Stem Cell Clinic

Induced Pluripotent Stem Cells Market is Expected to Grow at a CAGR of 7% During the Forecast Period 2026 – Market Research Posts

By adminJuly 27, 2020Stell Cell Research

The healthcare industry has been focusing on excessive research and development in the last couple of decades to ensure that the need to address issues related to the availability of drugs and treatments for certain chronic diseases is effectively met. Healthcare researchers and scientists at the Li Ka Shing Faculty of Medicine of the Hong Kong University have successfully demonstrated the utilization of human induced pluripotent stem cells or hiPSCs from the skin cells of the patient for testing therapeutic drugs.

The success of this research suggests that scientists have crossed one more hurdle towards using stem cells in precision medicine for the treatment of patients suffering from sporadic hereditary diseases. iPSCs are the new generation approach towards the prevention and treatment of diseases that takes into account patients on an individual basis considering their genetic makeup, lifestyle, and environment. Along with the capacity to transform into different body cell types and same genetic composition of the donors, hiPSCs have surfaced as a promising cell source to screen and test drugs.

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In the present research, hiPSC was synthesized from patients suffering from a rare form of hereditary cardiomyopathy owing to the mutations in Lamin A/C related cardiomyopathy in their distinct families. The affected individuals suffer from sudden death, stroke, and heart failure at a very young age. As on date, there is no exact treatment available for this condition.

This team in Hong Kong tested a drug named PTC124 to suppress specific genetic mutations in other genetic diseases into the iPSC transformed heart muscle cells. While this technology is being considered as a breakthrough in clinical stem cell research, the team at Hong Kong University is collaborating with drug companies regarding its clinical application.

The unique properties of iPS cells provides extensive potential to several biopharmaceutical applications. iPSCs are also used in toxicology testing, high throughput, disease modeling, and target identification. This type of stem cell has the potential to transform drug discovery by offering physiologically relevant cells for tool discovery, compound identification, and target validation.

A new report by Persistence Market Research (PMR) states that the globalinduced pluripotent stem or iPS cell marketis expected to witness a strong CAGR of 7.0% from 2018 to 2026. In 2017, the market was worth US$ 1,254.0 Mn and is expected to reach US$ 2,299.5 Mn by the end of the forecast period in 2026.

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Customization to be the Key Focus of Market Players

Due to the evolving needs of the research community, the demand for specialized cell lines have increased to a certain point where most vendors offering these products cannot depend solely on sales from catalog products. The quality of the products and lead time can determine the choices while requesting custom solutions at the same time. Companies usually focus on establishing a strong distribution network for enabling products to reach customers from the manufacturing units in a short time period.

Entry of Multiple Small Players to be Witnessed in the Coming Years

Several leading players have their presence in the global market; however, many specialized products and services are provided by small and regional vendors. By targeting their marketing strategies towards research institutes and small biotechnology companies, these new players have swiftly established their presence in the market.

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To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

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Induced Pluripotent Stem Cells Market is Expected to Grow at a CAGR of 7% During the Forecast Period 2026 - Market Research Posts

Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health – BioSpace

By adminJuly 27, 2020Stell Cell Research

INGELHEIM, Germany--(BUSINESS WIRE)-- Boehringer Ingelheim, a market leader in animal health, has acquired Global Stem cell Technology (GST), a Belgian veterinary biotech company. GST is dedicated to the research, development and production of evidence-based, regenerative medicines (stem cell therapies) used to treat orthopedic and metabolic diseases in animals. Boehringer Ingelheim already entered into a partnership with GST in 2018; in 2019, the companies launched Arti-Cell Forte in Europe.

Arti-Cell Forte is testimony to the innovation strength that lies within both companies. It is the first-ever stem cell product in the veterinary world granted marketing authorization by the European Commission. The acquisition and integration of GST will accelerate the development pipeline of Boehringer Ingelheim while maintaining its focus on setting new standards of care for animals.

Collaboration with external partners plays an essential role in helping us expand our portfolio. After two years of a very successful partnership, we have decided to acquire GST. We are convinced that its expertise in the field of state-of-the art stem cell products will help us bring even more innovative solutions to our customers, shares Jean-Luc Michel, Head of Global Strategic Marketing, Boehringer Ingelheim Animal Health.

