lim WS et al (2020) Dexamethasone in hospitalized patients with Covid-19preliminary report. N Engl J Med.

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BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress...

Cardiac Stem Cells Comments Off on BioCardia Announces FDA Approval of Its IND for NK1R+ Mesenchymal Stem Cells for the Treatment of Patients Recovering from Acute Respiratory Distress… | April 15th, 2022

April 9 (Reuters) - The first all-private team of astronauts ever launched to the International Space Station (ISS) were welcomed aboard the orbiting research platform on Saturday to begin a weeklong science mission hailed as a milestone in commercial spaceflight.

Their arrival came about 21 hours after the four-man team representing Houston-based startup company Axiom Space Inc lifted off on Friday from NASA's Kennedy Space Center, riding atop a SpaceX-launched Falcon 9 rocket.

The Crew Dragon capsule lofted into orbit by the rocket docked with the ISS at about 8:30 a.m. EDT (1230 GMT) on Saturday as the two space vehicles were flying roughly 250 miles (420 km) above the central Atlantic Ocean, a live webcast of the coupling from the National Aeronautics and Space Administration showed.

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The final approach was delayed for about 45 minutes by a technical glitch with a video feed used to monitor the capsule's rendezvous with the ISS, but it otherwise proceeded smoothly.

The multinational Axiom team, planning to spend eight days in orbit, was led by retired Spanish-born NASA astronaut Michael Lopez-Alegria, 63, the company's vice president for business development.

His second-in-command was Larry Connor, a real estate and technology entrepreneur and aerobatics aviator from Ohio designated as the mission pilot. Connor is in his 70s, but the company did not provide his precise age.

Rounding out the Ax-1 crew were investor-philanthropist and former Israeli fighter pilot Eytan Stibbe, 64, and Canadian businessman and philanthropist Mark Pathy, 52, both serving as mission specialists.

With docking achieved, it took nearly two hours for the sealed passageway between the space station and crew capsule to be pressurized and checked for leaks before hatches were opened to allow the newly arrived astronauts to come aboard the ISS.

The Ax-1 team was welcomed by all seven of the regular, government-paid crew members already occupying the space station: three American astronauts, a German astronaut from the European Space Agency and three Russian cosmonauts.

The NASA webcast showed the four smiling Axiom astronauts, dressed in navy blue flight suits, floating headfirst, one by one, through the portal into the space station, warmly greeted with hugs and handshakes by the ISS crew.

Lopez-Alegria later pinned astronaut wings onto the uniforms of the three spaceflight rookies of his Axiom team -- Connor, Stibbe and Pathy -- during a brief welcome ceremony.

Stibbe is now the second Israeli to fly to space, after Ilan Ramon, who perished with six NASA crewmates in the 2003 space shuttle Columbia disaster.

SCIENCE FOCUSED

The new arrivals brought with them two dozen science and biomedical experiments to conduct aboard ISS, including research on brain health, cardiac stem cells, cancer and aging, as well as a technology demonstration to produce optics using the surface tension of fluids in microgravity.

The mission, a collaboration among Axiom, Elon Musk's rocket company SpaceX and NASA, has been touted by all three as a major step in the expansion of space-based commercial activities collectively referred to by insiders as the low-Earth orbit economy, or "LEO economy" for short. read more

NASA officials say the trend will help the U.S. space agency focus more of its resources on big-science exploration, including its Artemis program to send humans back to the moon and ultimately to Mars.

While the space station has hosted civilian visitors from time to time, the Ax-1 mission marks the first all-commercial team of astronauts sent to ISS for its intended purpose as an orbiting research laboratory.

The Axiom mission also stands as SpaceX's sixth human spaceflight in nearly two years, following four NASA astronaut missions to the space station and the Inspiration 4 launch in September that sent an all-civilian crew into orbit for the first time. That flight did not dock with the ISS.

Axiom executives say their astronaut ventures and plans to build a private space station in Earth orbit go far beyond the astro-tourism services offered to wealthy thrill-seekers by such companies as Blue Origin and Virgin Galactic (SPCE.N), owned respectively by billionaire entrepreneurs Jeff Bezos and Richard Branson.

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Reporting by Steve Gorman in Los Angeles; Editing by Angus MacSwan, Daniel Wallis and Jonathan Oatis

Our Standards: The Thomson Reuters Trust Principles.

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Space station's first all-private astronaut team welcomed aboard orbiting platform - Reuters

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Early findings from the phase 1/2a TEM-GBM study presented at the 2022 AACR Annual Meeting displayed potential of temferon to affect the tumor microenvironment of glioblastoma.

Immune system activation and tumor microenvironment alteration were effects observed in patients with glioblastoma treatment with temferon, a genetically modified Tie2-expressing monocyte (TEM) targeting interferon-2 (IFN2), according to early findings of the phase 1/2a TEM-GBM study (NCT03866109) presented in a poster at the American Association for Cancer Research (AACR) 2022 Annual Meeting.

These results provide the initial evidence for on-target activity of Temferon in GBM, said Bernard Gentner, MD, study coauthor and the leader of the translational stem cell and leukemia research unit at San Raffaele Telethon Institute for Gene Therapy in Milan, Italy.

Temferon is an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector, driving myeloid-specific IFN2 expression. Genetically modified TEMs target IFN2 expression in the GBM tumor microenvironment.

In order to guarantee stable delivery of genetically engineered TEMs into the tumor, we transduce hematopoietic stem and progenitor cells with a lentiviral vector carrying the IFNa2 transgene transcriptionally regulated by the Tie2 promoter and by post transcriptional elements that guarantee that the transgene is expressed only in myeloid cells that are recruited into the tumor, Gentner said.

