Surveys consistently report that people fear total blindness more than any other disability, and currently the major cause of untreatable blindness is retinal disease. The retina, a part of the brain that extends into the eye during development, initiates vision by first detecting light with the rod and cone photoreceptors. Four classes of retinal neurons then begin the analysis of visual images. Defects in the optical media that transmit and focus light rays onto the retina (lens and cornea) can usually be dealt with surgically, although such treatments are not available in some parts of the world, resulting in as many as 20 to 30 million legally blind individuals worldwide. Untreatable retinal disease potentially causes legal or total blindness in more than 11 million people in the United States alone, but progress in treatments raises the possibility of restoring vision in several types of retinal blindness (1).

Retinal neurons comprise bipolar and horizontal cells, which are second-order neurons that receive signals from the photoreceptors in the outer retina. Third-order amacrine and retinal ganglion cells are activated in the inner retina by bipolar cells. Axons from the ganglion cells form the optic nerve and carry the visual message to the rest of the brain (see the figure). The cells most susceptible to blinding retinal disease are the photoreceptors and ganglion cells. Whereas progress has been made in combating blindness caused by photoreceptor degeneration, little can be done currently to address ganglion cell loss, such as occurs in glaucoma.

The approach that has been most successful in restoring photoreceptor loss that results in complete blindness is the use of retinal prosthetic devices, with two now approved for clinical use (2). These devices electrically stimulate either bipolar or ganglion cells. They require goggles that have a camera that converts visual stimuli into electrical stimuli that activate the device, which in turn stimulates the retinal cells. Several hundred of these devices have been implanted in blind or virtually blind individuals, 70 to 80% of whom report improvement in quality of life. For those who are completely blind, the ability to experience again at least some visual function is viewed as a miracle.

There are substantial limitations to the devices, however. The best visual acuity attained so far is poor (20/500) and visual field size is limited, but many improvements, mainly technical, are being developed and tested, including the potential use of electronic low-vision devices to increase visual field size and acuity (3). Retinal prostheses are not useful for patients who are blind because of loss of ganglion cells and/or the optic nerve, but prostheses that bypass the retina and stimulate more central visual structures, including the lateral geniculate nucleus (the intermediary between retina and cortex) and visual cortex, are being developed and tested in humans (4). There remain considerable technical issues, but preliminary data indicate that such devices are feasible.

A second approach to treat photoreceptor degeneration and potential blindness, now in the clinic, is gene therapy (5). This involves injecting a viral construct into the eye that contains a normal gene to replace an abnormal one. Success so far has been limited to the treatment of Leber congenital amaurosis (LCA) type 2, a rare form of retinitis pigmentosa in which the gene whose product is required to form the correct isomer of vitamin A aldehyde, the chromophore of the visual pigments, is mutated. Little of the correct isomer is made in LCA patients, resulting in substantial loss of photoreceptor light sensitivity. This is reversed when viral constructs encoding the normal gene are injected deep into the eye between the photoreceptors and pigment epithelium.

Two factors make this approach feasible in LCA: The genetic defect is monogenic, and many of the photoreceptors in the patients remain alive, although compromised. Thus, how broadly feasible gene therapy will be for treating the enormous range of inherited retinal diseases now known to exist (300) remains to be seen. But at least a dozen other gene therapy trials on monogenic inherited eye diseases similar to LCA are under way (6). Other methods to manipulate genes are now available, including CRISPR-mediated editing of retinal genes. So far, the experiments have been mainly on isolated cells or retinas, but these powerful techniques are likely to have eventual clinical applications.

A variation on the use of gene therapy techniques is optogenetics, in which light-sensitive molecules are introduced into non-photosensitive retinal cells. This approach holds much promise for restoring vision to totally blind individuals whose photoreceptors have been lost. Using viruses to insert genes encoding light-sensitive molecules into bipolar and ganglion cells, as well as surviving photoreceptor cells that are no longer photosensitive, has been accomplished in animals and shown to restore some vision (7). Again, technical issues remain: The cells made light-sensitive require bright light stimuli, and the light-sensitive cells do not adapt. That is, whereas photoreceptors normally allow vision over as much as 10 log units of light intensity, the cells made light-sensitive respond only to a range of 2 to 3 log units. Various methods to overcome these limitations are now being developed, and at least one clinical trial is under way. Experiments to make cortical neurons sensitive to light or other stimuli that better penetrate the skullmagnetic fields or ultrasound, for exampleare also being developed and tested in animals.

Other promising approaches to restore vision are being explored. In cold-blooded vertebrates, retinal cells (in fish) and even the entire retina (in amphibians) can regenerate endogenously after damage. Regeneration of retinal cells in zebrafish is now quite well understood (8). The regenerated neurons come from the major glial cell in the retina, the Mller cell. After retinal damage, Mller cells reenter the cell cycle and divide asymmetrically to self-renew and produce a progenitor cell that proliferates to produce a pool of cells capable of differentiating into new retinal cells that repair the retina.

A number of transcription factors and other factors identified as being involved in retinal regeneration in zebrafish have been shown to stimulate some Mller cell proliferation and neuronal regeneration in mice. Regenerated bipolar and amacrine cells, as well as rod photoreceptors, have so far been identified in mouse retinas, and these cells are responsive to light stimuli (9, 10). Further, cells postsynaptic to the regenerated neurons are activated by light stimuli, indicating that the regenerated neurons have been incorporated into the retinal neural circuitry. So far, the regenerative capacity of mammalian Mller cells is limited, but directed differentiation of specific types of neurons with a mix of factors appears to be a possibility. Regrowth of ganglion cell axons after the optic nerve is disrupted is also under active investigation, and although the number of axons regrowing is low (10%), those that do regrow establish synaptic connections with their correct targets (11). Therefore, endogenous regeneration is still far from clinical testing, but substantial progress has occurred.

The retina lines the back of the eye and consists of rod and cone photoreceptors, as well as four types of neuron: second-order bipolar and horizontal cells and third-order retinal ganglion cells (RGCs) and amacrine cells. Mller glial cells fill the spaces between the neurons. The pigment epithelium, critical for photoreceptor function, underlies the retina. Photoreceptors and RGCs are most susceptible to blinding retinal disease. Progress in combating photoreceptor degeneration has been made, but there are few strategies to address RGC loss.

A long-studied area of research is transplantation of retinal cells, particularly photoreceptors, into diseased retinas. In experiments with mice, transplanted postmitotic rod photoreceptor precursor cells derived from embryonic retinas or from stem cells appeared to integrate into diseased retinas in reasonable numbers and to be functional. A surprising and unexpected complication in the interpretation of these experiments was recently discovered. Rather than integrating into diseased retinas, the donor cells appear to pass material (RNA or protein) into remaining host photoreceptor cells, rejuvenating them, and these appear to be most of the functional cells (12). The current evidence suggests that only a small proportion of the donor cells integrate, but progress in overcoming this setback is being made.

More success has been reported with stem cells induced to become pigment epithelial (PE) cells, which provide essential support for photoreceptors. A number of blinding retinal diseases relate to the degeneration of the PE cells, and replacement using such cellsin a suspension or on a scaffoldis being actively pursued. PE cells do not need to integrate synaptically with retinal cells; they simply need to contact the photoreceptor cells. This is achieved when PE cells are placed between the retina and the back of the eye. Early clinical trials suggest that the transplants are safe, but retinal detachment, a serious complication, can occur and efficacy has yet to be shown (13).

The finding that donor photoreceptor cells can help diseased host retinal cells to recover function suggests that certain substances can provide neuroprotection. Indeed, a substantial number of such neuroprotective molecules have been shown to affect retinal disease progression, especially degeneration of photoreceptor cells. No one factor has been shown to be effective generally, but two have received much attention. One, ciliary neurotrophic factor (CNTF), promotes photoreceptor survival in light-induced photoreceptor degeneration and in several other models of retinal degeneration (14). Some evidence suggests that CNTF acts primarily on Mller cells, but how it works, and on what cells, is still unclear. The other factor, rod-derived cone viability (RDCV) factor, has received less research attention, but with recent industrial support, it is now being advanced to the clinic. Current evidence indicates that RCDV factor protects cones after rod degeneration.

