GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTC:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

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Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Benzinga

Bone Marrow Stem Cells Comments Off on Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations – Benzinga | March 26th, 2020

Rita de Brn gathers 20 of the best innovations that will make life better for all of us.

IF ever hope was needed, its now, during the coronavirus outbreak.

Cocooning, self-isolation, and lock-down are not conducive to positive thinking.

Nor are pandemics. But we can choose to focus our thoughts elsewhere.

Every day, universities and laboratories across the globe announce heartening observations, discoveries, breakthroughs, and cures that will save and enrich life on this planet.

Scientists havent yet succeeded in creating an invisible woman.

But whenever they do, her cloak may be waiting at the University of Rochester.

There, researchers can make objects disappear from view by strategically placing light beams to create a blind spot between them.

Compounds that can kill malaria parasites have been developed by Australian and US researchers.

Drugs based on these compounds should shortly enter phase one of clinical trials.

The birth, this year, of a baby born from eggs matured and frozen in a laboratory was a happy event that gives hope to women made infertile by chemotherapy.

The mother had treatment for breast cancer five years previously.

Researchers at Imperial College London have developed a wearable sensor that can track and monitor vital signs through fur and clothing.

The device will help sniffer dogs in their work, and monitor the health of companion animals.

University of Canterbury scientists are studying the brain networks that produce speech.

The research should benefit everyone who has a stutter or other speech disorder.

Esketamine has recently been licenced in the UK for use in the treatment of depression. The drugs antidepressant impact can take effect within hours.

Academic studies have long shown that dark night skies are crucial for plant life, wildlife, and human mental health.

Growing awareness of this has led to the Polynesian island of Niue becoming the worlds first dark-sky nation.

Washington University scientists have cured type 1 diabetes in mice, using pluripotent stem cells to efficiently create insulin-producing beta cells.

Their success brings hope of a cure one step closer for the 422m people the World Health Organisation estimates have the condition.

Videos from the European Space Agency and satellite images from NASA show air pollution clearing dramatically over Italy and China.

Economic slowdown, due to the COVID-19 outbreak, is thought to play a role.

A massive reduction in tourists to the Italian city, in recent weeks, has sharply reduced boat and cruise ship traffic.

As a result, the canal water is much cleaner, with swimming fish clearly visible, a phenomenon that has not been witnessed for decades.

Scientists have developed contact lenses that correct deuteranomaly, which is reduced sensitivity to green light.

Colour blindness affects approximately six percent of males.

The condition can make it difficult to recognise an unripe banana by its colour.

The FDA has recently approved Romosozumab, a drug that combines the benefits of earlier osteoporosis treatment drugs, while building more bone than was previously possible and helping prevent fractures.

The prospect of a single-dose vaccine, which offers long-lasting protection against multiple strains of influenza, is closer than ever.

The FDA has approved Aimmune Therapeutics peanut allergen powder.

The new immunotherapy is now being administered in US medical centres to youngsters aged between 4 and 17 years who are presenting with peanut allergies.

Making hydrogen fuel a commercially viable option in the energy market has proved elusive.

But the discovery by Tokyo-based scientists that Fe-OOH, a form of rust, is an efficient catalyst in the process, is viewed by environmentalists to be game-changing.

By combining water with plant-based cellulose nanocrystals, scientists have created a powerful, non-toxic adhesive.

Spinal-cord stimulation is a common treatment for chronic back and leg pain, outcomes for which are often disappointing.

A recent innovation, in the form of a closed-loop, spinal-cord stimulation system, delivers superior pain relief for up to 12 months after implant.

For the first time, mitral heart valves have been repaired in beating-heart surgery.

While the patient in this procedure was a dog, the surgical victory augurs well for humans aged 75 and over, roughly ten percent of whom have faulty mitral valves.

The lives of ten COVID-19 patients were recently saved in Italy,when 3D printers were successfully used to create breathing-valve spare parts for respirators.

Airbus is now taking bookings for low-Earth orbit payload slots on the International Space Stations new Bartolomeo platform.

It offers the ISSs only unobstructed view towards Earth and into outer space.

The mission is devoted to addressing sustainable development goals.

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The science of hope: Why tomorrows world will be better than todays - Irish Examiner

Spinal Cord Stem Cells Comments Off on The science of hope: Why tomorrows world will be better than todays – Irish Examiner | March 26th, 2020

Early research published in Mayo Clinic Proceedings examines the first case at Mayo Clinic of stem cell therapy tested in humans for spinal cord injury. The case study found stem cell intervention, which took place after standard surgery, and physical and occupational therapy, restored some function in a patient with spinal cord injury. The report, "Celltop Clinical Trial: First Report From a Phase I Trial of Autologous Adipose-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury" is published in the Nov. 27, 2019 edition of Mayo Clinic Proceedings.

The research discusses the experience related to the first case in a phase I safety study of mesenchymal stem cell treatment for spinal cord injury. Mohamad Bydon, M.D., a Mayo Clinic neurologic surgeon and the lead author, cautions that each patient is different, so it's too early to consider stem cell therapies as a treatment or cure for paralysis from spinal cord injury. Dr. Bydon adds that much like early trials in general, the stem cell trials are going to show variable response rates.

"Whilein this case, the first subject was a superresponder, others may not respond inthe same manner. We do not yet understand all of the necessary biology neededto achieve neurological recovery in paralyzed individuals," says Dr.Bydon. "One of our objectives in this study and future studies is tobetter delineate who will be a responder and why patients respond differently."

The research

The research centers on a 53-year-old man who suffered a spinal cord injury in a surfing accident that left him paralyzed below the neck. The patient had immediate improvements with standard therapy, but plateaued at six months post-injury. Researchers enrolled the patient in the study at Mayo Clinic nine months after the accident and injected the patient with stem cells 11 months after injury. After the stem cell injection, the patient significantly improved motor and sensory function.

Thecase study focuses on feasibility, safety and dosing of stem cell therapy. Thestudy team derived mesenchymal stem cells from the patient's fat cells andinjected them into the lower back in a procedure known as lumbar puncture.

Dr.Bydon; Wenchun Qu,M.D., Ph.D.,a physical medicine and rehabilitation physician; and Allan Dietz,Ph.D.,a transfusion medicine physician, led the multidisciplinary research team atMayo Clinic.

"Severespinal cord injury is a devastating condition for which scientists andphysicians are trying to find a cure. For the first time, we are inspiring hopethat people may receive better recovery in their function and quality of life,"says Dr. Qu. "Mayo Clinic has been taking the lead in translating thefruits of decades of research and treating neurological conditions, among whichhave been very important clinical trials where we evaluate the safety,feasibility and efficacy of adult stem cells for severe spinal cord injuries."

"This work both demonstrates the ability of cells to initiate repair and capitalizes on more than 10 years of work in the Immune, Progenitor and Cell Therapeutics Lab at Mayo Clinic. While there is still much to learn about the amazing ability of cells to heal tissue, this trial is an important step in advancing cell-based therapies toward clinical practice," says Dr. Dietz.

Investigatorscollected cerebrospinal fluid to look for new biological markers that mightgive clues to healing. Biological markers are important because they can helpidentify the critical processes that lead to spinal cord injury at a cellularlevel and could lead to new regenerative therapies.

Furtherstudy is needed to understand the effectiveness of stem cell lumbar injectionsand why patients may respond differently.

Currently,there is no way to reverse the devastating life-changing effects of paralysisfrom spinal cord injuries. Today, the only treatment is supportive care, suchas surgery and physical and occupational therapy.

Dr.Bydon says his early findings give hope that new regenerative therapies are onthe horizon for spinal cord injuries.

"Thehope is that we will have novel treatments for spinal cord injuries in the comingyears that will be different from what we have today. These will be therapies thatdo not rely upon supportive care, but therapies that rely on science to createa regenerative process for the spinal cord," says Dr. Bydon.

This research was made possible by funding from Mayo Clinic Transform the Practice Initiative and Regenerative Medicine Minnesota with support from the Mayo Clinic Center for Regenerative Medicine and the Department of Laboratory Medicine and Pathology Immune, Progenitor and Cell Therapeutics lab. The Transform the Practice Initiative aims to foster multidisciplinary teams of clinicians and researchers who align discovery and translational science, create new capacities and achieve solutions that improve the practice and address the unmet needs of patients.

###

Read the news release

Tags: #Mayo Clinic Proceedings, #Spinal cord injury research, #stem cell lumbar puncture, #stem cell research, Dr. Allan Dietz, Dr. Mohamad Bydon, Dr. Wenchun Qu, Mayo Clinic Center for Regenerative Medicine, Regenerative Medicine Minnesota, Research, spinal cord injury

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Mayo Clinic research is a step toward hope for spinal cord ...

