Cardiosphere-Derived Cells

The formation of cardiospheres from human and murine heart tissue was first described in 2004 by Messina and coworkers [16]. It was demonstrated that, when placed in adherent plates, heart explants generated a layer of fibroblast-like cells over which small, phase-bright cells migrated. These phase-bright cells were collected and transferred to nonadherent plates where they originated three-dimensional structures named cardiospheres. Cardiospheres were clonogenic and when co-cultured with rat neonatal cardiomyocytes expressed troponin I and connexin 43. Additionally, there was visual evidence that cardiospheres showed synchronous contractions with cardiomyocytes. When transplanted into infarcted hearts, these cells started to express myosin heavy chain as well as -smooth muscle actin and platelet endothelial cell adhesion molecule, which resulted in functional improvement. Curiously, when the expression of surface molecules was analyzed by flow cytometry, cardiospheres showed a 25% expression of c-kit. Thus, it is possible that c-kit+ cells contribute to the characteristics observed in cardiospheres, explaining the similar findings between these two cardiac progenitor/stem cell types.

However, it was only in 2007 that Marbns group described cardiosphere-derived cells (CDCs) [19]. They slightly changed Messinas protocol by placing cardiospheres in adherent plates where cells were grown in monolayers instead of three-dimensional structures. The advantage of this step was that cell expansion in monolayers was easier and faster, which would facilitate future clinical use. Flow cytometry showed that c-kit expression was still present in similar levels to those described by Messina and coworkers. Additionally, high expression levels of CD105 and CD90 were found, indicating a mesenchymal phenotype. When co-cultured with rat neonatal cardiomyocytes, CDCs presented spontaneous intracellular calcium transients and action potentials, as well as INa, IK1 and ICa,L currents. In vivo, injection of CDCs in acute myocardial infarctions (MI) prevented further ejection fraction deterioration 3 weeks after MI when compared to placebo and fibroblast injected mice. In 2009, Marbns group also reported functional benefit and reduction of infarct size in a porcine animal model after CDC injection [37], a preclinical model that prompted a phase I clinical trial (CADUCEUS, ClinicalTrials.gov, Identifier NCT00893360).

Nonetheless, the usage of cardiospheres as a source of cardiac stem cells has been refuted. Andersen and coworkers showed that even though cardiospheres can be produced from heart specimens, they do not hold cardiomyogenic potential and simply represent aggregated fibroblasts [38]. This group also found cells that expressed cardiac contractile proteins, such as myosin heavy chain and troponin T, in cardiospheres. However, the findings were attributed to the presence of contaminating heart tissue fragments in the explant-derived cell suspension. By adding a filtration step in which explant-derived cells were passed through cell strainers prior to cardiosphere formation, the presence of cells expressing cardiac contractile proteins was eliminated. In addition, this group showed that phase-bright cells were of hematopoietic origin and did not organize into spheric structures, a characteristic attributed to the fibroblast-like cells.

In response to Andersens findings, Marbns group published a revalidation of the CDC isolation method [39]. Using a strategy identical to the one described by Hsieh and colleagues [8], cardiomyocytes were irreversibly labeled with GFP after a tamoxifen pulse (see Fig. 8.1). Isolation of CDCs from these transgenic mouse hearts did not reveal the presence of GFP+ cells, refuting the possibility that cardiac differentiation of CDCs was due to the presence of contaminating myocardial tissue fragments. Additionally, they reported that cardiospheres were consistently negative for CD45, indicating that CDCs do not contain cells of hematopoietic origin. The authors also emphasized that Andersen and coworkers used different isolation protocols, which could justify the discrepancies found in results.

Even though they demonstrated that CDCs expressed myosin heavy chain after transplantation into myocardial infarctions in mice [17], indicating that cardiomyogenic differentiation was possible in vivo, an additional mechanism was proposed to explain the improvement in cardiac function. Chimenti and colleagues studied the relative roles of direct regeneration versus paracrine effects promoted by human CDCs in a mouse infarction model [40]. The paracrine hypothesis has been used frequently to explain the beneficial effects observed with several types of adult stem cells or bone marrowderived cells used in cell therapy experiments. According to this hypothesis, stem cells could act secreting signaling molecules, which may influence cardiomyocyte survival and angiogenesis and could also recruit endogenous cardiac stem cells. Chimenti and coworkers demonstrated that CDCs secrete high levels of insulin growth factor-1 (IGF-1), hepatocyte growth factor (HGF), and vascular endothelial growth factor (VEGF). Moreover, using in vivo bioluminescence assays, the authors showed that no cells could be found in the heart 1 week after injection, even though functional improvement persisted until 3 weeks post-MI. Therefore, it seems that cell persistence is not important for functional improvement, strengthening the paracrine hypothesis. To address this issue, the authors quantified capillary density and viable myocardium analyzing the contributions of human (injected) and mouse (endogenous) cells to each of these variables 1-week post-MI [40]. They found that, for both variables, the contribution of endogenous cells was more prominent than that of injected cells. Hence, the release of factors seems to be more important than direct regeneration in the improvement of cardiac function after cell therapy with CDCs.

Recently, results of a phase I clinical trial using CDCs were published [41]. The safety of autologous intracoronary delivery of CDCs to patients 1.5 to 3 months after MI was evaluated. Cells were obtained from endomyocardial biopsies and cultured according to the protocols previously established by Eduardo Marbns group. Patients with a recent MI (less than 4 weeks) and left ventricular ejection fraction ranging from 25% to 45% were eligible for inclusion. Twelve months after cell therapy, patients treated with CDCs had a 12.3% decrease in scar size, whereas the control group had a 2.2% reduction, as measured by late enhancement after gadolinium MRI. However, no differences were detected in ejection fraction between cell-treated and control groups. It is important to note that this was a safety study; therefore, phase II double-blinded placebo-controlled clinical trials still need to be performed to access efficacy of therapy with CDCs in humans. Additionally, a more thorough cell biologic characterization of CDCs is required to understand provenience, molecular identity, and mechanism of action of these cells as potential cardioprotective agents.

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Cardiac Stem Cell - an overview | ScienceDirect Topics

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Building on years of groundbreaking discoveries in stem cell research, scientists from Indiana University School of Medicine and Harvard Medical School have determined how to grow hairy skin using human stem cellsdeveloping one of the most complex skin models in the world.

The study, published June 3 in Nature, shows that skin generated from pluripotent stem cells can be successfully grafted on a nude mouse to grow human skin and hair follicles. That discovery could lead to future studies in skin reconstruction, disease modeling and treatment.

This is the first study to show that human hair can be grown completely from stem cells in a dish, which has been a goal of the skin biology community for decades, said Karl Koehler, PhD, assistant professor of otolaryngologyhead and neck surgery at Harvard Medical School and Boston Childrens Hospital.

The team of researchers was led by Koehler, whos also an adjunct assistant professor of otolaryngologyhead and neck surgery at IU School of Medicine, and Jiyoon Lee, PhD, a research associate in Koehlers lab.

The groups findings originate from several years of stem cell research within the Department of OtolaryngologyHead and Neck Surgery at IU School of Medicine. In 2013, scientists created inner ear tissue from mouse embryonic stem cells using a three-dimensional cell culture method. In 2017, they developed a method to grow inner ear tissue from human stem cells, and in 2018, the researchers grew hairy skin in a dish using mouse stem cells, a scientific first.

Through the three-dimensional culture technique developed in past experiments, the team incubated human stem cells for about 150 days in a ball-shaped cluster of cells, called a skin organoid. The interior of the aggregate of cells represent the top layer of skin (the epidermis) and the outside of the cluster develops the bottom layer of skin (the dermis).

Weve developed a new cooking recipe for generating human skin that produces hair follicles after about 70 days in culture, Koehler said. When the hair follicles grow, the roots extend outward radially. Its a bizarre-looking structure, appearing almost like a deep-sea creature with tentacles coming out from it.

After the incubation period, researchers tested whether skin organoids could integrate on the skin of nude mice. More than half of the organoids they grafted on the mice grew human hair follicles. The skin organoid developed from culture is akin to fetal facial skin and hair, Koehler said.

The experiments show that organoid generated hairy skin can integrate into mouse skin, Koehler said, which suggests potential applications in skin and facial reconstruction. Physicians typically perform skin grafts in surgery, meaning the removal of skin from one area of the body to transplant on skin thats been wounded.

This could be a huge innovation, providing a potentially unlimited source of soft tissue and hair follicles for reconstructive surgeries, said Lee, the first author of the study.

Taha Shipchandler, MD, associate professor of clinical otolaryngologyhead and neck surgery at IU School of Medicine and one of the papers authors, specializes in facial plastic and reconstructive surgery. Skin regeneration is of great interest for treating patients, he said.

If we can harness this growth into a medium, and easily apply it to patients, it would change the way we treat many injuries or reconstructions, Shipchandler said. This would have a profound effect on the medical field.

The other potential uses of hairy skin organoids vary widely, from developing drug or gene therapies for congenital skin disorders to recreating the earliest stages of skin cancer formation. In addition, more research is needed to analyze the development of sensory neurons and Merkel cellsspecialized touch sensing cells of the skinbundled within the organoid hair follicles, Koehler said, adding that the neurons potentially mimic the nerves mediating touch sensations.

Were setting up experiments where we wiggle the hairs and see if the neurons activate, Koehler said, as proof of concept that our skin can respond to touch in some way.

This research was supported by the Ralph W. and Grace M. Showalter Trust, Indiana Clinical Translational Sciences Institute, the Indiana Center for Biomedical Innovation and the National Institutes of Health.

###

IU School of Medicine is the largest medical school in the U.S. and is annually ranked among the top medical schools in the nation by U.S. News & World Report. The school offers high-quality medical education, access to leading medical research and rich campus life in nine Indiana cities, including rural and urban locations consistently recognized for livability.