Two of the most common retinal diseases in developed countriesage-related macular degeneration (AMD), the leading cause of legal blindness (visual acuity of less than 20/200), and glaucoma, the leading cause of total blindnessare not monogenic diseases, and so genetic treatments for them are not obvious. Attempts to understand the etiology of these diseases are under way, but currently their underlying causes are still unclear. A difficulty presented by AMD is that no animal model is readily available, because it is a disease of the fovea, which mediates high-acuity vision. Except for primates, other mammals do not possess this small critical retinal area. Whereas large primates are not feasible for extensive cellular or molecular studies, small primates such as marmosets that have a fovea are potential models but have not been used much to date.

Other approaches for restoring vision have been suggested and have even yielded some progress. From both normal humans and those with an inherited retinal disease, skin biopsy cells can be induced to form tiny retinal eyecups called organoids (15). Containing all retinal cell types, these structures could be a source of retinal cells for studying retinal disease development and possible therapies, as well as for cell transplantation. A fovea has not been observed in any organoid so far, but this is not beyond the realm of possibility. Another suggested approach is to surgically transplant whole eyes into blind individuals. This appears feasible, but whether there is sufficient optic nerve regrowth remains an open question.

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Restoring vision to the blind - Science Magazine

Skin Stem Cells Comments Off on Restoring vision to the blind – Science Magazine | May 21st, 2020

Cosmetic Skin CareMarketBusiness Insights and Updates:

The latest Marketreport by a Data Bridge Market Researchwith the title[Global Cosmetic Skin CareMarket Industry Trends and Forecast to 2026].The new report on the worldwide Cosmetic Skin CareMarketis committed to fulfilling the necessities of the clients by giving them thorough insights into the Market. The various providers involved in the value chain of the product include manufacturers, suppliers, distributors, intermediaries, and customers.The reports provide Insightful information to the clients enhancing their basic leadership capacity identified.Exclusive information offered in this report is collected by analysis and trade consultants.

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Cosmetic Skin Care Market is Thriving with Rising Latest Trends by 2026 | Top Players- L'Oreal, Unilever, New Avon, Estee Lauder Companies, Espa, Kao,...

Skin Stem Cells Comments Off on Cosmetic Skin Care Market is Thriving with Rising Latest Trends by 2026 | Top Players- L’Oreal, Unilever, New Avon, Estee Lauder Companies, Espa, Kao,… | May 21st, 2020

NantKwest, Inc. (NASDAQ: NK) today announced it has received authorization from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug application to treat patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 with BM-Allo.MSC, an allogeneic mesenchymal stem cell (MSC) product derived from human bone marrow. NantKwest has entered into an agreement with the National Marrow Donor Program (Be the Match) to provide donor material and has developed automated proprietary methods to expand and generate multiple dose forms utilizing a modular, closed system (GMP-in-a-box) from NantKwest affiliate ImmunityBio, Inc., to expand BM-Allo.MSCs, enabling the scalable manufacture and immediate distribution of cryopreserved BM-Allo.MSC product.

"There is an urgent need to develop broadly accessible treatment options for the devastating outcomes seen in the thousands of COVID-19 patients who are facing severe disease with ARDS and cytopathic storm," said Patrick Soon-Shiong, M.D., Chairman and Chief Executive Officer of NantKwest and ImmunityBio. "While MSC-derived treatments have shown promise in treating patients with ARDS, including those with COVID-19, the ability to scale production to support the overwhelming patient need has been a challenge. Our proprietary GMP-in-a-Box enables the rapid and scalable manufacture of our fully human BM-Allo.MSC product, overcoming this previous limitation to advance a promising new treatment to those patients who are most in need. Due to our proprietary methods, we are well positioned to rapidly advance BM-Allo.MSC during the current wave of COVID-19, with an anticipated trial initiation in Q2."

BM-Allo.MSC is a bone marrow-derived allogenic MSC product being developed to attenuate the inflammatory processes that drive ARDS in severe COVID-19 patients. MSCs are multipotent progenitor cells that give rise to cell types responsible for tissue repair and may restore effective immune function and contribute to viral clearance. Prior work with allogeneic MSC products in patients with ARDS has shown that such treatment is safe and may reduce key markers of inflammatory processes.

Trial Design

The Phase 1b, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BM-Allo.MSC versus current supporting care in treating patients with severe disease and requiring ventilator support (IND 019735). The therapeutic will be administered to a total of 45 patients receiving care in the critical care or ICU setting. The primary objectives of the study include overall safety and reduction in time on ventilator. The secondary objective will focus on the efficacy of BM-Allo.MSC in reducing the number of days patients require oxygen, duration of hospitalization, and mortality.

About NantKwest

NantKwest (NASDAQ: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering off-the-shelf living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com

haNK is a registered trademark of NantKwest, Inc.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning or implying that NantKwest will be successful in improving the treatment of cancer and/or Covid-19. Risks and uncertainties related to this endeavor include, but are not limited to, obtaining FDA approval of NantKwests NK cells, as well as other therapeutics, as part of the NANT Cancer Vaccine platform as a cancer treatment and/or Covid-19 treatment.

Story continues

Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements.

These and other risks regarding NantKwests business are described in detail in its Securities and Exchange Commission filings, including in NantKwests Quarterly Report on Form 10-Q for the Quarter ended March 31, 2020. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200518005217/en/

Contacts

Jen HodsonJen@nant.com 562-397-3639

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NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients - Yahoo...

Bone Marrow Stem Cells Comments Off on NantKwest Announces FDA Authorization of IND Application for Mesenchymal Stem Cell Product for the Treatment of Severe COVID-19 Patients – Yahoo… | May 21st, 2020

The killer is not the virus but the immune response.

The current pandemic is unique not just because it is caused by a new virus that puts everyone at risk, but also because the range of innate immune responses is diverse and unpredictable. In some it is strong enough to kill. In others it is relatively mild.

My research relates to innate immunity. Innate immunity is a persons inborn defense against pathogens that instruct the bodys adaptive immune system to produce antibodies against viruses. Those antibody responses can be later used for developing vaccination approaches. Working in the lab of Nobel laureate Bruce Beutler, I co-authored the paper that explained how the cells that make up the bodys innate immune system recognize pathogens, and how overreacting to them in general could be detrimental to the host. This is especially true in the COVID-19 patients who are overreacting to the virus.

I study inflammatory response and cell death, which are two principal components of the innate response. White blood cells called macrophages use a set of sensors to recognize the pathogen and produce proteins called cytokines, which trigger inflammation and recruit other cells of the innate immune system for help. In addition, macrophages instruct the adaptive immune system to learn about the pathogen and ultimately produce antibodies.

To survive within the host, successful pathogens silence the inflammatory response. They do this by blocking the ability of macrophages to release cytokines and alert the rest of the immune system. To counteract the viruss silencing, infected cells commit suicide, or cell death. Although detrimental at the cellular level, cell death is beneficial at the level of the organism because it stops proliferation of the pathogen.

For example, the pathogen that caused the bubonic plague, which killed half of the human population in Europe between 1347 and 1351, was able to disable, or silence, peoples white blood cells and proliferate in them, ultimately causing the death of the individual. However, in rodents the infection played out differently. Just the infected macrophages of rodents died, thus limiting proliferation of the pathogen in the rodents bodies which enabled them to survive.

The silent response to plague is strikingly different from the violent response to SARS-CoV-2, the virus that causes COVID-19. This suggests that keeping the right balance of innate response is crucial for the survival of COVID-19 patients.

Heres how an overreaction from the immune system can endanger a person fighting off an infection.

Some of the proteins that trigger inflammation, named chemokines, alert other immune cells like neutrophils, which are professional microbe eaters to convene at the site of infections where they can arrive first and digest the pathogen.

Others cytokines such as interleukin 1b, interleukin 6 and tumor necrosis factor guide neutrophils from the blood vessels to the infected tissue. These cytokines can increase heartbeat, elevate body temperature, trigger blood clots that trap the pathogen and stimulate the neurons in the brain to modulate body temperature, fever, weight loss and other physiological responses that have evolved to kill the virus.

When the production of these same cytokines is uncontrolled, immunologists describe the situation as a cytokine storm. During a cytokine storm, the blood vessels widen further (vasolidation), leading to low blood pressure and widespread blood vessel injury. The storm triggers a flood of white blood cells to enter the lungs, which in turn summon more immune cells that target and kill virus-infected cells. The result of this battle is a stew of fluid and dead cells, and subsequent organ failure.

The cytokine storm is a centerpiece of the COVID-19 pathology with devastating consequences for the host.