Spinal Cord Stem Cells Comments Off on Mayo Clinic research is a step toward hope for spinal cord … | March 25th, 2020

The positioning of the Global Cell Isolation/Cell Separation Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Isolation/Cell Separation Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872137/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Isolation/Cell Separation Market including are Beckman Coulter Inc. (Subsidiary of Danaher Corporation), Becton, Dickinson and Company, Merck KGaA, Terumo Bct, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., GE Healthcare, Miltenyi Biotec, Pluriselect Life Science Ug (Haftungsbeschrnkt) & Co. Kg, and Stemcell Technologies, Inc..

On the basis of Product, the Global Cell Isolation/Cell Separation Market is studied across Consumables and Instruments.

On the basis of Cell Type, the Global Cell Isolation/Cell Separation Market is studied across Animal Cells and Human Cells.

On the basis of Cell Source, the Global Cell Isolation/Cell Separation Market is studied across Adipose Tissue, Bone Marrow, and Cord Blood/Embryonic Stem Cells.

On the basis of Technique, the Global Cell Isolation/Cell Separation Market is studied across Centrifugation-Based Cell Isolation, Filtration-Based Cell Isolation, and Surface Marker-Based Cell Isolation.

On the basis of Application, the Global Cell Isolation/Cell Separation Market is studied across Biomolecule Isolation, Cancer Research, In Vitro Diagnostics, Stem Cell Research, and Tissue Regeneration & Regenerative Medicine.

On the basis of End User, the Global Cell Isolation/Cell Separation Market is studied across Biotechnology & Biopharmaceutical Companies, Hospitals & Diagnostic Laboratories, and Research Laboratories & Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Isolation/Cell Separation Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Isolation/Cell Separation Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Isolation/Cell Separation Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Isolation/Cell Separation Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Isolation/Cell Separation Market

The report answers questions such as:1. What is the market size of Cell Isolation/Cell Separation market in the Global?2. What are the factors that affect the growth in the Global Cell Isolation/Cell Separation Market over the forecast period?3. What is the competitive position in the Global Cell Isolation/Cell Separation Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Isolation/Cell Separation Market?5. What are the opportunities in the Global Cell Isolation/Cell Separation Market?6. What are the modes of entering the Global Cell Isolation/Cell Separation Market?Read the full report: https://www.reportlinker.com/p05872137/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

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The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at...

Bone Marrow Stem Cells Comments Off on The Global Cell Isolation/Cell Separation Market is expected to grow from USD 5,721.23 Million in 2018 to USD 15,089.25 Million by the end of 2025 at… | March 25th, 2020

In severe cases, it can also cause deadly hardening of internal organs like the lungs

MADISON, Wis. A year ago, Chuck Beschta couldn't walk more than a few minutes without stopping to rest.

"Just going out and doing normal activities outside raking the lawn mowing the grass shoveling the driveway whatever;snow blowing, those became impossible."

After months of testing he was diagnosed with severe scleroderma, which was hardening his skin but even worse. it was hardening his lungs, making it hard to breathe.

Scleroderma is an autoimmune rheumatic disease where an overproduction of collagen produced in the body tissues.

But in severe cases, it can also cause deadly hardening of internal organs like the lungs, giving some patients little hope of surviving.

Chuck's case was getting more dire.

"He was getting worse despite the best therapy we had to offer," explained Dr. Kevin McKown, a rheumatologist at the University of Wisconsin Hospital in Madison

Dr. McKown recommended a stem cell transplant newly approved for scleroderma to reboot chucks immune system.

"There's a process by which they try to remove the autoreactive immune cells, the cells that are caught in the immune process and then they infuse that back in and hope that the body will basically take up and graft that immune system

Rheumatologists at University of Wisconsin Health tested the treatment since they have already been conducting bone marrow transplants for decades.

Surgeons take out a sample of the patient's bone marrow, isolate the stem cells, and use radiation and chemotherapy to clean out their immune system. The same stem cells are later injected back into the patient's immune system with the hope that new cells will grow and the system is rid of the bad ones.

The process is dangerous when the cells are taken out because the patient's immune system is more vulnerable, making infections more likely to occur.

Chuck saw almost immediate results. His skin was softer and his breathing improved.

He hopes his scleroderma has been cured.

"I think we can be optimistic and so far the people who have been followed out as far as 10 years out don't seem to be getting it back," said Dr. McKown.

After four and a half years, 79% of patients who underwent the treatment were alive without serious complications compared to 50% that were treated with the original drugs.

Without a transplant, less than half the patients, like Chuck, who have diffuse scleroderma and severe lung disease live 10 years past diagnosis. stem cell transplants are commonly used to treat leukemia and lymphoma, cancers that affect the blood and lymphatic system.

If this story has impacted your life or prompted you or someone you know to seek or change treatments, please let us know by contacting Jim Mertens atjim.mertens@wqad.comor Marjorie Bekaert Thomas atmthomas@ivanhoe.com.

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YOUR HEALTH: A rare disease that hardens the skin - WQAD.com

Skin Stem Cells Comments Off on YOUR HEALTH: A rare disease that hardens the skin – WQAD.com | March 25th, 2020

The global autologous cell therapy market is poised to grow by USD 1.97 billion during 2020-2024, progressing at a CAGR of almost 22% during the forecast period. Request free sample pages

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200323005764/en/

Technavio has published a latest market research report titled Global Autologous Cell Therapy Market 2020-2024 (Graphic: Business Wire)

Read the 120-page report with TOC on "Autologous Cell Therapy Market Analysis Report by Therapy (Autologous stem cell therapy and Autologous cellular immunotherapies), Application (Oncology, Musculoskeletal disorders, and Dermatology), Geography (North America, APAC, Europe, South America, and MEA), and the Segment Forecasts, 2020-2024".

https://www.technavio.com/report/autologous-cell-therapy-market-industry-analysis

The market is driven by the increasing demand for effective drugs for cardiac and degenerative disorders. In addition, the limitations in traditional organ transplantations are fueling the demand for stem cell therapies. All these factors are anticipated to boost the growth of the autologous cell therapy market.

The demand for effective drugs for cardiac and degenerative disorders has been increasing across the world. In addition, the discovery of possible cardiac autologous cells has enabled vendors to develop novel drugs for the treatment of various cardiac diseases. For instance, Mesoblast is developing MPC-150-IM. It is a Phase III candidate for the treatment of advanced and end-stage chronic heart failure. Similarly, Shire has been developing autologous stem cell therapies for chronic myocardial ischemia. These products are expected to be launched during the forecast period and will have a positive impact on the growth of the global autologous cell therapy market.

Buy 1 Technavio report and get the second for 50% off. Buy 2 Technavio reports and get the third for free.

View market snapshot before purchasing

Major Five Autologous Cell Therapy Market Companies:

Bayer AG

Bayer AG operates its business through segments such as Pharmaceuticals, Crop Science, Consumer Health, and Animal Health. The company offers induced pluripotent stem cells. They are developed by reprogramming mature body cells to behave like embryonic stem cells that are injected to restore diseased tissue in patients.

Brainstorm Cell Therapeutics Inc.

Brainstorm Cell Therapeutics Inc. operates its business through an unified business segment. NurOwn is the key offering of the company. It is a cell therapy platform, which develops mesenchymal stem cells for the treatment of human diseases such as immune and inflammatory diseases.

Daiichi Sankyo Co. Ltd.

Daiichi Sankyo Co. Ltd. operates its business through segments such as Innovative Pharmaceuticals, Generic, Vaccine, and OTC Related. Heartcel is the key offering of the company. It is an immune-modulatory progenitor cell therapeutic agent, which is used for ischemic heart failure.

FUJIFILM Holdings Corp.

FUJIFILM Holdings Corp. operates its business through segments such as Imaging solutions, Healthcare and material solutions, and Document solutions. The company uses induced pluripotent stem cells to derive differentiated cells, which are used in researching various diseases and conditions.

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Holostem Terapie Avanzate Srl

Holostem Terapie Avanzate Srl operates its business through an unified business segment. Holoclar is the key offering of the company. It is an advanced therapy medicinal product containing stem cells indicated to repair the cornea after injury.

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Autologous Cell Therapy Market Therapy Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Application Outlook (Revenue, USD Billion, 2020-2024)

Autologous Cell Therapy Market Regional Outlook (Revenue, USD Billion, 2020-2024)

Technavios sample reports are free of charge and contain multiple sections of the report, such as the market size and forecast, drivers, challenges, trends, and more.