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Researchers grow hairy skin from human stem cells

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Whether through injury or simple wear and tear, the skins integrity and function can be easily compromised. Although this impacts billions of people worldwide, little is known about how to prevent skin degeneration.

The Harvard Stem Cell Institute (HSCI) Skin Program is committed to understanding why skin sometimes fails to heal or forms scars, as well as why skin inevitably becomes thin, fragile, and wrinkled with age. The Skin Programs ultimate goal is to identify new therapies for skin regeneration and rejuvenation.

Wound healing is a major problem for many older individuals. Furthermore, chronic, non-healing skin ulcers are a major source of health care costs and patient morbidity and mortality.

Human skin repairs itself slowly, via the formation of contractile scars which may cause dysfunction. In contrast, the axolotl salamander can readily regrow a severed limb, the spiny mouse has densely haired skin that heals with remarkable speed, and the skin of the growing human embryo can regenerate after trauma without the need for any scar formation. By studying these examples, scientists are finding clues for how to enhance skin healing through a more regenerative response.

During normal wound healing, scars form from dermal cells that align in parallel. But when this alignment is disrupted by a biodegradable scaffold that directs cells to grow in a random orientation, the cells follow the diverse differentiation program necessary for true regeneration.

HSCI scientists have also identified biomarkers for the key cells involved in skin regeneration, and are developing therapeutic strategies for their enrichment and activation. Ongoing clinical trials are using skin stem cells to treat chronic, non-healing ulcers, and early results are promising.

Additional approaches include 3D bioprinting, where skin stem cells are layered into a complex structure that mimics skin and could be potentially used for transplantation.

Skin aging can be thought of as a form of wounding, in which stem cells no longer maintain normal skin thickness, strength, function, and hair density. Understanding how to harness stem cells for scarless wound healing will also provide key insights into regenerating aged skin, a process termed rejuvenation. Multidisciplinary collaborators in the HSCI Skin Program are investigating the biological basis for how the skin ages over time and when exposed to ultraviolet radiation.

In addition to aging, skin stem cells also may mistake normal regions of the skin as wounds, then erroneously attempt to fill them. HSCI investigators are exploring whether this may be one of the underpinnings of psoriasis, a common and devastating disorder.

These areas of investigation are just the beginning. Skin stem cell biology has the potential to provide key insights into the mechanisms of regeneration for other organs in the body.

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Skin Regeneration and Rejuvenation | Harvard Stem Cell ...

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When you compare pictures of presidents who do not alter their hair color, they all leave office considerably grayer than when they started, which some link to the stress of the office.

Marie Antoinette syndrome is a condition in which scalp hair suddenly turns white. The name comes from the story that Marie Antoinettes hair turned white the night before she was to face the guillotine during the French Revolution.

The same thing happened to survivors of atomic bomb attacks during World War II. It has long been thought that genetics, aging and stress all contribute to developing gray hair.

New research has revealed how stress contributes to graying.

On average, humans have 100,000 hair follicles in their scalp, which produce hairs of one color or another. Hair color is determined by the types of melanin produced by cells called melanocytes. Melanocytes grow from melanocyte stem cells (MeSCs) inside the hair follicle.

With age, the number of MeSCs declines, leading to hair graying in stages from the occasional gray one, to salt and pepper, to gray and then white when all the MeSCs are gone. But how stress leads to gray hair has been a mystery.

It had been thought that stress-induced graying involved hormones such as corticosterone or autoimmune reactions. Scientists did experiments in mice and found that neither of those was the cause.

However, when they blocked the receptor for the fight-or-flight hormone, noradrenaline, they stopped hair graying in response to stress in mice. Finally, they had a clue.

The main source of noradrenaline is the adrenal glands. However, when the scientists removed the adrenal glands in mice, their hair still turned gray in response to stress. Another source of the hormone is the sympathetic nervous system (SNS), which is part of the autonomic nervous system that works to regulate many functions and parts of the body without us thinking about it.

The SNS controls the fight-or-flight response to stress to prepare the whole body for physical activity. SNS nerves and MeSCs are close together in the hair follicle, and blocking those SNS nerves prevented the hairs from turning gray in response to stress. Conversely, when the SNS nerves were over-activated, the mice went gray even without stress.

Normally, MeSCs are dormant unless hair is regrowing. In response to extreme stress, MeSCs reproduce and mature into melanocytes quickly. Large numbers of melanocytes then migrate from the follicle, leaving no MeSCs in the follicles and no melanocytes to provide the pigments that give hair its color. Once they are all gone, hair will never be its original color again.

This brings up the added question about other effects of stress, including a decline in immunity and the ability to fight off infections.

The SNS system also stimulates stem cells in the bone marrow to mature into the blood cells required to protect us from infections. Nearly every organ in the body contains stem cells, and stress could have an impact on those as well.

Medical Discovery News is hosted by professors Norbert Herzog at Quinnipiac University, and David Niesel of the University of Texas Medical Branch. Learn more at http://www.medicaldiscoverynews.com.

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How stress contributes to the graying of hair - Galveston County Daily News

Bone Marrow Stem Cells Comments Off on How stress contributes to the graying of hair – Galveston County Daily News | July 1st, 2020

Patients with cancer often incur bone marrow damage, resulting in the destruction of stem cells. Stem cell transplants are used to replenish lost or damaged cells that have been affected by cancer and depending on where the stem cells come from these, the procedure may be a bone marrow transplant (BMT), peripheral blood stem cell transplant, or a cord blood transplant.

Typically, in a stem cell transplant, physicians administer high doses of chemotherapy, occasionally in conjunction with radiation therapy, to kill all cancer cells. This is known as myeloablative therapy.

Here are the two main types of transplants, as outline by the American Cancer Society:

In an autologous stem cell transplant, the patient serves as their own donor. Auto means self, therefore this procedure means harvesting your own stem cells from either your blood or bone marrow, then freezing them for preservation. Following high-dose chemo and radiation therapy, the frozen cells are thawed and returned to the (self) donor. Autologous transplants are sometimes used for testicular cancer and brain tumors, but are mainly utilized to treat leukemia, lymphoma, and multiple myeloma. For the latter, autologous stem cell procedures offers patients a chance for achieving sustained remission. One advantage of autologous stem cell transplant is that youre getting your own cells back. When you getyour own stem cells back, you dont have to worry about them (called the engrafted cells or the graft) being rejected by your body, says the American Cancer Society.

Despite the benefits, as with all procedures, there are risks involved, including graft failure which occurs when the transplanted stem cells dont go into bone marrow fail to properly produce blood cells. A possible disadvantage of an autologous transplant is that cancer cells might be collected along with the stem cells and then later put back into your body, the ACS says, adding that another disadvantage of a autologous stem cell transplants is that your immune system is the same as it was before your transplant. This means the cancer cells were able to escape attack from your immune system before, and may be able to do so again.

But how exactly do physicians prevent any residual cancer cells from being transplanted with healthy cells? In a process known as purging, stem cells are treated before being infused back into the patients blood. Although purging carries its benefits, a potential downside, according to the ACS, is that normal cells may be lost during this process, which in turn could lead to unsafe levels of white blood cells as your body takes longer to produce normal blood cells. Cancer centers will also sometimes use in vivopurging, which involves not treating the stem cells, and instead administering anti-cancer drugs to patients post-transplant. The ACS notes, however, that the need to remove cancer cells from transplanted stem cells or transplant patients and the best way to do it continues to be researched.

Whereas autologous procedures infuse stem cells from your own body, allogeneic stem cell transplants use cells from a donor with a very similar tissue type (in many cases a relative, usually a sibling). In cases where the ideal donor is not a relative, physicians may opt to perform a matched unrelated donor (MUD) transplant, which as the ACS notes, are usually riskier than those with a relative who is a good match.

Allogeneic transplants comprise of the same process as autologous stem cell transplants where stem cells are harvested, frozen, and subsequently thawed and put back following high-dose chemo and/or radiation therapy. In some cases, the procedures involve the infusion of blood extracted from the placenta and umbilical cord of a newborn because the cord contains a high number of stem cells that quickly multiple. By 2017, an estimated 700,000 units (batches) of cord blood had been donated for public use. And, even more have been collected for private use. In some studies, the risk of a cancer not going away or coming back after a cord blood transplant was less than after an unrelated donor transplant, writes the ACS.

A benefit of an allogeneic transplant is that donor stem cells create their own immune cells, which may eliminate any residual cancer cells that remain after high-dose treatment, which is known as the graft-versus-cancer effect. Moreover, because the donor stem cells are free of cancer, donors can be asked to donate stem cells or white blood cells multiple times.

As with autologous stem cell procedures, this donor dependent transplant also carries risk. The transplant, or graft, might be destroyed by the patients body before reaching the bone marrow. Allogeneic stem cell transplants also augment the risk of graft-versus-host-disease, where cells from the donor attack healthy cells in the recipients body. Furthermore, despite the healthy cells being tested before transplant, allogeneic procedures still carry a certain risk of infections because, as the ACS writes, your immune system is held in check (suppressed) by medicines calledimmunosuppressivedrugs. Such infections can cause serious problems and even death.

Because theres a plethora of human leukocyte antigen (HLA) combinations, which are inherited from both parents, finding an exact donor match can often be an arduous task. The search usually starts at siblings, and theres a 25% chance of a sibling being a perfect match. In the event that a sibling does not match, the search moves onto extended family (and parents) who are less likely to match.

The ACS writes: As unlikely as it seems, its possible to find a good match with a stranger. To help with this process, the team will use transplant registries, like those listed here. Registries serve as matchmakers between patients and volunteer donors. They can search for and access millions of possible donors and hundreds of thousands of cord blood units.

