Category Archives: Stem Cell Treatments

BOSTON & BORDENTOWN, N.J.--(BUSINESS WIRE)--Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) and Caelum Biosciences today announced the initiation of the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care (SoC) therapy in AL amyloidosis. The CARES clinical program includes two parallel Phase 3 studies one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease and will collectively enroll approximately 370 patients globally. Enrollment is underway in both studies. The primary objective of the clinical program is to assess overall survival.

In AL amyloidosis, misfolded amyloid proteins can build up in many organs throughout the body, including the heart and kidneys, causing significant damage to these organs and impairing their function. While current treatments address the bone marrow disorder that creates the misfolded amyloid proteins, there are no approved therapies for the significant organ damage the disease causes, said John Orloff, M.D., Executive Vice President and Head of Research and Development at Alexion. CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from these organs. Data from Phase 1 studies suggest that this treatment approach may improve organ function and long-term survival. We look forward to investigating this further in the Phase 3 clinical program.

AL amyloidosis is particularly devastating when it affects the heart, with median survival in these patients of less than one year following diagnosis, said Michael Spector, President and Chief Executive Officer of Caelum. Long-term survival data from AL amyloidosis patients treated with CAEL-101 in the Phase 1a/1b study showed that 78 percent were still alive after a median follow-up time of more than three years. We recognize the urgent need for new treatments that address the organ damage caused by AL amyloidosis and are working together with the AL amyloidosis community and Alexion to advance the Phase 3 clinical program as quickly as possible.

About the CARES Phase 3 Clinical Program

The CARES clinical program consists of two parallel double-blind, randomized, event-driven global Phase 3 studies, which are evaluating the efficacy and safety of CAEL-101 in AL amyloidosis patients who are newly diagnosed and nave to standard of care (SoC) treatment (cyclophosphamide-bortezomib-dexamethasone (CyBorD) chemotherapy). One study is enrolling approximately 260 patients with Mayo stage IIIa disease and one study is enrolling approximately 110 patients with Mayo stage IIIb disease. The studies will be conducted at approximately 70 sites across North America, the United Kingdom, Europe, Israel, Japan, and Australia.

In each study, participants are being randomized in a 2:1 ratio to receive either CAEL-101 plus SoC or placebo plus SoC once weekly for four weeks. This will be followed by a maintenance dose administered every two weeks until the last patient enrolled completes at least 50 weeks of treatment. Patients will continue follow-up visits every 12 weeks.

The primary study objectives are overall survival and the safety and tolerability of CAEL-101. Key secondary objectives will assess functional improvement in the six-minute walk test (6MWT), quality of life measures (Kansas City Cardiomyopathy Questionnaire Overall Score & Short Form 36 version 2 Physical Component Score) and cardiac improvement (Global Longitudinal Strain, or GLS).

Phase 2 Study Results

The Phase 2 open-label dose escalation study was conducted to investigate higher doses of CAEL-101 than had been evaluated in Phase 1 studies with a primary objective to identify the best dose to advance into Phase 3 development. The study evaluated the safety and tolerability of CAEL-101 in 13 AL amyloidosis patients at three study sites who received up to 1000 mg/m2 of CAEL-101 (two times the Phase 1 dose) administered in combination with SoC treatment. The study met its primary objectives, supporting the safety and tolerability of CAEL-101 and the selection of the 1000 mg/m2 dose for the Phase 3 study.

Phase 1a/1b Long-Term Follow-Up Results Presented at ISA 2020

As previously reported, the Phase 1a/1b study of CAEL-101 was the first clinical trial to demonstrate improvement in cardiac function via GLS after treatment with an amyloid fibril targeted therapy in AL amyloidosis patients with amyloid cardiac involvement. New long-term follow-up data from the Phase 1a/1b study will be presented at the virtual International Symposium on Amyloidosis (ISA), September 14 to 18, 2020, in the poster titled, Long term follow-up of patients with AL amyloidosis treated on a phase 1 study of Anti-Amyloid Monoclonal Antibody CAEL-101 (Abstract #342, Divaya Bhutani, M.D., et. al, Columbia University Medical Center). These data demonstrate 78 percent survival (15/19) at a median follow-up of more than three years (37 months) in AL amyloidosis patients treated with CAEL-101 as well as durable organ response among evaluable patients, further supporting the advancement of CAEL-101 into Phase 3 development.

About CAEL-101

CAEL-101 is a first-in-class monoclonal antibody (mAb) designed to improve organ function by reducing or eliminating amyloid deposits in the tissues and organs of patients with AL amyloidosis. The antibody is designed to bind to misfolded light chain protein and amyloid and shows binding to both kappa and lambda subtypes. In a Phase 1a/1b study, CAEL-101 demonstrated improved organ function, including cardiac and renal function, in 27 patients with relapsed and refractory AL amyloidosis who had previously not had an organ response to standard of care therapy. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.

About AL Amyloidosis

AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded immunoglobulin light chains produced by plasma cells aggregate and form fibrils that deposit in tissues and organs. This deposition can cause widespread and progressive organ damage and high mortality rates, with death most frequently occurring as a result of cardiac failure. Current standard of care includes plasma cell directed chemotherapy and autologous stem cell transplant, but these therapies do not address the organ dysfunction caused by amyloid deposition, and up to 80 percent of patients are ineligible for transplant.

AL amyloidosis is a rare disease but is the most common form of amyloidosis. There are approximately 22,000 patients across the United States, France, Germany, Italy, Spain and the United Kingdom. AL amyloidosis has a one-year mortality rate of 47 percent, 76 percent of which is caused by cardiac amyloidosis.

About Alexion

Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. As a leader in rare diseases for more than 25 years, Alexion has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG) and neuromyelitis optica spectrum disorder (NMOSD). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D) as well as the first and only approved Factor Xa inhibitor reversal agent. In addition, the company is developing several mid-to-late-stage therapies, including a copper-binding agent for Wilson disease, an anti-neonatal Fc receptor (FcRn) antibody for rare Immunoglobulin G (IgG)-mediated diseases and an oral Factor D inhibitor as well as several early-stage therapies, including one for light chain (AL) amyloidosis, a second oral Factor D inhibitor and a third complement inhibitor. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, metabolic disorders and cardiology. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. This press release and further information about Alexion can be found at: http://www.alexion.com.

[ALXN-P]

About Caelum Biosciences

Caelum Biosciences, Inc. (Caelum) is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelums lead asset, CAEL-101, is a novel antibody for the treatment of patients with amyloid light chain (AL) amyloidosis. In 2019, Caelum entered a collaboration agreement with Alexion under which Alexion acquired a minority equity interest in Caelum and an exclusive option to acquire the remaining equity in the company based on Phase 3 CAEL-101 data. Caelum was founded by Fortress Biotech, Inc. (NASDAQ: FBIO). For more information, visit http://www.caelumbio.com.