Boehringer Ingelheim wants to lead a new wave of innovation in the veterinary field. This ambition is a natural fit with GSTs management, staff and vision. From the very beginning we aimed to change the veterinary field, a role we will continue to play as a new R&D division within Boehringer Ingelheim, says Jan Spaas, CEO of GST.

This decision is fully aligned with our recently refocused strategic direction. Stem cell research areas and regenerative medicine offer an exciting potential for the next wave of innovation we are actively pursuing. In addition, strengthening external partnerships to accelerate our innovative efforts and growth is one of the key elements of our strategy, adds Eric Haaksma, Head of Global Innovation at Boehringer Ingelheim Animal Health.

The companies did not disclose the financial terms of the deal.

For references and notes to editors, please visit:

http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-acquires-global-stem-cell-technology

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200727005234/en/

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Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health - BioSpace

3D Cell Culture Market Size, Share Global Comprehensive Research Study,Trends, Development Status, Opportunities, Future Plans, Competitive Landscape…

By adminJuly 27, 2020Stell Cell Research

Global 3D Cell Culture Market Report Focuses on the key 3D Cell Culture Market manufacturers, to study the sales, value, market share and development plans in the future. It is Define, describe and forecast the 3D Cell Culture Market by type, application, and region to Study the global and key regions market potential and advantage, opportunity and challenge, restraints and risks. Know significant trends and factors driving or inhibiting the 3D Cell Culture Market growth opportunities in the market for stakeholders by identifying the high growth segments. Strategically it examines each submarket with respect to individual growth trend and their contribution to the 3D Cell Culture Market

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The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and sales by manufacturers during the forecast period of 2020 to 2020.

The cell culture technique is present in biological areas for the development of drug discovery, regenerative medicine, and protein production The cell culture technique has evolved from 2D cell culture to 3D cell culture The 3D culture resembles physiological conditions closely and has various different advantages over the 2D culture conditions The 3D cell culture can be defined as the culture of living cells within micro-assembled devices and supports the display of three-dimensional structures mimicking tissue and organ-specific microarchitecture The factors driving the market include increasing application of biotech and pharmaceutical companies and hospitals and rise in the patient population affected by cancer The growing number of patients in need of organ transplantation is propelling the growth of the market However, the high cost of devices, regulatory framework, and lack of awareness amongst the masses are major challenges for the market The global market for 3D cell culture is segmented on the basis of technique, product, application, end user, and region On the basis type of technique, it is segmented into scaffold-based 3D cell culture and scaffold-free 3D cell culture The scaffold-based 3D cell culture is further segmented into hydrogel-based support and polymeric hard material based support The scaffold-free 3D cell culture is further segmented into hanging drop microplates, spheroid microplates containing ultra-low attachment (ULA) coating, and microfluidic 3D cell culture On the basis of product, it is segmented into consumables and instruments The consumables are further segmented into culture media, reagents, 3D multi-well plates, and glassware The instruments are further segmented into bioreactor, flow cytometer, and cell culture chips On the basis of application, it is segmented into drug discovery, cancer research, stem cell research, tissue screening and engineering, and regenerative medicine On the basis of end users, it is segmented into pharmaceutical and biotechnology companies, contract research organizations, and research and academic laboratoriesThe global 3D cell culture market accounted for USD 725

Here is List of Top 3D Cell Culture Market Key-Manufactures:

Global 3D Cell Culture market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global 3D Cell Culture market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

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The overviews, SWOT analysis and strategies of each vendor in the 3D Cell Culture market provide understanding about the market forces and how those can be exploited to create future opportunities. Major points like Competitive Situation and Trends, Concentration Rate Mergers & Acquisitions, Expansion which are vital information to grow/establish a business is also provided.

Key Factors Involved in the Report:

3D Cell Culture Market Forecast by regions, type and application, with sales and revenue, from 2020 to 2020.

3D Cell Culture Market Share, distributors, major suppliers, changing price patterns and the supply chain of raw materials is highlighted in the report.

3D Cell Culture Market Size (sales, revenue) forecast by regions and countries from 2020 to 2020 of 3D Cell Culture industry.

