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Clinical study using mesenchymal stem cells for the treatment of patients with severe COVID-19 – DocWire News

Posted: August 14, 2020 at 1:48 am

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Front Med. 2020 Aug 6. doi: 10.1007/s11684-020-0810-9. Online ahead of print.

ABSTRACT

The Coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 was identified in December 2019. The symptoms include fever, cough, dyspnea, early symptom of sputum, and acute respiratory distress syndrome (ARDS). Mesenchymal stem cell (MSC) therapy is the immediate treatment used for patients with severe cases of COVID-19. Herein, we describe two confirmed cases of COVID-19 in Wuhan to explore the role of MSC in the treatment of COVID-19. MSC transplantation increases the immune indicators (including CD4 and lymphocytes) and decreases the inflammation indicators (interleukin-6 and C-reactive protein). High-flow nasal cannula can be used as an initial support strategy for patients with ARDS. With MSC transplantation, the fraction of inspired O2 (FiO2) of the two patients gradually decreased while the oxygen saturation (SaO2) and partial pressure of oxygen (PO2) improved. Additionally, the patients chest computed tomography showed that bilateral lung exudate lesions were adsorbed after MSC infusion. Results indicated that MSC transplantation provides clinical data on the treatment of COVID-19 and may serve as an alternative method for treating COVID-19, particularly in patients with ARDS.

PMID:32761491 | DOI:10.1007/s11684-020-0810-9

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NIH names Dr. Rena D’Souza as director of the National Institute of Dental and Craniofacial Research – National Institutes of Health

Posted: August 14, 2020 at 1:48 am

News Release

Thursday, August 13, 2020

National Institutes of Health Director Francis S. Collins, M.D., Ph.D., has selected Rena N. DSouza, D.D.S., M.S., Ph.D., as director of NIHs National Institute of Dental and Craniofacial Research (NIDCR). A licensed dentist, Dr. DSouza is currently the assistant vice president for academic affairs and education for health sciences at the University of Utah, Salt Lake City. There she also serves as a professor of dentistry, the Ole and Marty Jensen Chair of the School of Dentistry and professor of neurobiology and anatomy, pathology and surgery in the School of Medicine and the Department of Biomedical Engineering. She is expected to begin her new role as the NIDCR director later this year.

Dr. DSouza is renowned for her research in craniofacial development, genetics, tooth development and regenerative dental medicine. She has worked as a proponent for NIH for decades, serving on critical advisory committees and as an expert consultant on multiple projects, said Dr. Collins. I look forward to having her join the NIH leadership team later thisyear. I also want to thank NIH Principal Deputy Director Lawrence A. Tabak, D.D.S., Ph.D., for his valuable leadership as the acting director of NIDCR since January 1, 2020.

As NIDCR director, Dr. DSouza will oversee the institutes annual budget of over $475 million, which supports basic, translational and clinical research in areas of oral cancer, orofacial pain, tooth decay, periodontal disease, salivary gland dysfunction, craniofacial development and disorders and the oral complications of systemic diseases. The institute funds approximately 770 grants, 6,500 researchers and 200 organizations. Additionally, NIDCR supports research training and career development programs for approximately 350 people at various stages of their careers, from high school students to independent scientists.

Dr. DSouza has been a principal investigator on multiple NIH and other federal grants since 1987 and has published 140 peer-reviewed journal papers and book chapters. Her research focuses on developmental biology and genetics; matrix biology; biomaterials, tissue engineering and stem cells; and clinical research. Her groups discovery that a novel mutation in PAX9 was responsible for a severe form of human tooth agenesis opened a new field of research to discover genes and mutations as well as therapies for common human inherited disorders of the craniofacial complex.

Dr. DSouzas career honors are significant. She was selected to be the inaugural dean of the University of Utahs School of Dentistry, which was established in 2012. She is currently the elected chair in Dentistry and Oral Health Sciences Section and elected as a fellow of the American Association for the Advancement of Science. She also is a former president of the American Association for Dental Research and the International Association for Dental Research,a fellow of the American College of Dentistsand the recipient of the 2017 American Association for Dental Research Irwin D. Mandel Distinguished Mentoring Award. Dr. DSouza served on the NIH Advisory Committee to the Director in 2013-14, and on NIH study sections. She is a devoted mentor and champion of diversity in the biomedical research workforce. Since 1985, she has served as a volunteer dentist for women in need and people struggling with homelessness in Salt Lake City, Dallas and Houston.

