Category Archives: Stem Cell Clinic

Orgenesis First Quarter 2020 Revenue Increases 348% to $1.9 Million Reflecting Success of CGT Biotech Platform – GlobeNewswire

GERMANTOWN, Md., May 11, 2020 (GLOBE NEWSWIRE) -- Orgenesis Inc. (NASDAQ: ORGS) (Orgenesis or the Company), a pioneering, global biotech company committed to accelerating commercialization and transforming the delivery of cell and gene therapies (CGTs) while lowering costs, today reported financial results for the first quarter ended March 31, 2020.

First Quarter 2020 Financial Highlights:

Vered Caplan, CEO of Orgenesis, commented, Step by step, our CGT Biotech Platform is gaining traction within the market, as illustrated by the year-over-year growth. In the first quarter of 2020, revenue increased to $1.9 million, or nearly an $8 million revenue run rate compared to $3.1 million for all of 2019. We believe our CGT Biotech Platform is poised for growth this year through industry partnerships that are currently underway with leading research institutes and hospitals around the world.

Earlier this year, we entered into a collaboration agreement with two of the leading healthcare research institutes in the U.S., whereby we plan to utilize our POCare Network to support their growing development and processing needs in order to advance and accelerate cell and gene-based clinical therapeutic research. We believe these collaborations with such high-profile institutions in the field of cell and gene therapy further validate the significant value proposition of our platform.

In addition to our POCare Network, we are building our pipeline of POCare Therapeutics and Technologies, with an ultimate goal of providing life-changing treatments to large numbers of patients at reduced costs within the point-of-care setting. Specifically, we are focusing on immuno-oncology, metabolic and autoimmune diseases, as well as anti-viral therapies. Most recently, we completed the acquisition of Tamir Biotechnology, Inc., including ranpirnase, a broad spectrum anti-viral platform. Ranpirnase has demonstrated clinical efficacy against HPV and other hard to target viruses based on its unique mechanism of action of killing the virus and modulating the immune system. Having demonstrated clinical activity against human papillomavirus, as well as preclinical activity against some of the worlds most persistent viral threats, we plan to aggressively pursue a number of complementary approaches with a goal to maximize the potential of ranpirnase.

We have received approval from regulators to continue working in our research and development labs during the current COVID-19 pandemic, and we are leveraging all our knowledge and expertise in the field of cell and gene therapy, including anti-viral technologies, in an attempt to find potential COVID-19 cures and therapies. Importantly, we have a strong balance sheet and are strategically positioned to bring a variety of therapies to market in a cost-effective, high-quality and scalable manner.

We also announced a joint venture agreement with RevaTis S.A. to advance the development of autologous therapies utilizing and banking muscle-derived mesenchymal stem cells (mdMSC) as a source of exosomes and other cellular products. Our plan is to combine RevaTis patented technique to obtain mdMSCs through a minimally invasive muscle micro-biopsy with our own automated/closed-systems, 3D printing, and bioreactor technologies. The goal of this JV is to lower the costs and accelerate the timeline of bringing these innovative therapies through the clinic and into commercialization.

The Companys complete financial results are available in the Companys Form 10-Q filed with the Securities and Exchange Commission on May 8, 2020 which is available at http://www.sec.gov and on the Companys website.

About Orgenesis

Orgenesis is a pioneering global biotech company which is unlocking the full potential of personalized therapies and closed processing systems through its Cell & Gene Therapy Biotech Platform, with the ultimate aim of providing life changing treatments at the Point of Care to large numbers of patients at low cost. The Platform consists of: (a) POCare Therapeutics, a pipeline of licensed cell and gene therapies (CGTs), and proprietary scientific knowhow; (b) POCare Technologies, a suite of proprietary and in-licensed technologies which are engineered to create customized processing systems for affordable point of care therapies; and (c) POCare Network, a collaborative, international ecosystem of leading research institutes and hospitals committed to clinical development and supply of CGTs at the point of care. By combining science, technologies and a collaborative network, Orgenesis is able to identify the most promising new therapies and provide a pathway for them to reach patients more quickly, more efficiently and at scale, thereby unlocking the power of cell and gene therapy for all. Additional information is available at: http://www.orgenesis.com.