TEM-GBM is an open-label, dose-escalation study evaluating the safety and efficacy of Temferon in up to 21 newly diagnosed patients with GBM harboring an unmethylated MGMT promoter. Following surgical resection, up to 15 patients were assigned to 1 of 3 escalating doses of Temferon and 1 of 2 different conditioning regimens in part A of the trial. In Part B, 6 more patients will receive a single dose of Temferon at the recommended phase 2 dose.

Following completion of radiotherapy, patients received a conditioning regimen consisting of carmustine (BCNU) and thiotepa (Tepadina) in cohorts 1 to 4 or busulfan (Busulfex) and thiotepa in cohort 5 prior to administration of Temferon.

In-patient monitoring occurs until hematological recovery, then patients will undergo regular follow-up for up to 720 days. At that point, patients are invited to participate in a long term follow-up study for an additional 6 years.

Eligible adults aged 18 to 70 years must have an ECOG performance score of 0 to 1, a Karnofsky performance score greater than 70%, and adequate cardiac, renal, hepatic, and pulmonary function. Patients with active autoimmune disease or who have received any oral or parenteral chemotherapy or immunotherapy within 2 years of screening are excluded.

The primary end points of the study are Temferon engraftment over the first 90 days, proportion of patients achieving hematologic recovery 30 days after autologous stem cell transplantation, and short-term tolerability of Temferon as defined by stable blood counts, absence of cytopenias, absence of significant organ toxicities greater than grade 2, and absence of Replication Competent Lentivirus.

By the October 15, 2021, data cutoff, the median follow-up was 267 days (range: 60-749). Patients in cohorts 1 to 3 received a dose 0.5-2.0 x 106/kg Temferon with an average vector copy number of 0.70 and a transduction efficiency of 54%. Those in cohorts 4 and 5 received 2.0 x 106/kg Temferon with an average vector copy number of 0.77 and a transduction efficiency of 49%.

Investigators observed increasing proportions of Temferon-derived differentiated cells, as determined by the presence of vector genomes in the DNA of peripheral blood and bone marrow cells, reaching up to 30% at 1 month in the highest treatment cohort (2.0 x 106/kg). Those differentiated cells persisted at lower levels for up to 18 months.

All patients showed in vivo Temferon engraftment, Gentner said. Engraftment was highest at 1 month, and in many patients resembled pretty much the input fraction. Engraftment then decreased, stabilizing at 3 to 6 months around 10%.

Despite the significant proportion of engineered cells, only very low-medium concentrations of interferon alpha were detected in the plasma and in the cerebral spinal fluid, indicating a tight regulation of the vector expression.

Gentner added that Temferon did not delay hemopoietic recovery, and neutrophil and platelet engraftment were similar to standard autologous stem cell procedure.

Investigators did not detect any dose limiting toxicities. Gentner said that, so far, adverse events have been related to progression or the transplant procedure, not to the IFN2 itself.

Gentner B, Finocchiaro G, Farina F, et al. Genetically modified Tie-2 expressing monocytes target IFN-2 to the glioblastoma tumor microenvironment (TME): Preliminary data from the TEM-GBM Phase 1/2a study. Poster presented at: 2022 AACR Annual Meeting; April 8-13, 2022; New Orleans, LA. Abstract 5213.

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Evidence Shows Novel Temferon May Have Activity in Glioblastoma - Cancer Network

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Courtesy of Pavlo Gonchar/SOPA Images/LightRocket via Getty Images

Drug pricing watchdog ICER, the Institute for Clinical and Economic Review, issued a draft report on bluebird bios gene therapy betibeglogene autotemcel for beta-thalassemia. Despite the proposed price tag of $2.1 million, ICERs not-yet-finalized report supports the therapys cost-effectiveness. This is good news for the recently beleaguered company.

Gene therapies are typically designed to cure a disease by replacing or fixing a damaged gene. Bluebirds therapy, which is listed under the brand name Zynteglo, had been approved in Europe and the UK, where its price is around $1.7 million (U.S.). However, the company pulled the therapy off the market in Europe over what it called a hostile pricing and reimbursement environment.

On April 5, bluebird bio announced it was beginning a comprehensive restructuring in hopes of cutting $160 million in costs over the next two years. It planned to re-focus on near-term catalysts, which include Zynteglo in the U.S., gene therapy for cerebral adrenoleukodystrophy (eli-cel) and a potential biologics license application (BLA) for lovotibeglogene autotemcel (lovo-cel) gene therapy for sickle cell disease. The BLA application is planned for 2023, while the U.S. regulatory decisions are expected this year. The PDUFA date for Zynteglo is Aug.19, 2022, and Sept. 16, 2022, for eli-cel.

As part of the restructuring, the company is cutting its workforce by about 30%.

ICER recommendations arent binding, but they have influence. If ICER says a drug is overpriced, it provides ammunition for payers, such as Medicare and insurers, to push back against proposed prices.

Gene therapies are very expensive. For example,Novartis Zolgensma, the one-time gene therapy onasemnogene abeparvovec for spinal muscular atrophy (SMA), is generally viewed as the most expensive drug with a price tag of $2.1 million. On the other hand, as an apparent cure for a disease that kills children by the age of two, it is very rare. The argument for these therapies, aside from their curative potential for otherwise incurable diseases, is that over the life of the patient, they are cost-effective.

Novartis and Spark Therapeuticss gene therapy Luxturna (voretigene neparvovec) runs about $850,000 per patient in the U.S. The therapy is for inherited retinal dystrophy with RPE65 mutations. It is typically diagnosed in childhood and eventually causes almost total blindness, and the therapy is essentially a cure.