Forward-Looking Statement

This press release contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Alexion and Caelum, including statements related to: the safety and efficacy CAEL-101 as a treatment for AL amyloidosis; CAEL-101 has the potential to be the first treatment to target and remove the amyloid deposits from the heart, kidney and other organs; data from the Phase 1 studies suggest that the treatment approach may improve organ function and long-term survival and enrollment of the Phase 3 trials. Forward-looking statements are subject to factors that may cause Alexion's and Caelums results and plans to differ materially from those expected by these forward looking statements, including for example: the anticipated safety profile and the benefits of the CAEL-101 may not be realized (and the results of the clinical trials may not be indicative of future results); the inability to enroll and complete the Phase 3 trial; results of clinical trials may not be sufficient to satisfy regulatory authorities; results in clinical trials may not be indicative of results from later stage or larger clinical trials (or in broader patient populations); the possibility that results of clinical trials are not predictive of safety and efficacy and potency of our products (or we fail to adequately operate or manage our clinical trials) which could cause us to discontinue sales of the product (or halt trials, delay or prevent us from making regulatory approval filings or result in denial of approval of our product candidates); the severity of the impact of the COVID-19 pandemic on Alexions or Caelums business, including on commercial and clinical development programs; unexpected delays in clinical trials; unexpected concerns regarding products and product candidates that may arise from additional data or analysis obtained during clinical trials or obtained once used by patients following product approval; future product improvements may not be realized due to expense or feasibility or other factors; delays (expected or unexpected) in the time it takes regulatory agencies to review and make determinations on applications for the marketing approval of our products; inability to timely submit (or failure to submit) future applications for regulatory approval for our products and product candidates; inability to timely initiate (or failure to initiate) and complete future clinical trials due to safety issues, IRB decisions, CMC-related issues, expense or unfavorable results from earlier trials (among other reasons); future competition from biosimilars and novel products; decisions of regulatory authorities regarding the adequacy of our research, marketing approval or material limitations on the marketing of our products; delays or failure of product candidates to obtain regulatory approval; delays or the inability to launch product candidates due to regulatory restrictions, anticipated expense or other matters; interruptions or failures in the manufacture and supply of our products and our product candidates; failure to satisfactorily address matters raised by regulatory agencies regarding our products and product candidates; uncertainty of long-term success in developing, licensing or acquiring other product candidates or additional indications for existing products; the adequacy of our pharmacovigilance and drug safety reporting processes; failure to protect and enforce our data, intellectual property and proprietary rights and the risks and uncertainties relating to intellectual property claims, lawsuits and challenges against us; the risk that third party payors (including governmental agencies) will not reimburse for the use of our products at acceptable rates or at all; delay of collection or reduction in reimbursement due to adverse economic conditions or changes in government and private insurer regulations and approaches to reimbursement; adverse impacts on supply chain, clinical trials, manufacturing operations, financial results, liquidity, hospitals, pharmacies and health care systems from natural disasters and global pandemics, including COVID-19 and a variety of other risks set forth from time to time in Alexion's filings with the SEC, including but not limited to the risks discussed in Alexion's Quarterly Report on Form 10-Q for the period ended June 30, 2020 and in their other filings with the SEC. Alexion disclaims any obligation to update any of these forward-looking statements to reflect events or circumstances after the date hereof, except when a duty arises under law.

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Alexion and Caelum Biosciences Announce Start of Phase 3 Studies of CAEL-101 in AL Amyloidosis - Business Wire

Im not saying my skin has aged significantly this year but my six-year-old recently asked me why I had asix-pack on my forehead. After six months of stressful days, sleepless nights and home-school nightmares, its become apparent that matters need taking in hand. And theres something about the early autumn, with its nip in the air, and its new-found appreciation for proper, non-negotiable routines that feels right for a skincare overhaul.

Fortunately, the seasons big skincare launches abound with new ways to reset your skin, from serious, sleeves-rolled-up jump-starting regimens, which last up to a month and deliver a rapid burst of intense reconditioning, to new strategies that claim todetoxify your daily regime without your having to somuch as cut down on caffeine.

Sorting out most modern-day skincare complaints from sluggish cell turnover caused by tiredness and stress to overstimulated skin (a result of using products not suited to one another), to undeserved lacklustre complexions caused by outdated products requires a bit of areboot. It could be a facial; it could be a peel. But inthedays when weve all become beauty hobbyists, performing DIY facials like pros, it could also be a pleasurable at-home experience for the price of a couple ofdecent salon treatments.

Dr Anita Sturnham, a London-based GP specialising in dermatology who launched her own excellent skincare line,Decree, last year, became so aware of how many of herpatients especially those suffering with breakouts, pigmentation and dehydration needed a thorough overhaul that she recently launched her own two-week Skin Reset Kit. Sturnham believes 90 per cent of the skin issues she sees are self-inflicted simply by using the wrong products and that stripping your skincare right back is an essential step for getting the best from your skin.

Another recent reset kit is Budapest brand Omoroviczas The Cure programme, which in nine days cycles through anacid phase (to resurface), a remineralise phase (tostimulate microcirculation) and a reconstruct phase (forrenewed elasticity). You can repeat it every three months, ideally to coincide with the change of seasons.

One of the best known brands for an intensive treatment is that of anthropologist-turned-dermatologist Dr Phillip Levy. A Geneva-based wound-healing specialist,he believes that only via resetting can you achieve some of the most visible anti-ageing results andhis Ultimate Stem Cell Spring Homecure (the springmeans spring clean but it can bestarted any time)is legendary. Manyofthe cures we have studied over the years seem to be everyday products nicely repackaged, he says.But to have something truly transformational, theyneed go deep enough to stimulate your own collagen, elastin and hyaluronic acid production, and last four weeks or even eight or more.

Its true that these regimes work best when they feel elevated from the everyday. And when it comes to products with a built-in sense of occasion, no one does it better than Sisley. Even before you get to the science and the scents, and the textures it has a particular French earnestness that makes every product feel like an event. Which must make LIntgral Anti-Age La Cure, its new skin-resetting regimen, at 775 for a four-week supply, a veritable tapis rouge.

For each of the four week-long phases Impulse, Reset, Consolidate, Renaissance theres a phial of creamy serum, about the size of an eye cream. You use each one for seven days, applying eight pumps of product morning and night (this feels a lot, and it takes a few minutes to properly sink in). You can follow with eye cream or moisturiser if you want to, but I didnt feel the need. The bottles have been slightly overfilled so as to ensure you dont run out, but when you get to the end of the seventh day, you must start the next one nonetheless. (This feels wasteful, but I was assured by Sisleys training manager Lorna Green that I could save up these last drops and use them a couple of weeks after the course, as a further boost).

The formulation works on the skins mitochondria the batteries where cellular energy is stored. Theylose the ability to restore themselves over time, particularly during intense periods of stress and hormonal changes, so following either one of those would be an ideal time to try it. The breakthrough wasthe discovery of the mechanisms of a process called autophagy (for which Japanese biologist Yoshinori Ohsumi won the Nobel Prize for medicine in2016), whereby damaged cell components such as mitochondria destroy themselves to protect the rest ofthe cell. La Cure boosts the elimination of these wasteelements, allowing the healthy cells left behind tosoak up energy and regenerate promoting the appearanceof healthier, more youthful skin. In skincare terms, this is no mean feat.

Where the real technology is happening, it wont be long before they eclipse the big jars of moisturiser completely

It sounds intense and its certainly super-active: by the end of the first week I had a small, yet determined, spot on my chin (which I cannot believe was a coincidence) and a little more redness than usual, too. The following week, cell detoxification week, my skin was starting to feel unusually smooth. By the end of the fourth week, my skin was smoother and clearer than I can ever remember. Its also, though, a real example of skincare as self-care: as much as the thought of a radically rejuvenated complexion, the daily reminder that youve sidelined your usual clutter of products in favour of something exceptional is almost enough to bring on a glow.