Notice Regarding Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon our current expectations, estimates and projections and reflect our beliefs and assumptions based upon information available to us at the date of this release. We caution readers that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Our actual results, performance or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including, but not limited to, the risk that the acquisition of Tamirs assets will not be successfully integrated with our technologies or that the potential benefits of the acquisition will not be realized, our ability to further develop ranpirnase following the acquisition, our reliance on, and our ability to grow, our point-of-care cell therapy platform, our ability to effectively use the net proceeds from the sale of Masthercell, our ability to achieve and maintain overall profitability, the development of our POCare strategy, the sufficiency of working capital to realize our business plans, the development of our trans-differentiation technology as therapeutic treatment for diabetes which could, if successful, be a cure for Type 1 Diabetes; our technology not functioning as expected; our ability to retain key employees; our ability to satisfy the rigorous regulatory requirements for new procedures; our competitors developing better or cheaper alternatives to our products and the risks and uncertainties discussed under the heading "RISK FACTORS" in Item 1A of our Annual Report on Form 10-K for the fiscal year ended December 31 2019, and in our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason.

Contact for Orgenesis:David WaldmanCrescendo Communications, LLCTel: 212-671-1021ORGS@crescendo-ir.com

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Orgenesis First Quarter 2020 Revenue Increases 348% to $1.9 Million Reflecting Success of CGT Biotech Platform - GlobeNewswire

Meat the Future – documentary Channel – CBC.ca

(Canada, documentary Channel Original, directed by Liz Marshall)

With animal agriculture occupying roughly 45% of the worlds ice-free surface area, producing more greenhouse gases than cars, the prospect of meat consumption doubling by 2050 is a wake-up call for solutions. The future may lie with clean meat, also referred to as cell-based meat, and cultivated meat a food science that grows real meat from animal cells without slaughtering animals.

Watch an interview with the director Liz Marshall and Good Food Insititue executive director Bruce Friedrich

Meat the Future chronicles the birth of a revolutionary industry, and the mission to make it delicious, affordable and sustainable. Documented exclusively from 2016-2019, by award-winning filmmaker Liz Marshall (The Ghosts in Our Machine), the film follows the victories, struggles and motivations of the pioneers who are risking everything to bring their product to market in the near future.

Meat the Future is a timely, character-driven film focusing largely on Dr. Uma Valeti, a former Mayo Clinic cardiologist, and the co-founder and CEO of Memphis Meats, an American food-tech start-up company. During his childhood in Vijayawada, India, Valeti would dream of meat growing on trees as an alternative to killing animals. Valetis co-founder, stem cell biologist Nicholas Genovese, grew up on a family farm where he considered himself the guardian of the animals he reluctantly sold for slaughter. Both men cite childhood memories as the motivation for their passion project.

MORE:New food science grows meat from cells without the need to breed, raise and slaughter animalsDocumentary Meat the Future shows us the possible future of meat

Valeti's inspiration came following his tenure at the Mayo Clinic. While practicing cardiology he was injecting stem cells into patients hearts as a part of a clinical trial to regenerate heart muscle, and it was this scientific procedure that triggered a risky, passion-driven career turn. In 2016, Memphis Meats attracted global attention with the unveiling of the worlds first cultured meatball, which cost $18,000 per pound, and in 2017, the worlds first clean chicken fillet and duck a lorange. Together with their team of scientists, Memphis Meats is at the forefront of an industry. They have attracted tens of millions of dollars in investment from the likes of billionaire influencers Bill Gates and Richard Branson, and food giants Tyson and Cargill. Their confidence is buoyed by the plummeting price of the product-in-progress. The affordability point is approaching, as witnessed onscreen over the course of three years.

On the food policy and regulatory side, Meat the Future shifts its focus to Washington, D.C. to witness historic public meetings. Ranchers, farmers and meat lobby groups fight to protect their established brand harvested in the traditional manner and cell-based meat start-ups urge America to be first to market.

Watch more Hot Docs At Home on CBC films

And there are salivating moments as well, as top-ranked chefs perform their magic on the meat-of-the-future.

After a documentary career of exploring global issues, I was determined to follow a solution-focused story, and in 2015, I encountered the emergence of cellular agriculture, says director Marshall. The future of cultivated meat is unknown, but its revolutionary promise and journey into the world is a powerful story that I believe will stand the test of time.

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Meat the Future - documentary Channel - CBC.ca

Researchers discover stem cells’ ‘death-defying’ quality that aids healing – ETHealthworld.com

Washington D.C: Already known for their shape-shifting abilities, stem cells can now add "death-defying" to their list of remarkable qualities, suggests a novel study.

The new study shows how stem cells, which can contribute to creating many parts of the body, not just one organ or body part, are able to postpone their own death in order to respond to an injury that needs their attention.

The study was done in planarians, which are tiny worms used as model organisms to study regeneration because of their ability to recover from any injury using stem cells.