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Related Reports on Healthcare Include:

Global Cancer Stem Cell Therapeutics Market Global cancer stem cell therapy market by type (allogeneic stem cell transplant and autologous stem cell transplant) and geography (Asia, Europe, North America, and ROW).

Global Mantle Cell Lymphoma Therapeutics Market Global mantle cell lymphoma therapeutics market by product (combination therapy and monotherapy) and geography (Asia, Europe, North America, and ROW).

About Technavio

Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.

With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200323005764/en/

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Technavio ResearchJesse MaidaMedia & Marketing ExecutiveUS: +1 844 364 1100UK: +44 203 893 3200Email: media@technavio.com Website: http://www.technavio.com/

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Global Autologous Cell Therapy Market 2020-2024 | Evolving Opportunities with Bayer AG and Brainstorm Cell Therapeutics Inc. | Technavio - Yahoo...

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LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

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SOURCE Partner Therapeutics, Inc.

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Cardiac Stem Cells Comments Off on Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – P&T… | March 25th, 2020

California: In a breakthrough study, researchers have found a potential treatment for life-threatening cardiac diseases by using gene therapy.

Danon disease is a very rare, life-threatening condition where the fundamental biological process of removing and recycling proteins does not work.

This impairment results in dysfunction of the heart, skeletal muscle, neurologic system, eyes, and liver. Most patients die or require heart transplants by the third decade of life.

In the study, which was published in Science Translational Medicine, researchers have identified a novel way to treat Danon disease using gene therapy.

Heart transplant is not always available for patients and does not treat the other organs affected in Danon disease. We knew we needed to find therapies specifically designed to address the underlying cause, said the lead researcher Eric Adler.

Danon disease is a result of mutations in the gene LAMP2. For nearly a decade, Adler and a team of researchers at UC San Diego Health have been working to determine whether gene therapy could provide a new treatment approach.

Gene therapy involves either replacing or repairing a gene that causes a medical problem or adding genes to help the body treat disease. In this case, Adler and the team focused on adding a specially designed gene that restores the LAMP2 function, resulting in improved cardiac and liver function.

We utilised mice that were a model for Danon disease and missing this specific LAMP gene. We applied gene therapy to a group of these mice and compared to mice that did not receive treatment, said Adler.

The mice that received gene therapy expressed positive results in heart, liver and muscle function. The hearts overall function of ejecting blood and relaxing improved, as did the bodys ability to degrade proteins and metabolism.

Danon disease is more common in males, and symptoms begin in early childhood or adolescence.

In many cases, the condition is inherited by a parent, typically the mother. We believe Danon disease is actually more common than we think, but it is often misdiagnosed, said Adler.

By utilising gene therapy, we were able to identify a possible new treatment approach other than a heart transplant. This study is a significant step for patients with Danon disease, Adler added.

Prior studies in Adlers lab have focused on using a patients skin cells to create stem cells. These stem cells were used to create a heart model, allowing researchers to study Danon disease at the cellular level.

The approach has provided new insight into the diseases pathology and led to the idea of using gene therapy. Our work is also proof that using stem cells to model diseases has great potential for helping develop new medicines, said Adler.

The next step, said Adler, is testing in patients with Danon disease. A Phase I clinical trial for safety and efficacy has begun.

This is the first trial using gene therapy to treat a genetic cardiac disorder and three patients are currently being treated, which means were that much closer to finding a cure for this terrible disease, and may be able to use similar methods to treat other diseases, said Adler.

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Study reveals gene therapy may help in treating cardiac disease - The Siasat Daily

Cardiac Stem Cells Comments Off on Study reveals gene therapy may help in treating cardiac disease – The Siasat Daily | March 24th, 2020

Veterans in Pain (VIP) is a national program for veterans who have been hurt severely in combat. Their mission is facilitating regenerative medical solutions for veterans suffering from chronic pain by connecting civilian physicians with our countrys heroes, nationwide.

Dr. Joseph Kanan and his medical staff at Tullahoma Chiropractic Center recently joined the program and performed their first pro bono procedure for a veteran named Ryan in February.

Ryan had severe right hip pain when he came in. My medical team and I gave him a $6,500 procedure, injecting stem cells into his hip, Kanan said. There is no insurance company that covers this procedure so either he would have had to pay for it himself or the VIP organization would have had to do it. We decided to do it for free.

Veteran Ryan, 36, thanks Dr. Kanan after his procedure at Tullahoma Chiropractic Center.

Stem cells are part of the bodys natural repair process. Humans have them in their bone marrow and fat cells. When they are placed at the site of damaged tissue, these stem cells can activate to become the healthy new cells the body needs for pain relief.

No-surgery stem cell therapy helps the body heal damage and relieve pain from arthritis, aging and injuries to joints, tendons, ligaments and muscles.

I think veterans do a lot for our country and there are very few doctors that are performing medical procedures like this, Kanan said. We were very glad to be able to do this for him.

Ryan, 36, lives three hours away. He drove to Tullahoma himself for the procedure. Veterans in Pain provided the funds for his hotel stay while he was in town.

The procedure was done on Feb. 13. He did feel better right after, but this is a procedure where the results take time. You experience 10 percent of improvement every month for 10 months, Kanan said. I own the clinic and I am a chiropractor, so I did not actually perform this procedure. My medical team Jana Wood and Dr. Frank Perry performed the procedure, which was giving injections into Ryans hip.

Tullahoma Chiropractic Center performs these scheduled procedures twice a month. The medical team has seen positive results from the injections, according to Kanan.

I just talked to a patient this morning that had the procedure done one year ago. He had doctors recommending a knee replacement on his left knee. My medical team conducted the stem cell procedure on his knee, Kanan said.

The experience was great. I came in and got the injection and now my knee is fluid. About three months after the injection, I felt a lot better, the patient said. It was much better than having a knee replacement. I am very passionate about golf and my knee was preventing me from doing what I loved. After a year, it is magnitudes better than it was one year ago.

Tullahoma Chiropractic Center is located at 1490 N. Jackson St.

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VANCOUVER, Washington, March 23, 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, announced today that the third and fourth coronavirus patients were treated with the Companys investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the cytokine storm that leads to morbidity and mortality in these patients.

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can.

About Coronavirus Disease 2019SARS-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 it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted 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. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. At this time, there are very limited treatment options for COVID-19.

About Leronlimab (PRO 140) The 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 successfully 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 can 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.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis. 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 a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additional clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important 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 further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain 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 CytoDyn CytoDyn is a 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 key 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 in 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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, 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 with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining 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 at http://www.cytodyn.com.

Forward-Looking Statements This press release contains 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. 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 Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-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, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn's Leronlimab, Bringing the Total to Four Patients - Associated...

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LEXINGTON, Mass., March 24, 2020 /PRNewswire/ --Partner Therapeutics, Inc. (PTx) announced that Leukine (sargramostim, rhu-GM-CSF)is being assessed in the SARPAC trial (sargramostim inpatients withacute hypoxic respiratory failure due toCOVID-19 EudraCT #2020-001254-22) at University Hospital Ghent to treat patients with respiratory illness associated with COVID-19. Major medical centers in Germany, Italy and Spain are considering joining the study. The study will evaluate the effect of Leukine on lung function and patient outcomes.

"Patients with COVID-19 who progress to acute hypoxic respiratory failure due to COVID-19 have very limited treatment options and a high mortality rate," said Prof. Bart Lambrecht, Principal Investigator for the trial at University Hospital Ghent and the Flanders Institute of Biotechnology (VIB). "We rapidly initiated this study with Leukine, because GM-CSF has profound effects on antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung, and can promote lung repair mechanisms."

Granulocyte macrophage colony stimulating factor (GM-CSF) is essential for the health of the lungs. Alveolar macrophages, a cell type found in the lungs, are dependent on GM-CSF for differentiation and normal functioning. GM-CSF is an immunomodulator that plays a critical role in host defense against pathogens and maintaining proper functioning of the immune system.1 GM-CSF confers resistance to influenza by enhancing innate immune mechanisms.2 In animal studies, GM-CSF reduced morbidity and mortality due to acute respiratory distress syndrome (ARDS) from viral pneumonia.3 In clinical studies, use of Leukine showed beneficial effects in patients with viral pneumonia.4,5 Recent data highlight the importance of understanding the immune status of patients and role of immunomodulating agents like GM-CSF to activate the immune system to help clear virus and reduce the risk of secondary infections.6

"Partner Therapeutics is committed to investigating Leukine in patients with COVID-19 and we are working with academic and government agencies here in the US and in Europe in this effort," said Dr. Debasish Roychowdhury, Chief Medical Officer at Partner Therapeutics. "We believe, like many investigators and scientists, that GM-CSF has multiple ways by which it may help these patients, including playing a role in clearing the infection, boosting the immune system and repairing damaged tissues."