Dr. DSouza received her bachelors degree in dental surgery from the University of Bombay, India, after which she completed her general practice residency. She earned her D.D.S., Ph.D. and masters degree in pathology/biomedical sciences from the University of Texas Health Science Center in Houston.

NIDCR is the nations leading funder of research on oral, dental, and craniofacial health. To learn more about NIDCR, visit https://www.nidcr.nih.gov/.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

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Global Circulating Tumor Cells (CTCS) and Cancer Stem Cells (CSCS) Market – Detailed Analysis of Current Industry Figures with Forecasts Growth By…

Posted: August 14, 2020 at 1:48 am

Market Study Report, LLC, has added a detailed study on the Circulating Tumor Cells (CTCS) and Cancer Stem Cells (CSCS) market which provides a brief summary of the growth trends influencing the market. The report also includes significant insights pertaining to the profitability graph, market share, regional proliferation and SWOT analysis of this business vertical. The report further illustrates the status of key players in the competitive setting of the Circulating Tumor Cells (CTCS) and Cancer Stem Cells (CSCS) market, while expanding on their corporate strategies and product offerings.

The report on Circulating Tumor Cells (CTCS) and Cancer Stem Cells (CSCS) market covers the key trends of the industry which impact its growth with reference to the competitive arena and key regions. The study highlights the challenges this industry vertical will face along with the growth opportunities which would support the business development in existing & untapped markets. Besides this, the report also includes few case studies including those which take into account the corona virus pandemic, with an intention to offer a clear picture of this business sphere to all stakeholders.

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Drug development for severe respiratory diseases supported with $3.9 million grant – Washington University School of Medicine in St. Louis

Posted: August 14, 2020 at 1:48 am

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New drug candidate targets asthma, COPD, other progressive lung diseases

Shown is a section of mouse lung with progressive lung disease, similar to asthma or COPD. The red staining shows excess mucus production that is characteristic of progressive lung disease and can occur in the aftermath of viral infection or other injury to the lungs. Researchers at Washington University School of Medicine in St. Louis have received a grant to develop a drug to block this process, potentially leading to a new treatment for debilitating lung disorders.

Researchers at Washington University School of Medicine in St. Louis have received a $3.9 million development award supporting new technologies and therapeutics to advance a first-in-class drug to treat debilitating lung diseases, including asthma and chronic obstructive pulmonary disease (COPD).

The research, funded by the Department of Defense, is led by Michael J. Holtzman, MD, the Selma and Herman Seldin Professor of Medicine and director of the Division of Pulmonary & Critical Care Medicine at Washington University.

Holtzmans team has designed a new drug candidate that blocks two important signaling systems in the lungs. These systems cause cells of the respiratory tract to become mucus-producing cells. An overabundance of these cells creates too much mucus, which can block breathing. Evidence suggests that the drug could stop and perhaps even reverse progressive damage from overproduction of mucus that is triggered by aggravations to the lung, including from respiratory viruses, smoking and air pollution.

Obstructive lung diseases, such as asthma and COPD, are the third leading cause of death due to disease in the United States, Holtzman said. But we have no effective treatments that address the root causes of these illnesses or halt disease progression. We can only try to relieve symptoms. This grant will allow us to continue research into a new drug candidate that our group developed and that has shown evidence of stopping and correcting what goes wrong in the lungs when this type of disease process is triggered.

In past research, Holtzman and his colleagues identified specialized stem cells in the lungs that give rise to mucus cells. During development, such stem cells are responsible for growing the lung itself. Some of these stem cells remain in the lungs into adulthood and periodically make new cells to line the inner surfaces of lung tissue, including those cells that make mucus. These stem cells also respond to injury to the lung such as a burn injury from inhaling smoke or a severe viral infection and orchestrate the repair process.