"Planarian stem cells, even when challenged and under a lot of duress, will still respond to an injury by delaying death," said Divya Shiroor, first author and a graduate student in Dr Carolyn Adler's lab, in the College of Veterinary Medicine.

This could have important implications for cancer research and therapies, particularly when examining chemotherapy and surgery options for patients.

"By understanding how injury prompts planarian stem cells to withstand radiation. We hope to identify genes that, if shared with mammals, could perhaps help hone existing therapies," Shiroor said.

Planarians are commonly used in basic research because of their similarities to humans. Like humans, planarians have stem cells, similar organs and similar genes, but are much more adept at responding to injury, thanks to their higher volume of stem cells and lack of a developed immune system, which in humans complicates the healing process.

"This really simplifies the process of understanding the effects of both injury and radiation on stem cells, and allows us to study it directly without being hampered by parallel processes integral to wound healing, such as inflammation, that get simultaneously triggered in mammals," Shiroor said.

By uncovering the mechanisms that govern stem cells after wounding in a system like planarians, researchers could also apply this knowledge when engineering stem cells to respond similarly in the human body.

Labs have many ways to understand how planarians use stem cells to successfully recover and regenerate, but the Adler lab's combination of radiation and injury to identify a novel stem cell response is unique. The researchers plan on digging deeper to understand how the stressed stem cells know that there is an injury and what role other cells may play in their response.

"We have identified a key gene that is required for stem cell persistence after radiation and injury. and we plan on using this as a stepping stone for further exploration," Shiroor said.

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Researchers discover stem cells' 'death-defying' quality that aids healing - ETHealthworld.com

On the Road As a Stem Cell Courier – CSRwire.com

Even in times of the COVID-19 crisis, life-saving blood stem cells are brought to patients - by committed people like Maria

Apr. 27 /CSRwire/ - Originally published by DKMS

Maria Schmiing is a DKMS employee and has also been a volunteer stem cell courier for about two years. A few days ago, she took a transplant from Germany to the US - a particularly difficult challenge in times of the COVID-19 crisis. Currently, entry to the US is only possible because DKMS, with the support of the US Stem Cell Donor Register: National Marrow Donor Program (NMDP/Be the Match), has obtained a special permit for stem cell couriers to enter the country - so that patients can receive urgently needed transplants.

"It was through an acquaintance of mine that I became aware of it several years ago. She is a teacher and carries out stem cell transports during the school holidays - I was immediately enthusiastic about it and signed up for it," says Maria Schmiing from Cologne. She applied to Ontime Onboard Courier GmbH, one of the transport companies that DKMS works with to bring life-saving blood stem cells to the recipients.

Maria's first assignment took her to Leiden in the Netherlands - an important place in the fight against blood cancer, as the World Marrow Donor Association (WMDA) has its headquarters there. "I was really excited before I even started the journey," she recalls.

Afterwards many further assignments followed, and it was because of this job as a courier that her desire to work at DKMS was born. "For me, the circle is complete; I'm doing something meaningful with my life. I am very aware of what I am doing this for: for the patients who need our help. What I think is great is that I am also really supported by my team and my managers, especially in the current situation."

Blood stem cell couriers like Maria Schmiing are currently in great demand to ensure that blood stem cell donations reach their recipients all over the world safely, even during the COVID-19 crisis. A few days ago the latest task for the 34-year-old was to travel to the US. "The procedure for a courier mission is actually always the same," she explains, "During the briefing the day before, we go through all documents together and the entire itinerary is discussed. Everything important detail is marked and addressed." But something is different at the moment: the couriers must carry a special permit that allows them to enter the US. "This must be presented upon entry and exit."

The next stop for Maria was the collection centre the next morning. There she received the life-saving blood stem cells from specially trained staff. These had previously been collected from a DKMS donor and prepared for transport. All documents and data were double checked based on the 4 eye principle before the transplant was handed over. "We especially look at the donor number and compare it, because we have to make sure that the patient receives the right transplant".

Afterwards Maria could start her journey. Stem cell couriers are allowed one additional piece of hand luggage only to be able to stay flexible on the way. "Most important are the blood stem cells or the bone marrow. We must not lose sight of the transplant during the entire journey. I look after this suitcase like my own personal treasure, like a mother who looks after her children. I am aware of the responsibility I carry and this stays with me until I have delivered the blood stem cells safely to the patient's clinic."

Before the departure to the US, she made sure that at the Frankfurt Airport the suitcase with the stem cells was not X-rayed. "I always explain that this is harmful to the transplant something most people know. Only after an officer has brought the suitcase through the security area, do I then follow. This is the only time we hand the suitcase over to somebody else. Fortunately, there were no problems either at the security check or at customs.