When the cells fail to terminate the inflammatory response, production of the cytokines make macrophages hyperactive. The hyperactivated macrophages destroy the stem cells in the bone marrow, which leads to anemia. Heightened interleukin 1b results in fever and organ failure. The excessive tumor necrosis factor causes massive death of the cells lining the blood vessels, which become clotted. At some point, the storm becomes unstoppable and irreversible.

One strategy behind the treatments for COVID is, in part, based in part on breaking the vicious cycle of the cytokine storm. This can be done by using antibodies to block the primary mediators of the storm, like IL6, or its receptor, which is present on all cells of the body.

Inhibition of tumor necrosis factor can be achieved with FDA-approved antibody drugs like Remicade or Humira or with a soluble receptor such as Enbrel (originally developed by Bruce Beutler) which binds to tumor necrosis factor and prevents it from triggering inflammation. The global market for tumor necrosis factor inhibitors is US$22 billion.

Drugs that block various cytokines are now in clinical trials to test whether they are effective for stopping the deadly spiral in COVID-19.

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Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 - The Conversation US

Bone Marrow Stem Cells Comments Off on Blocking the deadly cytokine storm is a vital weapon for treating COVID-19 – The Conversation US | May 21st, 2020

However, stem cells could provide the answer to treating and repairing spinal cord injuries.

A British professor, Geoffrey Raisman, undertook research which showed that specific stem cells could enable a paralysed man to walk again.

He used stem cells called olfactory ensheathing cells (OECs) from the nose of a patient and transplanted them into the spinal cord. OECs are unique cells which are part of the sense of smell. They allow nerve fibres in the olfactory system to constantly regenerate. Prof Raisman proved that broken nerve fibres in the spinal cord could repair themselves by using OECs that were transplanted into the spinal cord of the patient. These specific stem cells (OECs) facilitated the growth of the ends of severed nerve fibres and caused them to join together.

A doctor in Portugal also transplanted olfactory stem cells to treat spinal cord injury in over 100 patients. These studies showed that a few patients were able to regain at least limited motor function and sensation after transplantation.

Although its early days, these studies show that neuronal type stem cells (NSCs) hold great promise to treat various neurodegenerative diseases and injuries to the spinal cord. Stem cells possess the ability to differentiate into many types of neural cell, depending upon their environment and the stimulus that is provided.

At present there are 55 clinical trials investigating the application of stem cells in spinal cord injury. These trials are studying various sources of stem cells including mesenchymal stem cells, bone marrow, umbilical cord tissue and adipose tissue derived stem cells.

(Marsala M, et.al. Spinal parenchymal occupation by neural stem cells after subpial delivery in adult immunodeficient rats. STEM CELLS Translational Medicine, 2019; 9 (2): 177 DOI: 10.1002/sctm.19-0156)

Please note: Stem cell therapy for spinal cord injury is in a research phase, and is not an established therapy.

Cord blood stem cell therapy for spinal cord injury is not available in South Africa.

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Spinal Cord Injury And Stem Cells: New Perspectives ...

Spinal Cord Stem Cells Comments Off on Spinal Cord Injury And Stem Cells: New Perspectives … | May 21st, 2020

Spinal cord injury (SCI) involves damage to the area that can cause an impairment of loss of muscle control, movement and sensation. Currently, patients with injury to the spinal cord are managed with physical therapy, occupation therapy and other rehabilitation methods to cope with the physical changes.

However, stem cell research may present a new approach to the management of this patient group, ing for a potential improvement in the symptoms of the condition, such as incontinence, muscular control and sexual function.

Stem cells used in the treatment of SCI may come from various sources, including autologous mesenchymal CD34+ cells from own bone marrow, allogeneic mesenchymal cells from the human umbilical cord tissue or adipose tissue.

The bone marrow cells are taken from both hips of the patient, who is sedated with light general anesthetic. The cells are then tested for quality and bacterial contamination before they can be used in the research. Likewise, cells from umbilical cords are taken from healthy births and must pass rigorous screening prior to being passed for use in trials.

Scientific research conducted in animals with spinal cell injury has investigated the utility of stem cells in the repair of the injury. As a result of this research, a general understanding of the role that stem cells could play has been established. This includes:

Mesenchymal stem cells, also known as stromal stem cells, are a topic of interest in the research for treatment of spinal cord injury. The theory is for the stem cells to provide protection to and aid growth of the cells in the region of the injured spinal cord.

The safety and efficacy of different stem cell types have been investigated in several different studies. Various methods of administration have been trialed, including injection into the spine, the vein or the skin.

There has also been some research focused on embryonic stem cells in the management following spinal cord injury.

One study observed the effect of an injection of precursors of oligodendrocytes, to form the myelin sheath around the axons. However, after four patients were treated with the cells and observed for signs of restored nerve signaling, the study was discontinued. The belief that embryonic stem cells may be promising for spinal cord injury was not tainted.

Another study investigated the effect of hES cell-derived oligodendrocyte progenitor cells when injected into the site of thoracic spinal cord injury. Of five patients, none experienced serious side effects, and imaging tests revealed that the volume of injury was reduced in 80% of patients.

At this point in time, there is insufficient scientific evidence to recommend the used of stem cells for spinal cord injury as a routine practice. The technique is promising, however, offering the possibility of healing and the improvement of the symptoms, which is in contrast to the current practice that recommends coping mechanisms without a definitive cure or improvement.

For this reason, scientific research is likely to continue in the future in the hope of finding a suitable method to improve the quality of life for patients with spinal cord injury.

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Stem cell research for spinal cord injury

Spinal Cord Stem Cells Comments Off on Stem cell research for spinal cord injury | May 21st, 2020

Last week, she was given the all-clear to start re-entering the lab after it closed in March due to COVID-19 restrictions.

"We fired up the lab and turned everything back on. It felt fantastic to be back working towards research goals," she said.

Professor Sharon Ricardo's lab was closed under COVID-19 restrictions.Credit:Jason South

Over the last few months, she has been churning through grant writing and Zoom meetings.

She said her days spent video-conferencing and doing administrative work were "tiring but productive".

Professor Ricardo said a healthy balance between laboratory work and paperwork was important to her and her team as they "became researchers because we get excited about what we do".

They produce three-dimensional miniature kidneys from skin cells useful for disease modelling, called organoids.

The organoids are made by collecting patients' skin cells, developing them into stem cells, and "adding factors to the cell cultures to form mini kidneys," she said.

According to Professor Ricardo, the closure of the laboratories has seriously impeded some of her students' research.

One of her PhD students had one organoid experiment left to go when the restrictions came in to play and labs were closed.

"We had to freeze the lines and turn off all the incubators," she said.

The Universitys labs are reopening gradually. Hygiene and social distancing measures were being taken to ensure the safety of staff and students, she said.

"You go to the lab, perform what you need to do, and go home," said Professor Ricardo. Shes received strict instructions not to hang around the office.

Even with the new social distancing measures, she is very excited to be back with her colleagues.

"Every time I see somebody at work, I feel like I am seeing my best friend," she said.

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Universities Australia Chief Executive Catriona Jackson said COVID-19 has "upended almost every area of endeavour" across the university research sector.

"Australias researchers have pivoted their work to join the community in fighting the virus, from world-leading vaccine and treatment research to work on all aspects of the deep social and economic impact of the crisis," she said.

The pandemic has been devastating for the university research community. "The loss to university R&D [research and development] is estimated at $2.5 billion in 2020, placing at risk at least 38 per cent of research salaries," said Ms Jackson.

While specific regulations around reopening physical research facilities differ for each state and university, Ms Jackson said they are closely following guidance from medical authorities and government.

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Research frozen by COVID-19 begins to thaw - The Age

Skin Stem Cells Comments Off on Research frozen by COVID-19 begins to thaw – The Age | May 21st, 2020

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Weekly Update: Global Coronavirus Impact and Implications on Cosmetic Skin Care Market Forecast Report Offers Key Insights, Key Drivers, Technology -...

Skin Stem Cells Comments Off on Weekly Update: Global Coronavirus Impact and Implications on Cosmetic Skin Care Market Forecast Report Offers Key Insights, Key Drivers, Technology -… | May 21st, 2020

On Monday, it was announced thatNSW public schools will return to the classroom full time from next Monday, two months after COVID-19 restrictions forced around 800,000 children to study remotely.

Its a normal school week from next week and they need to be attending. Rolls will be marked as normal and unexplained absences will be followed up, NSW Education Minister Sarah Mitchell said on Tuesday.

However, many teachers are not pleased with how they discovered the return to full-time schooling, withNSW Teachers Federation president Angelo Gavrielatos saying the union had not been consulted before the governments decision.