Beta thalassemia is a genetic disease that impairs the ability of red blood cells to manufacture hemoglobin, the molecule in the body that carries oxygen. There are about 40,000 newly diagnosed cases in children each year around the world. People with the most severe form of it develop life-threatening anemia around four to six months of age and have to receive monthly blood transfusions and other treatments, such as iron-chelating drugs. The only other potential cure is hematopoietic stem cell transplantation (HSCT) but requires a donor with a matching human leukocyte antigen (HLA) profile within the appropriate age range.

Bluebirds Zynteglo appears to be another option for a cure, although how long the therapys effects last is something of an open question. The ICER report noted the uncertainties, but concluded that the evidence suggests that beti-cel provides net health benefits to patients with TDT.

The ICER report indicated, per Managed Healthcare Executive, that "patients could be treated without reaching the potential budget impact threshold at three prices (about $1.85 million, $2.11 million and $2.38 million per course of treatment). This analysis was done at several prices to document the percentage of patients who could be treated without crossing a potential budget impact threshold that is aligned with the overall growth in the U.S. economy.

In Phase III trials, 89% of patients who received the therapy became transfusion independent, and in Phase I/II and III trials, those patients remained transfusion-free for at least 42 months. In general, side effects were mild and no deaths were reported. In December 2021, bluebird presented data at the American Society of Hematology meeting from a long-term study (LTF-303) that showed adult and pediatric patients with beta-thalassemia who required regular red blood cell transfusions can produce normal or near-normal levels of total hemoglobin and remain transfusion-free with stable iron markers up to seven years after receiving beti-cel.

A 2017 study published in Blood found that on average, beta-thalassemia patients required 17 transfusions per year, 23 days apart. Mean total healthcare costs for the patients were $128,062, plus or minus $62,260 per year. Total costs were primarily driven by chelation and transfusion costs.

Although the severity of the disease varies, a 2009 study found that people with beta-thalassemia major often die from cardiac complications of iron overload by 30 years of age," making bluebird's new therapy, if it is successful, vital for these patients.

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Drug Price Watchdog Calls Bluebird Bio's $2.1 Million Gene Therapy Cost-Effective - BioSpace

Cardiac Stem Cells Comments Off on Drug Price Watchdog Calls Bluebird Bio’s $2.1 Million Gene Therapy Cost-Effective – BioSpace | April 15th, 2022

The addition of the innate cell engager AMF13 to preactivated and expanded natural killer (NK) cells may represent an effective treatment for pretreated patients with advanced lymphoma, according to findings from a phase 1/2 study (NCT04074746) that were presented during the 2022 AACR Annual Meeting. 1

Results showed that patients experienced a median overall response rate (ORR) of 89.5% (n = 17/19). Overall, 10 patients experienced complete responses (CRs) and 7 experienced partial responses (PRs).2

Lead author Yago Nieto, MD, PhD, a professor of medicine in the Department of Stem Cell Transplantation and Cellular Therapy at the University of Texas MD Anderson Cancer Center, in Houston, discussed the findings during a press conference during the meeting. He said the study team was pleasantly surprised by the quality of tumor responses in patients with resistant lymphomas.

This is the first clinical trial using off the shelf cord blood-derived cytokine-induced memory-likeex vivoexpanded NK cells precomplexed with the innate cell engager AMF13 construct to treat patients with CD30-positive relapsed/refractory Hodgkin lymphoma, he said. We saw very encouraging activity in this population of very heavily pretreated patients.

The current standard of care for relapsed CD30-positive lymphomas is brentuximab vedotin (Adcetris), an antibody-drug conjugate that delivers a toxic cytoskeleton destabilizing agent to cells expressing CD30. However, not all these lymphomas respond to brentuximab vedotin. When that treatment fails, those tumors then become extremely resistant to killing and patients are left with very few effective therapeutic options.

To address the problem, investigators enrolled 22 patients with relapsed or refractory CD30+ lymphoma into this single-center phase 1/2 trial, 20 of whom were diagnosed with Hodgkin lymphoma (HL). All had active progressive disease at enrollment, and none received bridging therapy. Patients were heavily pretreated, with a median of 7 (range, 1-14) prior lines of therapy. Nine underwent autologous stem cell transplantation (SCT) and 5 received allogeneic SCT.

Eligible patients had relapsed/refractory CD30-positive classical HL, B-cell non-Hodgkin lymphoma, anaplastic large-cell lymphoma, or peripheral T-cell lymphoma that was refractory or intolerant to brentuximab vedotin. They needed to have an ECOG performance status of 2 or below, and adequate renal, hepatic, pulmonary, and cardiac function.

The median age was 40 years (range, 20-75). Most patients were white (68.2%) and male 68.1%).

Patients receive 2 cycles of fludarabine/cyclophosphamide, followed by AFM13-CB NK cells at 3 dose levelsDL1 (106NK/gg), DL2 (107NK/kg), and DL3 (108NK/kg)on day 0 plus 3 weekly intravenous infusions of 200 mg AFM13, a CD30/CD16A bispecific antibody. Nineteen patients completed both planned cycles of treatment.

Nieto and colleagues isolated NK cells from cord blood, then used a mixture of cytokines to activate the cells into a memory-like state, making them more persistent and effective. They then expanded the cells in culture and complexed them with AFM13.

At a median follow-up of 11 months, progression-free survival (PFS) and overall survival (OS) rates across all 3 dose levels were 52% and 81%, respectively. Across all dose levels, 53% of patients experienced CR and 37% had PR. Eleven percent had progressive disease.

Expansion of NK cells occurred immediately after infusion and persisted for 3 weeks.

Investigators established DL3 as the recommend phase 2 dose (RP2D). All 13 (100%) patients treated at this dose level responded to therapy, including eight CRs (62%).Five of those patients were in CR after cycle 1, and 3 additional patients converted from PR to CR after cycle 2, Nieto added.