Once on the plane she informed the crew - an important and regular task for her - and did not let the suitcase out of her sight during the flight. "Sleep, of course, is out of the question. We are not allowed to drink alcohol 24 hours before and during the flight and we of course have to take the suitcase everywhere with us."

Upon arrival in the US, Maria noticed two differences "After landing, several security officers entered the plane and talked to the crew - only then were we allowed to disembark. In addition to this, they took the temperature of all passengers.

She then continued her journey by taxi to the transplant clinic. "Everything went really well, and I was met at the clinic by a member of staff. Again there, we double checked everything and went through the documents according to the four eye principle. Once we get back to Germany, there is also a debriefing and I then return the suitcase."

After handing a transplant over, there is always a moment of great relief for Maria: "The tension disappears. Afterwards she has a ritual, which is very important for her. "I go to the hotel, have a shower and then go out and raise a glass of beer for the patient. I think about how they are doing and what is still ahead of them. I then tell myself that from my side I've done everything I can to help them and I wish them all the best."

Going out and having a beer was not possible this time, as neither shops nor bars were open in the American city - even the hotel restaurant was closed. "I changed my ritual and toasted the unknown patient with a glass of tap water in my room!"

The next day she went back to Germany and soon the next flight will be scheduled for her - couriers are rare in this COVID-19crisis-ridden time. "My learning from this journey: I will take an emergency ration of trail mix with me, you never know," she says with a wink. She reflects on her commitment to patients. "I am still available when my help is needed. I am aware of the risk and take the best possible care and comply with all safety precautions. It is also clear that patients cannot wait - and despite everything with the current situation they should still be given a chance at life.

Learn more about how you can help deleteblood cancer atDKMS.org

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On the Road As a Stem Cell Courier - CSRwire.com

David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine – RESPECT.

Earlier, treating orthopedic problems just led to temporary cure but not the root cause of the problem. However, the case is not the same now. With emerging research and experience, Dr. David C. Karli says that regenerative medicine can completely repair the tissues using stem cell therapies. From professional athletes to ordinary people who strive to live a healthy and active life, regenerative medicine is a new ray of hope providing a healthy alternative for sports and musculoskeletal conditions and injuries.

Dr. David C. Karli is an Ivy-trained physician, a pioneer in orthopedic regenerative medicine and sports medicine, and the founder of Greyledge Technologies, one of the first FDA-audited biotech companies that prepare biologic implants to repair humans diseased or damaged tissues. Talking about the advancements in regen medicine, he says, Regenerative medicines multidisciplinary approach can cater to solutions for several untreatable orthopedic problems. With experts around the world pooling their knowledge, skills, and resources, a breakthrough in orthopedic treatment is leading to a miracle cure.

What is Regenerative Medicine?

Regenerative medicine is an interdisciplinary field that helps repair or replaces damaged or diseased human cells or tissues to restore normal function. The relatively new field of study comprises a broad range of scientific disciplines like molecular biology and genetics to immunology and biochemistry. Dr. Karli specializes in orthopedic applications where a patients diseased cells are replaced and re-implanted by the autologously collected healthy cells from the same patient.

About Dr. David C. Karli

Dr. David Karli graduated from Elizabethtown College, Pennsylvania, in 1993. Followed by receiving his MD degree from the University of Maryland, he pursued his residency in physical medicine and rehabilitation at Harvard Medical School, where he served as a chief resident in his final year. While serving as an attending physician at Harvard Medical School, Dr. Karli collaborated with his orthopedic surgeon colleagues and participated in the development of rehabilitation protocols for spinal disorders. He joined the Steadman Clinic in Vail, Colorado, where his research interest led him to take up Regenerative Medicine and successfully launch and develop Greyledge Technologies. This company focuses on autologous blood-based biotherapies for orthopedic injuries.

In his 23 years of experience, Dr. Karli has authored several research papers and publications on stem cell therapies and rehabilitation and lectured on spinal and musculoskeletal topics. He is a Diplomate of the American Board of Physical Medicine and Rehabilitation. Also, Dr. Karli is an active member of several societies, including the Regenerative Medicine Organization., the American Academy of PM&R, and the International Spinal Injection Society.

Greyledge Technologies

He founded the company Greyledge Technologies in 2010 with the mission to redefine orthopedic treatments and enhance the bodys response to injury. Greyledge Technologies develops biologic products by processing materials like human blood and bone marrow into implantable preparations. These biologic preparations are further developed and inserted into the human body replacing the diseased cells hence, stimulating the healing process and self-repair.