Shown is a section of healthy mouse lung.

We need a certain level of mucus to protect the lungs from viruses or particles that can be inhaled, Holtzman said. The stem cell population is important in maintaining normal lung function and in injury situations, where they help with the healing process. But, unfortunately, in some people these cells can go off the rails. Under certain conditions, particularly a severe respiratory viral infection, these stem cells become reprogrammed so that theyre activated even after the injury or infection is resolved. This leads to overproduction of mucus and excessive inflammation that can interfere with lung function with airway obstruction and difficulty breathing.

The new drug candidate is being designed to be taken by mouth or inhalation and to specifically target two related but distinct signaling molecules known as MAP kinases to control both arms of the immune and inflammatory response. Studying human cells, as well as mouse and pig models of respiratory disease following respiratory viral infections, the researchers found that not only does the drug reduce mucus production, it also nudges the rogue stem cells back toward their quieter and healthier state of readiness. The new grant will support studies in human cells, mice and pigs to establish evidence for the safety and effectiveness of the lead drug candidate and to help determine proper doses for subsequent studies in people. The safety work also will be facilitated by a subcontract to the teams biotechnology company known as NuPeak Therapeutics, which is specially designed for this drug development activity. The goal is to gather data to support approval for a first-in-human clinical trial.

Holtzman said the drug does not treat the viral infection itself; rather, it stops what he calls post-viral disease and its progression, which includes asthma and COPD. Post-viral lung disease also could include COVID-19, as an example of another severe respiratory viral infection that causes progressive and in some cases long-term lung disease in some patients well after the infectious virus has been cleared.

SARS-CoV-2, the virus that causes COVID-19, is similar to the viruses Holtzman and colleagues are working with to study their new drug candidate. The group is gathering key information in patient and animal models to determine whether the same therapeutic strategy could prove useful in treating COVID-19 as it has been for lung disease due to other related respiratory viruses.

Were just beginning to learn how the body responds to SARS-CoV-2, but it is very common for any respiratory viral infection, especially severe infections, to trigger this progressive disease process in some percentage of the patients who contract the virus, Holtzman said. Whats interesting is that the infectious form of the virus is gone when this process ramps up. Patients arent fighting the virus any more, theyre fighting their own immune system. In future work, we will be interested in finding out whether our drug candidate can help shut this process down regardless of the trigger, viral or otherwise.

This work is supported by the Department of Defense, grant number PR190726. Holtzman founded the biotechnology company NuPeak Therapeutics, which is facilitating development of the drug candidate.

Washington University School of Medicines 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Childrens hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Childrens hospitals, the School of Medicine is linked to BJC HealthCare.

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GMP Cell Banking Services Gain Momentum among Stem Cell Research Institutes Due to Cost-effectiveness and Quality They Offer – TMR Research Blog

Posted: August 14, 2020 at 1:48 am

The global GMP cell banking services marketis expected to gain stupendous demand avenues in the forthcoming years. This growth is attributed to increasing demand for GMP Cell banking services from the enterprises engaged in the pharmaceutical and stem cell research industries. Cell banks use a conventional technique named cryopreservation to keep the cells materials preserved. At the same time, cell banks also prevent the natural cell division process; thereby improve the shelf life of products preserved in the cell banks.

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One of the important factors owing to which GMP cell banking services are gaining momentum among scientists and research institutes is the cost-effectiveness of these services. In recent years, there is remarkable growth in the use of GMP cell banking services among gamut of research institutes from all across the world. This scenario depicts that the vendors working in the global GMP cell banking services market will witness stupendous demand opportunities in the forthcoming period.

Government Bodies Increase Flow of Funding to Discover Treatment Options for Rare Diseases

In recent years, there is noteworthy increase in the number of people living with various rare diseases. This situation has compelled scientists working in all worldwide locations to focus on the discovery of novel options to treat these health issues. To accelerate these research activities, government bodies of many countries from all over the world are financially supporting these research projects. This factor is positively impacting on the development of the global GMP cell banking services market.

On regional front, players working in the GMP cell banking services market are projected to gain fantastic development opportunities in North America and Asia Pacific. Presence of substantial mammalian cell is said to be one of the key reasons driving the growth of GMP cell banking services market in North America.

