Global Mesenchymal Stem Cells Market 2020 Coronavirus (COVID-19) Updated Analysis By Product (MSC-AT, MSC-UC, MSC-BM, Others); By Application…

Mesenchymal Stem Cells Industry Overview Competitive Analysis, Regional and Global Analysis, Segment Analysis, Market Forecasts 2026

The globalMesenchymal Stem Cells marketshave undergone huge change in the last few months. These changes were due to the outbreak of the pandemic which was first detected in the Wuhan city of China. COVID-19 which has occurred due to the coronavirus has taken many lives of people around the world. As the disease is spreading at a rapid rate many of the countries have ordered lockdown for maintaining social distancing. Due to the lockdown, many of the industries have halted their manufacturing units. There have been restrictions for cross border trading within the countries and also within the states. Owing to these conditions, trading conditions in various regions have been affected badly. The overall countries in the world are facing economic crisis thus affecting some of the major markets in the world.

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The research analysts from theMarket Research Storehave conducted a detailed study about the global Mesenchymal Stem Cells market. Owing to the above mentioned conditions, the global Mesenchymal Stem Cells market has undergone several changes on the global platform. All these updates are mentioned in the Mesenchymal Stem Cells market report study. The research analysts have conducted a thorough primary and secondary research for updating the market statistics as per the current market scenario. The detailed Mesenchymal Stem Cells market report is of over 150 pages including more than 30 tables and around 20 figures. The report includes pictorial representations of the market data in order to understand the Mesenchymal Stem Cells market in a simple and easy way.

The data that is included about the Mesenchymal Stem Cells market incorporates historical data from 2016 to 2019 and forecasts data from 2020 to 2026. The major players that are functioning in the Mesenchymal Stem Cells market areIrvine Scientific, Biological Industries, PromoCell GmbH, Miltenyi Biotec, Lonza, STEMCELL Technologies, Bio-Techne, Mesoblast, Axol Bioscience, Thermo Fisher. Details about all the market players, distributors, suppliers, and retailers are profiled in the Mesenchymal Stem Cells market report.

Read Detailed Index of full Research Study at::http://www.marketresearchstore.com/report/global-mesenchymal-stem-cells-market-report-2018-industry-300103

The Mesenchymal Stem Cells market is segmented into{MSC-AT, MSC-UC, MSC-BM, Others}; {Cell-based Screening Assays, Gene Therapy and Transplantation, Cell Differentiation and Gene Regulation}. Each of the market segments is described in detail within the report. Data about the segments are represented in both qualitative and quantitative format, thus enabling to understand the market in detail.

Major Advantages for Mesenchymal Stem Cells Market:

Well-organized description of the international Mesenchymal Stem Cells market along with the ongoing inclinations and future considerations to reveal the upcoming investment areas. The all-inclusive market feasibility is examined to figure out the profit-making trends to obtain the most powerful foothold in the Mesenchymal Stem Cells industry. The Mesenchymal Stem Cells market report covers data which reveal major drivers, constraints, and openings with extensive impact analysis. The current market is quantitatively reviewed from 2019 to 2028 to pinpoint the monetary competency of the global Mesenchymal Stem Cells market. Last but not least, PORTERS Five Forces Analysis shows the effectiveness of the customers and providers from a global perspective.

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Global Mesenchymal Stem Cells Market 2020 Coronavirus (COVID-19) Updated Analysis By Product (MSC-AT, MSC-UC, MSC-BM, Others); By Application...

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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19…

NEW YORK, July 06, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP.

The protocol was filed with the United States Food and Drug Administration (FDA) and provides physicians with access to remestemcel-L for an intermediate-size patient population1 under Mesoblast’s existing Investigational New Drug (IND) application. According to the FDA, expanded access is a potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

MIS-C is a life-threatening complication of COVID-19 in otherwise healthy children and adolescents that includes massive simultaneous inflammation of multiple critical organs and their vasculature. In approximately 50% of cases this inflammation is associated with significant cardiovascular complications that directly involve heart muscle and may result in decreased cardiac function. In addition, the virus can result in dilation of coronary arteries with unknown future consequences. Recent articles from Europe and the United States have described this disease in detail.2-5

Mesoblast Chief Medical Officer Dr Fred Grossman said: The extensive body of safety and efficacy data generated to date using remestemcel-L in children with graft versus host disease suggest that our cellular therapy could provide a clinically important therapeutic benefit in MIS-C patients, especially if the heart is involved as a target organ for inflammation. Use of remestemcel-L in children with COVID-19 builds on and extends the potential application of this cell therapy in COVID-19 cytokine storm beyond the most severe adults with acute respiratory distress syndrome.”