He said teachers had already planned for the previously announced staggered return to school, with face-to-face learning gradually scaled up throughout term two.

This caused a lot of concern, frustration and anger among teachers and principals across the state. They turned themselves inside out not once, not twice, but repeatedly, trying to come to terms with this crisis, Gavrielatos told ABC television.

This is a pandemic that we find ourselves in thats what makes what happened last night even more important and more disrespectful.

Listen: The risk And reality of a COVID19 second wave in Australia. Post continues below audio.

Mamamiaspoke to five teachers about how they discovered the news of the return to full-time schooling, and how they feel about it. Heres what they had to say.

I went on Facebook last night and saw an article and was shocked! I checked my staff emails and there was no information. I messaged every other teacher I knew and no one had any idea except for seeing it on Facebook.

We all found this out through Facebook, except for those who dont seem to have social media, who found out when Gladys Berejeklian announced it this morning. The principals were not informed so they were unable to inform us!

There has still been no official communication from the department or our union. It was infuriating to find out on Facebook! But I dont blame any principals or teachers or the Department of Education, as they all found out at the same time as I did, in the same way. Which is disgusting!

I think its been a really hard time to navigate. I have been frustrated by the way weve been treated, but I dont blame anyone.

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'I found out on Facebook.' 5 teachers share how they feel about returning to school full-time. - Mamamia

Skin Stem Cells Comments Off on ‘I found out on Facebook.’ 5 teachers share how they feel about returning to school full-time. – Mamamia | May 21st, 2020

Latest Patent Further Strengthens Intellectual Property Portfolio Covering Novel Platform for Precisely Controlling Core Cell Migration Mechanisms

Decelerator Technology Has Key Potential Applications in Treatment of Cancer and Fibrosis and Serves as Key Complement to Companys Cell Motility Accelerator Platform for Enhanced Tissue Repair

NEW YORK, May 20, 2020 (GLOBE NEWSWIRE) -- MicroCures, a biopharmaceutical company developing novel therapeutics that harness the bodys innate regenerative mechanisms to accelerate tissue repair, today announced the issuance of a new European patent providing broad protection for the companys first-of-its-kind cell movement decelerator technology, which has potential therapeutic applications in combating cancer metastases and fibrosis. The companys decelerator technology is being developed alongside MicroCures accelerator technology, which is designed to enhance repair of tissue, nerves, and organs following trauma. With the newly issued patent in the European Union (#3052117), the companys global patent estate now includes eight issued and 12 pending patents covering its underlying technology, as well as the therapeutic programs that have emerged from the platform.

Our proprietary platform technology represents a fundamentally new way of thinking about how to harness the bodys natural cell movement processes to drive therapeutic outcomes in response to a range of medical challenges. Whether it is removing the brakes from cells to accelerate their migration and drive tissue, nerve and organ repair, or putting the brakes on cell movement to combat tumor metastases and fibrosis, we are pioneering an entirely new treatment paradigm, said Derek Proudian, co-founder and chief executive officer of MicroCures. While we clearly recognize the importance of the development work we are undertaking in support of this platform, it is equally important to build a strong, wide-reaching intellectual property portfolio to protect it. This latest patent issuance provides us yet another key piece of intellectual property, bringing our total number of issued and pending patents to 20.

MicroCures technology is based on foundational scientific research at Albert Einstein College of Medicine regarding the fundamental role that cell movement plays as a driver of the bodys innate capacity to repair tissue, nerves, and organs. The company has shown that complex and dynamic networks of microtubules within cells crucially control cell migration, and that this cell movement can be reliably modulated to achieve a range of therapeutic benefits. Based on these findings, the company has established a first-of-its-kind proprietary platform to create siRNA-based therapeutics capable of precisely controlling the speed and direction of cell movement by selectively silencing microtubule regulatory proteins.

The company has developed a broad pipeline of therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. Unlike regenerative medicine approaches that rely upon engineered materials or systemic growth factor/stem cell therapeutics, MicroCures technology directs and enhances the bodys inherent healing processes through local, temporary modulation of cell motility. Additionally, the company is developing a decelerator technology based on the same foundational science. Instead of accelerating cell movement for therapeutic repair and regeneration, this technology is designed to slow or halt the movement of cells, potentially offering a unique, natural approach to preventing cancer metastases and fibrosis.

About MicroCures

MicroCures develops biopharmaceuticals that harness innate cellular mechanisms within the body to accelerate and improve recovery after traumatic injury. MicroCures has developed a first-of-its-kind therapeutic platform that precisely controls the rate and direction of cell migration, offering the potential to deliver powerful therapeutic benefits for a variety of large and underserved medical applications.

MicroCures has developed a broad pipeline of novel therapeutic programs with an initial focus in the area of tissue, nerve and organ repair. The companys lead therapeutic candidate, siFi2, targets excisional wound healing, a multi-billion dollar market inadequately served by current treatments. Additional applications for the companys cell migration accelerator technology include dermal burn repair, corneal burn repair, cavernous nerve repair/regeneration, spinal cord repair/regeneration, and cardiac tissue repair. Cell migration decelerator applications include combatting cancer metastases and fibrosis. The company protects its unique platform and proprietary therapeutic programs with a robust intellectual property portfolio including eight issued patents, as well as 12 pending patent applications.

Story continues

For more information please visit: http://www.microcures.com

Contact:

MicroCuresinfo@microcures.com

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MicroCures Announces Issuance of New European Patent Providing Broad Protection for First-of-its-Kind Cell Movement Decelerator Technology - Yahoo...

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Aggressive public health measures tostem the tidal wave of coronavirus infections have left people isolated,unemployed and wondering when it will all end. Life probably wont gocompletely back to normal until vaccines against the virus are available,experts warn.

Researchers are working hard on thatfront. At least six vaccines are currently being tested in people, says EstherKrofah, chief executive of the FasterCures center at the Milken Institute in Washington,D.C. We expect about two dozen more toenter clinical trials by this summer and early fall. That is a huge number,Krofah said at an April 17 briefing. Dozens more are in earlier stages oftesting.

In unpublished, preliminary results of a test of one vaccine, inoculated people made as many antibodies against the coronavirus as people who have recovered from COVID-19 (SN: 5/18/20). The mRNA-based vaccine induces human cells to make one of the viruss proteins, which the immune system then builds antibodies to attack. That study was small, only eight people, but a second phase of safety testing has begun.

But vaccinestake time to test thoroughly (SN: 2/21/20). Even with acceleratedtimelines and talk of emergency use of promising vaccines for health care workersand others at high risk of catching the virus, the general public will likelywait a year or more to be vaccinated.

In the meantime, new treatments may helpsave lives or lessen the severity of disease in people who become ill.Researchers around the world are experimenting with more than 130 drugs to findout if any can help COVID-19 patients, according to atracker maintained by the Milken Institute.

Some of those drugs are aimed atstopping the virus, while others may help calm overactive immune responses thatdamage lungs and other organs. Although researchers are testing a battery ofrepurposed drugs and devising new ones, there is still a great deal ofuncertainty over whether the drugs help, or maybe even hurt.

The wait is frustrating, but theres still much doctors and scientists dont know about how this new coronavirus affects the body. Getting answers will take time, and finding measures to counter the virus that are both safe and effective will take even more. Early results suggest that the antiviral drug remdesivir can modestly speed recovery from COVID-19 (SN: 5/13/20). It is not a cure, but the drug may become the new standard of care as researchers continue to test other therapies.

Scientists and journalists share a core belief in questioning, observing and verifying to reach the truth. Science News reports on crucial research and discovery across science disciplines. We need your financial support to make it happen every contribution makes a difference.

Antiviral drugs interfere with a viruss ability to replicate itself, though such drugs are difficult to create. Remdesivir is being tested in half a dozen clinical trials worldwide. The drug mimics a building block of RNA, the genetic material of the coronavirus (SN: 3/10/20). When the virus copies its RNA, remdesivir replaces some of the building blocks, preventing new virus copies from being produced, laboratory studies have shown.

Early results in COVID-19 patients given the drug outside of a clinical trial showed that 68 percent needed less oxygen support after treatment, as reported online April 10 in the New England Journal of Medicine (SN: 4/29/20). The drug went to very sick patients, including those who needed oxygen from a ventilator or through tubes in the nose. Other researchers have disputed those results, questioning the study methods and statistical analyses, which may have given an exaggerated impression of good outcomes. The studys authors say they have reanalyzed the data and still conclude that remdesivir has benefits.