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Opportunities in the World Nanotechnology Market to 2025 – Application of Nanotechnology in Wastewater Treatment and Enhanced Renewable Energy Driving…

Posted: August 12, 2020 at 5:53 pm

Dublin, Aug. 12, 2020 (GLOBE NEWSWIRE) -- The "Nanotechnology Market - Forecast (2020 - 2025)" report has been added to ResearchAndMarkets.com's offering.

Nanotechnology includes fields of science as diverse as molecular nanotechnology, surface science, organic chemistry, molecular biology, semiconductor physics, energy storage, micro-fabrication, and molecular engineering. The technology finds applications in a gamut of industries such as medicine & healthcare, environment, ICT, energy, nano-EHS, and others. A key application of nanotechnology is found in electronics and semiconductor products segment, which is estimated to grow at a substantial CAGR of 15.01% through to 2025.

Nanotechnology Market Growth Drivers:

Nanotechnology Market Trends:

Nanotechnology Market Challenges:The most challenging aspect in the nanotechnology market is scalability of production. Even though nanomaterials impart an outstanding functional performance in the laboratory or prototype stage, the scalability factor is dwarfing the nanotechnology market size. Hence, some of the most propitious applications are in the R&D stage. However, in the future, significant developments are expected in the application of nanotechnology with a profitable commercialization in the automotive, aerospace, and sporting goods industry. Furthermore, the technology will help in effective treatment of cancer which will support the vendors in the nanotechnology market.

Nanotechnology Market Research Scope:The base year of the study is 2020, with forecasts up to 2025. The study presents a thorough analysis of the competitive landscape, taking into account the market shares of the leading companies. It also provides information on unit shipments. These provide the key market participants with the necessary business intelligence and help them understand the future of the nanotechnology market. The assessment includes the forecast, an overview of the competitive structure, the market shares of the competitors, as well as the market trends, market demands, market drivers, market challenges, and product analysis. The market drivers and restraints have been assessed to fathom their impact over the forecast period. This report further identifies the key opportunities for growth while also detailing the key challenges and possible threats. The nanotechnology market research report also analyses the application of the same in various industries by product type that includes nano composites, nano devices, nano tools, nano materials, and others.

Key Topics Covered:

1. Nanotechnology Market - Overview2. Nanotechnology Market - Executive summary

3. Nanotechnology Market

4. Nanotechnology Market Forces

5. Nanotechnology Market -Strategic analysis5.1. Value chain analysis5.2. Opportunities analysis5.3. Product life cycle5.4. Suppliers and distributors Market Share

6. Nanotechnology Market - By Type (Market Size -$Million / $Billion)6.1. Market Size and Market Share Analysis 6.2. Application Revenue and Trend Research6.3. Product Segment Analysis

7. Nanotechnology Market - By Applications (Market Size -$Million / $Billion)7.1. Introduction7.2. Medicine and Healthcare Diagnosis7.3. Environment7.4. Energy7.5. Information and Communication Technologies7.6. Nano-EHS

8. Nanotechnology - By End Use Industry(Market Size -$Million / $Billion)8.1. Segment type Size and Market Share Analysis 8.2. Application Revenue and Trends by type of Application8.3. Application Segment Analysis by Type

9. Nanotechnology - By Geography (Market Size -$Million / $Billion)9.1. Nanotechnology Market - North America Segment Research9.2. North America Market Research (Million / $Billion)9.3. Nanotechnology - South America Segment Research9.4. South America Market Research (Market Size -$Million / $Billion)9.5. Nanotechnology - Europe Segment Research9.6. Europe Market Research (Market Size -$Million / $Billion)9.7. Nanotechnology - APAC Segment Research9.8. APAC Market Research (Market Size -$Million / $Billion)

10. Nanotechnology Market - Entropy10.1. New product launches10.2. M&A's, collaborations, JVs and partnerships

11. Nanotechnology Market Company Analysis11.1. Market Share, Company Revenue, Products, M&A, Developments11.2. include Nanosys11.3. QD Vision11.4. Arkema11.5. 10Angstroms11.6. 10x MicroStructures11.7. 10x Technology Inc11.8. 3M 3rd Millennium Inc11.9. 3rdTech Inc

For more information about this report visit https://www.researchandmarkets.com/r/r2psqq

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Opportunities in the World Nanotechnology Market to 2025 - Application of Nanotechnology in Wastewater Treatment and Enhanced Renewable Energy Driving...