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The Two Types of Stem Cell Transplants for Cancer Treatment - DocWire News

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- Partnership leverages Boehringer Ingelheims oncology expertise to lead trilaciclib SCLC launch sales engagements- G1 to retain full development and commercialization rights and book revenue for trilaciclib-New Drug Application (NDA) for trilaciclib submitted in June 2020

RESEARCH TRIANGLE PARK, N.C. and RIDGEFIELD, Conn., June 30, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX) and Boehringer Ingelheim today announced that the companies have entered into a co-promotion agreement for trilaciclib in the United States and Puerto Rico. Under the terms of the three-year agreement, G1 and Boehringer Ingelheim will collaborate on the commercialization of trilaciclib for its first potential indication in small cell lung cancer (SCLC), with the Boehringer Ingelheim oncology commercial team, well-established in lung cancer, leading sales force engagement initiatives. Discovered and developed by G1, trilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

We believe that trilaciclib has the potential to benefit patients with cancer being treated with chemotherapy across a broad range of solid tumors, said Mark Velleca, M.D., Ph.D., Chief Executive Officer of G1. Our clinical trials of trilaciclib in small cell lung cancer have demonstrated significant myelopreservation benefits, and we are excited to collaborate with Boehringer Ingelheims experienced commercial oncology team to bring this innovative therapy to patients with SCLC. In addition, this capital efficient launch structure provides us with the ability to make investments in a robust development program to assess trilaciclib in other solid tumors, including colorectal cancer and breast cancer.

Under the terms of the agreement, G1 will book revenue in the United States and Puerto Rico and retain global development and commercialization rights to trilaciclib. In the U.S. and Puerto Rico, G1 will lead marketing, market access and medical engagement initiatives; Boehringer Ingelheim will lead sales force engagements. G1 will make initial payments to Boehringer Ingelheim to cover start-up expenses and pre-approval initiatives to support a successful commercial launch. G1 will pay a promotion fee of a mid-twenties percentage of net sales in the first year of commercialization, which decreases to a low double-digit/high single-digit percentage in the second and third years of commercialization, respectively (subject to certain adjustments for sales above pre-specified levels to reward out-performance). There are no payments due by either party beyond the expiration of the three-year term of the agreement. The agreement does not extend to additional indications that G1 may pursue for trilaciclib.

Boehringer Ingelheims commitment to transform treatment expectations for the oncology community extends beyond research and drives us to explore innovative solutions for patients. We are pleased to be collaborating with G1 Therapeutics and applying our commercial strengths focused on lung cancer to support a new therapy for patients with clear synergies across customer audiences, said Kelli Moran, Senior Vice President, Specialty Care, Boehringer Ingelheim. This strategic agreement builds on Boehringer Ingelheims achievements in oncology and contributes to our long-term vision to give patients new hopeby taking cancer on.

G1 received Breakthrough Therapy Designation for trilaciclib from the U.S. Food and Drug Administration (FDA) in 2019 and submitted a New Drug Application (NDA) in June 2020. More than 25,000 people in the U.S. and Puerto Rico are diagnosed with SCLC each year. Approximately 90% of SCLC patients receive first-line chemotherapy treatment, and approximately 60% of those patients receive subsequent second-line chemotherapy treatment. Chemotherapy is an effective and important weapon against cancer. However,chemotherapy does not differentiate between healthy cells and cancer cells and kills both. One of the most common side effects of chemotherapy is myelosuppression the result of damage to stem cells in the bone marrow that produce white blood cells, red blood cells and platelets. Myelosuppression often requires the administration of rescue interventions such as growth factors and blood or platelet transfusions, and may also result in chemotherapy dose delays and reductions. Immune cell damage may decrease the ability of the immune system to fight the cancer, as well as infection. Trilaciclib has the potential to be the first proactively administered myelopreservation therapy that can make chemotherapy safer and improve the patient experience.

Additional information regarding this agreement is disclosed in a Current Report on Form 8-K filed by G1 with the U.S. Securities and Exchange Commission (available here).

About TrilaciclibTrilaciclib is a first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy. Trilaciclib has received Breakthrough Therapy Designation based on positive myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy treatment in patients with small cell lung cancer (SCLC). In a randomized trial of women with metastatic triple-negative breast cancer, trilaciclib improved overall survival when administered prior to chemotherapy. In June 2020, G1 submitted a New Drug Application (NDA) for trilaciclib for myelopreservation in SCLC and began a study in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL. The company expects to initiate a Phase 3 trial in colorectal cancer in the fourth quarter of 2020.

About G1 TherapeuticsG1 Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development and delivery of innovative therapies that improve the lives of those affected by cancer. The company is advancing three clinical-stage programs. Trilaciclib is a first-in-class FDA-designated Breakthrough Therapy designed to improve outcomes for patients being treated with chemotherapy. Rintodestrant is a potential best-in-class oral selective estrogen receptor degrader (SERD) for the treatment of ER+ breast cancer. Lerociclib is a differentiated oral CDK4/6 inhibitor designed to enable more effective combination treatment strategies.

G1 Therapeutics is based in Research Triangle Park, N.C. For additional information, please visit http://www.g1therapeutics.com and follow us on Twitter @G1Therapeutics.

About Boehringer Ingelheim in OncologyCancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hopeby taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science.Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approachesto help combat many cancers.

About Boehringer IngelheimMaking new and better medicines for humans and animals is at the heart of what we do. Our mission is to create breakthrough therapies that change lives. Since its founding in 1885, Boehringer Ingelheim is independent and family-owned. We have the freedom to pursue our long-term vision, looking ahead to identify the health challenges of the future and targeting those areas of need where we can do the most good.

As a world-leading, research-driven pharmaceutical company, more than 51,000 employees create value through innovation daily for our three business areas: Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. In 2019, Boehringer Ingelheim achieved net sales of around $21.3 billion (19 billion euros). Our significant investment of over $3.9 billion (3.5 billion euros) in R&D drives innovation, enabling the next generation of medicines that save lives and improve quality of life.

We realize more scientific opportunities by embracing the power of partnership and diversity of experts across the life-science community. By working together, we accelerate the delivery of the next medical breakthrough that will transform the lives of patients now, and in generations to come.

Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation and is part of the Boehringer Ingelheim group of companies. In addition, there are Boehringer Ingelheim Animal Health in Duluth, GA and Boehringer Ingelheim Fremont, Inc. in Fremont, CA.

Boehringer Ingelheim is committed to improving lives and strengthening our communities.Please visit http://www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives. For more information, please visit http://www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

G1 Therapeutics Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in theU.S. for trilaciclib in SCLC, trilaciclibs possibility to improve patient outcomes across multiple indications, rintodestrants potential to be best-in-class oral SERD, lerociclibs differentiated safety and tolerability profile over other marketed CDK4/6 inhibitors and the impact of pandemics such as COVID-19 (coronavirus), and are based on the companys expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the companys actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the companys filings with theU.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the companys ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the companys initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development-stage company; and market conditions. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contacts:Jeff MacdonaldG1 Therapeutics, Inc.Senior Director, Investor Relations & Corporate Communications919-907-1944jmacdonald@g1therapeutics.comSusan HolzBoehringer IngelheimDirector, Public Relations203-798-4265Susan.holz@boehringer-ingelheim.com

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G1 Therapeutics and Boehringer Ingelheim Announce Co-Promotion Agreement for Trilaciclib in Small Cell Lung Cancer in the United States and Puerto...

Bone Marrow Stem Cells Comments Off on G1 Therapeutics and Boehringer Ingelheim Announce Co-Promotion Agreement for Trilaciclib in Small Cell Lung Cancer in the United States and Puerto… | July 1st, 2020

Latest Research Report: Hematology Instruments and Reagents industry

This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

Global Hematology Instruments and Reagents Market documents a detailed study of different aspects of the Global Market. It shows the steady growth in market in spite of the fluctuations and changing market trends. The report is based on certain important parameters.

Hematology instruments are machines that analyze blood. Used in medical labs, hematology instruments can do blood counts, detect proteins or enzymes, and help to diagnose illnesses or genetic defects.Hematology is the branch of medicine which deals with the study, diagnosis, and treatment of blood-related disorders. It diagnoses issues related to white blood cells, red blood cells, platelets, bone marrow, and lymph nodes. Hematology also deals with the liquid portion of blood known as plasma. Some blood-associated diseases are anemia, leukemia, myelofibrosis, blood transfusion, malignant lymphomas, and bone marrow stem cell transplantation.

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Hematology Instruments and Reagents Market competition by top manufacturers as follow: , Sysmex, Danaher, Nihon Kohden, Siemens, Abbott Laboratories, Boule Diagnostics, HORIBA, Diatron, Drew Scientific, EKF Diagnostics, Mindray, Roche

The risingtechnology in Hematology Instruments and Reagentsmarketis also depicted in thisresearchreport. Factors that are boosting the growth of the market, and giving a positive push to thrive in the global market is explained in detail. It includes a meticulous analysis of market trends, market shares and revenue growth patterns and the volume and value of the market. It is also based on a meticulously structured methodology. These methods help to analyze markets on the basis of thorough research and analysis.

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Hematology Instruments and Reagents is the arena of accounting worried with the summary, analysis and reporting of financial dealings pertaining to a business. This includes the training of financial statements available for public ingesting. The service involves brief, studying, checking and reporting of the financial contacts to tax collection activities and objects. It also involves checking and making financial declarations, scheming accounting systems, emerging finances and accounting advisory.

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Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaRest of Asia PacificCentral & South AmericaMiddle East & Africa

Report Highlights: Detailed overview of parent market Changing market dynamics in the industry In-depth market segmentation Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape Strategies of key players and products offered Potential and niche segments, geographical regions exhibiting promising growth A neutral perspective on market performance Must-have information for market players to sustain and enhance their market footprint

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Global Impact of Covid-19 on Hematology Instruments and Reagents Market to Witness Promising Growth Opportunities During 20202026 with Top Leading...

Bone Marrow Stem Cells Comments Off on Global Impact of Covid-19 on Hematology Instruments and Reagents Market to Witness Promising Growth Opportunities During 20202026 with Top Leading… | July 1st, 2020

Febrero 2013

James T. Willerson, MD

James T. Willerson, MD,Texas Heart Institute

Heart and vascular disease (or cardiovascular disease, CVD) are the leading causes of death and disability in the world, despite a large proportion of it being preventable.