"In pre-clinical studies, GM-CSF protects the lungs from viral pneumonia and the influenza A virus", stated E. Scott Halstead, MD, PhD, Associate Professor, Penn State University College of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine. "Preliminary data indicate an apparent benefit of inhaled Leukine therapy for autoimmune pulmonary alveolar proteinosis ("aPAP") and suggest it has reduced the need for whole lung lavage therapy for patients receiving treatment. Collectively, the data suggest that aerosolized Leukine may prove to be a meaningful therapy to decrease mortality and increase ventilator-free days in patients with respiratory disorders associated with viruses such as COVID-19 and Influenza A."

For the treatment of COVID-19 associated acute hypoxic respiratory failure and ARDS, Leukine will be used in nebulized form for direct inhalation or through intravenous administration for patients already on a respirator. Nebulized Leukine has been studied in phase 2 and phase 3 randomizedtrials in pulmonary conditions that affect alveolar macrophages, such as aPAP. IV administration of Leukine has been studied extensively in other conditions and in phase 2 randomized trials in ARDS.

Leukine was initially approved in the United States in 1991 and has been approved for use in five clinical indications. Its safety and tolerability profile are well understood. In 2018, Leukine was approved for use as a medical countermeasure to treat Acute Radiation Syndrome (ARS) and has been procured for use by the U.S. Strategic National Stockpile. Leukine is distributed outside the U.S. on a named-patient basis through PTx's designated program manager, Tanner Pharma Group. The use of Leukine to treat respiratory disorders associated with COVID-19 is investigational and has not been fully evaluated by any regulatory authority.

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

About Leukine(sargramostim)Leukine is a yeast-derived recombinant humanized granulocyte-macrophage colony stimulating factor (rhuGM-CSF) and the only FDA approved GM-CSF. GM-CSF is an important leukocyte growth factor known to play a key role in hematopoiesis, epithelial repair, and augmentation of innate host defense by effecting the growth and maturation of multiple cell lineages as well as the functional activities of these cells in antigen presentation and cell mediated immunity.

Important Safety Information for LEUKINE (sargramostim)

Contraindications

Warnings and Precautions

Adverse Reactions

Adverse events occurring in >10% of patients receiving LEUKINE in controlled clinical trials and reported in a higher frequency than placebo are:

Please see full Prescribing Information for LEUKINE at http://www.leukine.com

Indications and Usage

LEUKINE (sargramostim) is a leukocyte growth factor indicated for the following uses:

About Partner Therapeutics, Inc.: PTx is an U.S.-based commercial-stage biotech company focused on the development and commercialization of therapeutics that improve health outcomes in the treatment of cancer. PTx's development focus spans the entire range of cancer therapy from primary treatments to supportive care. The company believes in delivering great products with the purpose of creating the best possible outcomes for patients and their families.

References

Cited References

Other RelevantReferences

SOURCE Partner Therapeutics, Inc.

http://www.partnertx.com

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Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness - PRNewswire

Bone Marrow Stem Cells Comments Off on Partner Therapeutics Announces Initiation of Clinical Trial to Evaluate Leukine in Patients with COVID-19 Associated Respiratory Illness – PRNewswire | March 24th, 2020

In the recently published 3D bioprinting and its potential impact on cardiac failure treatment: An industry perspective, authors Ravi K. Birla and Stuart K. Williams explore the potential for tissue engineering in cardiac medicine, and the eventual assembly of a bioprinted heart.

While heart failure usually requires a transplant, it can be challenging to find a suitable donor. Once a transplant is completed, there is a long road ahead too via a permanent need for immune suppression therapytreatment that is hard on patients. The usual survival rate for patients is typically under 13 years.

There are currently more than 6.2 million patients in the US with heart failure, and heart failure accounted for 78,356 mortalities in 2016, stated the authors.

In this study, the researchers review the challenges of bioprinting for the creation of heart tissue, as well as the logical and systematic process to bioprint human heart.

While medical science is full of progressive tools, treatments, and devicesespecially for heart patientsno technology has been more promising for the eventual fabrication of organs than tissue engineering. With the potential to yield a biofabricated heart, made up of both biologic and artificial construct, a total heart could feasibly emerge with modular parts for easy replacing.

Definition of tissue engineeringthe building blocks of tissue engineering are cells, biomaterials, and bioreactors. Cells are the functional elements of all tissue and organs, while biomaterials are designed to simulate the mammalian extracellular matrix and provide structural support. Bioreactors are custom devices to deliver physiological cues for 3D tissue/organ development and maturation. Electrical stimulation is delivered by parallel electrodes, while uniaxial stretch, illustrated by the single arrow, is designed to apply cyclic movement of the bioengineered tissue.

Cardiac tissue engineering encompasses:

The ability to bioengineer components of the heart or the entire bioartificial heart, both have applications in changing the standard of care for patients with heart disorders, explained the authors. Depending on the severity of the patient, a cardiac patch may be sufficient to augment lost contractile function, while in cases of chronic heart failure, a total bioartificial heart may be required.

In addition to spatial regulation of the cells, bioprinting also allows accurate placement of the biomaterials. This is where 3D bioprinting provides a powerful tool that allows us to accurately position different cell types in a very specific pattern, thereby allowing tight control over the heart bioengineering process.

Overview of cardiac tissue engineeringthe field of cardiac tissue engineering includes methods to bioengineer contractile 3D heart muscle, biological pulsating pumps, bioengineered left ventricles, bioartificial valves and vascular grafts, and biofabricated hearts. Contractile 3D heart muscle is designed to replicate the properties of mammalian heart muscle tissue and can be used as a patch to augment left ventricle pressure after myocardial infarction. Pulsating pumps are designed to generate intra-luminal pressure and can be used as biological pumps. Left ventricles can be used as a component of the heart or to replace under-performing ventricles in pediatric cases of hypoplastic left heart syndrome. Valves and vascular grafts can be used to replaced mammalian valves and blood vessels or as components of the bioengineered heart.

Major components of the human heartthe human heart consists of four chambers, four valves, the cardiac conduction system, contractile cardiomyocytes, and a complex vasculature. The four chambers are the left and right ventricle and aorta, while the four valves are the aortic and mitral valves and pulmonary and tricuspid valves. The cardiac conduction system consists of the SAN, AVN, bundle of His, and the Purkinje fibers. Cardiac vasculature consists of the greater vessels as well as the smaller micro-circulation. Cardiomyocytes are the cells responsible for heart muscle contraction.

So far, most research involving bioprinting of cardiac tissue has shown the initial feasibility of bioprinting hearts. With the amount of research and tools available today, such progress is inevitable.

Based on the current state of the art in whole heart bioengineering, we can safely say that human hearts will be available for clinical transplantation though we cannot assign a specific timeframe for this fate to be accomplished, state the authors.

Bioprinting of the human heart has its beginnings in the initial history of tissue engineering in 2003, and then further in research a few years later.

The 3D bioprinting processisolated cells are suspended in a custom formulated bioink and loaded into a syringe. Examples of cells required to bioprint hearts include contractile cardiomyocytes, conducting pacemaker and Purkinje cells, structural fibroblast cells and vascular smooth muscle cells, and endothelial cells. Pneumatic pressure is used to extrude the cell-loaded bioink through the printing tip, and a layer by layer approach is used to build tissue and/or organ

Scientific breakthroughs for 3D bioprinting human hearts.

There has continued to be rapidly growing success in bioprinting and the subsequent fabrication of heart tissue, allowing scientists to realize less of fantasy in such exercisesand more of a reality.

Process for bioprinting human heartspatient MRI images are used to model the heart. Dermal fibroblasts are isolated from patient skin biopsies and converted to iPS cells and then to cardiomyocytes. Cardiomyocytes are combined with bioinks and used to bioprint patient-specific human hearts. Bioprinted hearts are conditioned in bioreactors and used for transplantation.

The roadmap for bioprinting a heart includes:

The single most important challenge that needs to be overcome in the field, and one that in general staggers the field of cardiac stem cell therapy, is the immaturity of reprogrammed cardiomyocytes, conclude the researchers. Conversion of iPS cells to cardiomyocytes is now standard and reproducible, the differentiated cells resemble an embryonic phenotype, and driving these cells to an adult phenotype remains a critical challenge in the field of cardiac stem cell therapy.