At Greyledge Technologies, every patient is completely assessed and analyzed not only to guarantee that theyre fit to undergo the procedure yet additionally to create a personalized dynamic strategy that each patient can follow. The whole treatment takes a certain number of days wherein the family members and caretakers are informed about the medicinal dosages to follow after the procedure. After surgery, every patient is regularly followed-up by the rehabilitation team.

When asked in-depth about practicing regenerative medicine at Greyledge Technologies, Dr. Karli said, The treatment is entirely safe and effective as it requires no big surgeries or complicated operations. As the cells used are autologous, they do not pose any chances of immune rejection or untoward irreversible side effects. Neither do the cells need to be preserved. This makes the procedure swift and safe for all ages.

Dr. Karli says, Regenerative Medicine is emerging as one of the trending treatment options for patients who have lost all hope. Whats brilliant about this treatment is that it has the capability to thoroughly repair the damaged tissues at the molecular, structural, and functional level.

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David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine - RESPECT.

You could be someones only hope: A stem cell donor campaigning to beat blood cancer – Evening Standard

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A stem cell donor is urging people to sign-up after registration numbers drop by more than 50 per cent from this time last year.

Lockdown was the last thing on Sam Schmidts mind when he got the call to say that they had found a match and he was going to be the donor.

He had been expecting that call since his registration last year.

While most of us would have had second thoughts about going through with the process in the middle of a pandemic, the brave 24-year-old took the risk.

Sam Schmidt at the London clinic where he underwent the procedure (DKMS)

Accompanied by his parents, Sam went to the London Clinic this week to undergo the live-saving procedure to donate his stem cells to an anonymous patient with blood cancer.

You could be someones only hope. That really hit home for me especially when I got the call.

"I thought that Im definitely going to do this now because If I dont, Im essentially sentencing someone to a far less chance of survival. If you are someones match then thats an actual individual relying on you.

He registered with the charity DKMS - known as We Delete Blood Cancer - after meeting Peter McCleave, a 42-year-old father of two who was diagnosed with the condition shortly after running an Ironman Triathlon.

Hes one of those people that you meet and youre like, how on earth is someone as fit and healthy has him got blood cancer?

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Boris Johnson addresses the nation on the Coronavirus lockdown

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You could be someones only hope: A stem cell donor campaigning to beat blood cancer - Evening Standard

FDA Expediting Accelerated Development of Novel Therapies for COVID-19 – PR Newswire UK

PALM BEACH, Florida, April 28, 2020 /PRNewswire/ --The U.S. Federal government is working closely with companies and researchers to find treatments and vaccines to overcome the global health crisis. The FDA has been cutting red tape and has launched new programs that relax certain time consuming regulations while still assuring the efficacy and safety of the treatments. The FDA recently issued an update describing its most recent programs. The update stated that, as part of the administration's: " all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. Active healthcare stocks in news today include: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Mesoblast Limited (NASDAQ: MESO), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Gilead Sciences, Inc. (NASDAQ: GILD), Aytu BioScience, Inc. (NASDAQ: AYTU).

"The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump's all-of-America approach is making progress and providing new hope in our fight against the coronavirus."

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA's accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR)BREAKING NEWS - Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 - Citius Pharmaceuticals ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, this week announcedthat it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS." Read this full release at: https://ir.citiuspharma.com/press-releases/detail/96/citius-announces-pre-ind-submission-to-fda-under-the

In other healthcare news of note:

Mesoblast Limited (NASDAQ: MESO) recently announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City's Mt Sinai hospital.

In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced this week that first quarter 2020 financial results will be released after the market close on May 11, 2020. Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update, including the company's ongoing vaccine developments for COVID-19. A live and archived version of the audio presentation will be available online at http://ir.inovio.com/investors/events/default.aspx. This is a listen-only event but will include a live Q&A with analysts. Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10143530.

Gilead Sciences, Inc. (NASDAQ: GILD) Kite, a Gilead Company, and oNKo-innate recently announced the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells.

Current cancer immunotherapy approaches primarily focus on T cell mediated anti-tumor immunity, including checkpoint inhibition and chimeric antigen receptor (CAR) T cell therapy. Like T cells, NK cells are a class of lymphocytes (white blood cells) that play a critical surveillance and effector role in the immune system. NK cells and T cells each have the potential to attack cancer cells, but have different mechanisms for tumor cell killing. Thus, appropriately activated and targeted NK cells may represent a differentiated approach that would be potentially complementary and synergistic with T cell mediated anti-tumor strategies.