Soon after, the U.S. National Instituteof Allergy and Infectious Diseases announced that hospitalized patients withCOVID-19 who got intravenous remdesivir recoveredmore quickly than those on a placebo: in 11 days versus 15. Those findingshad not been reviewed by other scientists at the time of the announcement. Thedug provides researchers with a baseline for comparing other treatments. Wethink its really opening the door to the fact that we now have the capabilityof treating, Anthony Fauci, director of the NIAID said April 29 in a newsbriefing at the White House.

Antiviral medications used against HIV are also being tested against COVID-19. The combination of lopinavir and ritonavir stops an HIV enzyme called the M protease from cutting viral proteins so that the virus can replicate itself. The SARS-CoV-2 virus produces a similar enzyme. But early results from a small study in China showed that the combination didnt stop viral replication or improve symptoms (SN: 3/19/20), and there were side effects.

For now, the Society of Critical CareMedicine recommendsagainst using the drugs, and the Infectious Diseases Society of Americasays patients should get the drugs onlyas part of a clinical trial. Several large trials may report results soon.

The HIV drugs may not work well against SARS-CoV-2, even though the viruses have similar M proteases: The coronaviruss enzyme lacks a pocket where the drugs fit in the HIV version of the enzyme.

This illustrates why antiviral drugs areso difficult to develop. Designing a drug requires knowing the 3-D structure ofthe viruss proteins, which can take months to years. But researchers arealready getting some close-up views of the new coronavirus. A team in Chinaexamined the structure of the coronaviruss M protease and designed smallmolecules that could block a part of the protein necessary to do its job. Theteam describedtwo such molecules, dubbed 11a and 11b, April 22 in Science.

In test tubes, both molecules stopped the virus from replicating in monkey cells. In mice, 11a stuck around longer in the blood than 11b, so the researchers tested 11a further and found it seemed safe in rats and beagles. More animal tests will probably be needed to show whether it stops the virus, then multiple stages of human tests will have to follow. The drug development and testing process often takes on average 10 years or more, and can fail at any point along the way.

Meanwhile, hundreds of thousands of people worldwide have already recovered from COVID-19, and many are donating blood that might contain virus-fighting antibodies. Clinical trials are under way to test whether antibodies from recovered patients blood plasma can help people fight off the virus (SN: 4/25/20, p. 6). More such trials are planned.

Stopping the virus is only half the problem. In some people seriously ill with COVID-19, their immune system becomes the enemy, unleashing storms of immune chemicals called cytokines. Those cytokines trigger immune cells to join the fight against the virus, but sometimes the cells go too far, causing damaging inflammation.

Some of the drugs used to calm cytokines in cancer patients (SN: 6/27/18, p. 22) may also help people with COVID-19 ride out the storm, says cancer researcher Lee Greenberger, chief scientific officer of Leukemia and Lymphoma Society. Several of those drugs are being tested against the coronavirus now.

Hydroxychloroquine, a drug approved totreat autoimmune disorders such as lupus and rheumatoid arthritis, became ahousehold word after President Trump touted it as a possible COVID-19treatment.

The drug is being tested in numerouslarge clinical trials around the world to see if it might help calm cytokinestorms in COVID-19 patients as well. But so far, there is no solid evidence thatit works either to prevent infection in people or to treat people who alreadyhave the disease.

And in some studies the drug has caused serious side effects, including causing irregular heartbeats, says Raymond Woosley, a pharmacologist at the University of Arizona College of Medicine in Phoenix. People with heart problems, low potassium or low oxygen levels in their blood are at higher risk of these side effects, he says. And those are exactly the kinds of patients who are most vulnerable to COVID-19. So, the very sickest COVID patients are those at most risk for these life-threatening arrhythmias and cardiac effects.

Results of some rigorous clinical trialsof hydroxychloroquine are expected this summer. Meanwhile, the U.S. Food andDrug Administration allows the drug to be used when no other treatment isavailable and patients cant join a clinical trial.

Todays enthusiasm for any drug thatseems promising feels familiar, says Woosley. He remembers the excitement overAZT, the first drug used to fight HIV in the 1980s. It wasnt the best drug tocombat the AIDS epidemic, and better ones came later. Likewise, the firsttreatments for COVID-19 might be better than nothing, but not the best we willultimately get.

Meanwhile, we wait.

With hundreds of clinical trials going on around the world, some answers may come soon. But for now, keeping the coronavirus contained will probably require aggressive testing, tracing and isolating contacts of people who have the virus and continued social distancing.

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As we wait for a vaccine, heres a snapshot of potential COVID-19 treatments - Science News

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Coronavirus and Mesenchymal Stem Cells

Therapy for Pneumonia Patients infected by 2019 Novel Coronavirus

Treatment With Mesenchymal Stem Cells for Severe Corona Virus Disease 2019(COVID-19)

Mesenchymal Stem Cell Treatment for Pneumonia Patients Infected With 2019 Novel Coronavirus

On the website of the Harvard Stem Cell Institute you will find the following news release about the ongoing clinical trial conducted by our daughter company RHEACELLin patients suffering from limbal stem cell deficiency: Restoring vision: A stem cell therapy for cornea regeneration reaches the clinical-trial stage.

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and several European competent national regulatory authorities. The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) for the treatment of EB.

The international phase I/IIa clinical trial has been approved by the U.S. Food and Drug Administration (FDA) and the German regulatory authority (Paul Ehrlich Institute). The medicinal drug product tested in this trial has recently been granted Orphan Drug designation from the FDA and the European Medicines Agency (EMA) and Fast Track designation from the FDA for the treatment of LSCD.

In a comprehensive preclinical study program, safety and local tolerability of ABCB5+ MSCs following subcutaneous, intramuscular and intravenous application has been demonstrated (Tappenbeck et al., 2019).

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TICEBA >< Advantages of Skin Stem Cells

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New treatment for baldness has shown its effectiveness: for its realization has been applied proteins derived from stem cells of adipose tissue means. The experiment was carried out by scientists from South Korea.

The scientific staff of the Busan University as part of the experience tested the ability to cure the most familiar type of baldness androgenic alopecia, utilizing extract of stem cells of adipose tissue. This disease can not be attributed to the most hazardous to health, but it negatively affects the psychological status and life of the people. Highest quality drugs against the disease have side effects, including erectile dysfunction, therefore physicians continue to look for safe assets.

For the experiment, scientists from South Korea has invited nine women and 29 men of middle age who had suffered from androgenic alopecia. They were divided into two groups, representatives of one of them they rubbed my skin with the extract of stem cells, and the second placebo. Four months later, the experience of those volunteers, to whom was applied the protein to stem cells, the researchers found a significant increase in hair volume and diameter of follicles. Next, the researchers intend to perform a similar experiment with a larger number of respondents from different population groups.

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In South Korea the problem of hair loss solved with the help of stem cells of adipose tissue - The Times Hub

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Image: A scanning electron microscope image of SARS-CoV-2 (Photo courtesy of NIAID-RML)

The drug, interferon-lambda, is a manufactured form of a naturally occurring protein that has been given in previous clinical trials to more than 3,000 people infected with hepatitis viruses. Results in laboratory settings and in animals also suggest that lambda-interferon may be helpful in controlling viruses that cause respiratory illnesses such as influenza and SARS, an often fatal disease, as well as help snuff out other common viral infections. Interferon-lambda orchestrates the bodys natural defenses against infection by issuing a call in the troops order to constituent cells of the immune system. Receptors for interferon-lambda are restricted to the linings of the lungs, intestine and liver, thus producing fewer side effects.

The clinical trial is underway at Stanford Medicine will determine whether the drug can keep people who have just tested positive for the coronavirus out of the hospital, help them recover faster and make them safer to be around in the meantime. The researchers will also investigate whether the drug stems viral shedding, which would reduce transmission to family members and the community. The investigators are recruiting 120 participants who have just been diagnosed with cases of mild COVID-19 at Stanford Health Care and other local hospitals, emergency rooms, clinics and drive-through testing sites. Trial participants, randomly sorted into two groups, will be given single injections under the skin of either a placebo or interferon-lambda. Then they will be monitored for 28 days for symptoms, disease severity, rates of hospitalization, and duration and quantity of viral shedding.

Even though these individuals may not need hospitalization, infection with COVID-19 results in respiratory symptoms and lost productivity, said Upinder Singh, MD, professor of infectious diseases and of microbiology and immunology at the school, who is co-leading the study. Plus and this is important patients with mild disease contribute to community disease transmission. Limiting viral shedding from this group would reduce transmission to family members and others, which is crucial to controlling epidemic disease spread.