Remestemcel-L Remestemcel-L is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor and is administered in a series of intravenous infusions. Remestemcel-L is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in several diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1.www.clinicaltrials.gov; NCT04456439 2.Lancet2020; May 7. DOI: https://doi.org/10.1016/S0140-6736(20)31094-1 3.Lancet. 2020; (May 13) https://doi.org/10.1016/S0140-6736(20)31103-X 4.https://www.nejm.org/doi/full/10.1056/NEJMoa2021756 5.https://www.nejm.org/doi/full/10.1056/NEJMoa2021680

About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast’s licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward- looking statements include, but are not limited to, statements about: the timing, progress and results of Mesoblast’s preclinical and clinical studies; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblast’s product candidates, if approved; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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Expanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19...

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BCLI: KOL Event Gives Overview of the use of NurOwn in Alzheimer’s Disease; Raising Valuation to $25/Share – Zacks Small Cap Research

By David Bautz, PhD

NASDAQ:BCLI

READ THE FULL BCLI RESEARCH REPORT

Business Update

KOL Event for Alzheimers Program

On July 8, 2020, BrainStorm Cell Therapeutics, Inc. (NASDAQ:BCLI) conducted a Key Opinion Leader (KOL) webinar to discuss the companys upcoming Phase 2a clinical trial of NurOwn in patients with Alzheimers Disease (AD). The event included presentations by two of the lead investigators for the upcoming trial, Dr. Philip Scheltens, Professor of Cognitive Neurology and Director of the Alzheimer Centre at VU University Medical Center in Amsterdam, Netherlands, and Dr. Bruno Dubois, Professor of Neurology at the Neurological Institute of the Salptrire University Hospital in Paris, France. The presentation can be found here.

The companys Phase 2a trial (BCT-201-EU) is expected to enroll approximately 40 patients with prodromal to mild AD. It will be taking place at medical centers in France and the Netherlands. To be eligible for the trial, patients must have been diagnosed with prodromal to mild dementia at least six months prior to enrollment. In addition, patients must score between 20-30 on the Mini-Mental State Exam (MMSE) and have a Clinical Dementia Rating (CDR) global score of 0.5-1.0. The MMSE is a series of questions that are designed to assess a patients mental skills, with the maximum score being 30 points and a score of 20-24 suggesting mild dementia. The CDR is a scale used to characterize six domains of cognitive and functional performance with a score of 0.5 suggesting very mild dementia and a score of 1.0 suggesting mild dementia.

The primary objective of the trial is to assess the safety and tolerability of three intrathecal injections of NurOwn in AD patients. Following bone marrow aspiration during a 10-week run-in period, patients will be treated three times with NurOwn, with eight weeks between treatments. Follow-up visits will occur 12 and 26 weeks following the final injection of NurOwn for a total trial length of 52 weeks. The following figure gives an overview of the trial design.

Cerebrospinal fluid (CSF) and serum will be collected prior to treatment and again at Weeks 0, 8, and 16 to assess changes in various neurotropic, neurodegenerative, and inflammatory factors (e.g., VEGF, HGF, NfL, NfH, MCP-1, IL-6), markers associated with amyloid deposition (e.g., a40, a42), and markers of tau protein levels (e.g., p-tau, t-tau). Additional clinical outcome measures will be analyzed through administration of the following tests:

Clinical Dementia Rating ScaledSum of Boxes (CDR-SB)

Free and Cued Selective Reminding Test (FCSRT)

Neuropsychological Test Battery (NTB)

Delis-Kaplan Executive Function System (D-KEFS) subtests

Mini Mental State Examination(MMSE)

AmsterdamInstrumentalActivitiesofDailyLivingQuestionnaire-ShortVersion(A-IADL-Q-SV)

Alzheimers Disease

Alzheimers disease (AD) is the most common form of dementia in older adults. The disease is named after Dr. Alois Alzheimer, who identified the first case in a 50-year-old woman named Auguste Deter in 1902. Dr. Alzheimer followed her case until her death in 1906, at which point he first publicly reported on it (Alzheimer, 1907).

After Ms. Deters death, Dr. Alzheimer examined her brain and found many abnormal clumps (now known as amyloid plaques) and tangled bundles of fibers (now known as neurofibrillary tangles). Over the next five years, 11 similar cases were reported in the medical literature, with some of them already using the term Alzheimers disease (Berchtold et al., 1998).

The most common early symptom of AD is a gradually worsening ability to remember new information. This is due to neurons associated with forming new memories dying off first. As neurons in other parts of the brain die, individuals experience different symptoms, which include:

Memory loss that disrupts daily life

Inability to plan or solve problems

Difficulty completing familiar tasks

Confusion with location and time

Difficulty with visual images and spatial relationships

Problems with words in speaking or writing

Withdrawal from social activities

Changes in mood, including apathy and depression

Each person progresses through AD at a different rate, and little is known about how or why there is such a marked variation, thus predicting how it will affect someone is quite difficult. One thing that is common to everyone diagnosed with AD is that his or her cognitive and functional abilities will gradually decline. As the disease progresses symptoms can include confusion, irritability, aggression, mood swings, and long-term memory loss. In the final advanced stage of the disease, people need help with the basic activities of living (e.g., bathing, dressing, eating, and using the restroom), they lose the ability to communicate, fail to recognize loved ones, and eventually become bed bound and reliant on round-the-clock care (Frstl et al., 1999). The inability to move makes them more prone to infections, including pneumonia, which are often a contributing factor to the death of those with AD.