Aytu BioScience, Inc. (NASDAQ: AYTU) recently announced that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

DISCLAIMER: FN Media Group LLC (FNM), which owns and operates Financialnewsmedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM expects to be compensated forty five hundred dollars for news coverage of the current press releases issued by Citius Pharmaceuticals, Inc. by a non affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

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FDA Expediting Accelerated Development of Novel Therapies for COVID-19 - PR Newswire UK

What to do if you think you have COVID-19: a step by step guide – The Dickinson Press

If you've become ill and are experiencing symptoms such as fever, cough or difficulty breathing, call your physician prior to going to any clinic. He or she will screen you over the phone and prepare the clinic to accept you.

"Usually they're taken straight back to the room so they can be tested, and sometime they're tested in their car, depending on each facility's protocols," said Brett Kallis, director of nurses for Southwest District Health Unit.

Your sample will be sent to the state laboratory in Bismarck for testing, and you should have results within two to three days, provided to you by your health provider.

While waiting for your test results, you should self-isolate in your home and separate yourself from others in your household as much as possible. If you cannot completely separate yourself from others in your home, the North Dakota Department of Health advises you to avoid close contact.

"Do not snuggle, kiss or share food or drink and remember to wash your hands often. Avoid sharing dishes, cups, utensils, towels, bedding and other personal items in the home until they can be washed with soap and water. Clean all high-touch surfaces (counters, tabletops, doorknobs, toilets, phones, etc.) at least daily if not more often. Utilize household cleaning sprays and wipes according to the label instructions. Face masks can be worn when around other people or pets."

If your test results indicate that you are positive for COVID-19, continue to remain in your home, separate yourself from others in your home and monitor your symptoms. If you experience any of the following warning signs, call your health care provider immediately: difficulty breathing or shortness of breath, persistent pain or pressure in the chest, new confusion or inability to arouse, bluish lips or face.

A contract tracer will contact you for a list of people with whom you've been in contact since two days prior to the onset of your symptoms. They will then call those people, and you and them will need to self-isolate and monitor your symptoms. A public health worker will contact you once a day for you to report your symptoms.

Do not share drinks, utensils, bedding, towels or other personal items with others, and wash them after use. Wash your hands often with soap and water for at least 20 seconds, especially after blowing your nose, sneezing, coughing or using the bathroom. Continue to disinfect shared surfaces.

Remain in isolation at home until risk of transmission is low. According to the health department, this means, "You must remain at home isolated until seven days have passed since your symptom onset and you have been fever-free (have a temperature below 100.4 degrees Fahrenheit) for 72 hours without the use of fever-reducing medications and respiratory symptoms are improving."

However, if you are a health care worker or immunocompromised (i.e., HIV, take immunosuppressive medications, stem cell or bone marrow transplant), you must also have two negative COVID-19 tests, 24 hours apart.

If your results are negative, you should still remain home until you are fever-free without the use of fever-reducing medications for at least 24 hours and your symptoms have improved.

"When someone would test negative, it means that their viral load isn't high enough, so there could be a possibility that they could be a false negative, so continuing to watch for symptoms and monitor is the best thing," Kallis said.

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What to do if you think you have COVID-19: a step by step guide - The Dickinson Press

Stem cells in the clinic: how are they regulated? – European Pharmaceutical Review

Dr Roger Barker, University of Cambridge, UK and Eric Anthony, International Society for Stem Cell Research (ISSCR), describe how stem cells are regulated around the world and why this is important for patient safety.

Stem cells are used to aid in the understanding and treatment of a range of diseases. According to the International Society for Stem Cell Research (ISSCR), the potential of stem cells is evident from the use of blood stem cells to treat haematological diseases. Furthermore, clinical trials involving stem cells are currently underway for many other conditions, such as diabetes and Parkinsons disease.

However, due to the relative newness of stem cells as a therapy, tight regulations are required to ensure their use poses no risk to patients and that their translation to the clinic is supported by pre-clinical data.

European Pharmaceutical Reviews Victoria Rees spoke with ISSCRs Public Policy Director, Eric Anthony and Dr Roger Barker, Professor of Clinical Neuroscience at the University of Cambridge, to discover more about the regulations regarding stem cells.

Anthony explained that in the EU, stem cells are considered advanced therapeutics, which are medicines for human use based on genes, tissues or cells. The European Medicines Agency (EMA) determines whether products fall under the advanced therapeutics category based on the level of manipulation of the product and whether it is used homologously or non-homologously. However, one notable exception to this is platelet rich plasma (PRP), which the EMA does not count as an advanced therapy.