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Helping Transgender Patients Reap the Benefits & Navigate the Challenges of Hormone Therapy – NYU Langone Health

Posted: August 12, 2020 at 5:51 pm

For people with gender dysphoria, hormone therapy can significantly reduce mental distress and improve quality of life. NYU Langones multidisciplinary transgender program takes an intensely personalized approach to these treatments, centered on the individual patients goals, life circumstances, comorbidities, and evolving clinical response.

Although many medical centers offer gender-affirming hormone therapy, NYU Langone does so under the direction of an endocrinologist who specializes in transgender care. For these patients, the clinicians expertise can be crucial to optimizing outcomes, explains Michele B. Glodowski, MD, clinical instructor in the Department of Medicine, whose fellowship training included extensive clinical rotations at the University of Colorados Integrated Transgender Program.

Gender-affirming hormone therapy typically uses different doses and modalities from hormone replacement therapy for postmenopausal cisgender women or cisgender men with low testosterone. The risk of complications, including certain types of cancer, may be heightened as well. With testosterone, we often see weight gain, changes in LDL and HDL cholesterol, elevations in hematocrit, and increases in insulin resistance and blood pressure, Dr. Glodowski notes. Feminizing regimens, such as estradiol, can also trigger weight gain, raise the risk of cardiovascular disease, and often affect liver enzymes and triglycerides.

Besides enhancing her ability to monitor and manage side effects, Dr. Glodowskis training helps her tailor treatment to patients unique needs. Theres a whole spectrum of gender identity and gender expression, she says, so its important to provide a whole spectrum of care. It looks different for every individual. Some patients, for example, may identify as definitively male or female, others as nonbinary or gender-fluid. Some may choose to have hormone therapy in conjunction with gender confirmation surgery; others may choose hormonesor surgeryalone. And a wide range of external factors may influence patients therapeutic pathways.

Theres a whole spectrum of gender identity and gender expression, so its important to provide a whole spectrum of care.Michele B. Glodowski, MD

Even in 2020, people still lose their jobs or get kicked out of their homes because theyre trans, Dr. Glodowski observes. I want to make sure patients are comfortable with all the social aspects that can come into play with gender transition. If someone says, Im not ready to come out at work yet, we might slow the process down a bit. If they say, my parents have 30,000 questions, we might arrange a visit with mom and dad. Patients may wish to have their eggs or sperm frozen before hormone therapy begins, to preserve their fertility. Those who do sex work might benefit from screening for sexually transmitted diseases, or consultation with a social worker who can connect them with supportive services.

In collaboration with her colleagues in the multidisciplinary transgender programwhose specialties include plastic surgery, gynecology, and urology, in addition to endocrinologyDr. Glodowski is able to ensure that patients receive precisely the care they require.

NYU Langone Health has been certified for 7 consecutive yearswith a score of 100 percentby the Human Rights Campaign Foundation Healthcare Equality Index Report, which evaluates the work of medical facilities in providing equal healthcare access to LGBTQ+ Americans. One factor in that success is the centers patient-centered approach to transgender care.

In some practices, patients can walk into the office and have someone use the wrong pronoun, Dr. Glodowski says. The doctor might see them briefly, write a prescription, and thats basically it. At NYU Langone, everyone from the receptionists to the medical assistants to the physicians have been trained to be sensitive to gender identity. I spend 40 minutes with each new patient, and 20 minutes with any follow-ups. In addition, we have one clinic a week specifically dedicated to gender-affirming hormone therapy.