Competing Theories for the Cause of Alzheimers

The root cause of Alzheimers is still unknown; however, it is likely to involve a number of different factors as opposed to being due to one single cause. These factors are likely a combination of genetic, environmental, and lifestyle. There are a number of hypotheses that exist to explain the cause of the disease, with the two dominant hypotheses focused on amyloid and tau.

Amyloid hypothesis: This hypothesis proposes that extracellular beta-amyloid deposits are the fundamental cause of the disease (Hardy et al., 1991). Beta-amyloid is a fragment of the larger protein amyloid precursor protein (APP), mutations of which are known to cause FAD. Several lines of evidence support the amyloid hypothesis: 1) the location of APP is on chromosome 21, while those with Down Syndrome (trisomy 21) almost all show signs of AD by 40 years of age (Lott et al., 2005); 2) APOE4 is a major genetic risk factor for AD, and while apolipoproteins enhance the breakdown of beta-amyloid, some isoforms are less capable of performing this task than others, leading to more beta-amyloid buildup on the brain (Polvikoski et al., 1995); 3) mice that harbor a mutant form of APP develop amyloid plaques and Alzheimers-like pathology (Games et al., 1995). Lastly, amyloid plaques are readily identifiable by microscopy in the brains of AD patients (Tiraboschi et al., 2004). While the brains of many older individuals develop some plaques, the brains of AD patients show severe pathological changes specifically within the temporal neocortex (Bouras et al., 1994).

Tau hypothesis: Tau is a protein located mainly within the axonal compartment of neurons and is an important element in microtubule stabilization and neurite outgrowth. In AD, a proportion of tau protein becomes abnormally phosphorylated, dissociates from axonal microtubules, and accumulates in paired helical filaments inside the neuron (Goedert et al., 1991). When this occurs, the microtubules disintegrate causing the collapse of the neurons transport system (Igbal et al., 2005). Just as with beta-amyloid plaques, tau tangles are readily observable in the brains of those affected by AD.

In addition to amyloid and tau, inflammation has been an underappreciated and often overlooked mediator in patients with AD (Akiyama et al., 2000). A multitude of inflammatory markers are found in AD patients brains and a number of studies have shown a link between chronic inflammation and an increased risk of developing AD (Walker et al., 2017; Tao et al., 2018). Thus, a treatment such as NurOwn that can decrease inflammatory mediators could prove beneficial in AD patients.

On Track to Repot Topline Data from Phase 3 ALS Trial in 4Q20

On July 2, 2020, BrainStorm announced that all doses have been administered in the pivotal Phase 3 trial ofrecen NurOwn in patients with amyotrophic lateral sclerosis (ALS) and that it remains on track to report topline data in the fourth quarter of 2020.

The ongoing randomized, double blind, placebo controlled, multi-dose Phase 3 clinical trial is testing the ability of NurOwn to alter disease progression as measured by the ALSFRS-R (NCT03280056). Cells were extracted once from each patient prior to treatment, with all administrations of NurOwn derived from the same extraction of cells due to a cryopreservation process the company developed for long-term storage of mesenchymal stem cells (MSC). Just as with the companys prior studies, there was a 3-month run-in period prior to the first treatment with two additional NurOwn treatments occurring two and four months following the first treatment. The company is focusing the trial on faster-progressing ALS patients since those patients demonstrated superior outcomes in the Phase 2 trial of NurOwn.

BrainStorm Joins Russell 2000 and Russell 3000; Granted SME Status by EMA

On June 23, 2020, BrainStorm announced that its shares would be included in the Russell 2000 Index and the Russell 3000 Index. The annual reconstitution of the Russell indexes is done to capture the 4,000 largest U.S. stocks by market capitalization.

On June 15, 2020, BrainStorm announced that the company has been granted Small and Medium-Sized Enterprise (SME) status by the European Medicines Agency (EMA). SME status allows the company to participate in a number of financial incentives including a 90-100% reduction in the EMA fee for scientific advice, clinical study protocol design, endpoints and statistical considerations, quality inspections of facilities, and fee waivers for selective EMA pre- and post-authorization regulatory filings, including Orphan Drug and PRIME designations.