The median PFS was 67% and the median OS was 93% in the RP2D population.

Investigators did not record any cytokine release syndrome or graft vs host disease (GVHD), or neurotoxicity. Our preliminary results show an excellent tolerability profile, Nieto said.

There was no instance of infusion-related reactions (IRRs) associated with AFM13-NK cells across 40 infusions. There was 1 instance of grade 3 IRR and 4 grade 2 IRRs in 108 infusions of AFM13 alone. Investigators observed no dose limiting toxicities.

Never before in mankind have we seen this approach, really leading to pretty staggering results, Timothy Yap, MBBS, PhD, FRCP, a medical oncologist and associate director of translational research in the Institute for Personalized Cancer Therapy at the University of Texas MD Anderson Cancer Center, said. Everyone can see for themselves how impressive these results are. In addition to that, the actual tolerability profile is truly excellent with no instances of cytokine release syndrome, no neurotoxicity, no GVHD. Truly, truly impressive.

References

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Adding Bispecific Antibody to Natural Killer Cells May Be Effective in Heavily Pretreated Lymphoma - http://www.oncnursingnews.com/

Cardiac Stem Cells Comments Off on Adding Bispecific Antibody to Natural Killer Cells May Be Effective in Heavily Pretreated Lymphoma – www.oncnursingnews.com/ | April 15th, 2022

Evidence Rating Level:1 (Excellent)

Study Rundown:Duchenne muscular dystrophy (DMD) is an X-linked genetic disorder characterized by progressive muscle degeneration leading to significant reduction in life expectancy. Males with DMD have an estimated life expectancy of 22 years with heart and respiratory muscles affected in later disease stages. In this phase 2 trial, a formulation of allogenic cardiosphere-derived cells (CAP-1002) was evaluated against placebo in patients with DMD. CAP-1002 is, in essence, a concentrate of cardiac stem cells with potential disease-modifying properties such as regenerative abilities. Participants (n=20) were randomized 1:1 to receive either CAP-1002 or placebo every three months for four total infusions. Primary outcome was upper limb function measured by a scale of 0-6 (PUL). CAP-1002 was shown to slow PUL decline by 71% compared to placebo or by an absolute difference of 2.6 points. CAP-1002 was generally well-tolerated with only one severe adverse hypersensitivity reaction leading to withdrawal from the trial. Limitations of this study include the small sample size. Nonetheless, this study provides promising preliminary results for a potential disease-modifying therapy in DMD.

Click to read the study in the Lancet

Relevant Reading:Long-term effects of glucocorticoids on function, quality of life, and survival in patients with Duchenne muscular dystrophy: a prospective cohort study.

In-Depth [randomized controlled trial]:HOPE-2 was a randomized-controlled phase 2 clinical trial to assess to safety and efficacy of intravenous CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). The study enrolled patients aged 10 and older with genetically confirmed DMD. Participants had to score between 2-5 on the Performance of Upper Limb (PUL) scale with 0 being no useful function of hands and 6 being maximum overhead reach without compensation. 20 participants were assigned 1:1 to either CAP-1002 (n=8) or placebo (n=12) infusion every 3 months for a total of four infusions. Mean age of the enrolled male participants was 14 in both groups. Primary outcome was the upper limb function on the PUL scale. Patients who received CAP-1002 had a greater change in PUL score from baseline after 12 months compared to placebo (percentile difference 36.2, 95% CI 12.7-59.7). On the PUL scale, the placebo group had a mean change of -3.4 points from baseline, while the CAP-1002 had a -0.8 point change (difference of 2.6 points). This can also be interpreted as a 71% slowing of loss of function in the CAP-1002 group. Three patients in the CAP-1002 group had infusion-related hypersensitivity reactions, one leading to discontinuation. No other adverse events were seen in the two groups.

2022 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.

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#VisualAbstract: Cardiosphere-derived cell therapy slows disease progression in Duchenne muscular dystrophy - Physician's Weekly

Cardiac Stem Cells Comments Off on #VisualAbstract: Cardiosphere-derived cell therapy slows disease progression in Duchenne muscular dystrophy – Physician’s Weekly | April 3rd, 2022

The SARS-CoV-2 virus can infect specialized pacemaker cells that maintain the hearts rhythmic beat, setting off a self-destruction process within the cells, according to a preclinical study co-led by researchers at Weill Cornell Medicine, NewYork-Presbyterian and NYU Grossman School of Medicine. The findings offer a possible explanation for the heart arrhythmias that are commonly observed in patients with SARS-CoV-2 infection.

In the study, reported March 8 in Circulation Research, the researchers used an animal model as well as human stem cell-derived pacemaker cells to show that SARS-CoV-2 can readily infect pacemaker cells and trigger a process called ferroptosis, in which the cells self-destruct but also produce reactive oxygen molecules that can impact nearby cells.

This is a surprising and apparently unique vulnerability of these cellswe looked at a variety of other human cell types that can be infected by SARS-CoV-2, including even heart muscle cells, but found signs of ferroptosis only in the pacemaker cells, said study co-senior author Dr. Shuibing Chen, the Kilts Family Professor of Surgery and a professor of chemical biology in surgery and of chemical biology in biochemistry at Weill Cornell Medicine.

Arrhythmias including too-quick (tachycardia) and too-slow (bradycardia) heart rhythms have been noted among many COVID-19 patients, and multiple studies have linked these abnormal rhythms to worse COVID-19 outcomes. How SARS-CoV-2 infection could cause such arrhythmias has been unclear, though.