The global 3D Cell Culture market Growth is anticipated to rise at a considerable rate during the forecast period, between 2020 and 2020. In 2020, the market was growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

3D Cell Culture Market Trend for Development and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

3D Cell Culture Market Report also mentions market share accrued by each product in the 3D Cell Culture market, along with the production growth.

The study objectives of this report are:

Target Audience

Production Analysis: SWOT analysis of major key players of 3D Cell Culture industry based on a Strengths, Weaknesses, companys internal & external environments, Opportunities and Threats. It also includes Production, Revenue, and average product price and market shares of key players. Those data are further drilled down with Manufacturing Base Distribution, Production Area and Product Type.

Regional analysis

Geographically, the global 3D Cell Culture market is divided into global regions like Europe, North America, Asia- Pacific, Middle East, LATAM, and Africa.

Key Features of 3D Cell Culture Market Research Report:

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Total Chapters in 3D Cell Culture Market Report are:

Chapter 1 Overview of 3D Cell Culture Market

Chapter 2 Global Market Status and Forecast by Regions

Chapter 3 Global Market Status and Forecast by Types

Chapter 4 Global Market Status and Forecast by Downstream Industry

Chapter 5 North America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 6 Europe Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 7 Asia Pacific Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 8 Latin America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 9 Middle East and Africa Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 10 Market Driving Factor Analysis of Low End Servers

Chapter 11 3D Cell Culture Market Competition Status by Major Manufacturers

Chapter 12 3D Cell Culture Major Manufacturers Introduction and Market Data

Chapter 13 Upstream and Downstream Market Analysis of 3D Cell Culture Market

Chapter 14 Cost and Gross Margin Analysis of 3D Cell Culture Market

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Can progenitor cells go further than gene therapy in retinal disorders? A biotech’s answer shines in PhIIb – Endpoints News

By adminJuly 27, 2020Stem Cell Treatment

By the time the FDA approved Luxturna the pioneering gene therapy for an inherited retinal disease Henry Klassen had been researching and treating the group of diseases known as retinitis pigmentosa for more than 20 years.

Spark Therapeutics success there had not just inspired a $4.3 billion takeover by Roche, it had also emboldened other biotechs pursuing a therapy that would deliver one of the genes tied to different variations of the disorder. Nightstar Therapeutics subsequently scored its own buyout with Biogen, and MeiraGTx recently posted early but exciting data on its J&J-partnered program.

But Klassen went a different way.

Catching on the stem cell craze right at the turn of the millennium, he took inspiration from scientists who transplanted neural progenitor cells into the retina and developed a method to grow retinal progenitor cells instead as a therapy. Starting out as the director of stem cell research at the Childrens Hospital of Orange County, he continued the work at the University of California, Irvine, eventually spinning out a biotech dubbed jCyte in 2012.

Over the weekend jCyte reported positive Phase IIb results from what they call one of the largest studies ever conducted in RP, suggesting that patients on the treatment saw improved functional vision compared to the placebo group.

The credit to the gene therapies is that theyre actively trying to fix the gene underlying the problem. Thats very commendable, and were not doing that, Klassen told Endpoints News. But our treatment as it stands should have impact across a variety of different genotypes.

The study enrolled a total of 84 patients, of whom 74 were included for the final analysis. For each patient on the primary endpoint of best corrected visual acuity (measured with glasses on), the mean change from baseline to month 12 for the sham, low dose and high dose arms were +2.81, +2.96, and +7.43 letters, respectively.

In a post hoc analysis for a target subgroup, the difference was even more prominent: +1.85, -0.15, and +16.27 letters, respectively.

There was one serious adverse event in the low dose arm, but jCyte said the grade 3 ocular hypertension resolved with treatment and other side effects were generally minor.

CEO Paul Bresge noted that the target subgroup analysis was intended to hammer out the criteria they might use to recruit patients into Phase III which would likely have a similar design and use the same primary endpoint of BCVA, the gold standard in the context of FDA. The late-stage trial is slated for 2021.

We did enroll a very wide patient population into our Phase IIb, including patients that had vision anywhere from 20/80 to 20/800, just to learn which patients would potentially be the best responders, he said.

The target subgroup is characterized by having reliable fixation on the study eye, and a study eye that does not have significantly worse BCVA (15 letters) than the fellow eye.