Anthony said that the UK currently follows the rules that are adopted in the EU, which is likely to continue into next year at least. He suggested that after the UK discontinues its ties with the EU and its regulations, he expects its regulatory structure will remain similar.

The US Food and Drug Administration (FDA) also defines most stem cell products as advanced therapeutics, explained Anthony, based on minimal manipulation and homologous use. He highlighted that largely, stem cell products across the globe are defined in much the same way.

Barker explained that the key question every regulator has to ask relates to the source of the stem cells, whether in trials or in the clinic and the extent to which they have been manipulated. Other questions that regulators must answer include the consenting process behind the parent cells being used as well as determining what constitutes the final cell product. However, this latter question has proven to be quite complicated as it is often hard to know what every cell in a product is. Also, some therapies are given in an undifferentiated state with the aim of letting them differentiate and mature once grafted, which creates issues for defining the potency of the cells at the time of implantation. As stem cells will differentiate over months into the desired product, regulators need to know the correct processes are in place to ensure that this will happen in the way anticipated and that the right cells will develop out of the grafted stem cell product.

Another issue he discussed is the stability of stem cells. Once you have frozen them, how stable are they when you wake them up and transplant them at later stages?

In addition, one of the more pressing unresolved questions that Barker emphasised is the genetic variance of stem cells and their products and what this means for the safety of the cells. When researchers conduct whole genome sequencing of the stem cell products, it will convey many genetic variants but knowing what this means for the grafted cell or recipient patient is often an unknown.

Anthony explained that there are a number of consequences to giving patients unregulated stem cell treatments. The main factor is the risk posed to patients; in certain parts of the world, patients have died from stem cell therapies and others in the UK and US have been blinded, paralysed or infected by pathogens.

This, he explained, has a wider impact upon the whole field, as it can negatively impact those who have spent years developing techniques with great rationale which are then undermined by bad practice.

Companies that market unapproved stem cell therapies may not ensure their products are sourced correctly and there is also the danger of mishandling, contamination or undisclosed additives.

Barker highlighted that there is an ethical issue involved in the field of stem cells when unregulated stem cell products are used, it can exploit desperate patients. Therefore, regulations need to ensure patients stay safe and that the industry remains ethical, but not restrict pharma to the extent that it prevents any progress in the field.

A regulator cannot decide what a product is without actually examining the product, said Anthony, explaining this is one of the problems that regulators face. As regulators need to determine the safety and proper sourcing of stem cells physically, they are restricted by both time and financial constraints.

He also highlighted that the current regulations for stem cells mean some companies market their products as PRP, which are regulated as blood products, so are not treated in the same way as advanced therapies. However, these claims are not validated, making them unsubstantiated. As the EMA does not regulate PRP as an advanced therapy product, these companies exploit a loophole in regulation.

Despite this, Anthony does not believe there is a big hole in regulations that is allowing these companies to sell their products.

Instead, he argued that the wider issue for regulators is that these companies exist but the resources to properly inspect facilities and enforce regulations can be problematic. For example, there are up to 70 clinics in the UK, but there needs to be a substantial increase in the number of inspections, according to Anthony.

To improve the regulation of stem cells there needs to be more harmonisation across the globe, said Barker. If regulations across countries and continents could relate to one another, this would enable more consistency and clarity for companies and researchers. Issuing statements, documents and guidelines that anyone can use would be the ideal way to improve the industry, remarked Barker, especially as the definitions are already similar. This could also lead to an effective network for those in the field to connect to the relevant advisors.

Anthony concurred, arguing that there are providers and physicians who could use a better education about how certain products are regulated. For example, he explained, the UK and each EU member state decides its own hospital exemptions for stem cells however, in this regard, there could be better education for physicians about what is classified as an advanced therapy.

Both Barker and Anthony agree that the future of stem cell therapies requires collaboration, such as the synchronised education of clinicians, scientists and regulators. Enabling these groups to work together and earlier would streamline the process and ensure that products are safe and efficacious before going to market.

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Stem cells in the clinic: how are they regulated? - European Pharmaceutical Review

NHS’s oldest IVF clinic at risk of closure amid increasing privatisations – The Guardian

The UKs oldest NHS fertility clinic is at risk of closure and another has been put out to private tender, as IVF provision is increasingly privatised and rationed.

Hospital bosses want to close the internationally renowned department of reproductive medicine at St Marys hospital, Manchester, saying they cannot afford to fund a 10m upgrade of the unit, the Guardian has learned.