With any reset complete, the focus should then be on keeping your skin detoxified and renewed. One update worth looking at is a serum. Whereas the luxurious facecream at the end of your regime used to be the jewel in any skincare crown, these dayslightweight serums are where the real technology ishappening, and it wont be long before they eclipse thebig jars of moisturiser completely.

While serums used to be a targeted addition to your face cream specifically for age spots, say, or wrinkles the best new ones are genuinely impressive all-rounders. Este Lauder has just revamped Advanced Night Repair, one of the first ever mainstream skin serums and a product so ubiquitous that among beauty editors it has acronym status. (See also: Cliniques DDML, aka Dramatically Different Moisturizing Lotion). And in October, Suqqu, which hails from Japan where serums have been the mainstay of skincare much longer than here will launch Vialume, its most advanced line yet, containing glucosamine and amino-acid derivatives designed to targetall five key characteristics of great skin: moisture, firmness, smoothness, translucency and brightness.

Another product gaining increasingly scientific status is face oil, which should no longer be dismissed as the preserve of the militantly natural beauty brigade. Augustinus Bader, the world-leading wound-healing specialist whose Rich Cream was the runaway skincare success of 2018, has just launched The Face Oil, which contains a slew of delicious-sounding oils argan, babassu, hazelnut, karanja as wellas a healthy dose of TFC8, the complex of vitamins, amino acids and synthesised molecules that has made Baders products famous. Meanwhile, RVive Glow Elixir Hydrating Radiance Oil is bronze in colour and slightly shimmering although unusually, it leaves no evidence of glittery particles. Alongside a cocktail of seed oils, it contains the brands signature Bio-Renewal Protein, rendering it a real skincare/make-up hybrid and a great transitional product for this time of year.

Another need-to-know and a great option particularly for younger skin is Rihannas new Fenty Skin line. Theres Total Cleansr, which would work especially well as the first step of a double-cleanse, and Fat Water, which Ri-Ri calls a toner-serum hybrid but its the Hydra Vizor daily moisturiser that triumphs. This so-called Invisible Moisturizer has an SPF30 that leaves no white cast to the skin whatsoever, primarily because the product has a gorgeous pinkish hue and a blurring effect. The ghostly pallor left behind by so many SPF products is a particular challenge to people of colour and this range was designed to work seamlessly with make-up on all skin tones. It also smells great juicy with just the slightest medicinal tinge and comes in a refillable tube.

The recently launched skincare brand U Beauty wants to reset not just your skin, but the way you think about your whole regime. Were all doing too much, says founder Tina Craig, who until two years ago was working as an influencer/ambassador for the worlds biggest skincare brands but admits being as confused as anyone about what to use; she had ended up with a 13-step skincare routine. I started noticing that everyone Iknew had skin that looked translucent, which is not how it should look, she says. Then I looked at my grandma and relatives in Korea, and their skin was not like that. It was thick. Dense. Firm.

U Beauty is her answer to what she calls the cosmeticconfusion. Its first product, the Resurfacing Compound (which sold out three times on UK stockist Net-aPorter), was designed to replace toner, vitamin C, hyaluronicacid, AHAs, physical exfoliants, antioxidant serums and retinol products. From this month, theres alsoSuper Smart Hydrator, a moisturising serum that seeks out damaged cells and only treats the skin where itneeds it. Bookend these two with cleanser and SPF, saysCraig, and youre good to go.

Finally, could we reset the way we use products altogether? New US brand Noble Panacea is overseenby ascientific heavyweight: Sir Fraser Stoddart, who was awarded the 2016 Nobel Prize in chemistry. A microscopic delivery system releases its active ingredients into the skinin a programmed sequence, and it comes in individualdoses packed in mini sachets to ensure the optimal amount of these ingredients stays potent until theminute it reaches your skin.

On the one hand, they feel counter to the idea of luxury face creams more like a free sample from a beauty hall but on the other, the boxes made from renewable materials and ultra-hygienic 0.5ml doses feel modern and Covid-safe. (You can send them for recyling in a complimentary envelope to TerraCycle, with which the brand has partnered). And if nothing else, as its global ambassador ithas snapped up the actress Jodie Comer, who must havebeen pursued by every beauty company under the sun and as far as I can tell, theres no sign of a six-pack on her forehead.

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The great beauty reset: how to reboot your skin - Financial Times

If you were to read many of the adverts for stem cell therapy that you can find online, you would be forgiven for believing that stem cell therapy is nothing short of a panacea. It is, according to those ads, able to improve all sorts of conditions, from knee pain and osteoarthritis, hair loss to heart disease, diabetes and even autism.

Theres just one problem theres little science behind many of the claims.

Stem cells are only approved for use in treating certain cancers and blood disorders, yet a search for the term on Facebook or Google will return details of a large number of clinics offering treatments for many other conditions.

The harsh reality is that while there is a lot of promising research being undertaken in this area, nobody should be parting with large sums of money for what may be currently no more than snake oil treatments, according to Noel Caplice, who is professor of cardiovascular sciences in the department of medicine at University College Cork and a consultant cardiologist.

Caplice, who has more than 20 years experience monitoring stem cell research as part of his studies into heart disease, told The Irish Times that we should all be suspicious about the range of different ailments clinics are willing to treat with stem cells.

There should be red lights flashing and alarm bells ringing. No therapy treats everything from Parkinsons disease to multiple sclerosis to heart disease to knee pain thats idiotic. Medicine just doesnt work like that.

True stem cell therapy is extremely complex because you have to refine the type of cell youre going to give to the organ it will be used in, and there are different challenges in different organs. Legitimate scientists are working on these things, but they are not there yet. Its an incredibly difficult area of research.

Stem cells have long been considered a great hope of medicine. They are the bodys building blocks, the cells from which other types of cells develop. Under the right conditions they can be encouraged to become any other type of cell found in the body, such as blood cells, brain cells, heart muscle cells and so on.

At its simplest, stem cell therapy involves cultivating stem cells in the lab, guiding them to grow into specific types of other cells, and then injecting those healthy cells into diseased parts of the body where in certain circumstances they have been shown to help the bodys own cells to fight disease.

This effect was first shown around 30 years ago in experiments on mice. However, things have not been all plain sailing since then.

The initial promise of stem cells has not been fulfilled, and whats happened in the meantime is that commercial clinics offering treatments have gotten ahead of the science, said Caplice.

The first trials in mice showed incredible regeneration, but their progress turned out not to be so straightforward. When the initial trials were replicated, the researchers couldnt reproduce the same early data.

While research is ongoing and there have been a few significant breakthroughs using stem cells, notably in the case of combined stem cell and gene therapy for thalassemia and leukaemia, that has not stopped unscrupulous clinics from marketing all sorts of treatments under the banner of stem cell therapy.

In the private world anything goes. There are people spinning this therapy for multiple sclerosis, Parkinsons, solid organ deterioration a whole range of problems. Ten years ago there was even a boat operating off the west Cork coast that was treating people for multiple sclerosis using stem cells. This has been going on for decades in this parallel world, and its mostly driven by money, Caplice said.