Related Links:Stanford Medicine

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Stanford Researchers Investigate New Drug that Can Treat Mild COVID-19 Cases and Stem Viral Shedding - HospiMedica

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I didnt have any mum friends to give me the heads up on this a few years ago, and I vowed to never let someone else walk into that battlefield unprepared.

I know poo talk isnt very graceful, but knowledge is power, and absolutely no one had given me the much-needed secret poo power prep talk.

So, heres yours, with all the learnings that made my second time around much more bearable.

LISTEN: We take a look at the final month of pregnancy, including what to pack in your hospital bag. Post continues after audio.

Soften those bad boys up with stool softeners. If you ignore them, theyll go away only works for door-knockers. The longer you leave these guys, the harder theyll knock. With each passing day, your poo will join forces and create a solid army. A rock-solid army of pain.

Pushing can be a scary feeling. Everything down there is vulnerable, and I was worried I might give birth to my entire uterus mid poo. I didnt (phew). I found the stool softeners helped with this and I didnt need to use so much scary force the second time round.

So to sum it up? Prunes and prune juice are your friends, drink loads of water, and dont be afraid to ask for laxatives if you need them.

Hold your fragile stitched (or unstitched) front if that makes you feel more comfortable and secure. It may still be an uncomfortable experience, but it doesnt have to feel like the ass apocalypse I experienced. NO ONE PREPARED ME FOR IT.

Dont be scared though, Id still do it all again for my kids. Just be prepared so you can crap like a queen on the porcelain throne.

If you didnt struggle with a post-birth poo, I have only one question How does it feel to be one of Gods favourites?

This post originially appeared on Living My Family Life and has been edited and republished with full permission.

Katie Bowman is a mum to a 4-year-old girl and two-year-old twin girls. A part-time hairdresser, she spends her time blogging about her days of chaos on her Facebook page,Living My Family Life.

Feature Image: Supplied.

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'I need to talk about the 'third birth' no one prepares you for: The post-baby poo.' - Mamamia

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MINNEAPOLIS & EL SEGUNDO, Calif.--(BUSINESS WIRE)--Be The Match BioTherapies, an organization offering solutions for companies developing and commercializing cell and gene therapies, and NantKwest (Nasdaq: NK), a next generation, clinical-stage immunotherapy company focused on harnessing the unique power of the immune system using natural killer (NK) cells to treat cancer and infectious diseases, today announced an agreement through which Be The Match BioTherapies is providing donor material for a NantKwest Phase 1b clinical trial to address acute respiratory distress syndrome (ARDS), one of the primary causes of COVID-19 deaths.

The agreement combines Be The Match BioTherapies ability to provide high-quality cellular source material from the worlds largest registry of volunteer donors with NantKwests capabilities in manufacturing off-the-shelf cell therapies. NantKwests allogeneic cell therapy is derived from human bone marrow and designed to treat the ARDS that results from severe COVID-19 cases. The therapy, called BM-Allo.MSC, uses mesenchymal stem cells (MSCs), multipotent progenitor cells known to have immunomodulatory properties, to reduce the lung inflammation associated with ARDS. Similar work in Europe with allogeneic MSC products in patients with COVID-19 and ARDS has demonstrated safety and efficacy in reducing inflammatory processes.

NantKwest recently announced FDA authorization of its investigational new drug (IND) application for BM-Allo.MSC and is moving rapidly to initiate a Phase 1b trial in patients with severe COVID-19. To expedite trial initiation, Be The Match BioTherapies is providing cryopreserved donor stem cell material from the Be The Match BioBank, a program of the National Marrow Donor Program/Be The Match. The accelerated access to material, combined with NantKwests scalable manufacturing processes, will allow for rapid distribution of BM-Allo.MSC to patients in need.

There is an immediate need for COVID-19 therapies across all stages of the disease, including for patients with ARDS, which is one of the most critical conditions caused by COVID-19, said Patrick Soon-Shiong, MD, Chairman and Chief Executive Officer of NantKwest. Thanks to the quality source material provided by Be The Match BioTherapies, we are prepared to rapidly scale manufacturing of this much-needed therapy, potentially saving numerous patients lives.

Through our teams unparalleled ability to identify, source and deliver high-quality donor material we have the opportunity to support the advancement of a cell therapy with potential to change the world. We are proud to partner with NantKwest to support our mission to save lives through cellular therapy and continue to make a difference for critically ill patients around the globe, said Chris McClain, Senior Vice President, Sales and New Business Development at Be The Match BioTherapies.

About Be The Match BioTherapies

Be The Match BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by the industry-leading experience of the National Marrow Donor Program (NMDP)/Be The Match, and a research partnership with the CIBMTR (Center for International Blood and Marrow Transplant Research), the organization designs solutions that advance the development of cell and gene therapies across the globe.

Be The Match BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the Be The Match Registry, the worlds largest and most diverse registry of more than 22 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies. Be The Match BioTherapies uses proven infrastructure consisting of regulatory compliance and managed logistics experts, as well as cell therapy supply chain case managers to successfully transport and deliver regulatory compliant life-saving therapies across the globe. Through the CIBMTR, Be The Match BioTherapies extends services beyond the cell therapy supply chain to include long-term follow-up tracking for the first two FDA-approved CAR-T therapies.

For more information, visit http://www.BeTheMatchBioTherapies.com or follow Be The Match BioTherapies on LinkedIn or Twitter at @BTMBioTherapies.

About NantKwest

NantKwest (Nasdaq: NK) is an innovative, clinical-stage immunotherapy company focused on harnessing the power of the innate immune system to treat cancer and virally-induced infectious diseases. NantKwest is the leading producer of clinical dose forms of off-the-shelf natural killer (NK) cell therapies. The activated NK cell platform is designed to destroy cancer and virally-infected cells. The safety of these optimized, activated NK cellsas well as their activity against a broad range of cancershas been tested in Phase I clinical trials in Canada and Europe, as well as in multiple Phase I and II clinical trials in the United States. By leveraging an integrated and extensive genomics and transcriptomics discovery and development engine, together with a pipeline of multiple, clinical-stage, immuno-oncology programs, NantKwests goal is to transform medicine by delivering living drugs-in-a-bag and bringing novel NK cell-based therapies to routine clinical care. NantKwest is a member of the NantWorks ecosystem of companies. For more information, please visit http://www.nantkwest.com.

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Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths - Business Wire

Bone Marrow Stem Cells Comments Off on Be The Match BioTherapies and NantKwest Announce Collaboration to Accelerate Development of Cell Therapy to Prevent COVID-19 Deaths – Business Wire | May 19th, 2020

Global Cell Therapy Technologies Marketwas valued US$ 12 billion in 2018 and is expected to reach US$ 35 billion by 2026, at CAGR of 12.14 %during forecast period.

The objective of the report is to present comprehensive assessment projections with a suitable set of assumptions and methodology. The report helps in understanding Global Cell Therapy Technologies Market dynamics, structure by identifying and analyzing the market segments and projecting the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, growth strategies, and regional presence. To understand the market dynamics and by region, the report has covered the PEST analysis by region and key economies across the globe, which are supposed to have an impact on market in forecast period. PORTERs analysis, and SVOR analysis of the market as well as detailed SWOT analysis of key players has been done to analyze their strategies. The report will to address all questions of shareholders to prioritize the efforts and investment in the near future to the emerging segment in the Global Cell Therapy Technologies Market.

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The report study has analyzed revenue impact of covid-19 pandemic on the sales revenue of market leaders, market followers and disrupters in the report and same is reflected in our analysis.

Global Cell Therapy Technologies Market: Overview

Cell therapy is a transplantation of live human cells to replace or repair damaged tissue and/or cells. With the help of new technologies, limitless imagination, and innovative products, many different types of cells may be used as part of a therapy or treatment for different types of diseases and conditions. Celltherapy technologies plays key role in the practice of medicine such as old fashioned bone marrow transplants is replaced by Hematopoietic stem cell transplantation, capacity of cells in drug discovery. Cell therapy overlap with different therapies like, gene therapy, tissue engineering, cancer vaccines, regenerative medicine, and drug delivery. Establishment of cell banking facilities and production, storage, and characterization of cells are increasing volumetric capabilities of the cell therapy market globally. Initiation of constructive guidelines for cell therapy manufacturing and proven effectiveness of products, these are primary growth stimulants of the market.