Once reproduced by independent research labs, coupled with the availability of commercial bioreactors for electromechanical stimulation, the availability of mature cardiomyocytes will provide a clear pathway to 3D bioprint human hearts for clinical transplantation.

Bioprinting is used in a wide variety of applications today, from cardiac patches and cellularized hearts to the creation of heart valves, and more, ultimately shaping an overall transformation of cell culture. What do you think of this news? Let us know your thoughts! Join the discussion of this and other 3D printing topics at 3DPrintBoard.com.

Continued here:
The Progress & Ongoing Challenge of 3D Bioprinting Cardiac Tissue - 3DPrint.com

IPS Cell Therapy Comments Off on The Progress & Ongoing Challenge of 3D Bioprinting Cardiac Tissue – 3DPrint.com | March 24th, 2020

Since 1998, advances incord bloodtechnology havemade cord blood transplantsa viable alternativeto traditional bone marrow transplantsin patients requiring astem cell transplant. While bone marrow transplants continue be a more commonprocedure, evidencesuggests this trendmay be changing. But is a cord blood transplant really a more effective procedure? The truth is, it depends on the circumstance.

Both bone marrow and cord bloodstem celltransplants are designed to replace unhealthy cells with healthy ones.

A bone marrow transplant involves the use of bone marrow that is transplanted from a donor into a recipient to cultivate new stem cells. Bonemarrow is a spongy tissue located inside the bones. Most commonly, bonemarrow is extracted fromthe breastbone, skull, hips, ribs or spine, as these contain stem cells that producewhite blood cells (leukocytes), which fight against infection; red blood cells (erythrocytes), which carry oxygen in order to eliminate waste from the organs and tissue; and platelets, which are responsible for making the blood clot. Bone barrow is removed from the donor under a general anesthetic. It isfiltered, treated, and either transplanted immediately into the recipient, or tested, frozen, and stored for later use.

Cord bloodis collected from a newbornsumbilical cord after delivery, so that it may be tested, frozen, and subsequently stored in acord blood bankfor future use.

There are many different criteria used to evaluate whether or not a cord blood transplant is right for you. When making your decision, it is important that both you and your doctor keep the following in mind:

In addition, cord blood transplants are generally better-suited for those younger than 30 years and, depending upon the quantity of available stem cells, may not be suited for patients over a certain weight. Bone marrow transplants, on the other hand, are not recommended for individuals with kidney, lung, liver, or heart conditions.

Sources

Cord Blood vs. Bone Marrow Transplants.Stem Cell Transplants: Bone Marrow vs Cord Blood. N.p., n.d. Web. 06 Feb. 2017.

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Bone Marrow vs. Cord Blood Stem Cell Transplant | Americord

Bone Marrow Stem Cells Comments Off on Bone Marrow vs. Cord Blood Stem Cell Transplant | Americord | March 23rd, 2020

DetailsCategory: DNA RNA and CellsPublished on Monday, 23 March 2020 16:33Hits: 250

GOSSELIES, Belgium I March 23, 2020 I BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today announces it has received regulatory approvals for its Clinical Trial Applications for the next studies of both of its lead candidates. These two studies are the pivotal JTA-004 PhaseIII clinical study targeting osteoarthritic knee pain and the PhaseIIb study of its allogeneic cell therapy product, ALLOB, in patients with difficult tibial fractures. The JTA-004 trial has been approved by regulatory authorities in Denmark, and the ALLOB by Belgian regulatory authorities.

Bone Therapeutics now has completed preparations for these trials. It is ready to initiate recruitment in both of these studies as soon as the current situation regarding COVID-19 allows, in those two countries. Bone Therapeutics has taken this decision to support healthcare systems in the respective trial countries, enabling them to concentrate on treating COVID-19 patients whilst necessary.

Bone Therapeutics is now ready to commence clinical trials on both its lead products. Receiving regulatory approvals for both Clinical Trial Applications completes the preparative activity for both studies, said Miguel Forte, CEO, Bone Therapeutics. This means that as soon as the current situation allows, we will be able to start recruiting patients for both clinical studies and continue to develop options for patients suffering knee osteoarthritic pain and difficult tibial fractures, both of which are conditions with a high unmet medical need.

The JTA-004 phase III study is a controlled, randomized, double-blind study. It will evaluate the potential of a single, intra-articular injection of JTA-004 to reduce osteoarthritic pain in the knee compared to placebo or Hylan G-F 20, the leading osteoarthritis treatment on the market. The study expects to enrol 676patients with mild to moderate symptomatic knee osteoarthritis in approximately 20centres in 7European countries and Hong Kong SAR.

The ALLOB Tibial Fracture PhaseIIb study is a randomized, double-blind, controlled study in which the fracture healing potential of ALLOB in patients with difficult fractures in the shinbone (tibia) will be evaluated and compared to standard of care alone after a follow-up period of 6 months. ALLOB will be applied by single percutaneous injection 24-72hours post reduction surgery in patients with fresh tibial fractures at risk for delayed or non-union. The study is expected to enrol approximately 178patients in approximately 40sites in up to 7European countries.

About JTA-004

JTA-004 is companys next generation of intra-articular injectable for the treatment of osteoarthritic pain in the knee. Consisting of a unique mix of plasma proteins, hyaluronic acid, a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain. In a phaseII study involving 164 patients, JTA-004 showed an improved pain relief at 3 and 6 months compared to Hylan G-F20, the global market leader in osteoarthritis treatment.

About Knee Osteoarthritis

Osteoarthritis (OA), also known as degenerative joint disease, is the most common chronic joint condition in which the protective cartilage in the joints progressively break down resulting in joint pain, swelling, stiffness and limited range of motion. The knee is one of the joints that are mostly affected by osteoarthritis, with an estimated 250M cases worldwide.

The prevalence of knee osteoarthritis (KOA) is expected to increase in the coming years due to increasingly aging and obese population. Currently, there is no cure for KOA and treatments focus on relieving and controlling pain and symptoms, preventing disease progression, minimizing disability, and improving quality of life. Most drugs prescribed to KOA patients are topical or oral analgesics and anti-inflammatory drugs. Ultimately, severe KOA lead to highly invasive surgical interventions such as total knee replacement.

About ALLOB and Bone Therapeutics proprietary, scalable cell therapy manufacturing process

ALLOB is the companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells. These cells are derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors. To address critical factors for the development and commercialization of cell therapy products, Bone Therapeutics has established a proprietary, optimized production process that improves the consistency, scalability, cost effectiveness and ease of use of the ALLOB platform. This optimized production process significantly increases the production yield, generating 100,000 of doses per bone marrow donation. Additionally, the final ALLOB product is cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the healthcare site. The process does therefore substantially improve product quality, reduce overall production costs, simplify supply chain logistics, increase patient accessibility and facilitate global commercialization compared to an autologous approach. Bone Therapeutics has implemented the optimized production process to produce clinical batches for the upcoming Phase IIb clinical trial in patients with tibial difficult-to-heal fractures.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and bone diseases. The Company has a broad, diversified portfolio of bone cell therapies and an innovative biological product in later-stage clinical development, which target markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf protein solution, JTA-004, which is entering PhaseIII development for the treatment of pain in knee osteoarthritis. Positive PhaseIIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement. The clinical trial application (CTA) for the pivotal PhaseIII program has been approved by the Danish relevant authorities allowing the start of the study.

Bone Therapeutics other core technology is based on its cutting-edge allogeneic cell therapy platform (ALLOB) which can be stored at the point of use in the hospital, and uses a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells from healthy donors into bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery, and are produced via a proprietary, scalable cutting-edge manufacturing process. Following the CTA approval by the Belgian regulatory authority, the Company is ready to start the PhaseIIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process.

The ALLOB platform technology has multiple applications and will continue to be evaluated in other indications including spinal fusion, osteotomy and maxillofacial and dental applications.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

SOURCE: Bone Therapeutics

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Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |...

Bone Marrow Stem Cells Comments Off on Regulatory authorities approve JTA Phase III study in osteoarthritic knee pain and ALLOB Phase IIb study in difficult fractures | DNA RNA and Cells |… | March 23rd, 2020

VANCOUVER, Washington, March 23, 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, announced today that the third and fourth coronavirus patients were treated with the Company's investigational new drug, leronlimab. The treatment of the third patient occurred on Friday and the fourth coronavirus patient was treated on Saturday. These patients are under the care of the same leading medical center in the New York City area that treated the first and second patients.

The treatment with leronlimab is being administered under an emergency IND recently granted by the U.S. Food and Drug Administration (FDA). The treatment with leronlimab is intended to serve as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19).