According to Frank Barry, professor of cellular therapy at the regenerative medicine institute with NUI Galway, a negative side effect of the off-label use of stem cells is that it makes it harder for researchers to raise money for research.

It damages our reputation to have people doing this. We all get painted with the same brush, and it makes it much harder to raise money. When these maverick clinics are exposed for their bad practices, there is a blow-back effect on us even though were completely unconnected, he said.

The sad thing is that there are genuinely quite exciting applications of stem cell therapy that will be possible in the future. All of these are undergoing scientifically-designed clinical trials that are carefully done, carefully managed, are placebo-controlled, double blind the works. Some of these trials are going quite well and suggest that the outcome will be good.

The biopharmaceutical company Takeda Ireland, for example, is currently developing a treatment for inflammatory bowel disease using the results of a trial that was conducted into stem cells.

Thats a dreadful condition that blights peoples lives. This is a new treatment so thats very exciting. That project achieved market authorisation because of careful work done over many years in high quality clinical trials, said Barry.

My own work is in the treatment of arthritis with stem cell therapy, and thats also going well. Were in the middle of a big trial thats been running in a number of clinical sites around Europe, and we think that when its finished itll be positive.

Running trials like these takes a lot of time and a lot of money. In the meantime bad actors are stepping into the gap that exists between promising early results and actual rigorous and robust science.

The harsh reality is that you cant recommend that a patient has stem cell therapy for anything that isnt directly authorised. If someone does that now theyre getting it off-label, so to speak, and basically theyre taking their chances, said Barry.

I can understand why someone might want to do that, but its not authorised. I would hold out a great deal of hope that when all the work is done there will be strong proof supporting this kind of treatment. But at the moment you can spend a huge amount of money essentially for nothing because there isnt the evidence to support treatment.

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Stem cell therapy: why we need to be suspicious about cure-all claims - The Irish Times

The Abu Dhabi Stem Cell Centre (ADSCC) has now treated more than 2,000 patients suffering from Covid-19, with 1,200 already fully recovered from the effects of the virus.

ADSCC announced today that it had succeeded in ramping up the number of treatments from 73 in the initial clinical trial.

The large increase was as a result of a major effort by staff at the centre to treat as many people as possible following the UAE Government's decision to make it available free of charge to all moderate-to-high risk Covid-19 patients in the country.

Also read: UAE expects Covid-19 vaccine by end of 2020 or early 2021

The Government's decision came after the treatment, branded UAECell19, demonstrated efficacy and an impressive safety profile reflected in the absence of significant changes in adverse events reported, an absence of any unexpected serious reactions (such as anaphylaxis, allergic reactions or sudden death) and an absence of any lung complications as determined by radiological exams from inhalation of the nebulized product.

A team of doctors and researchers at ADSCC, led by Dr Yendry Ventura, announced in May that they had developed a new treatment for Covid-19 patients. UAECell19, an autologous stem cells based therapy, appears to help the body fight the virus and makes the disease less harmful.

Following an initial trial, researchers were able to conclude that UAECell19 reduced the duration of hospitalisation from 22 days to just six, when compared to patients who had received standard treatment.

Further analyses revealed that patients treated with the stem cells were 3.1 times more likely to recover in less than seven days than those treated with standard therapy, and 67 per cent of the patients who received the stem cells treatment owed this recovery to the new treatment.

ADSCC has since secured intellectual property rights protection for UAECell19, which opens the way for the treatment to be shared widely so more patients can benefit.

ADSCC said researchers are at various stages of several investigatory efforts to establish effectiveness (Phase 3 trial), optimal efficacy of dosage, and efficacy to treat other respiratory diseases such asthma, COPD, and cystic fibrosis.

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UAE stem cell therapy for coronavirus treats over 2000 patients, 1200 fully recover - Khaleej Times

Summary

A review of 423 patients treated at MSK finds that most people with cancer dont fare any worse if they get COVID-19 than other people who are hospitalized for that infection.

In the early days of the COVID-19 pandemic, many doctors worried that people undergoing treatment for cancer would do particularly poorly if they became infected with the virus that causes the disease. Thats because treatments for cancer, especially chemotherapy, can lower a persons immune defenses and put them at higher risk for all kinds of infections.

But according to a new study from Memorial Sloan Kettering published June 24 in Nature Medicine, most people in active cancer treatment dont fare any worse if they get COVID-19 than other people who are hospitalized with the infection. Further research is needed to look at the effects of certain drugs mainly immunotherapies called checkpoint inhibitors, which did seem to make COVID-19 worse. But the researchers say their findings suggest that no one should delay cancer treatment because of concerns about the virus.

If youre an oncologist and youre trying to figure out whether to give patients chemotherapy, or if youre a patient who needs treatment, these findings should be very reassuring, says infectious disease specialist Ying Taur, one of the studys two senior authors.

Infectious disease expert Ying Taur has cared for many MSK patients who were hospitalized with COVID-19.

The study looked at 423 MSK patients diagnosed with COVID-19 between March 10 and April 7, 2020. Overall, 40% were hospitalized for COVID-19, and 20% developed severe respiratory illness. About 9% had to be placed on a mechanical ventilator, and 12% died. The investigators found that patients taking immunotherapy drugs called immune checkpoint inhibitors were more likely to develop severe disease and require hospitalization. But other cancer treatments, including chemotherapy and surgery, did not contribute to worse outcomes.

The big message now is clear: People should stay vigilant but not stop or postpone checkpoint immunotherapy or any other cancer treatment.

Factors that did make COVID-19 worse were the same as those seen in studies of people who didnt have cancer. We found that being older, as well as preexisting conditions like heart disease and diabetes, are all drivers of severe COVID-19 illness, says MSK Chief Medical Epidemiologist Mini Kamboj, the studys other senior author. This wasnt surprisingbecause these connections are well established.

Although the study wasnt large enough to make determinations about every treatment and every cancer type, patterns did emerge. Dr. Taur says there was initially great concern about people receiving high doses of chemotherapy for leukemia, especially those who had recently undergone bone marrow or stem cell transplants. Thats because transplants require a persons entire immune system to be wiped out with chemotherapy before they receive new blood cells, leaving them susceptible to all kinds of infections.

Surprisingly, though, Dr. Taur cared for recent transplant recipients who were infected with COVID-19 but didnt have any symptoms. If you think about it more, it makes sense, he says. Most of the complications seen in people with COVID-19 seem to be caused by the bodys immune response to the virus.

On the other hand, immunotherapy drugs called checkpoint inhibitors work by freeing up the immune system to attack cancer. Patients receiving these agents may develop a more robust reaction to the virus that causes COVID-19. This may explain why this study observed higher rates of complications in people with COVID-19 infection who were treated with checkpoint inhibitors.

Even with immune checkpoint inhibitors, though, these findings should not affect whether patients get treated. Everyone who needs these drugs should still receive them, Dr. Kamboj says. Its just important for doctors to be extra vigilant about testing and monitoring for the virus and for people with cancer to take extra precautions to avoid infection.

A study published in May 2020 by MSK immunotherapy expert Matthew Hellmann focused exclusively on people with lung cancer who got COVID-19. The researchers didnt find the same risks from immune checkpoint drugs as this Nature Medicine study. More research in this area is needed.