Conclusion

Were excited about the potential for NurOwn in AD and we look forward to the initiation of the Phase 2a trial later in 2020. We have recently made a few changes to our model, including the inclusion of NurOwn in AD and lowering of the discount rate from 20% to 15% for all indications. We model for the company to file for approval of NurOwn in AD in 2026 and to be granted approval in 2027. We currently estimate peak sales of over $2 billion for NurOwn in AD in both the U.S. and E.U. Using a 25% probability of approval leads to an NPV of $113 million. Combined with the NPV for NurOwn in ALS ($700 million) and MS ($41 million) along with the companys current cash position and potential cash from warrants leads to a valuation for the company of a bit less than $900 million. Dividing by the companys current fully diluted share count of 35.7 million leads to a valuation of $25 per share.

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BCLI: KOL Event Gives Overview of the use of NurOwn in Alzheimer's Disease; Raising Valuation to $25/Share - Zacks Small Cap Research

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‘Where All the Patients Went’; Statin Price Fixing; Antiplatelets for COVID-19? – MedPage Today

Heart disease accounted for a large proportion of excess non-COVID deaths in the early weeks of the pandemic, according to a study in JAMA. "Frankly, that would explain where all the patients went," John Puskas, MD, told the Washington Post.

Autopsy findings in COVID-19 unexpectedly turned up rare platelet-producing cells in the heart, suggesting that antiplatelet drugs might be worth trying, the Post also reports.

Mesoblast said it's providing compassionate use of its allogeneic mesenchymal stem cell product candidate remestemcel-L for COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome.

Federal prosecutors charged Glenmark Pharmaceuticals with conspiring with other drugmakers to inflate the price of pravastatin. (Politico)

Efforts in the community to boost bystander CPR appeared to improve survival for out-of-hospital cardiac arrest. (JAMA Network Open)

Bempedoic acid (Nexletol) was associated with lower LDL across statin and indication groups in pooled analysis of its phase III trials. (JAMA Cardiology)

Higher hospital and surgeon-level case volumes were linked to lower 30-day and 1-year mortality after mitral valve surgery for primary mitral regurgitation in national registry data. (JAMA Cardiology)

Comorbidities appear to be behind the worse outcomes for Black patients in stent trials. (JACC: Cardiovascular Interventions)

No surprise: Getting recommended physical activity was linked to better survival in national data. (The BMJ)

The FDA and European regulators cleared the Linq II insertable cardiac rhythm monitor with remote programming, Medtronic announced.

Arrow International's Arrow AutoCAT2 and AC3 Optimus intra-aortic balloon pumps are under Class I recall due to the possibility of motor connector wire breakage.

Abiomed's latest percutaneous left ventricular assist device, Impella 5.5, yielded 84% survival to explant and 76% cardiac recovery in a cardiogenic shock trial. (MassDevice)

First-in-human data from the phase II MOCA-1 trial supported the safety of CorFlow Therapeutics's CoFI diagnostic system for ST-elevation myocardial infarction in results presented at the virtual PCR e-Course, the company said.

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'Where All the Patients Went'; Statin Price Fixing; Antiplatelets for COVID-19? - MedPage Today

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Dr Borehams Crucible: Mesoblast within months of 3 major trial results, key regulatory decision – Stockhead

The worlds biggest listed pure-play stem cell developer has a busy slate of clinical work, notably in therapies for advanced heart failure, chronic back pain and graft-versus-host disease (GvHD).

Now these programs are approaching a thrilling denouement and, as the Demtel man enthused, theres more: Mesoblast (ASX:MSB) is also undertaking an expanded coronavirus trial after a 12-patient effort showed promising results in treating acute respiratory distress syndrome (Ards), the usual cause of death with COVID-19.

The patients received infusions of Mesoblasts allogeneic (off the shelf) mesenchymal stem cell candidate, remestemcel-L, acquired from Osiris for $106m in 2013.

Meanwhile, results from two phase III trials are expected this (September) quarter: a 566-patient effort for chronic heart failure and a 404-patient trial for chronic lower back pain caused by disc degeneration.

And in September, the US Food and Drug Administration will rule on whether or not the company can market its GvHD therapy on American shores.

Mesoblast founder and CEO Prof Silviu Itescu notes that across all its therapies the company is targeting the most severe cases where alternative therapies dont exist.

Mesoblasts proprietary process selects precursor and stem cells from the bone marrow of healthy adults, creating a master cell bank. This cell kitty is then expanded into thousands of doses for off-the-shelf use, without the need for tissue matching.

Mesoblast is targeting a common market across all its disease indications: inflammation. In the case of heart disease, tissue macrophages (cells) churn out inflammatory factors that damage heart muscle and cause fibrosis and vascular dysfunction.

The stem cells respond to severe inflammation by switching the culprit macrophages off and converting them to nice cells that actually protect the heart muscle.

This is the central mechanism in each of our disease states: heart failure, back pain, GvHD and rheumatoid arthritis, Professor Itescu says. We have the potential to make a big difference in some very big disease states where inflammation is central.