The 2019 coronavirus disease (COVID-19) pandemic has also made telehealth a crucial component of the transgender programs endocrinology practice. Although the crisis has waned in New York City, many patients prefer to continue with video visitsciting both safety and convenienceafter an initial in-person consultation. At the height of the pandemic, many providers turned to telehealth to limit in-person visits for non-urgent care, Dr. Glodowski explains. But there is a high rate of suicidal ideation and suicide in patients who are trans-identified. For this patient group, almost all care can be described as urgent, especially for someone whos new to hormones and may be experiencing severe dysphoria.

With those who are beginning a course of hormone therapy, Dr. Glodowski typically schedules a video visit to discuss treatment goals, the expected timeline of physiological changes, and potential side effects. We want to make sure that every patient is very well informed, she explains. As treatment progresses, she will order lab work and discuss results with patients via video link, as well as checking on therapeutic progress and the patients comfort level with the regimen.

Whether a visit is in-person or remote, she adds, its always essential that we provide patients with a safe, gender-affirming space.

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Testosterone Replacement Therapy Market Demand Forecast Analysis by Emerging Growth Factors and Revenue – Owned

Posted: August 12, 2020 at 5:51 pm

Transparency Market Research (TMR) has published a new report titled, Testosterone Replacement Therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalTestosterone Replacement Therapy marketwas valued at US$ 1,613.7 Mn in 2018 and is projected to expand at a CAGR of 4.4% from 2019 to 2027.

Overview

Growing Awareness about Testosterone Replacement Therapy to Drive Market

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North America to Dominate Global Market

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Competitive Landscape

The global Testosterone Replacement Therapy market has been segmented as follows:

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Testosterone Replacement Therapy Market Demand Forecast Analysis by Emerging Growth Factors and Revenue - Owned

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Landmark transplant in 1960s Virginia performed with heart stolen from a Black man – Live Science

Posted: August 12, 2020 at 5:49 pm

On May 25, 1968, surgeons in Richmond, Virginia, performed a successful heart transplant, one of the world's first, on a white businessman. The heart that they used was taken from a Black patient named Bruce Tucker who had been brought to the hospital the day before, unconscious and with a fractured skull and traumatic brain injury. He was pronounced brain dead less than 24 hours later.

Tucker's still-beating heart was then removed without his family's knowledge or prior permission; their horrified discovery from the local funeral director that Tucker's heart was missing was a devastating blow.

The surgeons' actions, which led to America's first civil suit for wrongful death, are brought to light in the new book "The Organ Thieves: The Shocking Story of the First Heart Transplant in the Segregated South" (Simon and Schuster, 2020) by Pulitzer Prize-nominated journalist Charles "Chip" Jones. Jones raises troubling questions about the ethics of this pioneering transplant, revealing its deep roots in racism and discrimination toward Black people in health care.

Related: 7 Reasons America still needs civil rights movements

The first human organ transplant, a kidney, took place in 1954, and by the late 1960s, "superstar" surgeons were vying to be the first to successfully transplant a human heart, Jones told Live Science.

"In terms of science, it was the medical parallel to the space race," Jones said.

Dr. Richard Lower and Dr. David Hume, surgeons at the Medical College of Virginia (MCV) in Richmond, were at the forefront of that race, but it was South African surgeon Dr. Christiaan Barnard who performed the first heart transplant on Dec. 3, 1967. In May of 1968, MCV admitted to its hospital a patient with severe coronary disease who was a promising candidate for a heart transplant. But Lower and Hume had yet to find a viable heart donor.

And with time running out for their sick patient, they needed one fast.

Tucker, a Richmond factory worker who had sustained a serious head injury in a fall, was brought to the MCV Hospital on May 24, 1968. Though Tucker's personal effects included one of his brother's business cards, officials were unable to locate a family member on behalf of the unconscious man. And because the hospital claimed Tucker had no family and had liquor on his breath (he had been drinking prior to his accident), he was profiled as a "charity patient" and marked as a potential heart donor.

"He was in the wrong place at the wrong time," Jones said.

Tucker was connected to a ventilator, unable to breathe on his own. A junior medical examiner performed an electroencephalogram (EEG) to determine electrical activity in Tucker's brain; the examiner declared that there was none. The surgeons pronounced this to be sufficient evidence of brain death; Tucker was removed from the ventilator, and Hume and Lower removed Tucker's heart for the transplant, Jones wrote.