Dr. Kamboj notes that one aspect of this research that sets it apart from other studies is that it included at least 30 days of follow-up after a COVID-19 diagnosis. Also, it reported severe respiratory illness as a main outcome rather than death.

Having that follow-up time is something that a lot of other studies have not included because everyone is in a rush to get their data out. In addition, reporting death rates can overestimate infection-related mortality, especially in the early phase of an epidemic, Dr. Kamboj says. Also, the clinical spectrum and course of this disease is still not fully understood, especially in people with cancer. We wanted to give patients enough time to recover and make sure they didnt need to be readmitted to the hospital.

Even with immune checkpoint inhibitors, though, these findings should not affect whether patients get treated. Everyone who needs these drugs should still receive them.

She adds that another strength of the study is that patient outcomes were not affected by constraints caused by a lack of space or supplies even though MSK is in the heart of the COVID-19 epicenter in New York City, where other hospitals faced overcrowding and other issues. This gave researchers a true picture of how cancer patients fare with COVID-19. We saw a surge during the peak of the epidemic in New York, but everyone got the care they needed, Dr. Kamboj explains. We had enough ventilators for everyone who needed them. We never had to make decisions about who to admit to intensive care because of a lack of critical equipment.

Drs. Taur and Kamboj agree that this is just one of many studies that will need to be done on the connections between cancer and COVID-19. We still need to find out more. We need to look at the connections between COVID-19 and particular types of cancer as well as outcomes related to specific chemotherapy drugs, Dr. Taur concludes. But the big message now is clear: People should stay vigilant but not stop or postpone checkpoint immunotherapy or any other cancer treatment.

Read more here:
Should You Delay Cancer Treatment Because of COVID-19? Study Says Most Treatments Dont Worsen Coronavirus Infection - On Cancer - Memorial Sloan...

How to help reverse the damage.

As opposed to visiting your dermatologist to treat a bout of hormonal acne or undergo a hyperpigmentation laser session, hair loss is something that most people are a little more reticent to discuss. Women especially might feel embarrassed or ashamed to admit that they are experiencing above-average thinning, when in reality,50 percent of women will eventually see excessive hair loss. Stress is just one of the many culprits that can cause you to shed upwards of 100 hairs in a dayas compared to the normal 50100 hairsbut considering that were in a global pandemic, in addition to addressing systemic police brutality, wed say that the timing is ripe for a little bit of balding.

Accepting that hair loss might happen right now is just step one. Step two is realizing that you can address it, even if you cant fix patchiness overnight. We spoke with dermatologist Dr. Jeanine Downie of Image Dermatology, and Shab Reslan, hair health expert at HairClub, to learn more about the relationship between stress and thinning hair, as well as the products and treatments that can help reverse the damage.

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Your hair is never just stagnantthe follicles, or roots of your hair, are in a constant cycle of growing, shedding, and resting. Dr. Downie explains that the anagen or growth phase is genetically determined, and according to Reslan, it can last anywhere from three to five years (sometimes longer). The catagen or transitional phase occurs after the anagen phase, signalling the end of active hair growth for about two to three weeks. Finally, theres the telogen or resting phase, which lasts for roughly three months, wherein the hair remains in the follicle until it is pushed out by new growth. According to Dr. Downie, this is the phase that can be made worse by significant stress, which shifts your hair into the resting phase when it is more easily shed.

While hair loss is a constant problem for which people seek treatment, both Dr. Downie and Reslan are seeing more patients during this period of extreme stress and anxiety, even those who have never struggled with hair thinning before. When youre feeling stressed, your body is experiencing an increase in its cortisol levels. Dr. Downie explains, Cortisol is pumped out of your adrenal glands, which sit on top of your kidneys. Once this is in your system, cortisol interacts with your hormones and can cause your hair to go into the resting phase. This resting phase is when your hair is most susceptible to falling out. And aside from seeing increased hair shedding, she notes that stress can also cause your scalp to itch, which might in turn lead you to scratch and prompt those hairs to fall out.

Says Reslan, The true culprit of stress-induced hair loss is inflammation and its damaging effects on the cells in our body, namely our hair follicles. New studies have shifted the focus on hair loss from managing stress hormones, such as cortisol, to instead preventing stress itself. This is why were noticing more adaptogens (natural stress relievers) being incorporated in hair supplements, hair products, and wellness products all around. In other words, incorporating an at-home wellness practice like meditation or acupressure might be a wise decision right now.

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Dr. Downie urges her patients to remember that treating any type of hair loss is a long gamethe only real short-term options are regularly trimming your hair and using deep-penetrating protein conditioners at home. Reslan breaks the treatment cycle into four pillars: using a gentle shampoo and conditioner to maintain a healthy scalp; using topicals to nourish your follicle and stimulate growth; taking supplements to boost your nutrient intake and reinvigorate your hair growth; and visiting your hair-treatment professional to undergo laser sessions.

Navigating the world of hair supplements can be tricky, as there is little in the way of regulation. Dr. Downie recommends Nutrafol or Viviscal to everyone experiencing hair loss, stress-related or not, which can help you see results in four to six months. Be advised, you cannot target hair regrowth to just your headyour hair will grow everywhere.

In terms of lasers, there are a few options that she offers her patients depending on the severity of their case. KeraLase is a treatment option wherein you open the channels of the hair follicle with a laser and then put in Kerafactor, which is a cytokine and stem-cell-rich patented formula that works better than PRP [platelet-rich plasma] to grow hair. And while you may have heard about low-level-laser light therapy caps, she does not recommend them for her patients, nor does she suggest direct PRP treatment. Reslan does reveal that shes seen results from clients and friends who use a laser cap regularly, so when in doubt, speak with your treatment specialist for her own recommendation.

In case you cant get in to see your dermatologist for the foreseeable future, Dr. Downie does endorse using Rogaine (aka Minoxidil), but only the 5-percent foam formulation, although she feels that it is quite sloppy in terms of results. Otherwise, eating a balanced diet, exercising regularly, getting enough sleep, and avoiding any and all heat-styling tools will all promote healthier hair growth and reduce the likelihood of stress-related hair loss. Just remember to be patient with yourselfregrowth is not an overnight process. Says Reslan, Hair grows half an inch every month, so you can expect to see fuller-looking hair around three to four months [after starting treatment and embracing lifestyle changes]. And even though it might be traumatic to experience stress-related hair loss, it is an acute problem, and if you act fast, it is reversible.

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Expert Advice for How to Treat Stress-Related Hair Loss - Coveteur

Two small studies published recently suggested most men hospitalised with COVID-19 are bald, generating headlines around the world.

While this may sound strange, science does offer a plausible explanation.

Male pattern baldness is associated with high levels of male sex hormones called androgens. And androgens seem to play an important role in the entry of SARS-CoV-2, the coronavirus that causes COVID-19, into cells.

So its possible high levels of androgens might increase the risk of severe infection and death from COVID-19.

This hypothesis is important to identify people at risk and raises the possibility of new treatment strategies for COVID-19.

Its been obvious from early in the pandemic. Men are at greater risk of severe infection and death from COVID-19 than women.