In the new study, the researchers, including co-senior author Dr. Benjamin tenOever of NYU Grossman School of Medicine, examined golden hamstersone of the only lab animals that reliably develops COVID-19-like signs from SARS-CoV-2 infectionand found evidence that following nasal exposure the virus can infect the cells of the natural cardiac pacemaker unit, known as the sinoatrial node.

To study SARS-CoV-2s effects on pacemaker cells in more detail and with human cells, the researchers used advanced stem cell techniques to induce human embryonic stem cells to mature into cells closely resembling sinoatrial node cells. They showed that these induced human pacemaker cells express the receptor ACE2 and other factors SARS-CoV-2 uses to get into cells and are readily infected by SARS-CoV-2. The researchers also observed large increases in inflammatory immune gene activity in the infected cells.

The teams most surprising finding, however, was that the pacemaker cells, in response to the stress of infection, showed clear signs of a cellular self-destruct process called ferroptosis, which involves accumulation of iron and the runaway production of cell-destroying reactive oxygen molecules. The scientists were able to reverse these signs in the cells using compounds that are known to bind iron and inhibit ferroptosis.

This finding suggests that some of the cardiac arrhythmias detected in COVID-19 patients could be caused by ferroptosis damage to the sinoatrial node, said co-senior author Dr. Robert Schwartz, an associate professor of medicine in the Division of Gastroenterology and Hepatology at Weill Cornell Medicine and a hepatologist at NewYork-Presbyterian/Weill Cornell Medical Center.

Although in principle COVID-19 patients could be treated with ferroptosis inhibitors specifically to protect sinoatrial node cells, antiviral drugs that block the effects of SARS-CoV-2 infection in all cell types would be preferable, the researchers said.

The researchers plan to continue to use their cell and animal models to investigate sinoatrial node damage in COVID-19and beyond.

There are other human sinoatrial arrhythmia syndromes we could model with our platform, said co-senior author Dr. Todd Evans, the Peter I. Pressman M.D. Professor of Surgery and associate dean for research at Weill Cornell Medicine. And, although physicians currently can use an artificial electronic pacemaker to replace the function of a damaged sinoatrial node, theres the potential here to use sinoatrial cells such as weve developed as an alternative, cell-based pacemaker therapy.

Many Weill Cornell Medicine physicians and scientists maintain relationships and collaborate with external organizations to foster scientific innovation and provide expert guidance. The institution makes these disclosurespublic to ensure transparency. For this information, see profiles for Dr. Todd Evans, and Dr. Robert Schwartz.

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Are COVID-19-Linked Arrhythmias Caused by Viral Damage to the Heart's Pacemaker Cells? - Weill Cornell Medicine Newsroom

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The following is management's discussion and analysis ("MD&A") of certainsignificant factors that have affected our financial position and operatingresults during the periods included in the accompanying financial statements, aswell as information relating to the plans of our current management. This reportincludes forward-looking statements. Generally, the words "believes,""anticipates," "may," "will," "should," "expect," "intend," "estimate,""continue," and similar expressions or the negative thereof or comparableterminology are intended to identify forward-looking statements. Such statementsare subject to certain risks and uncertainties, including the matters set forthin this report or other reports or documents we file with the Securities andExchange Commission from time to time, which could cause actual results oroutcomes to differ materially from those projected. Undue reliance should not beplaced on these forward-looking statements which speak only as of the datehereof. We undertake no obligation to update these forward-looking statements.

The following discussion and analysis should be read in conjunction with ourfinancial statements and the related notes thereto and other financialinformation contained elsewhere in this Form 10-K

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Cost of sales consists of the costs associated with the production of MyoCathand test kits, product costs, labor for production and training and lab andbanking costs consistent with products and services provided.

Cost of sales was $52,030 in the year ended December 31, 2021 compared to$64,117 in the year ended December 31, 2020. The decrease is due to the decreasein revenues.

Research and development expenses were $0 in 2021 remaining the same as $0 in2020.

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Options outstanding at December 31, 2021 110,643,884 $ 0.0247

Options exercisable at December 31, 2021 93,491,384 $ 0.0256

Available for grant at December 31, 2021 34,168,070

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Our primary sources of revenue are from the sale of test kits and equipment,training services, patient treatments, laboratory services and cell banking.

Patient treatments and laboratory services revenue are recognized when thoseservices have been completed or satisfied.

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Depreciation is computed using the straight-line method over the assets'expected useful lives or the term of the lease, for assets under capital leases.

Cash and cash equivalents include cash on hand, deposits in banks withmaturities of three months or less, and all highly liquid investments which areunrestricted as to withdrawal or use, and which have original maturities ofthree months or less.

We allocate the proceeds received from equity financing and the attached optionsand warrants issued, based on their relative fair values, at the time ofissuance. The amount allocated to the options and warrants is recorded asadditional paid in capital.

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Our opinion is that inflation has not had, and is not expected to have, amaterial effect on our operations.

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In 2021, we continued to finance our operational cash needs with cash generatedfrom financing activities.

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As of December 31, 2021, we had $8,016,314 in outstanding debt, net of debtdiscount of $273,216.

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Refer to Note 1. Organization and Summary of Significant Accounting Policies inthe notes to our financial statements for a discussion of recent accountingpronouncements.

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Cardiac Stem Cells Comments Off on U.S. STEM CELL, INC. Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-K) – Marketscreener.com | April 3rd, 2022

-- Yescarta is First CAR T-cell Therapy to Receive NCCN Treatment Guideline Category 1 Recommendation --

Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has approved Yescarta (axicabtagene ciloleucel) CAR T-cell therapy for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Yescarta demonstrated a clinically meaningful and statistically significant improvement in event-free survival (EFS; hazard ratio 0.398; P

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220401005519/en/

Earlier this month, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines in Oncology for B-cell Lymphomas to include Yescarta for "Relapsed disease

Christi Shaw, Chief Executive Officer of Kite : "Kite started with a very bold goal: creating the hope of survival through cell therapy. Today's FDA approval brings that hope to more patients by enabling the power of CAR T-cell therapy to be used earlier in the treatment journey. This milestone has been years in the making. On behalf of the entire Kite community, we would like to thank the patients and physicians who have been on this journey with us. You are what drives us every day to explore the full potential of cell therapy."