In the US alone, 82.6 million Americans have some form of CVD. Someone dies from CVD every 33 seconds. More than 40,000 children are born each year with a congenital heart defect.

One of the most promising new avenues for CVD treatment is the use of adult stem cells, to help heal and regenerate damaged hearts.

How can stem cells help the heart?

Stem cells are actually part of our natural circulating rescue system. They travel out of the bone marrow and patrol the circulation system looking for areas of injury to repair. We also have resident stem cells in every organ of the body.

Our first-in-the-world stem cell research at the the Stem Cell Center of the Texas Heart Institute, and subsequent clinical trials in humans, have shown that a patient's own stem cells, harvested from their bone marrow, can help generate new heart muscle tissues and blood vessels in hearts damaged by heart attacks or severe heart failure.

Advances in Stem Cells

After years of study, we have found that when people reach their early 60s, and they begin to have health issues with their bodies, their stem cells also lose their restorative powers. Subsequent research has shown, however, that certain specific cells can be taken from the body fat or bone marrow of healthy young individuals and may be used therapeutically in older patients without adverse immunological reaction. Clinical trials are ongoing and we are constantly learning more about this.

As a result of this work, the National Heart Lung and Blood Institute has established a nationwide consortium of leading medical and research institutions, the Cardiovascular Cell Therapy Research Network (CCTRN), to carry cardiac cell therapy research forward. We are very optimistic about the future of this type of stem cell therapy.

Building New Organs and Reversing Disease

Another area of great promise is the emerging field of regenerative medicine. Dr. Doris Taylor recently joined the Texas Heart Institute as Director of Regenerative Medicine Research. Through her pioneering work, we now have the capability to deplete animal and human hearts of all of their cellular structure and regenerate the "decellularized" scaffolds into healthy organs by the infusion of stem cells. These methods also work on other organs in the body. Many believe that these "bioartificial" organs are the early steps toward our ability to grow new organs for people using their own adult stem cells. We are optimistic that the technology will allow us to begin safe clinical trials in humans within only a few years.

In sum, many advances in stem cells, genetics, and regenerative medicine hold great promise and these fields are advancing rapidly. The next decade or more will undoubtedly be a golden age for progress. We are determined to push the field forward until heart and vascular disease are a thing of the past and our children have a more heart-healthy future ahead of them.

James T. Willerson, MD, is a living legend in cardiovascular medicine. He is the President and Medical Director of the Texas Heart Institute, and the immediate past President of the University of Texas Health Science Center in Houston. Dr. Willerson is a native Texan; he attend UT Austin, Baylor College of Medicine, Harvard Medical School, and trained at Massachusetts General Hospital in Boston. Dr. Willerson has received numerous honors and awards, including the Gold Heart Award, the highest award from the American Heart Association. He has been elected a Fellow in the Royal Society of Medicine of the UK, and made an Honorary Member of the Societies of Cardiology in Peru, Spain, Greece, Venezuela, and Chile. Dr. Willerson is currently President of the International Academy of Cardiovascular Sciences. There is also a swimming scholarship named for him at UT Austin.

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Stem Cells for Cardiac Patients

Cardiac Stem Cells Comments Off on Stem Cells for Cardiac Patients | June 29th, 2020

Cardiovascular diseases are the leading cause of mortality worldwide according to the World Health Organization, mainly due to the occurrence of coronary heart disease and stroke but also to congenital diseases. Because of the phenomenon of population aging and unhealthy ways of life which contribute to ...

Cardiovascular diseases are the leading cause of mortality worldwide according to the World Health Organization, mainly due to the occurrence of coronary heart disease and stroke but also to congenital diseases. Because of the phenomenon of population aging and unhealthy ways of life which contribute to increased risk factors, the number of death from cardiovascular diseases is expected to rise in the near future. So far the heart has been considered to be an organ composed of terminally differentiated cells and not capable of self-regeneration. However recent decisive advancements in this field of research provided evidence that cardiac tissues have the potential for a limited self-renewal. This novel concept thus expands the possibilities for cell-based therapies in the heart to replace dead cardiac muscle cells, since not only exogenous cells could be transplanted but also endogenous progenitor cells could be re-activated. The latest improvements in stem cell bioengineering enable scientists to produce cardiomyocytes from the differentiation of embryonic stem cell lines, but also from adult (animal and human) cells via the so-called induced pluripotent stem cells (iPSCs). The iPSC technology offers the unique opportunity to create cellular models of human adult diseases such as inherited arrhythmia, which proves useful for toxicity studies and drug design. Moreover many of these embryonic or adult cell lines could be considered as candidates for transplantation, provided they would be successful in surviving, migrating, differentiating, distributing, and aligning after engraftment, fundamental properties which still remain huge challenges according to recent studies. Indeed while human embryonic stem cell-derived cardiac myocytes are not yet satisfactory for regeneration of the myocardium in terms of safety and efficacy, the production of sufficient quantities of adult iPSC-derived cardiomyocytes would require immense costs. An alternative promising approach is the use of autologous bone marrow stem cells that can be injected in patients via intra-coronary or intra-myocardial delivery. More clinical trials will be necessary to determine whether this method provides real improvements in ischaemic heart disease. The scope of this Research Topic is to propose a platform of exchange and discussion for scientists interested in the utilisation of stem and progenitor cells for cardiac repair. Our emphasis will range from physiological aspects to bioengineering and clinical applications. Hence we aim at bringing ideas of collaboration and improvements, preliminary results and new perspectives, in order to start answering the following questions: 1)What would be the ideal cell type for therapy? 2)Are we ready yet for cell transplantation? 3)Can we make progress in the maturation of cardiomyocytes derived from stem cells? 4)Cell therapy or engineered heart tissue? For which disease?

Important Note: All contributions to this Research Topic must be within the scope of the section and journal to which they are submitted, as defined in their mission statements. Frontiers reserves the right to guide an out-of-scope manuscript to a more suitable section or journal at any stage of peer review.

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Heart repair, cardiac regeneration and stem cells ...

Cardiac Stem Cells Comments Off on Heart repair, cardiac regeneration and stem cells … | June 29th, 2020

Transparency Market Research (TMR)has published a new report on theamniotic membrane marketfor the forecast period of2019-2027. According to the report, the global amniotic membrane market was valued at ~US$ 980 Mnin2018and is projected to expand at a CAGR of ~10%from2019to2027.

GlobalAmniotic Membrane Market:Overview

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Increase in Research on Stem Cell Biology & Regenerative Medicineto Drive Market

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Cryopreserved Amniotic Membrane Products to Dominate Market

Ophthalmology to be Promising Application

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Hospitals Account for Major Share of Global Market

North America to Dominate Global Amniotic Membrane Market

Global Amniotic Membrane Market: Competitive Landscape

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Amniotic Membrane Market by Product, Application and Forecast to 2027 TMR - 3rd Watch News

Skin Stem Cells Comments Off on Amniotic Membrane Market by Product, Application and Forecast to 2027 TMR – 3rd Watch News | June 29th, 2020

Overview:

Breast implants are artificial prosthesis used for enhancement of breast muscles for a cosmetic reason. Breast augmentation or breast reconstruction refers to the aesthetic treatment of the breast to look more youthful and appealing. There are a wide range of breast implants used in performing aesthetic procedures including those used to treat deformities, injuries, or damages.

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Breast reconstruction requires tissue expanders, which help in the expansion of breast muscles and skin, followed by the permanent insertion of a breast implant after the removal of the tissue expander. These procedures improve symmetry after mastectomy and have an aesthetic appearance. The US is the major revenue contributor to this market. However, the lack of reimbursement issues may restrict the market growth. The vendors in this market are striving to address the issues by conducting evidence-based studies regarding the efficacy of breast augmentation or reconstruction.

Market Analysis:

The global breast implants market is expected to witness a CAGR of 5.89% during the forecast period 20172023. The global breast implants market size is analyzed based on three segments product type, end-users, and regions.

Factors, such as increase in beauty consciousness, growing awareness about reconstructive breast surgeries, favorable demographics across the globe, increasing aging population, are expected to drive the market growth during the forecast period. The market is witnessing emerging trends, such as an increase in the demand of composite breast implant treatments, a rise in medical tourism, and an increase in the disposable income, which will drive the market at a significant pace during the forecast period.

Regional Analysis:

The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (ROW). The Americas is the leading region for the breast implants market growth followed by Europe. Asia Pacific and ROW are set to be the emerging regions. Brazil is the most attractive market in Latin America, the popularity and the usage of breast implants are expected to rise significantly in the coming years.

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Product Analysis:

Silicone and saline breast implants are the most popular among breast augmentation and reconstruction procedures and the most common surgical aesthetic procedures among end-users. Silicone breast implants dominated the market with a revenue of $1 billion in 2016 and is expected to grow at a CAGR of 6% during the forecast period. The saline breast implants segment is growing at a slow rate and is far behind the silicone breast implants segment in terms of market growth. This is due to their low adoption rate and few other complications. In 2016, there were about 64,674 saline surgical breast implants, and these implants are more prone to rippling as they have less firmness.

On an average, women have started spending $300-500 billion a year on beauty products. Moreover, advances in technology, such as use of microspheres in lightweight breast implants and the use of stem cells, are gaining popularity as a safe and simple method of breast augmentation. Furthermore, the market is also witnessing various mergers, acquisitions, and collaborations among the top players, which is defining the future of the global breast implants market.

The major products in the market include:

Key Players:

The market is fragmented with many players but dominated by the top 5 players. Allergan, Mentor Worldwide, GC Aesthetics, and Sientra hold more than 85% of the market share in the total global breast implants market.