Bruce Patterson, M.D., CEO of IncellDx, a diagnostic partner and advisor to CytoDyn, said, "IncellDx has developed specific companion diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We believe that leronlimab acts by enhancing the immune response while mitigating the cytokine storm'that leads to morbidity and mortality in these patients."

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn said, "We are encouraged that the onsite medical team is reporting no safety issues and our team continues to be responsive and supportive in any way we can."

About Coronavirus Disease 2019SARS-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 it is unclear how easily the virus spreads. COVID-19 is thought to be transmitted 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. It is believed that symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure, and that symptoms in patients have ranged from non-existent to severe and fatal. At this time, there are very limited treatment options for COVID-19.

About Leronlimab (PRO 140) The 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 successfully 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 can 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.

In the setting of cancer, research has shown that CCR5 plays an important role in tumor invasion and metastasis.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. Additional research is being conducted with leronlimab in the setting of cancer and NASH with plans to conduct additionalclinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation and may be important 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 further support the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD and that blocking this receptor from recognizing certain 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 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 key 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 in 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 plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in the first quarter of 2020 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, 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 with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients, with some patients on leronlimab monotherapy remaining 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. The Company's 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 Company's cash position, (ii)the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv)the Company's ability to enter into partnership or licensing arrangements with third parties, (v)the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Company's ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Company's clinical trials, (viii)the results of the Company's 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 Company's 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 Company's 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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Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn's Leronlimab, Bringing the Total to Four Patients - Benzinga

Bone Marrow Stem Cells Comments Off on Two Additional Coronavirus Patients Treated at Leading New York Hospital with CytoDyn’s Leronlimab, Bringing the Total to Four Patients – Benzinga | March 23rd, 2020

How many sufferers are currently on the Covid 19 Charit stations, and what is the treatment of the patients who come to you?

We have on our Covid 19 ward currently has nine patients, including some who are doing reasonably well but cannot be well cared for at home, and those who are a little more serious and who need support from one to two liters of oxygen per minute. Some of them also have to be checked repeatedly to determine whether they need to be transferred to the intensive care unit and mechanically ventilated. And finally there are eleven ventilated patients in our Covid intensive care unit today.

When should ventilation be?

What is important is the respiratory rate, i.e. the frequency with which the patient breathes and the saturation of his blood with oxygen . We observe: How much oxygen do I give, how much is received? This is a good parameter for the extent of lung damage. The patient experiences exhaustion at a certain point, then we have to ventilate. Covid 19 has something very destructive to the lung cells.

[Die neuesten Entwicklungen und Hintergrnde zum Coronavirus knnen Siehier in unserem Newsblog mitverfolgen.]

If everything goes well, the situation will improve within three days, so that we can weave the patient, ie wean from the ventilator, but it can also take a week or two last. This type of ventilation is not enough for a subgroup, here we use a kind of replacement lung outside the body. All of this is not new territory for intensive care medicine, but it is very complex and personnel-intensive.

Sick every year 750. 000 People with pneumonia, 290. 000 from them to the hospital. So there is plenty of experience with pneumonia. What is special about the current situation?

If you look at the classic bacterial pneumonia, then come against the bacteria use antibiotics. In these cases, you can often see a black-and-white effect: seriously ill people quickly get well with medication. That is now different in the treatment of the Covid virus infection 19 Antibiotics play no role at first, they may come into play later with complications caused by bacteria. What we have so far against Covid 19 is insufficient.

Which drugs are used?

First there is an old preparation from HIV treatment, Kaletra, which contains the active substances against retroviruses lopinavir and retonavir contains. However, the effect and possible side effects have to be weighed here, because the agent can, for example, increase liver values. In the New England Journal of Medicine (NEJM), a paper from China has just appeared in which its use made no difference. However, there was only very late, namely twelve to 13 days after Beginning of the disease, therapy started.

Then there is a candidate from Ebola research, the active ingredient Remdesivir. According to the first findings, it seems to be rather effective, but of course the experiences are not endless. Studies are ongoing and you can use it as part of an individual healing attempt. However, it is currently difficult to get hold of the drug, it is not supplied in large quantities. It is very important that you can only have it within the framework of a formalized process. There is a narrow treatment window: the patient must be intubated, but he must not have circulatory failure.

What about the malaria drug hydroxychloroquine, about which a violent dispute has arisen between the virologists in France after a small, uncontrolled study?

Hydroxycloroquine appears with every new virus infection because it has a certain effectiveness. However, this active ingredient also has side effects, especially on the cardiac conduction system. It is therefore important to monitor the patient's ECG. A large randomized clinical trial of hydroxychloroquine is currently underway under the direction of the University Hospital in Tbingen.

What about clinical studies, science comes In view of the tense situation in everyday clinical practice, rightly so?

Yes, we will do better than a few years ago at EHEC! In the end, there were no really new insights. This is changing this time, we are closely networked, randomized clinical studies are being carried out that span several centers, and the procedures are being coordinated. Not everyone can do what they want. We have come together in competence networks. Physicians, large clinics and scientists from basic research have been working well together for years in the CAP network for pneumonia acquired outside the hospital, which was funded by the Federal Ministry of Research and is now working as a foundation. Large international clinical trials are now underway.

The French national research institution Inserm announced yesterday that its Aegis the substances Kaletra, Remedesvir and Hydrochloroquine, which we have just spoken about to be compared in a large international study called Discovery, the WHO launched the large-scale study Solidarity. Agents that are already being used against other diseases are being tested. How about the ACE2 inhibitor, of which there is currently a lot of talk ?

We have Access to the inhibitor that attaches to ACE2 and its associated protease and can thus block virus uptake into the cell, and we will also test it in a study. However, this ACE2 inhibitor has so far only proven its effectiveness in cell culture. The question remains whether and in what dose it works in humans. I know of a dozen other drug candidates whose investigation is planned as part of studies in our clinic. This also includes some experimental approaches that are used to block signaling pathways in the cell so that the virus cannot replicate, or in which stem cells are used. Another approach is to restore the tightness of the vessels. With severe pneumonia, there is water in the lungs where there used to be air. The lungs look white on the x-ray.

What about the idea , use blood plasma from people who have survived the disease to heal the sick?

This is obvious and is currently being pursued. If you think about it further, you could use antibody-based therapy. The cells that made the antibody in a previous patient are isolated beforehand and ultimately let them produce large amounts of antibody.

In addition to this search for new therapies Research on other questions is also important: In the BMBF-funded project PROGRESS-net, we have been dealing with the genetic differences between patients with severe pneumonia for some time. We want to understand why some of them have to go to intensive care later because they develop lung failure and possibly sepsis. And we want to be able to predict it.

What situation are we in now and how will it go on? Currently the therapeutic instruments are very modestly equipped. It is now the phase of science and clinical trials. However, unlike Italy at the moment, we have the chance not from Covid 19 to be overwhelmed if we test sensibly and know where we stand.

We are in a different situation from the plague in the Middle Ages, where people are were smart enough to use contact blocks, but the epidemic only came to a halt after there were no longer enough victims. We can hope that in the end a new therapeutic or a new vaccine will put an end to the spook.

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The therapeutic options are still insufficient - Bandera County Courier

Cardiac Stem Cells Comments Off on The therapeutic options are still insufficient – Bandera County Courier | March 23rd, 2020

Hair loss has long been a chief complaint among women, especially as they age. It affects some 30 million women in the United States alone, according to the Cleveland Clinic, and will significantly impact more than 50 percent of women during their lifetime. The most common cause is female-pattern hair loss (FPHL), also known as androgenetic alopecia. It's a chronic and progressive condition that has a genetic component, but it's also caused by factors related to the actions of hormonesovarian cysts, use of high androgen index birth control pills, pregnancy, and menopause, explains Ken L. Williams Jr., D.O., hair restoration specialist, surgeon, founder of Orange County Hair Restoration in Irvine, California.

Other medical conditions are also to blame for hair loss in women, including thyroid disorders, polycystic ovary syndrome, anemia, and chronic illnessand the use of certain medications, many of which treat these conditions, can also lead to hair loss in women. "Certain types of autoimmune disorders result in a slightly different and often less dramatic hair loss problem known as alopecia areata, an inflammatory condition that causes hair to come out in clumps or patches," says Dr. Williams Jr.