He added that investigators also observed encouraging results with the secondary endpoints such as low light mobility, contrast sensitivity kinetic visual fields and a vision function questionnaire, although the data werent disclosed.

Typically people think about the disease as a narrowing of this peripheral vision in a very nice granular way, but thats actually not what happens, he said about the visual fields finding. What happens in the disease is that patients lose like islands of vision. So what were doing in our tests is actually measuring [] islands that the patients have at baseline, and then what were seeing after treatment is that the islands are expanding. Its similar to the way that one would track, lets say a tumor, in oncology of course were looking for the opposite effect. Were looking for the islands of vision to expand.

The therapy works primarily by preserving photoreceptors, Klassen posits, not by generating new ones. But what he thinks is happening is that photoreceptors are regenerating the outer segment if photoreceptors are radios, these would be the antenna thereby regaining some function.

That could position it as a treatment for a different stage of the disease than Sparks or Nightstars. Klassen, whos also researching retinal reconstruction using stem cells, is happy to not view it through the competitive lens.

If you look into the future, one could imagine that gene therapies will be most effective very early in the course of a disease before photoreceptors are lost, he said. Then as photoreceptors begin to be lost anyway, if that happens, then a therapy like ours would become extremely valuable. And if ours starts to lose power late in the course of a disease, maybe cell transplantation under the retina could have a role.

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Can progenitor cells go further than gene therapy in retinal disorders? A biotech's answer shines in PhIIb - Endpoints News

BrainStorm Cell Therapeutics to Announce Second Quarter Financial Results and Provide a Corporate and R&D Update – Stockhouse

By adminJuly 27, 2020Stem Cell Treatment

NEW YORK, July 27, 2020 /PRNewswire/ -- BrainStorm-Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in developing innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company will hold a conference call to update shareholders on financial results for the second quarter ended June 30, 2020, and provide a corporate update, at 8:00 a.m., Eastern Daylight Time (EDT), on Wednesday, August 5 2020.

On the call, BrainStorm CEO Chaim Lebovits will present a corporate update, including details on the timeline for the data readout of the Company's Phase 3 pivotal trial studying the safety and efficacy of NurOwn® (MSC-NTF cell) in people with ALS. In addition, Dr. Revital Aricha. Brainstorm's Vice President of Research and Development, will provide an R&D update including recently announced data from the Company's groundbreaking preclinical study evaluating NurOwn-derived exosomes for the treatment of COVID-19 ARDS.

Thereafter, senior management officers will join the call for a Q&A session. Participants are encouraged to submit their questions prior to the call by sending them to: q@brainstorm-cell.com. Questions should be submitted by 5:00 p.m. EDT, Monday, August 3, 2020.

Teleconference Details BRAINSTORM CELL THERAPEUTICS 2Q 2020

The investment community may participate in the conference call by dialing the following numbers:

Participant Numbers:

Toll Free: 877-407-9205 International: 201-689-8054

Those interested in listening to the conference call live via the internet may do so by visiting the "Investors & Media" page of BrainStorm's website at http://www.ir.brainstorm-cell.com and clicking on the conference call link.

Those that wish to listen to the replay of the conference call can do so by dialing the numbers below. The replay will be available for 14 days.

Replay Number:

Toll Free: 877-481-4010 International: 919-882-2331 Replay Passcode: 36017

Teleconference Replay Expiration:

Wednesday, August 19, 2020

About NurOwn®

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors (NTFs). Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also recently received acceptance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS) and initiated enrollment in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six U.S. sites supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. BrainStorm also recently received U.S. FDA clearance to initiate a Phase 2 open-label multicenter trial in progressive multiple sclerosis (MS). The Phase 2 study of autologous MSC-NTF cells in patients with progressive MS (NCT03799718) started enrollment in March 2019. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe-Harbor Statement

Statements in this announcement other than historical data and information, including statements regarding future clinical trial enrollment and data, constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, BrainStorm's need to raise additional capital, BrainStorm's ability to continue as a going concern, regulatory approval of BrainStorm's NurOwn treatment candidate, the success of BrainStorm's product development programs and research, regulatory and personnel issues, development of a global market for our services, the ability to secure and maintain research institutions to conduct our clinical trials, the ability to generate significant revenue, the ability of BrainStorm's NurOwn treatment candidate to achieve broad acceptance as a treatment option for ALS or other neurodegenerative diseases, BrainStorm's ability to manufacture and commercialize the NurOwn treatment candidate, obtaining patents that provide meaningful protection, competition and market developments, BrainStorm's ability to protect our intellectual property from infringement by third parties, heath reform legislation, demand for our services, currency exchange rates and product liability claims and litigation,; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