Pure play players:

POLYTECH Health & Aesthetics GmbH, GROUPE SEBBIN SAS, Establishment Labs S.A., HansBiomed Co. Ltd, CEREPLAS, LABORATOIRES ARION, Ideal Implant, Guangzhou Wanhe Plastic Materials Co., Ltd., Silimed, G&G Biotechnology Ltd, Shanghai Kangning Medical Supplies Ltd, and Implantech Associates Inc.

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Competitive Analysis:

The global breast implants market is fragmented and has immense growth opportunities for the vendors, especially in the developed regions. The presence of large, small, and local vendors in the market creates high competition. The market is dominated by Allergan, Mentor Worldwide, GC Aesthetics, and Sientra. These vendors are consolidating their position in the market by acquiring smaller companies, expanding their business operations by leveraging their product portfolio across the globe. The competitive environment in the market will intensify further with an increase in product/service extensions, product innovations, and M&A. They form strategic alliances for marketing and manufacturing of breast implants.

Benefits:

The report provides complete details about the usage and adoption rate of breast implants for breast augmentation or reconstruction. This helps the key stakeholders to know about the major trends, drivers, investments, vertical players initiatives, and adoption rate in the upcoming years along with the details of pure play companies entering the market. Moreover, the report provides details about the major challenges that are going to impact the market growth. Additionally, the report gives complete details about key business opportunities to key stakeholders to expand their business, improve their revenue, and to analyze the market before investing or expanding the business in this market.

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Breast Implants Market Growth Opportunities Created by Covid19 Outbreak - Cole of Duty

Skin Stem Cells Comments Off on Breast Implants Market Growth Opportunities Created by Covid19 Outbreak – Cole of Duty | June 29th, 2020

New York City, United States The effect of the coronavirus pandemic and the lockdown it activated is unmistakably obvious in budgetary markets. Yet, there is still no clearness on the more profound effect that it is having across organizations and modern areas. In view of evaluations made by various examiners and industry body Ficci, here is an effect investigation in human services area.

Spinal Cord Trauma Treatment Market: Global Industry Analysis 2012 2016 and Forecast 2017 2025is the recent report of Persistence Market Research that throws light on the overall market scenario during the period of eight years, i.e. 2017-2025. According to this report, Globalspinal cord trauma treatment marketis expected to witness significant growth during the forecast period.

This growth is expected to be primarily driven by increasing incidence of spinal cord trauma, and increasing government support to reduce the burden of spinal cord injuries. Additionally, development of nerve cells growth therapy is expected to boost the market in near future.

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Company Profiles

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The global market for spinal cord trauma treatment is is estimated to be valued at US$ 2,276.3 Mn in terms of value by the end of 2017. The global spinal cord trauma treatment market is expected to expand at a CAGR of 3.7% over the forecast period to reach a value of US$ 3,036.2 Mn by 2025end.

Global Spinal Cord Trauma Treatment Market: Trends

Global Spinal Cord Trauma Treatment Market: Forecast by End User

On the basis of end user, the global spinal cord trauma treatment market is segmented into hospitals and trauma centers. Hospitals segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period.

Hospitals and trauma centers segments are expected to approximately similar attractive index. Hospitals segment accounted for 53.2% value share in 2017 and is projected to account for 52.5% share by 2025 end.

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Global Spinal Cord Trauma Treatment Market: Forecast by Injury Type

On the basis of injury type, the global spinal cord trauma treatment market is segmented into complete spinal cord injuries and partial spinal cord injuries.

Partial spinal cord trauma treatment segment is expected to show better growth than the completed spinal cord treatment segment due to higher growth in the incidence rate of partial spinal cord trauma than the complete spinal cord trauma. With US$ 1,870.3 Mn market value in 2025, this segment is likely to expand at CAGR 3.8% throughout the projected period.

Global Spinal Cord Trauma Treatment Market: Forecast by Treatment Type

On the basis of treatment type, the global spinal cord trauma treatment market is segmented into corticosteroid, surgery, and spinal traction segments.

Surgery segment dominated the global spinal cord trauma treatment market in revenue terms in 2016 and is projected to continue to do so throughout the forecast period. Surgery segment is the most attractive segment, with attractiveness index of 2.6 over the forecast period.

Global Spinal Cord Trauma Treatment Market: Forecast by Region

This market is segmented into five regions such as North America, Latin America, Europe, APAC and MEA. Asia-Pacific account for the largest market share in the global spinal cord trauma treatment market.

Large patient population due to the high rate of road accidents and crime is making the Asia Pacific region most attractive market for spinal cord trauma treatment. On the other hand, MEA and Latin America is expected to be the least attractive market for spinal cord trauma treatment, with attractiveness index of 0.3 and 0.5 respectively over the forecast period.

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Explore Extensive Coverage of PMR`sLife Sciences & Transformational HealthLandscape

Feminine Hygiene Product Market Feminine Hygiene Products Market Segmented By Sanitary Pads/Napkins, Tampons, Panty Liners, Menstrual Cups, and Feminine Hygiene Wash.For More Information

Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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Spinal Cord Trauma Treatment Market Size : Technological Advancement and Growth Analysis with Forecast to 2025 - 3rd Watch News

Spinal Cord Stem Cells Comments Off on Spinal Cord Trauma Treatment Market Size : Technological Advancement and Growth Analysis with Forecast to 2025 – 3rd Watch News | June 29th, 2020

SAN FRANCISCO, June 29, 2020 /PRNewswire/ --Entitled "Randomized, Double Blind, Placebo-Controlled, Safety and Efficacy Study of Dutogliptin in Combination with Filgrastim in Early Recovery Post-Myocardial Infarction: rationale, design and first interim analysis", the presentation provides an initial insight into patient outcomes of the trial that is currently ongoing in multiple centers. Patients included in this trial experienced a severe form of Myocardial Infarction known as STEMI. Soon after the initial intervention to re-establish adequate blood flow to the coronary arteries, patients begin a two-week treatment with Recardio's dutogliptin, a small molecule that enables sustained homing of mobilised stem cells to the site of cardiac injury. By releasing paracrine factors, stem cells have been shown to have significant repair and regenerative effects that improve healing and recovery of cardiac function after the infarction.

More information about the clinical program is available by visiting the "clinicaltrials.gov" website at the following link:https://clinicaltrials.gov/ct2/show/NCT03486080

About Recardio

Recardio Inc. is a clinical-stage life science company focusing ontherapies for cardiovascular, oncology and infectious diseases. The company is located in San Francisco, California, and hasoperations in the USA and Europe.The company's lead drug candidate, dutogliptin, is a DPP-IV inhibitor that has demonstrated significant effects in activating various chemokines like SDF-1, a protein that is critical for cardiac regeneration. In addition to its current Phase 2 cardiovascular clinical program, Recardio will fully develop the therapeutic platform as a regenerative medication for patients with various cardiovascular diseases including acute myocardial infarction and chronic heart failure, with the potential of improving heart function, quality of life and survival.

For more information, visit:http://www.recardio.eu/or contact[emailprotected]

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Interim Analysis of Recardio's Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology - PRNewswire

Cardiac Stem Cells Comments Off on Interim Analysis of Recardio’s Phase II Clinical Trial to Be Presented at the 2020 Congress of the European Society of Cardiology – PRNewswire | June 29th, 2020

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. The approval is based on results from the Phase 3 KEYNOTE-177 trial, in which KEYTRUDA significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) compared with chemotherapy, the current standard of care. In the study, treatment with KEYTRUDA also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months [95% CI, 5.4-32.4] versus 8.2 months [95% CI, 6.1-10.2]).

Todays approval has the potential to change the treatment paradigm for the first-line treatment of patients with MSI-H colorectal cancer, based on the important findings from KEYNOTE-177 that showed KEYTRUDA monotherapy demonstrated superior progression-free survival compared to standard of care chemotherapy, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. Our commitment to pursuing biomarker research continues to help us bring new treatments to patients, particularly for those who have few available options.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

This approval was granted less than one month following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. This review also was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among its international partners. For this application, a modified Project Orbis was undertaken, and the FDA is collaborating with the Australian Therapeutic Goods Administration, Health Canada and Swissmedic on their ongoing review of the application.

Patients with unresectable or metastatic MSI-H colorectal cancer have historically faced poor outcomes, and until today, chemotherapy-containing regimens were the only FDA-approved first-line treatment options, said Luis A. Diaz, M.D., head of the division of Solid Tumor Oncology, Memorial Sloan Kettering Cancer Center. In patients who were treated with KEYTRUDA and responded (n=67) in the KEYNOTE-177 trial, 43% of patients experienced a duration of response lasting two years or longer. This approval helps address the unmet need to provide a new monotherapy treatment option for patients.

Data Supporting the Approval

The approval was based on data from KEYNOTE-177 (NCT02563002), a multi-center, randomized, open-label, active-controlled trial that enrolled 307 patients with previously untreated unresectable or metastatic MSI-H or dMMR colorectal cancer. Microsatellite instability (MSI) or mismatch repair (MMR) tumor status was determined locally using polymerase chain reaction or immunohistochemistry, respectively. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible.

Patients were randomized 1:1 to receive KEYTRUDA 200 mg intravenously every three weeks or investigators choice of the following chemotherapy regimens given intravenously every two weeks:

Treatment with KEYTRUDA or chemotherapy continued until Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression of disease as determined by the investigator or unacceptable toxicity. Patients treated with KEYTRUDA without disease progression could be treated for up to 24 months. Assessment of tumor status was performed every nine weeks. Patients randomized to chemotherapy were offered KEYTRUDA at the time of disease progression. The main efficacy outcome measure was progression-free survival (PFS) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, and overall survival (OS). Additional efficacy outcome measures were objective response rate (ORR) and duration of response (DOR).