CAR T-cell therapies are individually made starting from a patient's own white blood cells, called T-cells. The cells are removed through a process similar to donating blood and sent to Kite's specialized manufacturing facilities where they are engineered to target the patient's cancer, expanded, and then returned to the hospital for infusion back into the patient. Referring physicians and patients can immediately begin accessing Yescarta CAR T-cell therapy for this new FDA-approved indication through Kite's 112 authorized treatment centers across the U.S.

Frederick L. Locke, MD, ZUMA-7 Principal Investigator and Co-Leader of the Immuno-Oncology Program at Moffitt Cancer Center, Tampa, Florida : "Today's approval marks an exciting new standard of care. The ZUMA-7 trial enabled us to look at the broader picture of what happens to patients after a decision is made to follow a particular treatment path. What we found was that axi-cel resulted in three times as many patients receiving treatment with curative intent (CAR T-cell therapy), and an overall better outcome for patients than the previous standard of care. Additionally, we have now amassed significant experience with CAR T-cell therapy to better manage or prevent side-effects, making this treatment more accessible for older patients and those with medical conditions for whom the standard of care might be difficult."

SOC therapy for this patient population has historically been a multi-step process expected to end with a stem cell transplant. The process starts with chemoimmunotherapy, and if a patient responds to and can tolerate further treatment, they move on to high-dose chemotherapy (HDT) followed by a stem cell transplant (ASCT).

Jason Westin, MD, MS, FACP, ZUMA-7 Principal Investigator, Director, Lymphoma Clinical Research, and Associate Professor, Department of Lymphoma/Myeloma at The University of Texas MD Anderson Cancer Center : "Definitive clinical trial results such as these do not come along often and should drive a paradigm shift in how patients with relapsed or refractory LBCL are treated moving forward. Patients who do not respond to or relapse after initial treatment should quickly be referred to a CAR T-cell therapy authorized treatment center for evaluation."

Kite CAR T-cell therapy products are widely covered by commercial and government insurance programs in the U.S. Kite has also invested in expansion of manufacturing capacity ahead of today's FDA decision to support patient access.

Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS): "LLS was an early supporter of CAR T-cell therapy research, and to be able to see this innovative advance become available as an earlier line of treatment is truly remarkable. Current standard of care is a difficult process for patients, and no one knows at the start who will make it to stem cell transplant. With today's FDA decision, patients will have earlier access to this potentially curative treatment."

Yescarta was initially approved by the FDA in 2017 based on the ZUMA-1 trial for a smaller population of LBCL patients who failed two or more lines of therapy. The ZUMA-1 trial has recently reported durable 5-year survival results, with Yescarta showing 42.6% of study patients alive at 5 years and that 92% of those patients alive at 5 years have needed no additional cancer treatment at this important milestone.

As the only company dedicated exclusively to the research, development, commercialization, and manufacturing of cell therapy on a global scale, Kite has all functions critical to cell therapy vertically integrated. This structure enables the continual refinement and support of the highly specialized and complex end-to-end processes needed to support and improve upon patient outcomes with CAR T-cell therapy.

About ZUMA-7 Study

The FDA approval of Yescarta CAR T-cell therapy for adult patients with large B-cell lymphoma (LBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy is based on results from the ZUMA-7 study. Patients had not yet received treatment for relapsed or refractory lymphoma and were potential candidates for autologous stem cell transplant (ASCT). Results were presented in a Plenary session at the American Society of Hematology's (ASH) Annual Meeting & Exposition in December 2021 and simultaneously published in the New England Journal of Medicine (NEJM).

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus current standard of care (SOC) for second-line therapy (platinum-based salvage combination chemoimmunotherapy regimen followed by high-dose therapy [HDT] and ASCT in those who respond to salvage chemotherapy) in adult patients with relapsed or refractory LBCL within 12 months of first-line therapy. In the study, 359 patients in 77 centers around the world were randomized (1:1) to receive a single infusion of Yescarta or current SOC second-line therapy. The primary endpoint is event-free survival (EFS) as determined by blinded central review and defined as the time from randomization to the earliest date of disease progression per Lugano Classification, commencement of new lymphoma therapy, or death from any cause. Key secondary endpoints include objective response rate (ORR) and overall survival (OS). Additional secondary endpoints include patient reported outcomes (PROs) and safety.

Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment (40.5% vs. 16.3%) and a four-fold greater median EFS (8.3 mo. vs. 2.0 mo.) compared to SOC (hazard ratio 0.398; 95% CI: 0.308-0.514, P

Nearly three times as many patients randomized to Yescarta ultimately received the definitive CAR T-cell therapy treatment (94%) versus those randomized to SOC (35%) who received on-protocol HDT+ASCT. More patients responded to Yescarta (ORR: 83% vs. 50%, odds ratio: 5.31 [95% CI: 3.1-8.9; P

Fifty-five percent of patients in the SOC arm subsequently received CD19-directed CAR T-cell therapy off study.

In the study, Yescarta had a safety profile that was consistent with previous studies. Among the 168 Yescarta-treated patients evaluable for safety, Grade 3 cytokine release syndrome (CRS) and neurologic events were observed in 7% and 25% of patients, respectively. In the SOC arm, 83% of patients had high grade events, mostly cytopenias (low blood counts).