Luckily, we've come a long way in terms of treating hair loss. After all, 100 years ago, remedies involved things like snake oil and bat and chicken dung. "In more recent years, clinically tested topical and oral products, such as Minoxidil and Propecia, have become available, as well as procedures like PRP (platelet rich plasma therapy), and hair transplants," shares Anabel Kingsley, consultant trichologist and brand president for Philip Kingsley. She finds a holistic, personalized, multi-pronged approach to be the most effective way to treat any form of hair loss. "Since there is no 'one size fits all,' you want to optimize all possible factors that can affect the hair growth cycle, such as general health, nutrition, and stress levels, as well as the condition of your hair and scalp," she says.

At Philip Kingsley, she treats clients with their Trichotherapy Regime ($215, saksfifthavenue.com), which is specifically formulated for women with fine hair and reduced volume. "It tackles hair loss from all possible angles via the scalp with intensive daily Scalp Drops($89, neimanmarcus.com),a daily Stimulating Scalp Tonic ($28, net-a-porter.com), a thickening protein spray, and targeted masks to optimize the scalp environment," Kinglsey explains. "It also contains carefully formulated nutritional supplements to help give hair support from within."

Related: The Best Shampoos to Support Thinning Hair and Fight Female Hair Loss

Over-the-counter solutions won't work for every person suffering from hair loss, but there are a number of medical interventions that can stimulate hair growthanti-androgen medication, for example, is recommended for clients experiencing prolonged hair loss. "These medications help prevent further hair loss and encourage some hair regrowth from dormant hair follicles," says Dr. Williams Jr. There is also stem cell therapy, which has expanded greatly over the last few years in treating medical disease. "As opposed to embryonic cells, the initial stigma of using stem cells has decreased since the discovery of using bone marrow, fat cells, umbilical cord cells, and even skin cells to extract stem cells," he explains.

Surgery is also an option, and there are currently two primary surgical techniques or methods used in performing hair transplantation: Follicular Unit Transplantation (FUT) and Follicular Unit Extraction (FUE). "With the FUT technique, a section of scalp is excised with a scalpel, the scalp is brought together with sutures or staples and the hair follicles or hair grafts are inserted into tiny slits placed by the surgeon in the balding recipient area," Dr. Williams Jr. says. "The follicles with a single hair are placed in the front rows to define and create a natural hairline and the more dense, natural occurring follicular units are placed by hand in areas where hair density is needed the most."

FUE, a minimally invasive technique that is being hailed as the most significant improvement in hair surgery, uses a minimal depth scoring punch device to loosen the follicle from the surrounding tissues. "With the FUE procedure, a 0.9 or 1.0 millimeter punch minimal depth scoring excision is used in the skin around the upper part of the follicular unit (hair follicles)," he continues. "The hair follicle is then extracted directly from the scalp and manually placed into tiny slits in the balding area similar to the strip method."

There are still several hair restoration solutions left to be discoveredand experts believe most of us will see the concept of hair cloning come to fruition in their lifetime. "Hair cloning would in effect, disassemble a few hair follicles, multiply these cells in the laboratory and then reintroduce them into the scalp to both rejuvenate miniaturizing hair follicles and induce brand new hairs," Dr. Williams Jr. says. "Other groups have tried this but it has been found that when human follicle cells are cultured, they rapidly lose their functionality."

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The Forefront of Treating Hair Loss in Women - Yahoo Lifestyle

Skin Stem Cells Comments Off on The Forefront of Treating Hair Loss in Women – Yahoo Lifestyle | March 23rd, 2020

It's not your imagination, it turns out. Stress can turn a person's hair gray. It's said that if you look at before and after pictures of any eight-year U.S. president the impact of the office on hair color is clear, though in fairness, it may be that candidates dye their hair and then at some point stop doing so. Nonetheless, scientists from Harvard have not only verified the conventional wisdom on our graying noggins, but have also figured out why stress is so brutal to our follicular pigmentation.

The new research from Harvard scientists is published in the journal Nature.

Image source: Ververidis Vasilis/Evan El-Amin/Vacclav/Shutterstock/Big Think

Senior author of the study Ya-Chieh Hsu, professor of Stem Cell and Regenerative Biology at Harvard, explains what prompted her research:

"Everyone has an anecdote to share about how stress affects their body, particularly in their skin and hair the only tissues we can see from the outside. We wanted to understand if this connection is true, and if so, how stress leads to changes in diverse tissues. Hair pigmentation is such an accessible and tractable system to start with and besides, we were genuinely curious to see if stress indeed leads to hair graying."

It turns out that stress activates nerves associated with our basic fight-or-flight system, and these nerves permanently damage pigment-regenerating melanocyte stem cells in hair follicles, causing them to cease production of melanin that normal provides color to hair follicles.

Hsu's team studied the issue using mice, and was somewhat stunned at their findings. "When we started to study this, I expected that stress was bad for the body but the detrimental impact of stress that we discovered was beyond what I imagined," recalls Hsu.

The scientists stressed the mice using a combination of three methods:

Image source: Helga Lei/Shutterstock

Hsu and her colleagues first suspected an immune system reaction was at the root of graying hairs only to discover that mice without immune systems still turned gray in response to stressors. The next suspect was cortisol produced by the adrenal glands however, this proved not to be so. "Stress always elevates levels of the hormone cortisol in the body," says Jsu, "so we thought that cortisol might play a role. But surprisingly, when we removed the adrenal gland from the mice so that they couldn't produce cortisol-like hormones, their hair still turned gray under stress."

Image source: Judy Blomquist/Harvard University

Finally, the researchers investigate the possibility that the system responding to stressors was the mice's sympathetic nervous systems, the part of the nervous system that kicks into action with the fight-or-flight impulse. The sympathetic nervous system is a vast network of nerves that connects, among other places, to hair follicles in the skin. In response to stress, the system sends a rush of the chemical norepinephrine to the follicles' melanocyte stem cell, causing them to quickly burn through and deplete their stores of pigment.

Say Hsu, "After just a few days, all of the pigment-regenerating stem cells were lost. Once they're gone, you can't regenerate pigments anymore. The damage is permanent." Great for survival, not so good for hair color.

Sympathetic system nerves are magenta above. Melanocyte stem cells are yellow.

Image source: Hsu Laboratory, Harvard University

"Acute stress," says lead author of the study Bing Zhang, "particularly the fight-or-flight response, has been traditionally viewed to be beneficial for an animal's survival. But in this case, acute stress causes permanent depletion of stem cells."

The research, done in collaboration with other Harvard researchers, presents a new appreciation of the effect the sympathetic system can have on the body's cells during stress.

One of these collaborators, Harvard immunologist Isaac Chu, notes, "We know that peripheral neurons powerfully regulate organ function, blood vessels, and immunity, but less is known about how they regulate stem cells. With this study, we now know that neurons can control stem cells and their function, and can explain how they interact at the cellular and molecular levels to link stress with hair graying."

Given this finding regarding the direct impact of stress on follicular stem cells, the question of what it else it may affect becomes an obvious one. As Hsu sums it up, "By understanding precisely how stress affects stem cells that regenerate pigment, we've laid the groundwork for understanding how stress affects other tissues and organs in the body."

This importance of the study therefore goes way beyond graying heads. "Understanding how our tissues change under stress is the first critical step," says Hsu, "toward eventual treatment that can halt or revert the detrimental impact of stress. We still have a lot to learn in this area."

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An unusual chance to see stress at work - Big Think

Skin Stem Cells Comments Off on An unusual chance to see stress at work – Big Think | March 23rd, 2020

After the World Health Organization (WHO) declared that thecoronavirus outbreakis officially a pandemic, countries around the world have responded accordingly.Universitiesin Canada and the US are closing, non-essential conferences andsports leaguesare being canceled, and people are being advised to halt all travel plans. Anyone can get infected, and the only way to slow down the outbreak is toreduce the number of people getting infected.

Amidst this fear, the most widespread advice for anyone experiencing symptoms is tosocially distance themselves. But what, exactly, does that mean? How is this different from self-isolation? What if you live with family? What if only one person in a family of four is experiencing symptoms? Why is this even important?

How do I know if I need to socially distance myself? How is that different from self-isolation and strict isolation?

Everyone should besocially distancingthemselves! Essentially, that means deliberately distancing yourself from other individuals to reduce COVID-19 transmission rates.

On the other hand,self-isolationor self-quarantine is when you have been in contact with someone who was diagnosed with the coronavirus, or someone who was exhibiting symptoms. Self-isolation also applies for people who are asymptomatic, but have secondary medical issues (diabetes, heart condition) that may make a coronavirus infection more dangerous for them.

Lastly,isolationis when you have been diagnosed with COVID-19, or if you are exhibiting any flu-like symptoms. At this point, you will receive instructions for isolation from your medical provider.

What does social distancing entail?