Patients were enrolled and randomized to KEYTRUDA (n=153) or chemotherapy (n=154). The baseline characteristics of these 307 patients were: median age of 63 years (range, 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, and 48% had an ECOG PS of 1; and 27% received prior adjuvant or neoadjuvant chemotherapy. Among the 154 patients randomized to receive chemotherapy, 143 received chemotherapy per the protocol. Of these 143 patients, 56% received mFOLFOX6, 44% received FOLFIRI, 70% received bevacizumab plus mFOLFOX6 or FOLFIRI, and 11% received cetuximab plus mFOLFOX6 or FOLFIRI. The median follow-up time was 27.6 months (range, 0.2 to 48.3 months).

In this study, KEYTRUDA monotherapy significantly reduced the risk of disease progression or death by 40% (HR=0.60 [95% CI, 0.45-0.80; p=0.0004]) and showed a median PFS of 16.5 months (95% CI, 5.4-32.4) compared with 8.2 months (95% CI, 6.1-10.2) for patients treated with chemotherapy. For PFS, in the KEYTRUDA arm, there were 82 patients (54%) with an event versus 113 patients (73%) in the chemotherapy arm. At the time of the PFS analysis, the OS data were not mature (66% of the required number of events for the OS final analysis). For patients treated with KEYTRUDA, the ORR was 44% (95% CI, 35.8-52.0), with a complete response rate of 11% and a partial response rate of 33%, and for patients treated with chemotherapy, the ORR was 33% (95% CI, 25.8-41.1), with a complete response rate of 4% and a partial response rate of 29%. Median DOR was not reached (range, 2.3+ to 41.4+) with KEYTRUDA versus 10.6 months (range, 2.8 to 37.5+) with chemotherapy. Based on 67 patients with a response in the KEYTRUDA arm and 51 patients with a response in the chemotherapy arm, 75% in the KEYTRUDA arm had a duration of response greater than or equal to 12 months versus 37% in the chemotherapy arm, and 43% in the KEYTRUDA arm had a duration of response greater than or equal to 24 months versus 18% in the chemotherapy arm.

Among the 153 patients with MSI-H or dMMR colorectal cancer treated with KEYTRUDA, the median duration of exposure to KEYTRUDA was 11.1 months (range, 1 day to 30.6 months). Adverse reactions occurring in patients with MSI-H or dMMR colorectal cancer were similar to those occurring in 2,799 patients with melanoma or non-small cell lung cancer treated with KEYTRUDA as a single agent.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High (TMB-H)

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

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FDA Approves Merck's KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -...

Cardiac Stem Cells Comments Off on FDA Approves Merck’s KEYTRUDA (pembrolizumab) for First-Line Treatment of Patients With Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer -… | June 29th, 2020

Canine Stem Cell Therapy Market report provides (6 Year Forecast 2020-2026) including detailed Coronavirus (COVID-19) impact analysis on Market Size, Regional and Country-Level Market Size, Segmentation Market Growth, Market Share, Competitive Landscape, Sales Analysis and Value Chain Optimization. This Canine Stem Cell Therapy market competitive landscape offers details by topmost key manufactures (VETSTEM BIOPHARMA, Cell Therapy Sciences, Regeneus, Aratana Therapeutics, Medivet Biologics, Okyanos, Vetbiologics, VetMatrix, Magellan Stem Cells, ANIMAL CELL THERAPIES, Stemcellvet) including Company Overview, Company Total Revenue (Financials), Market Potential, Presence, Canine Stem Cell Therapy industry Sales and Revenue Generated, Market Share, Price, Production Sites and Facilities, SWOT Analysis, Product Launch. For the period 2014-2020, this study provides the Canine Stem Cell Therapy sales, revenue and market share for each player covered in this report.

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Synopsis of Canine Stem Cell Therapy Market:The non-invasive stem cell obtaining procedure, augmented possibility of accomplishing high quality cells, and lower price of therapy coupled with high success rate of positive outcomes have collectively made allogeneic stem cell therapy a preference for veterinary physicians. Moreover, allogeneic stem cell therapy is 100% safe, which further supports its demand on a global level. Pet owners are identified to prefer allogeneic stem cell therapy over autologous therapy, attributed to its relatively lower costs and comparative ease of the entire procedure.

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Allogeneic Stem Cells Autologous Stem cells

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Veterinary Hospitals Veterinary Clinics Veterinary Research Institutes

Canine Stem Cell Therapy Market: Regional analysis includes:

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Canine Stem Cell Therapy Market 2020-2026: Analysed By Business Growth, Development Factors, Applications, And Future Prospects - 3rd Watch News

Cardiac Stem Cells Comments Off on Canine Stem Cell Therapy Market 2020-2026: Analysed By Business Growth, Development Factors, Applications, And Future Prospects – 3rd Watch News | June 29th, 2020

Pune, Maharashtra, India, June 29 2020 (Wiredrelease) Data Bridge Market Research A New Business Intelligence Report released by Data Bridge Market Research with title Global Exosome Therapeutic Market size, share, growth, Industry Trends and Forecast 2027 has abilities to raise as the most significant market worldwide as it has remained playing a remarkable role in establishing progressive impacts on the universal economy. The Global Exosome Therapeutic Market Report offers energetic visions to conclude and study the market size, market hopes, and competitive surroundings. The research is derived through primary and secondary statistics sources and it comprises both qualitative and quantitative detailing. This report has been crafted as the result of persistent efforts lead by knowledgeable forecasters, innovative analysts and brilliant researchers who indulge in detailed and diligent research on different markets, trends and emerging opportunities in the successive direction for the business needs.

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DBMR Analyses that the Exosome Therapeutic Market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

Increased number of exosome therapeutics as compared to the past few years will accelerate market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

KNOW YOUR OPTIONS IN THE FIGHT AGAINST COVID-19

The COVID-19 Pandemic has created bottlenecks across industry pipelines, sales funnels, and supply chain activities. This has created unprecedented budget pressure on company spending for industry leaders. This has increased requirement for opportunity analysis, price trend knowledge and competitive outcomes. Use the DBMR team to create new sales channels and capture new markets previously unknown. DBMR helps its clients to grow in these uncertain markets.

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The Global Exosome Therapeutic market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Exosome Therapeutic Market Share analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins. For each manufacturer covered, this report analyzes their Exosome Therapeutic manufacturing sites, capacity, production, ex-factory price, revenue and market share in global market.

Major Players in Global Exosome Therapeutic Market Include

evox THERAPEUTICSEXOCOBIOExopharmAEGLE TherapeuticsUnited Therapeutics CorporationCodiak BioSciencesJazz Pharmaceuticals, Inc.Boehringer Ingelheim International GmbHReNeuron Group plcCapricor TherapeuticsAvalon Globocare Corp.CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC.Stem Cells Group..

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New Exosome Therapeutic Market Developments in 2019

In January 2019, Codiak BioSciences has collaborated with Jazz Pharmaceuticals, Inc. to develop and commercialize exosome therapeutics to treat cancer. The collaboration will help the company to address issues which have been often implicated in solid tumors and hematological malignancies.

In October 2018, Avalon GloboCare Corp. has collaborated with Weill Cornell Medicine to form standards in cGMP-grade for human endothelial cells sourced exosome which is significant for organ regeneration and vascular health and isolation and identification of exosomes sourced from tissue for liquid biopsy and clinical use. The collaboration will help the company to lead market as exosome isolation system as will be first in the world for standardization processing of cGMP-grade exosomes for clinical studies.

In July 2018, Capricor Therapeutics has formed collaboration with the U.S. Army Institute of Surgical Research (USAISR) to discover potential for CAP-2003 (exosomes) in order to address trauma-related conditions and injuries. The collaboration will help to test CAP-2003 as a tool for preservation of life.

This research is categorized differently considering the various aspects of this market. It also evaluates the current situation and the future of the market by using the forecast horizon. The forecast is analyzed based on the volume and revenue of this market. The tools used for analyzing the Global Exosome Therapeutic Market research report include SWOT analysis.

The Global Exosome Therapeutic segments and Market Data Break Down are illuminated below:

By Type (Natural Exosomes, Hybrid Exosomes

By Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others)

By Therapy (Immunotherapy, Gene Therapy, Chemotherapy)

By Transporting Capacity (Bio Macromolecules, Small Molecules

By Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others)

By Route of administration (Oral, Parenteral)

By End User (Hospitals, Diagnostic Centers, Research & Academic Institutes)

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The Global Exosome Therapeutic Market in terms of investment potential in various segments of the market and illustrate the feasibility of explaining the feasibility of a new project to be successful in the near future. The core segmentation of the global market is based on product types, SMEs and large corporations. The report also collects data for each major player in the market based on current company profiles, gross margins, sales prices, sales revenue, sales volume, photos, product specifications and up-to-date contact information.

What are the strengths and weaknesses of the key vendors?

Definitively, this report will give you an unmistakable perspective on every single reality of the market without a need to allude to some other research report or an information source. Our report will give all of you the realities about the past, present, and eventual fate of the concerned Market.

Scope of the Exosome Therapeutic Market

The global exosome therapeutic market is segmented on the basis of countries into U.S., Mexico, Turkey, Hong Kong, Australia, South Korea, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua and Uruguay.

All country based analysis of the exosome therapeutic market is further analyzed based on maximum granularity into further segmentation. On the basis of type, the market is segmented into natural exosomes and hybrid exosomes. Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. On the basis of therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. On the basis of transporting capacity, the market is segmented into bio macromolecules and small molecules. On the basis of application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. On the basis of route of administration, the market is segmented into pa oral and parenteral. On the basis of end user, the market is segmented into hospitals, diagnostic centers and research & academic institutes and others.