There are several possible factors at play here. For one, men are more likely to suffer from chronic conditions known to pose a higher risk of serious illness from COVID-19. These include heart disease and diabetes.

Another is that mens immune systems are not as good as womens at warding off the severe effects of viral infections.

These factors are indirectly influenced by sex hormones. Now it seems sex hormones might also have a direct effect on SARS-CoV-2s ability to enter our cells and establish infection.

In one study of 122 male COVID-19 patients admitted to hospitals in Madrid, 79% were bald about double the population frequency.

Another small study in Spain observed a similar overrepresentaton of baldness among men hospitalised with COVID-19.

Read more: Starting to thin out? Hair loss doesn't have to lead to baldness

Male pattern baldness is strongly associated with a higher level of dihydrotestosterone (DHT), a more active derivative of testosterone, and one of the androgen family of male sex hormones.

Confirming this correlation between baldness and susceptibility to COVID-19 with larger samples, controlling for age and other conditions, would be significant. It would suggest a higher DHT level could be a risk factor for severe COVID-19.

SARS-CoV-2 enters human lung cells when a protein on the virus surface (the spike protein) latches onto protein receptors (ACE2 receptors) embedded in the cells surfaces.

How does this work? Recently scientists discovered that an enzyme called TMPRSS2 cleaves the SARS-CoV-2s spike protein, enabling it to bind to the ACE2 receptor. This allows the virus to enter the cell.

The gene that encodes TMPRSS2 is activated when male hormones, particularly DHT, bind to the androgen receptor (a protein on the surface of cells, including hair cells and lung cells).

So the more male hormone, the more androgen receptor binding, the more TMPRSS2 is present, and the easier it is for virus to get in.

A preliminary, non-peer-reviewed study which correlated the androgen levels of hundreds of people in the UK with COVID-19 severity supports this theory. Higher androgen level was associated with susceptibility to and severity of COVID-19 in men (but not women, who have much lower androgen levels in their blood).

The same researchers showed that inhibiting androgen receptors reduced the ability of SARS-CoV-2s spike protein to bind to ACE2 receptors on stem cells in culture.

Over- or underproduction of androgens in the body causes a variety of conditions in both men and women.

For instance, men with benign prostate enlargement overproduce androgen, as do women with polycystic ovary syndrome.

Many such conditions are treated with androgen deprivation therapy (ADT), which inhibits the production or effect of androgens. For instance, prostate cancer, in which cancer cell growth is fuelled by androgens, is routinely treated with ADT.

Conversely, some people have low androgen production, or mutations that affect the binding and action of androgens such as women with androgen insensitivity syndrome caused by mutations of the androgen receptor.

It will be important to find out whether, as the androgen hypothesis predicts, patients with over- or under-production of male hormones are at greater or lesser risk of COVID-19.

Read more: How can I treat myself if I've got or think I've got coronavirus?

If the androgen link holds up, this would encourage exploration of anti-androgens as a way to prevent and treat COVID-19.

Many anti-androgens are already approved for the treatment of other conditions. Some, like baldness treatments, have been used safely for years or decades. Some, like cancer treatments, can be tolerated for months.

A study which looked at men hospitalised with COVID-19 in Italy showed the rate of infection was four times lower in prostate cancer patients on ADT than in untreated cancer patients.

Perhaps a single dose given to someone who tests positive to SARS-CoV-2, or has just been exposed, would suffice to lower the chance of the virus taking hold.

But we need research to confirm this. Several androgen-suppressing drugs are now undergoing clinical trials to determine whether they reduce complications among men with COVID-19.

It will be important to verify that anti-androgen treatment works in the lungs as well as the prostate, and is effective in cancer-free patients. Wed also need to find out what dose is effective, and when it should be administered.

Anti-androgen treatments have several side effects in men, including breast enlargement and sexual dysfunction, so medical oversight is a must.

The androgen link could go a long way to explaining why men are more susceptible to COVID-19 than women. It also may explain why children younger than ten seem very resistant to COVID-19 because, until puberty, boys as well as girls make little androgen.

The more we know about who is at heightened risk from COVID-19, the better we can target information.

The androgen link also opens up an avenue for the discovery of drugs which might mitigate some of the impact of COVID-19 as it continues to sweep the globe.

Read more: COVID-19's deadliness for men is revealing why researchers should have been studying immune system sex differences years ago

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Coronavirus and sex hormones baldness may be a risk factor and anti-androgens a treatment - The Conversation AU

Stephen Raffone had difficulty breathing. He coughed up sputum and was wheezing. Doctors told him he had chronic obstructive pulmonary disease (COPD), a condition that causes blocked airflow from the lungs.

As a result, he was being treated for stage 4 COPD.

His doctor was also treating him for cellulitis, an inflammatory and painful bacterial skin infection where extremities appear red and swollen and the area can feel hot and tender to the touch, as well as poor circulation.

My legs were beginning to get ulcerated and they were breaking down, said Raffone.

He was administered the Roman Catholic Churchs Last Rites three times several years ago when he was a patient in Richmond University Medical Center.

Raffone, who is now 63, was in need of a lung transplant.

He was a heavy smoker and it took its toll. However, because he was in a weakened state due to other serious health conditions, doctors told him hed never survive the surgery.

The Westerleigh resident, who has been in need of 24-hour care for the last several years, requires the assistance of two nurses who rotate 12-hour shifts.

One, a close family friend, suggested Raffone see a medical specialist who performs stem cell therapy, a procedure where the patients own stem cells are removed, treated and returned to his or her own body after a conditioning regimen.

She contacted Dr. Alexandre M. Scheer of Scheer Medical Wellness and he agreed to see Raffone.

Dr. Alexandre M. Scheer (Courtesy/Stephen Raffone)Staten Island Advance

But since Raffone was unable to leave his home, Scheer visited Raffone for a consultation and to evaluate his condition.

Fast forward a year and a half and Scheer has continued with those visits almost every Saturday free of charge also underwriting the cost for treatments, as well as Uber rides from Manhattan to Staten Island, in order to perform the stem cell procedure.

RAFFONES NURSE SPEAKS

One of Raffones nurses recounted Raffones journey.

She explained that when they started to explore stem cell therapy she placed calls to several doctors, but the biggest thing that jumped out at her was the astronomical cost.

But there was something about Dr. Scheer. And I just knew he was the right one, said the registered nurse for more than 30 years. "He wasnt interested in money. His goal is his patients outcome. Stephen did pay for the first set of treatments, but since then, Dr. Scheer has not taken a dime.

When the patient began treatments, the first therapy was a tremendous boost and then every week after that he was treated for seven weeks. In the beginning, the doctor visited every week and brought whatever supplies was needed. The PRP (platelet rich plasma) treatments are daily.

I draw the blood, I spin the blood," she said. We have a small centrifuge here so it separates the blood. The PRP is given by a nebulizer. It takes about 30 minutes. And once a week he gets a protein enriched plasma, which takes about a half hour, she added.

He has chronic venous ulcerations of the both lower extremities from the knee down, she said.

Raffone has end stage COPD. But since he started the treatments, hes gone to the hospital only once. And he has tested negative for antibody COVID-19.

RAFFONES TREATMENT BEGINS

Raffone was required to install the centrifuge machine with needles and plasma tube, a laboratory device used for the separation of fluids, gas or liquid, based on density. Separation is achieved by spinning a vessel containing material at high speed.