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Global Cell Therapy Technologies Market: Drivers and Restraints

The growth of cell therapy technologies market is highly driven by, increasing demand for clinical trials on oncology-oriented cell-based therapy, demand for advanced cell therapy instruments is increasing, owing to its affordability and sustainability, government and private organization , investing more funds in cell-based research therapy for life-style diseases such as diabetes, decrease in prices of stem cell therapies are leading to increased tendency of buyers towards cell therapy, existing companies are collaborating with research institute in order to best fit into regulatory model for cell therapies.Moreover, Healthcare practitioners uses stem cells obtained from bone marrow or blood for treatment of patients with cancer, blood disorders, and immune-related disorders and Development in cell banking facilities and resultant expansion of production, storage, and characterization of cells, these factors will drive the market of cell therapy technologies during forecast period.

On the other hand, the high cost of cell-based research and some ethical issue & legally controversial, are expected to hamper market growth of Cell Therapy Technologies during the forecast period

AJune 2016, there were around 351 companies across the U.S. that were engaged in advertising unauthorized stem cell treatments at their clinics. Such clinics boosted the revenue in this market.in August 2017, the U.S. FDA announced increased enforcement of regulations and oversight of clinics involved in practicing unapproved stem cell therapies. This might hamper the revenue generation during the forecast period; nevertheless, it will allow safe and effective use of stem cell therapies.

Global Cell Therapy Technologies Market: Segmentation Analysis

On the basis of product, the consumables segment had largest market share in 2018 and is expected to drive the cell therapy instruments market during forecast period at XX % CAGR owing to the huge demand for consumables in cell-based experiments and cancer research and increasing number of new product launches and consumables are essential for every step of cell processing. This is further expected to drive their adoption in the market. These factors will boost the market of Cell Therapy Technologies Market in upcoming years.

On the basis of process, the cell processing had largest market share in 2018 and is expected to grow at the highest CAGR during the forecast period owing to in cell processing stage,a use of cell therapy instruments and media at highest rate, mainly in culture media processing. This is a major factor will drive the market share during forecast period.

Global Cell Therapy Technologies Market: Regional Analysis

North America to held largest market share of the cell therapy technologies in 2018 and expected to grow at highest CAGR during forecast period owing to increasing R&D programs in the pharmaceutical and biotechnology industries. North America followed by Europe, Asia Pacific and Rest of the world (Row).Scope of Global Cell Therapy Technologies Market

Global Cell Therapy Technologies Market, by Product

Consumables Equipment Systems & SoftwareGlobal Cell Therapy Technologies Market, by Cell Type

Human Cells Animal CellsGlobal Cell Therapy Technologies Market, by Process Stages

Cell Processing Cell Preservation, Distribution, and Handling Process Monitoring and Quality ControlGlobal Cell Therapy Technologies Market, by End Users

Life Science Research Companies Research InstitutesGlobal Cell Therapy Technologies Market, by Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey players operating in the Global Cell Therapy Technologies Market

Beckman Coulter, Inc. Becton Dickinson and Company GE Healthcare Lonza Merck KGaA MiltenyiBiotec STEMCELL Technologies, Inc. Terumo BCT, Inc. Thermo Fisher Scientific, Inc. Sartorius AG

MAJOR TOC OF THE REPORT

Chapter One: Cell Therapy Technologies Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Cell Therapy Technologies Market Competition, by Players

Chapter Four: Global Cell Therapy Technologies Market Size by Regions

Chapter Five: North America Cell Therapy Technologies Revenue by Countries

Chapter Six: Europe Cell Therapy Technologies Revenue by Countries

Chapter Seven: Asia-Pacific Cell Therapy Technologies Revenue by Countries

Chapter Eight: South America Cell Therapy Technologies Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Cell Therapy Technologies by Countries

Chapter Ten: Global Cell Therapy Technologies Market Segment by Type

Chapter Eleven: Global Cell Therapy Technologies Market Segment by Application

Chapter Twelve: Global Cell Therapy Technologies Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Cell Therapy Technologies Market Report at:https://www.maximizemarketresearch.com/market-report/global-cell-therapy-technologies-market/31531/

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Global Cell Therapy Technologies Market : Industry Analysis and Forecast... - Azizsalon News

Bone Marrow Stem Cells Comments Off on Global Cell Therapy Technologies Market : Industry Analysis and Forecast… – Azizsalon News | May 19th, 2020

The study is anticipated to consist of approximately thirty patients with potential involvement of the NIH of Mexico in other CytoDyn trials

VANCOUVER, Washington, May 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe/critical COVID-19 population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn is also enrolling a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population later in the week.

We look forward to evaluating leronlimab as a treatment option for patients of COVID-19. We have seen the devastation of this disease on the citizens of Mexico and are looking forward to providing effective treatment options to mitigate the devastation of COVID-19, said Dr. Gustavo Reyes Tern, head of the Coordinating Commission of National Institutes of Health and High Specialty Hospitals of Mexico, an organization that coordinates the main institutions of medical care and public research in the country.

The NIH of Mexico is committed to help alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people and the contagious nature of COVID-19 is relentless. We look forward to working with the NIH of Mexico to rapidly commence with the proposed study. We also believe that this study results, along with the ongoing Phase 2 study, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients, said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19...

Bone Marrow Stem Cells Comments Off on CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19… | May 19th, 2020

Despite many breakthroughs in cardiovascular treatment, heart attacks and heart failure still pose a very large threat to the American population. The largest challenge in patients who have had a cardiac complication is the restoration of function to the damaged heart. Since damaged heart tissue is very difficult for the body to replace, physicians are continually looking for new methods of treating the heart.

Regenerative treatment through the use of stem cells is showing a large amount of potential at not only helping reverse the resulting damage of a cardiac attack, but in actually re-growing the damaged tissue in order to restore function.

To understand what stem cells can potentially do for the heart, it is important to first understand the different heart cells that can be damaged in a cardiac event. Destruction of the heart muscle cells, called cardiomyocytes, is the primary cause behind loss of function in a damaged heart. These cells are the muscle behind heart contraction, which sends blood to the rest of the body.

Secondly, vascular endothelial cells (inner lining of blood vessels) and smooth muscle cells (outer lining of blood vessels) each play an important role in the formation of new arteries. These serve to draw nutrients and oxygen to the remaining cardiomyocytes following heart damage, directly influencing the capabilities of a damaged heart.

Numerous studies are being conducted into the purposing of stem cells this manner, with one study providing evidence that bone marrow stem cells were able to develop into the required myocardial cells in mice. The ability to develop human hematopoietic stem cells for heart muscle is already documented technique, with the method of application into humans and the results of implantation still under study.

The research currently being performed on stem cells for cardiac treatment is focused on developing known stem cell traits into a working cure for cardiac complications. The current hurdles researchers face include how to best expand stem cells injected into the heart, how to best deliver the cells, and how to discover new niches (groupings) of stem cells in the body.

Delivery: Current methods of delivery include generic IV injection, which is minimally invasive with varying degrees of success. The most dependable method is to have direct injection into the heart, which requires surgery for visualization. Complications may include potentially clogging the arteries with the introduced stem cells and the invasiveness of the surgery.

Expanding Stem Cells: The majority of transplanted stem cells fail to reach the area of damage. It is crucial for a physician to be able to accurately deliver a large amount of stem cells to offer the patient the best treatment. Methods of better stem cell isolation, identification, and expansion into tissue are currently being developed.

Physician First Choice offers stem cell therapy for cardiac disease. The clinic has multiple stem cell doctors with extensive experience in stem cell therapy for numerous conditions. The stem cell clinic sees patients from all over California and the country, providing both IV stem cell therapy and injections into arthritic joints and areas with tendonitis and ligament injury.

Call (888) 988-0515 for more information and scheduling today!

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cardiac disease and stem cells | Stem Cell Treatment in ...

Cardiac Stem Cells Comments Off on cardiac disease and stem cells | Stem Cell Treatment in … | May 18th, 2020

Coronavirus health scams are rampant, with businesses taking advantage of peoples fears to sell all sorts of unproven products for the prevention and treatment of COVID-19. Some of these snake oil cures are innocuous, such as elderberry juice, but others can be harmful, such as colloidal silver.