If possible,do not leave the house. Try to stay at least six feet away from other people, and avoid coming in direct contact with them. Social distancing can also be done by avoiding crowds and mass gatherings, canceling upcoming events, working from home, moving classes online, and communicating electronically instead of personally visiting people.

What if I live with other people?

Even if no one in the household is exhibiting symptoms, it is best to keep distance for at least two weeks, which would be the viruss incubation period.On the other hand, if you need to self-isolate, try to sleep in separate rooms, and keep6 feet away from each other. Frequently wash your hands, andfrequently keep your surrounding areas clean. If possible, avoid touching your face, especially after being in contact with shared possessions or furniture. Wash all plates and utensils thoroughly with warm soap and water, or use a dishwasher with a drying cycle.

How can I help vulnerable people?

If there are vulnerable and at-risk individuals in your neighborhood, consider getting groceries and other essentials for them, and leave the items at their doorstep. Frequently call or check up on your friends and family, since social distancing can be quite lonely.

Why is social distancing important for everyone, including young and asymptomatic people?

According to data fromSouth Korean authorities, translated byDr. Eric Feigl-Ding, young people between the ages of 20 and 29 are carrying 30% of the disease in South Korea, with the majority beingasymptomatic, meaning they are not experiencing symptoms. This means that while you mayfeelfine, if you are sick you can still infect a large number of people by just being out and about!

Why is social distancing important?

By now you have probably seen a version of the graph that explains why we need to "flatten the curve." Through social distancing and pro-active measures, we can not only delay the "peak" of the outbreak, easing demand for hospital and emergency services, but can also reduce how bad the outbreak could be.

Do you still have questions about social distancing, isolation, or anything else about the coronavirus pandemic?

Ask our community of scientists now!

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Keep coronavirus from spreading in Hawai'i. Cancel your vacation - Massive Science

Skin Stem Cells Comments Off on Keep coronavirus from spreading in Hawai’i. Cancel your vacation – Massive Science | March 23rd, 2020

You get home from work and walk through the door. Your house is the Zone of Least Contamination, and the outside world is the Zone of Full Contamination. All day long youve been forced to interact with keyboards, doorknobs, subway poles, and handshakes. Youve stood in the same air as strangers, cringing in agony as sloughed off skin cells and droplets of spittle fly off their bodies and into your shared space. If you live in a densely populated city, youve been forced to press your body up close to theirs and breathe in shared, stale air.

This is a normal day if you have Obsessive Compulsive Disorder like I do, a disease thats still widely misunderstood and parodied in culture. Now imagine those painful, intrusive thoughtsevery cell in your body feeling swollen with contagion, the crushing fear that if you dont spend three hours decontaminating yourself and your house youll actually diecompounded by the coronavirus pandemic, which seems like the ultimate validation of all your obsessive tendencies.

What exactly happens to the obsessive-compulsive mind in the midst of a global pandemic, when a fear of germs and contamination suddenly seems perfectly rational? As of March 20, more than 244,000 cases of novel coronavirus have been reported worldwide, and at least 10,000 people have died. In Italy, which has the largest outbreak outside of China, the entire country is on lockdown, all shops and venues have closed, and prison revolts are breaking out across the region, as incarcerated people recognize the unique threat they face living in close quarters, with deeply uneven access to quality medical care. In the U.S., markets are in freefall, a national emergency has been declared, and even Broadway theaters have gone dark. UNESCO estimates that around 776 million students across the globe are currently out of school because of the virus. Even for someone without OCD, this kind of a public health crisis is impossible (and inadvisable!) to ignorelife as we know it has fundamentally changed.

What exactly happens to the obsessive-compulsive mind in the midst of a global pandemic?

But for folks with abnormally high levels of serotonin reuptake and a hyperactive amygdala, our threat-detection meter is malfunctioning constantly. Upsetting thoughts are paired with cognitive alarm bells, dousing your body in fear, anxiety, and adrenaline. Your system gets used to this feedback loop and starts to equate your thoughts and fears with actual danger. Next thing you know, the thought, What if that doorknob had coronavirus on it? becomes I just got coronavirus and now Im going to die. And with the 24-hour news cycle blaring desperate pleas to wash your hands, wash your hands, WASH YOUR HANDS!! the idea of getting a handle on that harmful feedback loop becomes even more impossible.

Unsurprisingly, the coronavirus panic has hit people with OCD especially hard. The disorder is going to become exacerbated in every sense, Dr. Robert Lancer, a psychologist and co-founder of the New York Center for OCD and Related Anxiety Disorders, told ELLE.com. Folks with OCD are very vulnerable to the power of suggestion, so hearing that hand sanitizer is selling out and seeing people wearing masks in public is going to trigger their need to compulsively purify.

Ute GrabowskyGetty Images

Nadia*, a 16 year old in Alberta suffering from OCD, described how intense her fear has gotten amid the outbreak. I freak out every time I touch my face, constantly ask for reassurance. I dont leave my house on the weekends anymore and I was crying every morning before school. I forgot my lotion at home one day and washed my hands to the point that they felt like sandpaper.

Its difficult for Nadia to escape her triggers, especially on social media. Twitter news has played a huge part in my panic and got me scared about it in the first place. When anyone talks about it my mind starts going crazy.

Smith, a 26 year old who lives in New York, said theyve been shocked by how much the pandemic has affected them. Im on medication for my OCD and I had it relatively under control before this started, but now it has constructed real barriers to my ability to function in the city. The stress is making it hard to focus on work; Im more isolated and more reluctant to participate in anything at all.

Lancer described this slow retreat into total isolation as inevitable. The more they avoid, the more the threshold is raised on what could be contaminated, he explained. The need to avoid is more and more...but avoidance is, in and of itself, a compulsion. The more they give in to that compulsion, the more extreme it will get. Now that so many Americans are on self-imposed quarantine, or at home due to school and work closures, this avoidance feels justified.

Although scientists say that decontamination and avoidance practices are our best bets for flattening the curve of infection, the rhetoric of intensified hand washing, surface sanitization, and social isolation runs directly counter to OCD therapeutic recommendations. Cognitive Behavioral Therapy, one of the most common and effective treatments available in treating OCD, requires patients to break the ritual behaviors associated with their contamination obsessions. This usually involves a complete moratorium on all non-essential behavior associated with the compulsive rituals.

So for someone like Nadia, who is trying to break her ritualized hand-washing, a public health crisis acts as license to immerse herself fully in the behavior that holds her mind captive. Shes now up to 60-plus hand washes in a seven hour period.

I feel like it makes people with contamination OCD compulsions seem more valid, which results in us feeling a lot more inclined to agree with the intrusive thoughts rather than fighting them, she said.

"Im more isolated and more reluctant to participate in anything at all."

John, a 47 year old man living in the UK, agreed that the constant (but warranted) surge of messaging urging him to decontaminate has been detrimental to his mental health.

The irrationality of the condition feels more rational now, he said. The compulsions feel more justified. Any psychological progress I've made has been wiped out.

As an OCD sufferer myself, my heart goes out to our anxious little community as we try to navigate an unprecedented global disaster. Its scary enough to be living through this time with a normal relationship to dirt and germs, and Im sure there are even folks out there who do not suffer from OCD who have still descended into full paranoid germaphobia.

The actual illness isnt even the only concern that could affect our mental health. The economic realities were all facingas layoffs begin and industry after industry is hobbled or shuts downleaves freelancers, independent contractors, gig workers, small businesses, and day laborers vulnerable to a partial or complete loss of income, with no expectation of if or when their job could come back. Its enough to drive anyone insane with worry.

But to those of us whose amygdalas were screaming out in terror even before this all started, my advice is this: Listen to the incoming guidelines and restrictions and follow standard hygienic protocol. But please, for the love of God, stay off of social media, news outlets, and message boards. I know the compulsion to check in on the minute-by-minute feed is gnawing on the back of your brain stem at all times, but the best thing you can do for yourself is only read the completely relevant updates.

Theres so much misinformation out there, Lancer also said. Dont seek that information out compulsively; if you have OCD, you already arent thinking about it rationally, and all that doubt and uncertainty over what to believe is going to override your ability to have a safe and reasonable response.

Instead, check in with your therapist about establishing a baseline acceptable standard for virus-limiting decontamination practices, and otherwise continue your work to limit compulsive behavior. And if you cant afford therapy (well hey, wouldnt now be a great time for Medicare for All?), here are some great resources to check out. Community support is the greatest balm to the soul in times of extreme alienation; and if we know OCD, we know its primary goal is to alienate us inside our own minds. Solidarity to my squeaky clean community.

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OCD, the Coronavirus Freakout, and Me - ELLE.com

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