The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

About LBCL

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment.

About Yescarta

Please see full Prescribing Information , including BOXED WARNING and Medication Guide.

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Limitations of Use : YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

U.S. IMPORTANT SAFETY INFORMATION

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

CYTOKINE RELEASE SYNDROME (CRS)

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non-Hodgkin lymphoma (NHL), including Grade 3 in 9%. CRS occurred in 93% (256/276) of patients with large B-cell lymphoma (LBCL), including Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death. For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days). CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA-5, including Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL.

Key manifestations of CRS ( 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event. The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing Grade 3 CRS. The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities.

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated.

NEUROLOGIC TOXICITIES

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life-threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including Grade 3 in 25%. The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including Grade 3 in 21%. The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL.

The most common neurologic toxicities ( 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred. Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred.

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event. The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities. The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS.

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS. Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at http://www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

HYPERSENSITIVITY REACTIONS

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

SERIOUS INFECTIONS

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 infections occurred in 17% of patients, including Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%. YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines.

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported. The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed.

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing.

PROLONGED CYTOPENIAS

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion.

HYPOGAMMAGLOBULINEMIA B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment.

SECONDARY MALIGNANCIES

Secondary malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period.

ADVERSE REACTIONS

The most common non-laboratory adverse reactions (incidence 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting.

The most common adverse reactions (incidence 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias.

The most common non-laboratory adverse reactions (incidence 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with manufacturing operations in North America and Europe. Kite's singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com .

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the possibility of unfavorable results from ongoing or additional clinical trials involving Yescarta; Kite's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Yescarta; Kite's ability to receive regulatory approvals in a timely manner or at all, including additional regulatory approvals of Yescarta, and the risk that any such approvals may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing Yescarta; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Kite and Gilead, and Kite and Gilead assume no obligation and disclaim any intent to update any such forward-looking statements.

U.S. Prescribing Information for Yescarta including BOXED WARNING , is available at http://www.kitepharma.com and http://www.gilead.com .

Kite, the Kite logo, Yescarta, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc. or its related companies.

For more information on Kite, please visit the company's website at http://www.kitepharma.com . Follow Kite on social media on Twitter ( @KitePharma ) and LinkedIn .

View source version on businesswire.com: https://www.businesswire.com/news/home/20220401005519/en/

Jacquie Ross, Investors investor_relations@gilead.com

Mary Lynn Carver, Media mcarver@kitepharma.com

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Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial -...

Cardiac Stem Cells Comments Off on Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial -… | April 3rd, 2022

According to The Insight Partners new research study on Epithelial Cell Culture Media Market Forecast to 2027 COVID-19 Impact and Global Analysis by Product Type and End User, the market is expected to reach US$ 303,040.33 thousand by 2028 from US$ 128,155.95 thousand in 2020; it is estimated to grow at a CAGR of 11.4% from 2021 to 2028.

Certain age-related diseases, abnormalities, and trauma damage the tissues and organs. Regenerative medicines have the potential to replace or heal tissues and organs, along with normalizing congenital defects. In the last decade of the century, tissue engineering techniques have emerged impressively, and they are now being employed in broader areas of regenerative medicine. Thus, it has now become possible to use these techniques in the development of clinical therapies for the maintenance, repair, replacement, and enhancement of biological functions. Further, the regenerative medicines developed using cell-based models can potentially assist researchers in the early intervention of degenerative diseases and traumatic injuries.

Download sample PDF Copy of Epithelial Cell Culture Media Market study at: https://www.theinsightpartners.com/sample/TIPRE00022539/

PromoCell GmbH; Merck KGaA; ATCC; AXOL Bioscience Ltd.; Thermo Fisher Scientific, Inc.; Bio-Techne Corporation; Celprogen, Inc.; Lonza Group AG; HiMedia Laboratories; and Cell Biologics, Inc. are among the leading companies operating in the epithelial cell culture media market.

Geographically, the epithelial cell culture media market is segmented into North America, Europe, Asia Pacific (APAC), the Middle East and Africa (MEA), and South and Central America (SCAM). North America held the largest market share in 2020. In 2020, the US held the largest share of the market in North America. The market growth in North America is attributed to the key driving factors such as the presence of various market players and increasing demand for cell culture products from biopharmaceutical and biotechnology companies.

Human amniotic epithelial cells (hAECs) from placental tissues have gained substantial attention in the field of regenerative medicine owing to their proliferative capacity, easy access, multilineage differentiation potential, and safety. These are perinatal stem cells that have embryonic stem cell-like properties and the capability to be induced to differentiate. Thus, a growing focus on bringing advancements in regenerative medicine is likely to boost the adoption of epithelial cell cultures, thereby bolstering the demand for the respective culture.

Inquiry Before Buying on epithelial cell culture media market at: https://www.theinsightpartners.com/inquiry/TIPRE00022539/

Below is the list of the growth strategies done by the players operating in the epithelial cell culture media market:

In May-21 Bio-Techne has released MimEX GI, a new product line for generating 3-dimensional (3-D) gastrointestinal tissue on a 2-D surface.

In Sep-2020 Axol Bioscience and Censo Biotechnologies Announce Merger. The newentitywould become a global leader in the iPSC-based neuroscience, immune cell, and cardiac simulation industries for drug development and screening.

The report segments the epithelial cell culture media market as follows:

By Product Type

Human Mammary Epithelial CellsBronchia/Trachea Epithelial CellsRenal Epithelial CellsOthers

By End User

Biopharmaceutical CompaniesAcademic and Research Laboratories

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Epithelial Cell Culture Media Market to exceed USD 303040.33 thousand by 2028 says, The Insight Partners - Digital Journal

Cardiac Stem Cells Comments Off on Epithelial Cell Culture Media Market to exceed USD 303040.33 thousand by 2028 says, The Insight Partners – Digital Journal | April 3rd, 2022

With its tail flipping rhythmically from side to side, this strange synthetic fish scoots around in its salt and glucose solution, using the same power as our beating hearts.