Backed by the Pratt familys listed investment vehicle Thorney Investments, Mesoblast debuted on the ASX in 2004 and reached a peak valuation of $2.5bn in 2011 before suffering a reality check.

Culprits included a phase II heart trial that failed to meet primary endpoints, a badly executed Nasdaq listing and Israel pharma house Teva Pharmaceuticals decision to walk away from a heart program partnership in 2016.

Mesoblast dual listed on the Nasdaq in November 2015, accompanied by a $US63m capital raising.

The companys Ards and GvHD programs are based on mesenchymal stem cell assets acquired from US pharma group Osiris Therapeutics in October 2013.

Mesoblasts own-developed cells are called mesenchymal precursor cells and they are being developed for rheumatoid arthritis and diabetic nephropathy, as well as the aforementioned heart failure and lower back pain programs.

Ards is bought on by an excessive immune response to the virus in the lungs. The immune cells produce inflammatory cytokines, which destroy lung tissue and can also damage the liver, kidney and heart.

Remestemcell-L has the potential to tame the cytokine storm in Ards and may offer a life-saving treatment for those unfortunate individual sufferers of COVID-19 Ards, Professor Itescu says.

Mesoblasts COVID-19 proclamations have been coming so thick and fast that its been Ard(s) just to keep up. But the core excitement cluster was around Mesoblasts April 23 disclosure of the results of the trial at New Yorks Mt Sinai Hospital, covering moderate to acute Ards cases.

Under the compassionate use protocol, the patients were treated with two infusions of remestemcel-L over the first five days.

The results? Nine of the 12 patients came off a ventilator within a median 10 days, with 83 per cent survival (the Grim Reapers spin on this is that two of them died).

In comparison, only 9 per cent of patients at one reference hospital (38 out of 445 patients) were able to come off the ventilator with standard-of-care treatment.

Another US hospital reported that only 38 patients of 320 or 12 per cent survived.

Of course, 12 people good and true are adequate numbers for a jury, but sub-optimal to comprise a statistically significant trial.

Thus, the company is enrolling 300 patients in a phase III, randomised, controlled trial of severe Ards patients at 30 sites.

The first patients were dosed in early May, with about 15 sites established as the company chases the disease from the northeast to the southern states.

Mesoblast chief medical officer Professor Fred Grossman says the company is carefully choosing hot spots such as Alabama which, as of late May had the no vacancy signs outside its intensive care wards.

The sites are recruiting quite quickly, he says. There is a tremendous interest in this study.

The trial leaders will undertake an interim analysis at 30 days, and when 30 per cent of patients have reached their primary endpoint. At that point the trial can be dumped on futility grounds, or expanded to the control group because it appears to be working.

Remestemcell-L has investigational new drug (IND) status with the US Food and Drug Administration, meaning the company swiftly can initiate trials on patients with very dismal prospects.

Long-suffering Mesoblast investors will recall that the companys shares tumbled 28 per cent in November 2018 after a 159-patient trial of Rexlemestrocel-L (Revascor) for end-stage heart failure did not meet its primary endpoint of weaning patients from left ventricle assist devices (LVADs or heart pumps).

The company claimed the endpoint was set by the independent !!! investigators and was of little real clinical interest. What really mattered was that the trial showed reduced gastrointestinal bleeding by 76 per cent and hospitalisations by 65 per cent.

Investors are now nervously awaiting the first readout of the broader 566-patient chronic heart failure trial across 59 US sites.

Mesoblast targeted patients with class three or four disease, the sickest 15 to 20 per cent of patients who have failed standard-of-care drugs.

Class three patients have a 20 per cent chance of dying within two years while with class four its a case of flip a coin that you will be around in 12 months.

At this stage, Mesoblast retains its heart treatment rights except in China, where it is partnered with Tasly Pharmaceutical.

Mesoblasts phase III back pain trial aimed to enroll 404 patients with lower back pain caused by degenerative disc disease.

The endpoint of the trial, dubbed MPC-06-ID, is an improvement in pain and function over 24 months.

As with the heart trial, results are imminent and its a toss-up as to what release will hit the ASX announcements feed first.

The company is liaising with its global back pain partner Grunenthal GmbH about the clinical protocol for a European phase III confirmatory trial.

In Japan, Mesoblast is partnered with JCR Pharmaceutical for its approved GvHD treatment called Temcell and its off and racing in that smallish but enthusiastic market.

Meanwhile, the company is angling to enter the US market for a similar GvHD treatment, branded Ryoncil.

GvHD afflicts about half of the 30,000 patients annually undergoing allogeneic bone marrow transplant, typically for blood cancers, with their bodies rejecting the alien transplant.

In March, the FDA granted priority review with a September 30 action date, but we might have a good idea of the outcome in August.