In Leeds, the entire NHS provision of fertility and other gynaecology services was put out to tender earlier this year, with private clinics invited to bid for a 10-year contract estimated at 70m to provide reproductive care.

Two years ago North Bristol NHS trust sold off its IVF clinic to a private provider, saying it was no longer feasible because of a reduction in NHS-funded patients.

In England, the proportion of fertility treatment funded by the NHS dropped from 39% in 2012 to 35% in 2017, according to figures published last year by the regulator, the Human Fertilisation and Embryology Authority (HFEA). This is at odds with the rest of the UK, where public funding has remained stable or increased.

When it opened in 1982, four years after the first test tube baby, Louise Brown, was born in nearby Oldham, St Marys was the UKs first fully NHS funded IVF unit. It now performs over 2,000 fertility treatments every year, including around 1,200 IVF cycles, and offers highly specialised fertility preservation for cancer patients. It is also a top research centre, which led on the use of ovarian reserve tests to guide ovarian stimulation, the development of stem cell lines from human embryos, and the effects of IVF on baby birth weights.

The Manchester University NHS foundation trust (MFT) said no decisions had been made over the units future. But staff were briefed last month that the HFEA and local clinical commissioning groups (CCGs) had been told that all licensed treatment and research on the site may end by April 2021 if an alternative solution cannot be found.

MFT, which runs the hospital, is also exploring options including redeploying services and some of its 107 staff including many highly specialised roles but confirmed to staff that closure was a possibility.

The Guardian spoke to 10 members of staff at St Marys aware of the mooted closure. One said they understood the matter to be settled: St Marys have taken a proposal to the MFT group board to discontinue the IVF service and the group board have said, Yes, OK. How they discontinue it is what they need to decide next, they said.

If the change goes ahead, CCGs, which fund fertility treatment, will have to pay private clinics to carry out IVF and other fertility services. But staff at St Marys warn that the private sector will not be able to carry out some of the most specialised services currently offered by the NHS.

We offer highly specialised procedures in the NHS which private providers wont touch because they dont make money and are too difficult. For example, we aim to see women diagnosed with cancer within a week who want to freeze their eggs before they start chemotherapy. Many of these women are already very poorly and need really high quality anaesthetic care during egg collection, and that is just not available in the private sector because of the medical complications, said one source.

They added: Private clinics are also unlikely to help patients with kidney problems or heart problems. But when they come to us, we can address these issues before they begin IVF: a huge advantage of being part of a multi-disciplinary NHS Trust. Those patients will be disadvantaged if this happens.

They also expressed concerns about screening procedures in the private sector. In the NHS, anyone applying for fertility treatment undergoes a series of stringent checks, including an assessment of the welfare of the child: Our checks and ethics advisory committee often flag issues including prison sentences, a serious history of domestic violence, even people on the sex offender register. At private clinics they dont do anything like the same background checks.

A number of separate proposals were put to MFT to try to save some or all of the clinic, including turning the service into a social enterprise and forming a partnership with a private provider, as is being proposed in Leeds.

The deadline to apply to run the Leeds service was 23 March, the day the government announced the coronavirus lockdown in the UK. Shortly afterwards, clinics stopped all new treatments and the HFEA ordered private and NHS clinics to stop treating patients in the middle of an IVF cycle by 15 April.

A spokesperson for the MFT, which runs St Marys hospital, said no decision had been taken to shut the clinic permanently.

They said: Services provided by the department of reproductive medicine at St Marys hospital are regularly reviewed as part of a usual cycle to ensure that we continue to provide the best possible care and treatments for all our service users. No decisions have been made, therefore it would be inappropriate to provide any further detail before the outcome of any review has been finalised.

The HFEA said it could not disclose informal discussions between clinics and inspectors.

Many St Marys staff are worried not just about their patients and their jobs, but the logistics of closing down the clinic. Moving thousands of sperm samples and embryos held in freezers, for use in both treatment and research, was a mind-boggling challenge, said one.

One staff member said: Although possible relocation was mentioned, the fact that no viable alternative has been identified and that the cost was described as being too high left us thinking that this is not being explored and that closing the unit is the direction of travel. We are worried for our jobs but our biggest concern is for our patients, particularly those with the most complex needs who cannot be served elsewhere without high costs.

IVF provision has been put under pressure, nationally, by NHS funding cuts over the past decade leading to a postcode lottery of provision. Now only a minority of English CCGs offer the recommended three funded IVF cycles, with some refusing to fund any NHS fertility treatment at all.

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NHS's oldest IVF clinic at risk of closure amid increasing privatisations - The Guardian