This nifty miniaturized circulatory system, developed by scientists at Harvard and Emory universities, can keep swimming to the beat for more than 100 days.

The inventors have high hopes for the strange little device, composed of living heart muscle cells (cardiomyocytes) grown from human stem cells.

The creation of the 'biohybrid' fish focuses on two key regulatory features of our hearts: their ability to function spontaneously, without need for conscious input (automaticity); and messaging initiated by mechanical motion (mechanoelectrical signaling).

This insights learned from the research will hopefully allow researchers to more closely examine these aspects in heart diseases.

"Our ultimate goal is to build an artificial heart to replace a malformed heart in a child," saysHarvard University bioengineer Kevin Kit Parker.

While it's straightforward enough to create something that may look like a heart, making something that actually functions like one is a much harder challenge. The wriggling fishbot is a big step towards this, building on previous work using rat heart muscles to build a jellyfish biohybrid pump and a cyborg stingray.

"I could build a model heart out of Play-Doh, it doesn't mean I can build a heart,"explainsParker.

"You can grow some random tumor cells in a dish until they curdle into a throbbing lump and call it a cardiac organoid. Neither of those efforts is going to, by design, recapitulate the physics of a system that beats over a billion times during your lifetime while simultaneously rebuilding its cells on the fly.

"That is the challenge. That is where we go to work."

With two layers of cardiomyocytes on each side of the tail fin, the biohybrid fish is built to be autonomous it can self-perpetuate its own movement.

When one side squeezes tight, the other side is stretched, triggering a feedback mechanism that causes the stretched side to contract and then trigger the same mechanism on the other side in an ongoing cycle.

This system of asynchronous muscle contractions is based on insect flight muscles.

Each contraction automatically triggers the other muscle pair to contract. (Lee et al., Science, 2022)

The physical bending is the mechanical motion that activates the electrical signal forming ion channels in the muscles. These ion channels trigger the muscles to activate and contract.

Exposing the system to streptomycin and gadoliniumknown to disrupt ion channels in musclesended up decreasing swimming speeds and breaking the relationship between the mechanical stretching and triggering of the next contraction on the other side. This confirmed the ion channels were indeed involved with the rhythmic contractions.

"By leveraging cardiac mechano-electrical signaling between two layers of muscle, we recreated the cycle where each contraction results automatically as a response to the stretching on the opposite side," saysHarvard University bioengineer Keel Yong Lee.

"The results highlight the role of feedback mechanisms in muscular pumps such as the heart."

Parker and colleagues also integrated a pacemaker-like system into the biohybrid: an isolated cluster of cells that control the frequency and coordination of these movements.

"Because of the two internal pacing mechanisms, our fish can live longer, move faster, and swim more efficiently than previous work," explainsbiophysics researcherSung-Jin Park, the co-first author of the study.

The tissue wide contractions of the biohybrid fish are comparable to the zebrafish that the biohybrid is modeled after more efficiently propelling the little device around than mechanical robotic systems.

"Rather than using heart imaging as a blueprint, we are identifying the key biophysical principles that make the heart work, using them as design criteria, and replicating them in a system, a living, swimming fish, where it is much easier to see if we are successful," says Parker.

This research was published in Science.

Originally posted here:
Scientists Made a 'Fish' From Human Cardiac Cells, And It ...

Cardiac Stem Cells Comments Off on Scientists Made a ‘Fish’ From Human Cardiac Cells, And It … | March 22nd, 2022

According to the latest report by IMARC Group, titled Stem Cell Banking Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2021-2026 the global market reached a value of US$ 10.4 Billion in 2020. Stem cell banking refers to the process of collecting, storing and freezing stem cells for potential future use. Embryo, placenta, umbilical cord, bone marrow and cord blood are some of the common sources for obtaining stem cells. These cells are cryopreserved and are used to replace damaged organs, tissues and treat various diseases, such as leukemia, diabetes, thalassemia and cardiac disorders. Moreover, stem cells can regenerate and produce red blood cells (RBCs), platelets and white blood cells to protect the body in case of an infection. As a result, they are widely used for clinical, personalized and research applications.

Request Free Report Sample:https://www.imarcgroup.com/stem-cell-banking-market/requestsample

The global stem cell banking market is primarily being driven by the rising geriatric population. Due to the increasing prevalence of fatal chronic diseases, preserved stem cells are used in various medical therapies for the treatment of immune, blood, degenerative and metabolic disorders. Moreover, various technological advancements, such as the utilization of artificial intelligence (AI) solutions to identify productive and healthy stem cells, are providing a thrust to the market growth. Other factors, including the implementation of various government initiatives promoting public health, along with significant improvements in the medical infrastructure, are creating a positive outlook for the market. Looking forward, IMARC Group expects the market to reach a value of US$ 21.5Billion by 2026.

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As the novel coronavirus (COVID-19) crisis takes over the world, we are continuously tracking the changes in the markets, as well as the industry behaviors of the consumers globally and our estimates about the latest market trends and forecasts are being done after considering the impact of this pandemic.

Competitive Landscape with Key Players:

Key Highlights of the Market Segmentation:

Breakup by Product Type:

Breakup by Service Type:

Breakup by Bank Type:

Breakup by Utilization:

Breakup by Application:

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Stem Cell Banking Market: Top Companies, Investment Trend, Growth & Innovation Trends 2021-2026 The Bite - The Bite

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