Why? Because thats when the FDAs relevant advisory committee meets to vote on the matter and the (virtual) gathering is open to the public.

A date is yet to be set. While advisory committee views are not binding on the FDA, they usually presage the final decision.

If approved, Mesoblast could be selling Ryoncil in the US by the time were carving the Christmas turkey (badly, in the case of your columnist).

Buoyed by the COVID-19 results, Mesoblast in May wasted no time tapping institutional investors for an idle $US90m ($129.6m) in a placement.

Mesoblast already had a healthy cash balance of $US60m.

The raising was struck at $3.20 a share, a modest 7 per cent discount to the prevailing price.

The funds, in the main, will be used to scale-up manufacturing of remestemcell-L and to support the phase III trial, as well as for working capital and general corporate purposes.

The company also has $US67m available through existing financing facilities and partnerships.

Mesoblast reported revenue of $US31.45m for the nine months to March 2020, up 113 per cent. The reported loss narrowed 34 per cent to $US45.3m, reflecting curtailed research and development spend by $US7.5m, or 15 per cent.

The revenue included $US5.9m of JCR royalties from Temcell sales in Japan and milestone revenue of $US25m.

The company stands to pocket up to $US150m of royalties and milestones from Grunenthal prior to any European launch of Revascor.

Successful sales could result in up to $US1bn in milestone payments.

Over the last decade, Mesoblasts ASX shares have traded as high as $9 (October 2011) and as low as $1.03 (December last year).

To the Meso-sceptics the company has promised far too much with limited commercial success, while raising $1bn since listing 16 years ago.

Dare we say that Mesoblast now looks more focused and to be getting somewhere?

When we last covered Mesoblast in March 2019, Professor Itescu said he was 95 per cent certain the company would do what no other Aussie biotech in phase III had done: win FDA drug approval.

Well, Clinuvel has stolen that Aussie first honour, but Mesoblast is well placed to get over the line with a GvHD treatment in the US, which presents a market eight times the size of Japans.

Its certainly rare for a biotech to expect results for three major trials and a key regulatory decision in the space of months.

If the heart and back pain results are definitively positive and the FDA green lights GvHD, the company hits the jackpot. If two or more of them bomb lets not go there.

Your ultra conservative columnist regards the COVID-19 stuff as the icing on the cake with an outside chance of success, especially given the hundreds of other programs in the coronavirus-busting sector.

Disclosure: Dr Boreham is not a qualified medical practitioner and does not possess a doctorate of any sort. But he hopes to become proficient in turkey carving by December 25.

This column first appeared in Biotech Daily.

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Dr Borehams Crucible: Mesoblast within months of 3 major trial results, key regulatory decision - Stockhead

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Impacts of the COVID-19-Mesenchymal Stem Cells Market Size Current and Future Industry Trends, 2020-2028 – 3rd Watch News

A recent report published by QMI on mesenchymal stem cells market is a detailed assessment of the most important market dynamics. After carrying out a thorough research of mesenchymal stem cells market historical as well as current growth parameters, business expectations for growth are obtained with utmost precision. The study identifies specific and important factors affecting the market for mesenchymal stem cells during the forecast period. It can enable manufacturers of mesenchymal stem cells to change their production and marketing strategies in order to envisage maximum growth.

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According to the report, the mesenchymal stem cells market has been segmented by source (bone marrow, umbilical cord blood, peripheral blood, lung tissue, synovial tissues, amniotic fluids, adipose tissues), by application (injuries, drug discovery, cardiovascular infraction, others).Insights about the regional distribution of market:The market has been segmented in major regions to understand the global development and demand patterns of this market.

For the mesenchymal stem cells market, the segments by region are North America, Asia Pacific, Western Europe, Eastern Europe, Middle East, and Rest of the World. During the forecast period, North America, Asia Pacific and Western Europe are expected to be major regions on the mesenchymal stem cells market.

North America and Western Europe have been one of the key regions as they have an established healthcare infrastructure for product innovations and early adaptations. This is estimated to drive demand for the mesenchymal stem cells market in these regions. In addition to this, some of the major companies operating in this market are headquartered in these regions.

Asia Pacific is estimated to register a high CAGR mesenchymal stem cells market. The APAC region has witnessed strategic investments by global companies to cater to the growing demand for healthcare solutions in recent years. The Middle East and Rest of the World are estimated to be emerging regions for the mesenchymal stem cells market.

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Market Players Cell Applications, Inc., Cyagen Biosciences Inc. Axol Bioscience Ltd., Cytori Therapeutics Inc., Stem Cell Technologies Inc., Celprogen, Inc.

Reasons to Buy This Report:o It provides niche insights for a decision about every possible segment helping in the strategic decision-making process.o Market size estimation of the mesenchymal stem cells market on a regional and global basis.

o A unique research design for market size estimation and forecast.o Identification of major companies operating in the market with related developmentso Exhaustive scope to cover all the possible segments helping every stakeholder in the mesenchymal stem cells market.