Related: What happens to your body when you're an organ donor?

Decades later, in 1981, the Uniform Determination of Death Act provided a legal definition of death: "irreversible cessation of circulatory and pulmonary functions" and "irreversible cessation of all functions of the whole brain," which means that the entire brain including the brain stem has ceased to function, according to Johns Hopkins Medicine.

But in 1968, the legal concept of death was not as clearly defined, Jones said.

"There was no statutory framework that would let doctors know how to proceed in a situation like this, where they had a patient that they legitimately thought had no chance of recovery," Jones explained. "And time was of the essence, in their view, to save a very sick man." However, the doctors were also quick to presume that Tucker was indigent and without family a racially motivated judgment, according to Jones.

Related: The 9 most interesting transplants

Tucker's family learned that his heart was missing from the funeral director; they pieced together what had happened from news reports (Tucker's identity was not initially released to the public, Jones wrote). Eventually, Tucker's family would file a civil lawsuit for wrongful death, which went to trial in 1972. Representing them was attorney L. Douglas Wilder, who later became the first elected Black governor in the U.S.

According to Wilder, Lower "willfully, wrongfully, wantonly and intentionally pronounced Bruce O. Tucker dead ahead of his actual death, in violation of the law, well knowing that he was not legally qualified to do so." State law required family notification and waiting for 24 hours before performing surgery.

"They skirted the process that was in place in Virginia because they were so eager to finally do the operation," Jones said.

The famous case of Henrietta Lacks presents a similar collision between medical ethics and racism. Lacks, a Black woman (also from Virginia), was diagnosed in 1951 with cervical cancer. A doctor collected cells from one of her tumors and then reproduced them indefinitely in the lab; after Lacks' death, those cells were then distributed widely among scientists for years without her family's knowledge or permission. Known as the HeLa cell line, they were used in research that led to cancer treatments and to the discovery of the polio vaccine, but decades passed before Lacks' family learned of her medical "immortality."

In 2013, the National Institutes of Health (NIH) reached an agreement with the family for permitting future research involving data from HeLa cells; the new process requires application through a panel that includes descendants and relatives of Lacks, Live Science previously reported.

The injustices experienced by Lacks, Tucker and their families stemmed from racism that is deeply embedded in America's medical infrastructure, Jones noted. In fact, when medical colleges in America adopted a more hands-on approach to anatomical studies during the 19th century, instructors frequently trained their students in human anatomy using cadavers of Black people that were stolen from African American cemeteries, Jones wrote.

Grave robbing was technically illegal, but when Black people were the victims, authorities tended to look the other way, according to Jones. Medical schools would hire a "body man" (also known as a "resurrectionist") to procure bodies; at MCV, the designated grave robber was a Black man named Chris Baker, a janitor at the school who lived in the basement of the college's Egyptian Building.

Most of the country's medical schools abandoned this racist method of procuring cadavers by the mid-1800s, but records suggest that it continued in Virginia until at least 1900, Jones said.

"There were news reports of bodies being 'snatched' from the Virginia state pen, which is about five blocks from the medical college," he said.

Jones unexpectedly discovered a reminder of this crime while researching his book, in a mural displayed in MCV's McGlothlin Medical Education Center. Painted between 1937 and 1947 by Richmond artist George Murrill, the mural celebrates the medical college's history. And it includes the image of a corpse being furtively carried away from a grave in a wheelbarrow.

"It shows how the legacy of racism is literally right under people's noses," Jones said.

"The Organ Thieves" is available to buy on Aug. 18; read an excerpt here .

Originally published on Live Science.

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 – PRNewswire

Posted: August 12, 2020 at 12:48 am

FLORHAM PARK, N.J., Aug. 5, 2020 /PRNewswire/ --Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.The University of California Irvine is the first CA site to open for patient enrollment.

CIRM's COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001, in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

"Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses," said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. "We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California."

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says "CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection."

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray. The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

About NK CellsNK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company's Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

About COVID-19The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

About CelularityCelularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact:

Name:Dani Frank

Email:[emailprotected]

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Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19 - PRNewswire

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