Some Points from Table of Content:

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Regulatory Scenario by Region/Country1.4 Market Investment Scenario Strategic1.5 Market Analysis by Type1.5.1 Global Exosome Therapeutic Market Share by Type (2020-2027)1.5.2 Type 11.5.3 Type 21.5.4 Other1.6 Market by Application1.6.1 Global Exosome Therapeutic Market Share by Application (2020-2027)1.6.2 Application 11.6.3 Application 21.6.4 Other1.7 Exosome Therapeutic Industry Development Trends under COVID-19 Outbreak1.7.1 Region COVID-19 Status Overview1.7.2 Influence of COVID-19 Outbreak on Exosome Therapeutic Industry Development

Global Market Growth Trends2.1 Industry Trends2.1.1 SWOT Analysis2.1.2 Porters Five Forces Analysis2.2 Potential Market and Growth Potential Analysis2.3 Industry News and Policies by Regions2.3.1 Industry News2.3.2 Industry Policies3 Value Chain of Exosome Therapeutic Market3.1 Value Chain Status3.2 Exosome Therapeutic Manufacturing Cost Structure Analysis3.2.1 Production Process Analysis3.2.2 Manufacturing Cost Structure of Exosome Therapeutic3.2.3 Labor Cost of Exosome Therapeutic3.3 Sales and Marketing Model Analysis3.4 Downstream Major Customer Analysis (by Region)

4 Players Profiles4.1 Player 14.1.1 Player 1 Basic Information4.1.2 Exosome Therapeutic Product Profiles, Application and Specification4.1.3 Player 1 Exosome Therapeutic Market Performance (2015-2020)4.1.4 Player 1 Business Overview4.2 Player 24.2.1 Player 2 Basic Information4.2.2 Exosome Therapeutic Product Profiles, Application and Specification4.2.3 Player 2 Exosome Therapeutic Market Performance (2015-2020)4.2.4 Player 2 Business Overview4.3 Player 34.3.1 Player 3 Basic Information4.3.2 Exosome Therapeutic Product Profiles, Application and Specification4.3.3 Player 3 Exosome Therapeutic Market Performance (2015-2020)4.3.4 Player 3 Business Overview4.4 Player 44.4.1 Player 4 Basic Information4.4.2 Exosome Therapeutic Product Profiles, Application and Specification4.4.3 Player 4 Exosome Therapeutic Market Performance (2015-2020)4.4.4 Player 4 Business Overview4.5 Player 54.5.1 Player 5 Basic Information4.5.2 Exosome Therapeutic Product Profiles, Application and Specification4.5.3 Player 5 Exosome Therapeutic Market Performance (2015-2020)

4.5.4 Player 5 Business Overview5 Global Exosome Therapeutic Market Analysis by Regions5.1 Global Exosome Therapeutic Sales, Revenue and Market Share by Regions5.1.1 Global Exosome Therapeutic Sales by Regions (2015-2020)5.1.2 Global Exosome Therapeutic Revenue by Regions (2015-2020)5.2 North America Exosome Therapeutic Sales and Growth Rate (2015-2020)5.3 Europe Exosome Therapeutic Sales and Growth Rate (2015-2020)5.4 Asia-Pacific Exosome Therapeutic Sales and Growth Rate (2015-2020)5.5 Middle East and Africa Exosome Therapeutic Sales and Growth Rate (2015-2020)5.6 South America Exosome Therapeutic Sales and Growth Rate (2015-2020)

11 Global Exosome Therapeutic Market Segment byTypes12 Global Exosome Therapeutic Market Segment by Applications13 Exosome Therapeutic Market Forecast by Regions (2020-2027)ContinuedComplete Report Is Available| Get Free TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market

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Exosome Therapeutic Market Size, 2020-New Technological Change Helping Market, Application, Driver, - PharmiWeb.com

Cardiac Stem Cells Comments Off on Exosome Therapeutic Market Size, 2020-New Technological Change Helping Market, Application, Driver, – PharmiWeb.com | June 29th, 2020

Hematopoietic stem cell transplantation is a curative therapy for many patients suffering from life threatening blood disorders. This treatment is currently limited by the availability of compatible bone marrow donors and, as a result, transplant of unrelated donor umbilical cord blood is an attractive alternative.This approach has the advantages of rapid availability and reduced stringency for a complete donor/recipient match, but is limited by a relatively low number of stem cells within a single cord blood unit. One focus of the Stem Cell Regulators research group, led by Prof. Jonas Larsson, is the development of new strategies to expand stem cells ex vivo, allowing for the treatment of patients who otherwise would lack a suitable donor.

When grown outside the body hematopoietic stem cells proliferate and differentiate from an immature state to more mature blood cell types. explains Prof. Larsson. We aim to identify novel ways to counteract this maturation, pushing stem cells to self-renew and increase in numbers.

In a study published in the journal Blood, the Larsson group targeted the enzyme LSD1, part of the CoREST complex, known to mediate the epigenetic modification of DNA and pushing the differentiation of stem cells into mature blood cells.

We hypothesised that by reducing LSD1 levels using small molecule drugs we could halt stem cell differentiation and stimulate expansion. explains postdoctoral researcher Agatheeswaran Subramaniam and first author on the paper.

This turned out to be the case for both cord blood derived and adult bone marrow stem cells, with LSD1 inhibition expanding stem and progenitor cells from different sources and different stages of development.

To gain insights into how targeting LSD1 led to the expansion of stem cells, the group performed gene expression profiling. They compared LSD1 inhibition to treatment with UM171, a human hematopoietic stem cell promoting molecule identified in 2014 and currently in phase II clinical trials, despite an as yet unidentified mechanism of action. The gene signatures of LSD1 inhibition and UM171 treatment were strikingly similar.

The research group then postulated that these treatments could be working by the same mechanism.

Through a collaboration with Prof. Roman Zubarev at Karolinska Institute, the key targets of UM171 were established using a technique known as Thermal Proteome Profiling. This approach, which identifies interactions between small molecules and proteins, confirmed the direct binding of UM171 to LSD1, as well as to the core structural component of the CoREST complex, RCOR1.

Extensive analyses by Kristijonas emaitis, a PhD student in the Larsson lab, revealed that UM171 directs the components of the CoREST complex to degradation via the ubiquitin proteasome pathway, the system used by the cell to break down proteins.

In this study have we identified a novel target for human hematopoietic stem cell expansion ex vivo, as well as taking steps to understanding the previously undetermined mechanism of action of UM171. reflects Agatheeswaran. The most striking finding was the extremely rapid and efficient degradation of members of the CoREST complex by UM171.

What remains unclear is exactly how the CoREST complex is targeted and its degradation triggered. An understanding of this has the potential to reveal principles that can be exploited for purposes not only limited to stem cell expansion.

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

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New Insights Into the Ex Vivo Expansion of Transplantable Human Blood Stem Cells - Technology Networks

Bone Marrow Stem Cells Comments Off on New Insights Into the Ex Vivo Expansion of Transplantable Human Blood Stem Cells – Technology Networks | June 29th, 2020

A Nottinghamshire girl needs to find a bone marrow donor within weeks as she battles leukaemia for the second time.

Amy Bartlett, 14, of West Bridgford, was described as a playful, happy and energetic girl before her blood cancer diagnosis.

Having spent part of her childhood in New Zealand, she was a water baby representing her school in water polo and loved to be in the pool and sea, taking part in the little nippers surf life-saving programme.

More recently, she enjoyed being a member of West Bridgfords Colts football team.

In 2018, when she was 12, Amy began to complain of feelings of aches in her wrists and ribs and developed a small rash across her tummy and back.

Tests at Nottingham Childrens Hospital later confirmed she had leukaemia - devastating and heartbreaking news for Amy and her family.

Amy showed strength from the get-go, reassuring her parents that she could fight the blood cancer.

"Mummy, it is ok its better I get it, than another smaller child. I am stronger and so have a better chance to beat it," were her first words after the news was broken to her.

Her leukaemia was categorised as high risk, meaning despite her young age, she had to receive the most intensive rounds of chemotherapy administered to children diagnosed with the disease, causing her hair to fall out within just a few days of treatment starting.

Having not had the smoothest ride through her treatment, suffering liver problems, developing steroid induced diabetes and several allergies to medications she was given, Amy soon needed a wheelchair to get in and out of hospital.

Turning the 12-year-olds life upside down, Amy could not go back to school, but tried desperately hard to keep up with her school work.

Counting down the days until the planned end of her therapy on July 4, the entire family were holding onto the light at the end of the tunnel, when the devastating news of a relapse shattered their dreams.

Her mum Marie said: How do you tell your daughter, whose tiny body has been through so much already, that the cancer she has fought so hard to overcome has returned?

"It ripped my heart out to tell her and hold her whilst trying to convince her that she had done it once and she could do it again.

The relapse has meant that Amy has restarted her intensive chemotherapy. The plan is to then proceed to a bone marrow/stem cell transplant, if a suitable donor match can be found.

Amys family say: We need to find a match for Amy ideally within the next two to three weeks, so time is of the essence.

Her brother, Marcus, has been tested but unfortunately he is not a match.

Amys story comes at a time when new donors are needed urgently amidst falling numbers of people signing up to registers, as planned large scale donor recruitment and awareness sessions cannot be run due to Covid-19, but individuals can still request to join the register independently.

Dr Jesky, Amys Consultant at Nottingham University Hospitals, said: For children or adults, like Amy, whose leukaemia has sadly returned, undergoing a stem cell transplant offers the highest chance of a cure.

"Often these donors are volunteers as many patients do not have a suitable family match. Young men are particularly encouraged to register as they are the most frequent chosen donors.

"For the donor the process of donating is simple but for the patient this donation could give them a second chance at life.

NUH is encouraging people to consider signing up to one of the bone marrow registers to increase the chances of finding a potential match for Amy and others who are in similar circumstances. By doing so, you could be the match that saves a life.

There are four main donor registries.

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You only need to register to one as the information from all registers is collated when looking for a match.