Among the products with considerable potential for harm are unproven stem cell therapies. Unfortunately, the emergence of this particular line of sham COVID-19 treatments isnt all that surprising. For more than a decade, businesses have been aggressively pitching unsubstantiated and unlicensed stem cell products to vulnerable and often desperate individuals with illnesses or injuries for which no known treatment exists, such as Alzheimers disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD) and spinal cord injuries. The results have sometimes been deadly.

There are some medical conditions for which stem cell therapies have been shown to be safe and effective, but they are few in number mostly cancer and several blood and immune disorders.

Leigh Turner, a bioethicist at the University of Minnesota, has been investigating the direct-to-consumer marketing of spurious stem cell therapies and related exosome products in the United States for nearly a decade. In an article published recently in the journal Cell Stem Cell, Leigh describes the latest twist in this cynical saga: how some stem cell businesses are seizing the [COVID-19] pandemic as an opportunity to profit from hope and desperation.

MinnPost spoke with Turner late last week about what he found when researching that paper. The following is an edited transcript of the interview.

MinnPost: Companies seem to be using the same kind of marketing strategies to sell unproven stem cell therapies for COVID-19 as they have for other medical conditions.

Leigh Turner: Yes. These are opportunistic businesses. They look for marketplace opportunities, ways to generate e-revenue streams. And the COVID-19 pandemic is another business opportunity. Its not like theyve pivoted away from what they did in the past. If they were marketing stem cell treatments for Parkinsons disease, or ALS or spinal injuries, they havent stopped doing that. Theyve just added that theyve now got a stem cell treatment or an exosome therapy to treat or prevent COVID-19.

MP: They seem to be marketing their products primary as immune system boosters.

Leigh Turner

MP: At least one company is telling people that they should bank their stem cells to use as a treament if they get infected with the coronavirus.

LT: There are several business models at play right now. One is, come on in and get your stem cell immune booster to reduce your chances of getting COVID-19. They may also claim it will reduce your symptoms should you get it. Another marketing pitch is a bit more cautious. It says that if you come in now when youre in good health, they will bank your cells. Youll pay for the initial extraction of cells and also monthly or yearly for banking. The company then claims that should you fall ill with COVID-19 down the road, youll have those healthy cells available for you to use. Of course, they dont offer a lot of detail about how the cells would actually help you. You just supposed to take it for granted that they will.

MP: Theres no evidence of that.

LT: No. Its all just pseudoscience. But there is a meaningful hypothesis behind it. Thats how these businesses operate by fusing science with pseudoscience, credible research with junk claims.

MP: What is that hypothesis?

LT: There are companies and academic institutions right now that are interested in testing stem cell products, but not as immune boosters, not to prevent COVID-19 and not to eliminate the virus if someone gets infected. The studies right now are focusing on a very particular population of people with COVID-19 those who are typically in ICUs, suffering from acute respiratory distress syndrome. The hypothesis is that if certain types of stem cell products are administered to those people, we may be able to reduce inflammation in the lungs and help shorten the illness. But its a hypothesis.

MP: A good one?

LT: Its not an outrageous hypothesis. If you look at the existing literature, there have been studies done in the past that used stem cells for lung and respiratory disease. So far, those studies suggest that if you use clinical-grade stem cells and if you do it in a very rigorous way the safety profile is pretty good. But none of those studies has established extensive evidence of efficacy yet. Ideally, what you want is carefully designed, carefully conducted clinical trials testing that hypothesis and generating that evidence. These businesses the ones marketing stem cell therapies directly to individuals are not part of that scientific world.

MP: How do those businesses pull their customers in? How do they find them?

LT: They are typically big on social media. Im talking generally here, but they have Twitter accounts. They have YouTube channels. They have a Facebook page. Theyre not just putting up a website and hoping that somebody walks in the door. They hire social media marketing companies. They use marketing firms. They have pretty sophisticated marketing strategies that are tailored to particular demographics. It may be that they are targeting an elderly population, for example, because if youre interested in reaching people with COPD, youre not going to be trying to find 18-year-olds. Some businesses here in Minneapolis and elsewhere will have what they describe as educational seminars, which are basically infomercials. They are marketing events. They will try to get people to come to a convention center, a hotel [conference] room or a restaurant. Everything is free, but what theyll do is use hard-sell sales tactics to get people to commit, to write a check. Often theyll tell people that if they sign on today, theyll knock $2,000 or so off the price. But, of course, theyre not holding these events right now. They cant have these public gatherings.

MP: So, how are they selling people these products now, during the pandemic?

LT: More of it is happening online. One company, for example, uses a graduated pricing model. If its one person, its one price point. If its you and a family member, you both get a break on the procedure. And if its you and two additional family members, the price goes down even more. They use these things to try to get people to come in the door. One company in California has adapted to the pandemic in a different way. They have a do-it-yourself model. You dont have to even come into the clinic. You can buy their kit, and they ship it to your home. You then do the procedure at your dining room table.

MP: These stem cell products and treatments are quite expensive.

LT: Yes, some of the businesses Ive look at charge tens of thousands of dollars, although thats not necessarily for treating COVID-19. For COVID-19, it appears to be in the thousands-of-dollars category. In some cases, we dont know. The businesses can be pretty cagey. In some cases, they try to size up the customer and figure out how much they can extract from that person.

MP: Government agencies are cracking down on some of these stem cell businesses.

LT: The FDA (Food and Drug Administration), FTC (Federal Trade Commission) and Department of Justice have said that theyre going to be aggressive with dealing with these scams. And they have. Some businesses have already received letters from the regulators. That may be having a deterrent effect during the pandemic. Some businesses may want to jump in, but are afraid to do so. They may be waiting to see what happens before they take the chance.

MP: But the regulatory agencies are obviously not finding all of the businesses marketing unproven COVID-19 therapies.

LT: There is a lot of marketing fraud. And sometimes its quite challenging to figure out whats going on. Some of the clinics that I looked at didnt say, Were offering an immune booster for COVID-19. It was more just chatter. Clinics would put up a seven-minute video from one of their doctors about COVID-19 and emerging stem-cell research coming out of China, saying it was really encouraging. Then they would say, If you have any questions about stem cells and COVID-19, give us a call. So, whats the takeaway when a business does that? Does that mean they are selling stem cell treatments for COVID-19? Or are they just trying to get people to call? Its hard to know whats happening. If I had to guess, I say its a workaround. The businesses dont want to put it on their website, because thats too easy for someone from the FTC or the FDA to find. If they just put up a video, they can say theyre not marketing anything, that it was just meant to be educational.

MP: These businesses seem to rely on anecdotal cases or really small studies from China to support their claims.

LT: They use China in a couple of different ways. There was a case report, for example, that was published as a preprint. It wasnt published by a journal. It hasnt gone through peer review. It was just a preprint that someone put online. Its the case of a single individual with COVID-19 who received stem cells. Thats been written up in a very hyperbolic way, when really, its just a case report. Its one person. Some people get COVID-19 and recover anyway. You cant draw any conclusions from it about stem cells being efficacious, but its been written up that way. There was another study, very preliminary research, in which mesenchymal stem cells were administered to seven individuals with COVID-19 with various degrees of severity. A placebo was given to three individuals. The article doesnt provide the source of the stem cells. Nor does it provide much insight about the individuals who were given placebos, although they appear to be about 10 years older than [those receiving the stem cells]. It raises some interesting questions. It provides a basis for further research. But, unfortunately, some of the news media reports have been hyperbolic. Stem cell businesses use both these papers when marketing directly to consumers. They refer to these studies, and they also attach themselves to the bubbly media coverage.

MP: Consumers need to know that these products can be dangerous.

LT: Yes. The danger comes in several forms. Part of it is that these are financial scams lifting money off people who are worried and anxious. But, also, giving someone a product that hasnt been carefully tested in well-designed clinical trials raises a lot of concerns. Some businesses have released contaminated stem cell products into the marketplace. People end up getting infections and having to be hospitalized. It can be a very serious thing. Theres also the possibility that the wrong type of cell goes to the wrong part of the body and causes harm. When a company claims, for example, that a stem cell product will regenerate lung tissue and be an immune booster, one thing I would worry about is pulmonary embolisms. If someone is being given something that hasnt been thoroughly tested, its hard to know what would go wrong, but its easy to know something could go wrong.

FMI: Youll find the article on Cell Stem Cells website.

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Unproven stem cell products are being peddled as COVID-19 'therapies,' U of M researcher reports - MinnPost

Spinal Cord Stem Cells Comments Off on Unproven stem cell products are being peddled as COVID-19 ‘therapies,’ U of M researcher reports – MinnPost | May 18th, 2020