Initially, Dr. Scheer sent a plastic surgeon to my home to perform liposuction, a type of fat-removal procedure used in plastic surgery, where they separate the fat and preserve the stem cells, Raffone said. They did this four times weekly at the beginning. Dr. Scheer has been visiting my home pretty much each week since Sept. 22, 2018. But right now the stem cell therapy is done once a month."

They draw blood out and spin it. Its all done through IV. Right now stem cell infusion is done once a month and daily through a nebulizer. Dr. Scheer does it on Saturday and my nurse and dear friend to Dr. Scheer does it during the week. My house looks like a hospital. Dr. Scheer is keeping me alive and everything is healing up so well, said Raffone.

Stephen Raffone's left leg before stem cell treatment. (Courtesy/Stephen Raffone)Staten Island Advance

Raffone says he wanted to come forward with his account at this time because hes so grateful and especially today when so many negative stories are in the news.

We need some good stories. There are very few people like Dr. Scheer, especially now during the COVID-19 crisis, he said.

My nurse draws the blood and puts it in a centrifuge when the doctor cant make it from the city. But Dr. Scheer is still coming to my house in spite of the COVID-19 crisis," Raffone continued.

Raffone has been confined to a bed one that he says turns you from side to side and upside down. But Dr. Scheer is confident that when restrictions are lifted and physical therapy sessions resume, Raffone will be able to walk.

The stem cell therapy is not only helping to combat Raffones COPD, but it has also helped him with cellulitis on his leg.

Stephen's Raffone healed left leg after stem cell therapy. (Courtesy/Stephen Raffone)Staten Island Advance

Scheer, a staunch supporter of stem cell therapy, has a background in neurosurgery and regenerative medicine. He performs surgery at several surgical centers in Manhattan.

It has to do with the amount of cells your bone marrow," he said. What we do is . . . saturate the body with stem cells. It suppresses the inflammatory response. COVID-19 also is an inflammatory disease. The COVID-19 kills the lungs. So you dont have oxygen going through. The stem cells protect, so you have continual oxygen transfer.

Dr. Scheer, who practices at Sheer Medical Wellness in Manhattan, says you can regenerate yourself.

I want my patients to be fine. I will pay for the patient. Im happy Stephens alive. And then my life is made. Stephen will now be able to walk after physical therapy. He was on 12 liters of oxygen daily. Hes now on two liters. I know his nurse very well and thats how we connected. The stem cell treatment is the appropriate treatment for him. I pay out of pocket because I know the right treatment for his condition," he added.

Dr. Scheer points out in China and in Israel stem cell therapy is the treatment they use for COVID- 19.

Its where you take Eastern and Western medicine and put it together. The patients body and will to live and having the right outlook on life has a lot to do with proper health. Our group is so big. We have 40 different doctors in my practice. Im the medical director, he said. Stem cell treatment is the future of medicine. At $10,000 a treatment, its very expensive. And the number depends on the issue at hand.

THE INITIAL CALL

When Scheer spoke to Raffone, He said I cant get out of bed,' the doctor said. "I drove to Staten Island and I got to know Stephen and his family very well. Its not a one-time treatment. Im seeing him on a weekly basis. There is a relationship that occurs. And thats what matters and thats what keeps people alive. Hope is what keeps them alive. And Im doing this since 2001. The treatment involves platelet enriched plasma that suppresses inflammatory reactions in the lungs. Whats happening is youre able to suppress the inflammatory reaction. His legs and his heart are getting better as well. This is a treatment until we can get him walking.

Scheer says Raffone must undergo physical therapy in oder for him to walk around freely.

And hell be able to travel to my office. Im not giving up on him. Im paying out of pocket. A quarter of my patients, I pay for. Stephen has gone through so much. Hes alive because of stem cell therapy. And due to his lung condition with COVID, he has not contracted it."

Scheer says its been a team effort, with multiple doctors coming into play.

Stephen is keeping himself alive. Im just the tool that can help. I just do the best I can for as many people as I can.

Read this article:
Westerleigh resident is alive because of stem cell therapy by his doctor -- for free. Heres his story. - SILive.com

Researchers atAirlangga University (Unair) and the State Intelligence Agency (BIN) released on June 12what appeared to be an encouraging statement:the discovery of five combination drug therapies and two stem cell therapies for treating COVID-19.

The acute respiratory disease caused by the SARS-CoV-2 virus has claimed at least 2,000 lives in Indonesia to date.

The joint statementattributed to Unair andBIN also said that themedicines were ready for distributionin treating COVID-19 patients.

Drug combinations

The five combination therapiesfor COVID-19 are: lopinavir/ritonavir with azithromycin, lopinavir/ritonavir with doxycycline, lopinavir/ritonavir with clarithromycin, hydroxychloroquine with azithromycin, and hydroxychloroquine with doxycycline.

In addition, the statementclaimed that the researchers had identified two types of isolated stemcells that inhibitedSARS-CoV-2 activity:hematopoietic stem cells (HSCs) and natural killer (NK) cells.

Their goodwill to bring an end tothe pandemic should be appreciated. Unfortunately, their conclusions seem premature and could lead to more damaging consequences for the public.

In theory, the drug combinationsrecommended by Unair and BIN have the potentialto inhibit SARS-CoV-2. Lopinavir and ritonavir are protease inhibitors that are currently used to treat people with HIV/AIDS. Hydroxychloroquine is a malarial treatment, while azithromycin, doxycyclineand clarithromycin are antibiotics that can fight secondary bacterial (not viral) infections in COVID-19 patients who have developed pneumonia.

However, theory does not necessarily work inpractice. Noneof these drugs have been provenin any clinical study to bea safe and effective treatmentfor COVID-19. The World Health Organization (WHO) has started clinical trials involving thousands of patients in dozens of countries to test the efficacy and safety of these drugs. So far, there has been no clear indication that these drugs, whether individually or in combination,are effective in treating COVID-19.

In fact, evidence exists that hydroxychloroquine may worsen the condition of patients, which led the WHO to suspend the clinical trial of the drug.

Unair and BIN are correct in conducting in vitro (test tube) experiments to verify the effect and toxicity of the drugs for SARS-CoV-2. Unfortunately, they have not communicated in any clear way on how they designed, executedand analyzed their experiments.

We do not know how they cultured the virus, what kind of negative controls they used, what kind of cells they testedor whether the cells they usedcontained the necessary receptors for SARS-CoV-2 to enter a human cell. More importantly, it is crucial to note thatthe results of in vitro experiments(however encouraging) cannot be assumed to be safe and effectivetreatments for direct use in human patients. For example, the United States Food and Drug Administration (FDA) on averageapprovedless than 10 percent of drugs that performed well in vitroas safe for humanprescription.

The human lungs contain millions of cells comprising dozens of different types that perform intricate interactions. The proposed drugs can also affect other organs in the human body and cause adverse reactions.

Instead of announcing that these five combination therapiesare ready for treating COVID-19, Unair and BIN should first run arandomizedcontrolled trial (RCT) to confirm their findings.Recruiting diverse patient populations is also critical to ensuring thefairness and robustness of the study.