1 . The DKMS Registry (age restriction is 18 to 55 years): https://www.dkms.org.uk/en/register-now

2. The Anthony Nolan Registry (age restriction is 16 to 30 years): https://www.anthonynolan.org/8-ways-you-could-save-life/donate-your-stem-cells

3 . The Welsh Bone Marrow Registry (age restriction is 17 to 31 years): https://www.welsh-blood.org.uk/giving-blood/bone-marrow-donor-registry/

4 . The NHS British Bone Marrow Registry (eligibility determined when you attend to give a blood donation): https://www.bbmr.co.uk/joining-the-register/

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Teenager needs a donor within weeks as she battles leukaemia for second time - Nottinghamshire Live

Bone Marrow Stem Cells Comments Off on Teenager needs a donor within weeks as she battles leukaemia for second time – Nottinghamshire Live | June 29th, 2020

Image Credit: Gulf News

DUBAI: Plasma and stem cell (SC) therapies are two of the emerging star treatments being used in the fight against the SARS-CoV-2 virus.

Against COVID-19, they're considered stop-gap measures, while the world awaits a vaccine. Both, however, have proven effective against severe cases infections caused by the novel coronavirus, which has already killed over 502,000 and infected 10.1 million as of Monday (June 29, 2020).

Plasma and SC therapies have similarities, as well as obvious differences. We outline them below:

Q: What are their similarities?

Both plasma and stem cell therapies rely on rejuvenating damaged body tissue. Theyboth form part of what's described as regenerative medicine, a fast-emerging branch of medical science involving techniques thathelp restore the functionof tissues or organs.

Being regenerative treatments (or therapies), they encourage your body to use its natural abilities to heal injuries or other types of tissue damage or inflammation.

The journal Platelets refer to platelet-rich plasma (PRP) and stem cell (SC) therapies as the "mainstream medical technologies" to repair and rejuvenate a damaged tissue or organ caused by injury or chronic diseases.

Q: What are the key differences?

Plasma-rich platelets are components of blood that contain platelet concentrations above the normal level.

Platelets are the frontline workers in carrying out a healing response to injuries. They release growth factors for tissue repair.Plasma therapy uses the liquid portion of blood (plasma, yellowish) which includes a higher concentration of platelets the part of blood that contributes to clotting and healing.

Stem cells, on the other hand, are generic cells. They are the prime cells -- unspecialised, undifferentiated, immature cells. Based on specific stimuli, they can divide and differentiate into specific type of cells and tissues.

Q: What are stem cells?

Stem cells are the basic, generic building blocks of life. In a sense, they unspecialised, undifferentiated, immature cells. They can divide and differentiate into specific type of cells and tissues, based on based on specific stimuli.

Its this ability to differentiate into other types of cell that make stem cells interesting to medical science.

In adults, they are usually obtained from bone marrow. In infants, stem cells are usually taken from the umbilical cord.

Scientists have found stem cells present in blood vessels, the brain, skeletal muscles, skin and the liver.

They can be difficult to find and work with. Stem cells are also categorised by their potential to differentiate into different cell types. These include, pluripotent and multipotent stem cells.

Q: What are the advantages of stem cell-based therapies?

SCs are generic (or primitive) cells obtained either from embryos or from the adult tissues, that have the capacity of self-renewal and can differentiate into as many as 200 different cell types of the adult body.

SC also produces certain growth factors and cytokines that accelerate the healing process at the site of tissue damage. Cytokines are secreted by certain cells of the immune system and have an effect on other cells. SC is used to treat degenerative and inflammatory conditions by replacing the damaged cells in virtually any tissue or organ, where PRP applications serve no benefit.

Q: How is stem cell therapy helping fight COVID?

In the UAE, a medical research team has developed a first-in-the-world technique using inhaled stem cells that harvestedfrom the patients themselves. Following the initial success of the technique in 73 patients, the procedure has been ramped up.

In May, the ADSCC team, led by Dr Yendry Ventura, unveiled the new treatment. The UAECell19 is an autologous (cells obtained from the same individual)stem cells therapy which helped cut hospital stay from 22 days to six, relative to patients who were given standard treatment.

Q: What's the record of UAECell19 stem cell therapy?

According to the Abu Dhabi team, patients given the stem cell therapy were up to 3.1x more likely to recover in less than seven days compared to those given standard treatment.

Researchers also stated that 67% of the patients who received the stem cells treatment owed this recovery to the new treatment.

ADSCC has secured a patent for UAECell19. Protection of the intellectual property rights for the therapy opens doors for it tobe shared more widely so more patients can benefit.

Q: What is convalescent plasma?

Plasma is the liquid portion of whole blood. It is composed largely of water and proteins, and it provides a medium for red blood cells, white blood cells and platelets to circulate through the body.

Convalescent refers to a person recovering from an illness or medical treatment.

Convalescent plasma, also known as immunoglobulins, is plasma taken from the blood of a person who has recovered from a disease.

Research shows that recovered COVID-19 patients develop antibodies in the blood against the virus. Antibodies are proteins that might help fight the infection.

Q: What are platelets?

Platelets, a component of the blood, are repair agents. They are frontliners in the healing response to injuries. Platelets are also called thrombocytes, blood cells that trigger blood clotting and other necessary growth healing functions.

PLATELET FACTS

[] When the platelet count is less than 50,000, bleeding is likely to be more serious if you're cut or bruised.

[] Some people make too many platelets. They can have platelet counts from 500,000 to more than 1 million.

Q: What is platelet-rich plasma (PRP)?

PRP is a component of blood that contains platelet concentrations above the normal level -- usually five times higher concentrations of platelets above the normal values. It includes platelet-related growth factors and plasma-derived fibrinogen (a blood plasma protein that's made in the liver), among others.

Q: Has it been used to treat other diseases?

Yes. Convalescent plasma hasbeen used as a last resort to improve the survival rates of patients with SARS (2003), as well as the "Spanish Flu" (1918-1920), as well as other infectious diseases.The Lancetcitesseveral studies that showed a shorter hospital stay and lower mortality in patients treated with convalescent plasma than those who were not treated with it.

It's been gaining ground in the COVID-19 fight around the world. In the last few weeks, convalescent plasma therapy has helped treat at least 170 patients at the Infectious Disease Department at Rashid Hospital in Dubai.

THROMBOCYTOPENIA

[] This can be caused by many conditions by medicines, cancer, liver disease, pregnancy, infections (including COVID-19), and an abnormal immune system.

Q: Why is convalescent plasma important?

If you are one of the thousands of patients fully-recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. That's because you fought the infection, your plasma now contains COVID-19 antibodies.

These antibodies provided one way for your immune system to fight the virus when you were sick, so your plasma may be able to be used to help others fight off the disease.

Q: I have fully recovered from COVID-19. Am I eligible donate plasma?

Yes, you are. Health authorities, including the US Food and Drug Administration, encourage people who have fully recovered from COVID-19 for at least two weeks to consider donating plasma.

You can help save the lives of other patients.

However, you must first undergo some tests to check if you're eligible to meet donor criteria. Doctors will determine that. COVID-19 convalescent plasma must only be collected from recovered individuals if you are eligible.

A lab test must document a prior diagnosis of COVID-19. In general, FDA protocol requires individuals to have complete resolution of symptoms for at least 14 days prior to donation.

Q: Is a negative lab test for COVID-19 a must before being considered to donate blood plasma?

No. The FDA guideline states: A negative lab test for active COVID-19 disease is not necessary to qualify for donation.

Q: I havent had COVID-19. What can I do to help?

You shouldconsider donating blood. One blood donation can save up to three lives.

Link:
COVID-19: Plasma therapy vs stem cell therapy, what's the difference? - Gulf News

Bone Marrow Stem Cells Comments Off on COVID-19: Plasma therapy vs stem cell therapy, what’s the difference? – Gulf News | June 29th, 2020

Michael Schumacher is still surviving as he continues to battle complications from the near-fatal head injury he sustained while skiing in 2013. It was reported that the F1 legend is set to undergo another round of stem cell procedure that will help regenerate his nervous system.

Facts about the reported new operation on Schumi

With this surgery, his family and doctors are hoping that he will be able to recover functions in parts of his body. This is because it is aimed at his sensory system that was affected by his injuries.

The Daily Mail reported that currently, Michael Schumacher is being treated and cared for by French cardiologist Dr. Philippe Menasche, a medical expert specializing in stem cell research. It was revealed that a series of surgeries are needed for this treatment, so this is just one of the racing champs operations for his recovery.

In an article that appeared in an Italian publication Le Dauphine, it was reported that Dr. Menasche will do seminal heart surgery on Schumi in his next surgery schedule. It was added that this will take place soon, but the exact date was not revealed.

It is also believed that this will be the second time that the said doctor is operating on Michael Schumacher. The first procedure was said to have been done in September 2019, and Schumi was in the hospital for about three days. At any rate, in this operation, his damaged cells will be replaced with healthy ones that will be taken from his bone marrow.

An experimental stem-cell surgery?

Michael Schumacher has not recovered from his accident that happened more than six years ago. He is currently being treated in his own home in Switzerland, but his exact condition is still a mystery since his family continues to keep everything related to his health a secret.

Dr. Nicola Acciari, a leading neurosurgeon, previously claimed that Michael Schumacher has osteoporosis and suffering from muscle atrophy since he is unable to move for years. The goal is to regenerate Michaels nervous system, The Sun quoted him as saying in connection to the stem cell therapy.

However, Jean-Michel Dcugis, a French journalist, shared to British daily national newspaper, The Times, that the procedure is experimental at this point since Dr. Menasche is actually a cardiologist.

"Our sources say that Michael Schumacher is receiving stem cell perfusions that produce a systemic anti-inflammatory effect, The Sun quoted Dcugis as saying. "It's quite mysterious as Menasch works only on the heart. He is carrying out experiments with secretome that is made by a laboratory from new stem cells and injected into veins, until now only on animals.

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Michael Schumacher is reportedly getting another stem-cell surgery; Journalist alleged it will be an experimental procedure - EconoTimes

Bone Marrow Stem Cells Comments Off on Michael Schumacher is reportedly getting another stem-cell surgery; Journalist alleged it will be an experimental procedure – EconoTimes | June 29th, 2020