Market Segmentation:By Source:o Bone Marrowo Umbilical Cord Bloodo Peripheral Bloodo Lung Tissueo Synovial Tissueso Amniotic Fluidso Adipose Tissues

By Application:o Injurieso Drug Discoveryo Cardiovascular Infractiono Others

By Region:o North Americao North America, by Country? US? Canada? Mexicoo North America, by Sourceo North America, by Application

o Western Europeo Western Europe, by Country? Germany? UK? France? Italy? Spain? The Netherlands? Rest of Western Europeo Western Europe, by Sourceo Western Europe, by Application

o Asia Pacifico Asia Pacific, by Country? China? India? Japan? South Korea? Australia? Indonesia? Rest of Asia Pacifico Asia Pacific, by Sourceo Asia Pacific, by Application

o Eastern Europeo Eastern Europe, by Country? Russia? Turkey? Rest of Eastern Europeo Eastern Europe, by Sourceo Eastern Europe, by Application

o Middle Easto Middle East, by Country? UAE? Saudi Arabia? Qatar? Iran? Rest of Middle Easto Middle East, by Sourceo Middle East, by Applicationo Rest of the Worldo Rest of the World, by Country? South America? Africao Rest of the World, by Sourceo Rest of the World, by Application

Years Covered in the Study:Historic Year: 2016-2017Base Year: 2018Estimated Year: 2019Forecast Year: 2028

Objectives of this report:o To estimate the market size for mesenchymal stem cells market on a regional and global basis.o To identify major segments in mesenchymal stem cells market and evaluate their market shares and demand.

o To provide a competitive scenario for the mesenchymal stem cells market with major developments observed by key companies in the historic years.o To evaluate key factors governing the dynamics of mesenchymal stem cells market with their potential gravity during the forecast period.Customization:This study is customized to meet your specific requirements:

o By Segmento By Sub-segmento By Region/Countryo Product Specific Competitive Analysis

Contact:Quince Market InsightsAjay D. (Knowledge Partner)Office No- A109Pune, Maharashtra 411028Phone: +91 706 672 4848 +1 208 405 2835 / +44 121 364 6144 /Email: [emailprotected]Web:www.quincemarketinsights.com

ABOUT US:QMI has the most comprehensive collection of market research products and services available on the web. We deliver reports from virtually all major publications and refresh our list regularly to provide you with immediate online access to the worlds most extensive and up-to-date archive of professional insights into global markets, companies, goods, and patterns.

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Impacts of the COVID-19-Mesenchymal Stem Cells Market Size Current and Future Industry Trends, 2020-2028 - 3rd Watch News

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IHS Pets: Bringing Cell And Gene Therapy To Cats, Dogs & Horses – Anti Aging News

Integrated Health System is bringing cell and gene therapy to cats, dogs, and horses. Recently IHS Pets has helped a paralyzed dog with a spinal cord injury to walk again after it was treated with experimental PRP and prolotherapy. Click here to see the video.

Telomeres

Aging is the root of virtually every complex noncommunicable disease in humans and animals. Telomeres are the protective end caps on the ends of our chromosomes, they are as important for the health of both humans and our pets, and they play roles in longevity.

One of the contributing factors in the lifespan in dog breeds is telomere length. As in humans researchers have found that telomere length is a strong predictor of average life span among 15 different breeds consistent with telomeres playing a role in life span determination. Dogs lose telomeric DNA ~10-fold faster than humans, which is similar to the ratio of average life spans between these species. As such telomerase therapy may be beneficial to pets as well as their human caretakers.

Telomerase gene therapy has been shown to extend lifespan in animals, this therapy may help to increase bone mineral density, improve motor performance, improve metabolism, and improve brain function.

Follistatin

The loss of muscle mass with age is just as problematic for animals as it is to humans; in cats for instance a study showed that for each 100g loss of lean body mass increased the risk of death by 20%. This is typically accompanied by frailty, and it is a contributing factor to metabolic syndrome, diabetes, heart disease, and overall mortality.

Diet and exercise have been shown to pay key roles in keeping pets healthy, but the loss of muscle mass is unavoidable without an effective intervention. Enter follistatin: myostatin blocks muscle growth, when it is inhibited then follistatin is able to let muscles grow freely to stop them from wasting away.

Follistatin gene therapy has been shown to be safe and effective in animals, this therapy may help to protect against frailty, increase muscle density, increase strength, and increase endurance.

Klotho: The Queen of Anti-Aging Proteins

1 in 3 cats will suffer from renal disease, but these numbers are under scrutiny with some suggesting that estimate may be too conservative. Chronic kidney failure can occur gradually over months or years, and it is one of the most common conditions affecting older cats with most cases progressing over time worsening the disease.