Despite their good intentions, all the drugs that Unair and BIN researchers have proposedare strong medicines, whether individually or in combination, that can potentially cause unwanted sideeffects and even death. Surely none of us want to rush into an unproven treatmentin order to avoid developing even more overwhelming health problems in the future.

Stem cell therapy

Stem cell therapy is another COVID-19treatment that Unair and BIN researchers have proposed. Stem cells are undifferentiated cells thathas the potential to develop into many different types of cells in human body. One type of stem cell they have proposed is hematopoietic stem cells (HSCs), whichdevelop into blood cells, includingimmune cells that help the body fight pathogens and infections.

However, stem cell therapy is still considered very risky, expensiveand limited to treating a few cancers, such as leukemia. No evidence exists that stem cell therapy is efficient in treating viral infections in the human bodysuch asCOVID-19.

As with the drug therapies, the Unair and BIN researchers did not say how they performed their stem cell experiment. We have no information oncrucial aspects likestem cell culturing protocol, the stem cell's differentiation status, tumorigenic potential, proliferation capacity orexcretion patterns, and how they tested stem cell activity against SARS-CoV-2.

Even if the researchersestablished a sound experimentalprotocol for their in vitro experiments, administering stem cell therapy to COVID-19 patients is an extremely dangerous procedure that can result in undesirable costs, such as malignancy, the stem cells attacking other healthy cellsand possibly death.

Injecting stem cells into the human body carries a huge risk of immuno-rejection (think of a blood type A patient receivinga bloodtype B infusion, but witha much more severe reaction). The doctors administering the treatment must isolate autologousstem cells from the individual patient or allogenic stem cells froma separate donor, culture them, and reinject the treated cells into the patient. These processes are extremely laborious, time-consumingand expensive, and there is no clear indication that the treatment will produce a safe and successful outcome against viral infection.

This is hardly a sound strategy to use during a pandemic. Furthermore, thecommon procedureis to administer powerful immunosuppressants to reduce the strength of thepatients immune system, particularly in the allogenic scenario, which would minimizethe risk of immuno-rejection. However, it would be unwise to shut down a COVID-19patient's immune system that is neededto work properly for their body to fight SARS-CoV-2.

Unair and BIN's valiant effortsshould still be applauded, as they are committed to treating COVID-19 and ending the pandemic. The public is waiting impatiently for the health crisis to subside so they canresume their normal lives.

However, everyone should realize that discovering treatments and developing a potential vaccine for a disease that was virtually unknown six months ago takes a lot of time and resources.

Unair and BIN said that they had submitted their research to at least seven peer-reviewed internationaljournals, but this does not mean that their research is validated immediately. It still needs reviewing and questioned by their scientific peers.

It is necessary for the researchers to publish their findings onan open access, preprint repository for biological or medical research papers like BiorXiv or MedrXiv, so that scientists and people around the worldcan scrutinize and engage in healthy scientific discourse.

We absolutely deserve good news during the pandemicon safe medical treatmentsand vaccines. We also deserve complete, clear and transparent public communications from all COVID-19 stakeholders, including researchers and governments, to ensure that all actions are evidence-based, safeand effective.

The writer is a research scientist with a PhD in biochemistryfrom the University of Cambridge, which he earned as a recipient of the 2015-2019 Gates Cambridge Scholarship program.

Disclaimer: The opinions expressed in this article are those of the author and do not reflect the official stance of The Jakarta Post.

Excerpt from:
Preventing misleading claim of COVID-19 cure - The Jakarta Post - Jakarta Post

When Dr Yendry Ventura began work to set up the Abu Dhabi Stem Cell Centre in late 2018, there was, he says, nothing else "related to stem cell therapy in the emirate.

Fast forward to today and the situation has changed dramatically. After opening in December last year, the centre has already received international press coverage over to its research into a treatment for Covid-19.

Their groundbreaking work has involved taking stem cells from a patients blood and returning them, via a nebuliser, as a fine mist to the lungs.

There they help regenerate lung cells and improve the body's immune response by preventing an overreaction to the infection that can damage healthy cells.

What characterises the method, says Dr Ventura, is that very little manipulation of the cells is needed for the treatment to be effective.

The future for the stem cells lies in regenerative medicine, in which you can treat almost all the degenerative conditions.

Dr Yendry Ventura

We separate a specific layer of cells from the blood, Dr Ventura told The National. Were the first one to use these cells with this route with this method.

We believe this way the cells can be aimed much better to the affected organs - the upper and lower respiratory tract.

In April, the centres efforts to develop a Covid-19 treatment led to the recovery of all 73 patients the treatment was initially trialled on. A quarter had been in intensive care.

The results appeared so promising that this month the centre secured intellectual property rights to the technique, allowing the treatment to be widely licensed, including to facilities abroad.

The ongoing work exemplifies how the centres specialists have been able to apply their expertise to help in a time of crisis, Dr Ventura said.

But the new research is a departure from the facilitys usual purpose, which involves developing cutting-edge stem cell treatments for conditions such as cancer and heart disease.

Stem cells were first extracted from humans and grown in laboratories less than a quarter of a century ago.

The human body is mostly made of specialised cell types, such as heart muscle cells, kidney cells or nerve cells, all of which have a particular form related to their function.

Stem cells, however, have not yet undergone the process of developing into a specialised cell type, and are able to be manipulated to perform a specific function.

In adults, stem cells are found in tissues including fat and bone marrow, and these can be turned into cell types.

One technique that the Abu Dhabi Stem Cell Centre plans to implement is haematopoietic stem cell transplantation, which involves stem cells being removed from an individual who is due to have cancer treatment.

The cells are then processed in a laboratory and injected into the patient after they have undergone chemotherapy or radiotherapy.

In this way, they can replace stem cells destroyed by the treatment, allowing a patient to tolerate a higher dose of therapy.

Dr Ventura says that similar treatments were applicable to most cancers of the blood as well as cancers that produce solid tumours.

There are many of these therapies still in research stage, but if you conquer this research, you can have a programme in which you can ... treat many kinds of cancers at the same time in one centre, he said.

The reality is that cell therapy is curing cancer We need to improve this therapy and make it available for many other people.

The future for the stem cells lies in regenerative medicine, in which you can treat almost all the degenerative conditions.

You can create in the future, if you have the right technologies, even artificial organs.

Set up with private sector funding in collaboration with the UAE authorities, the Abu Dhabi Stem Cell Centre works closely with experts at Sheikh Khalifa Medical City.

But the institution is keen to forge further partnerships with both public and private sector medical institutions.

Currently, it operates seven days a week and has more than 100 staff, including nurses, technicians and doctors who specialise in immunology, haematology, pathology, orthopaedics, urology and radiology.

In another initiative, the facility has recently begun running Minimal Residual Disease tests, which look at how many malignant cells remain in a patients blood or bone marrow.

These tests are useful for people with a variety of blood cancers, including lymphoma, leukaemia and myeloma. But they require fresh samples from the patient, so the lack of UAE testing facilities has, until now, required patients to travel abroad.

We try to implement the tests here in the Abu Dhabi Stem Cell Centre so that the patient does not need to travel anymore, said Dr Ventura.

Updated: June 17, 2020 04:31 PM

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Coronavirus: inside the UAE stem cell centre working to treat Covid-19 - The National