Klotho is known to play a significant role in the development of chronic kidney disease, and researchers are now turning to its broader role in the anging process as a whole; such as induces expression with gene therapy in mice has been shown to extend lifespan by targeting many of the same pathways as caloric restriction. Blocking Klotho has been shown to cause premature aging.

Klotho also helps to protect the brain, and contributes to more differences in intelligence than any one single gene. Research from the University of California has shown it to protect the brains of mice and improve brain function within 4 hours; and this result included young mice, old mice, and those that were models of Alzheimers disease.

In addition Klotho also plays a critical role in the inflammaging process. Inflammaging is the long term result of the chronic physiological stimulation of the innate immune system which can become damaging during the aging process.

Circulating levels of Kloto decreases with age, this decrease is associated with an increased risk of age related disease. Gene therapy with Klotho has been shown to increase lifespan in animal models, and it may improve kidney function, brain function, clear damage caused by oxidative stress, and protect against cardiovascular disease.

With the remarkable progress being made in genetics, gene therapy may play increasingly prominent and transformative roles in medicine for both humans and animals due to the potential to treat diseases and congenital disorders.

Pets can be an important part of life, they calm us, make us laugh, and create a bond of unconditional love. The company does note that all therapies are experimental, they are not approved by any regulatory body, and they make no claims that outcomes will be positive or beneficial.

IHS Pets is the veterinary wing of Integrated Health Systems, BioViva Sciences exclusive partner. IHS connects with doctors and patients who are interested in the power of gene therapy to pave the way to healthy aging and longevity.

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IHS Pets: Bringing Cell And Gene Therapy To Cats, Dogs & Horses - Anti Aging News

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Calidi Biotherapeutics Announces Appointment of Jim Schoeneck, Accomplished Biotech Executive, to Board of Directors – StreetInsider.com

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Calidi Biotherapeutics Announces Appointment of Jim Schoeneck, Accomplished Biotech Executive, to Board of Directors - StreetInsider.com

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Biology of Mesenchymal Stem Cells | Bentham Science

Title: Biology of Mesenchymal Stem Cells

VOLUME: 4ISSUE: 3

Author(s):Franz Jakob, Catarina Limbert, Tatjana Schilling, Peggy Benisch, Lothar Seefried and Regina Ebert

Affiliation:Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg, Brettreichstrasse 11, D-97074 Wuerzburg, Germany.

Keywords:Mesenchymal stem cells (MSC), epithelial mesenchymal transition, mesoderm, tissue healing, ageing, regeneration of bone, Surface Antigens

Abstract: Mesenchymal stem cells (MSC) are derived from mesodermal precursor and are committed towards mesenchymal differentiation. They are scattered all over the organism, situated in bone, cartilage, adipose tissue and accompany organs for tissue regeneration and structural and functional support. MSC populations are not homogenous, their signature is variable according to their localization. A process called epithelial mesenchymal transition is fundamental for the development of mesoderm. Epithelial-mesenchymal interactions specify MSC and this may influence their regeneration potential. Multipotent adult MSC are used for research in tissue regeneration and engineering. Crude mixtures of bone marrow- derived MSC are clinically applied for tissue healing, but complex transplantable tissue engineered constructs are still under development. The role and regeneration potential of MSC in inflammation and ageing organisms remains to be characterized. The establishment of reprogrammed homogenous MSC cultures of high plasticity might allow developing these cells towards multiple cell-based therapeutic strategies. Many applications can be envisioned, e.g. regeneration of bone, cartilage and tendon or engineering of beta cells and neurons. Since homogenous MSC with high plasticity represent a promising tool for the treatment of many diseases, research in this area of adult stem cells should be supported with high priority.

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Biology of Mesenchymal Stem Cells | Bentham Science

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Mesenchymal Stem Cells and Skeletal Regeneration …

This book covers our current understanding of the role of mesenchymal stem cells (MSCs) and other mesenchymal progenitors in skeletal regeneration, encompassing bone, cartilage and whole joint regeneration. The expansion reflects developments in the field to include data on the use of MSCs in drug development, growth factors, scaffolds and biomechanical manipulations for skeletal trauma and diseases, including osteoporosis and arthritis.

Written for an audience of clinicians and young researchers who are exposed to MSCs in their work, this work summarizes recent findings pertaining to the definition and characterization of MSCs in skeletal tissues and discusses the mechanisms of their actions in regeneration of bone in vivo. The authors describe recent findings pertaining to the efficacy of MSC therapies in animal models and in human clinical trials and bring together literature showing that the ways MSCs are extracted, expanded and implanted can considerably affect bone formation outcomes. Finally, it presents the latest knowledge on the nature of native MSCs in skeletal tissues, which provide a platform for novel in situ tissue regeneration approaches for systemic bone disease such as osteoporosis.

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Mesenchymal Stem Cells and Skeletal Regeneration ...

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