CONTACTS

Investor Relations: Preetam Shah, MBA, PhD Chief Financial Officer BrainStorm Cell Therapeutics Inc. Phone: +1-862-397-1860 pshah@brainstorm-cell.com

Media: Paul Tyahla SmithSolve Phone: +1-973-713-3768 Paul.tyahla@smithsolve.com

View original content:http://www.prnewswire.com/news-releases/brainstorm-cell-therapeutics-to-announce-second-quarter-financial-results-and-provide-a-corporate-and-rd-update-301100141.html

SOURCE Brainstorm Cell Therapeutics Inc

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BrainStorm Cell Therapeutics to Announce Second Quarter Financial Results and Provide a Corporate and R&D Update - Stockhouse

Unproven stem cell therapies, and now, strong words from the FDA – BioNews

By adminJuly 27, 2020Stem Cell Clinics

27 July 2020

There has been general concern around the reports of untested stem celltreatments being sold before they have been proven safe and effective. A recent publication by the US' Food and Drug Administration (FDA)represents an informal forewarning to the rogue doctors operating outside of the regulatory regime that they may not get extra time to comply with the agency's strict regulation of regenerative medicine products.

This piece, which uses strong language, underscores the regulatory agency's firm commitment to evidence-based regenerative products.

In 2017, the FDA articulated the regulatory criteria for product marketing through the publication of four guidance documents. These documents build upon the agency's existing risk-based, flexible regulatory regime. They enable stakeholders to understand better how the regulatory criteria apply to their products by clarifying complex technical definitions such as 'minimal manipulation' and 'homologous use'.

This coming November will mark the end of the three years of enforcement discretion announced by the FDA when it first set up this stringent regulatory framework. This approach allows product manufacturers sufficient time to engage with the agency to comply with the requirements, eg, to determine whether they must submit a marketing authorisation application to the FDA for their approval. In the recent piece, there is no indication of a deadline extension.

The authors, Dr Stephen Hahn (FDA's new commissioner) and Dr Peter Marks (Centre for Biologics and Evaluation and Research (CBER) director), state that '... these products, whether autologous (taken from the patient) or allogeneic (donated), are not inherently safe and may be associated with serious adverse consequences'. This piece places the unproven stem cell therapy issue in the context of the COVID-19 pandemic, during which some clinics selling unproven stem cell therapies have exploited the fears of the vulnerable public.

It also indicates that 'the increasing number of adverse events being reported following the widespread use of unapproved regenerative medicine therapies at hundreds of clinics across the country make it necessary for the FDA to act to prevent harm to individuals receiving them.' This point is indeed commendable as it represents the increasingly proactive measures being taken by the FDA in taking enforcement action.

The authors request engagement from patients, their family and friends as well as clinicians 'to help to ensure that instead of remaining unintentionally or intentionally hidden, potentially harmful unapproved regenerative medicine therapies are identified and then removed from the market.' Some clinics may attempt to avoid being on the FDA's radar, however, there is reliable research that should help inform the FDA about the emergence of hundreds, if not a thousand such centres in the US.

Crucially, the article provides some useful and practical guidelines for patients to refer to when evaluating whether a cellular product is offered in compliance with the FDA regulations. For patients contemplating therapies involving a cellular product, the authors recommend the following steps as appropriate practices: first, they need to verify whether the product is FDA-approved or whether an investigational new drug (IND) application for the product is currently on file with the FDA. Next, the patient must provide written informed consent to participate in a clinical trial under that IND and compliance with institutional review board (IRB) requirements.

Moreover, the patient must not be charged for either the unapproved product or for participation in the clinical trial unless there is evidence of benefit to the patient, in which case the amount charged must not exceed the actual direct costs to create the product (cost recovery). And this must be documented by a certified public accountant.

On a critical note, patients (and family, friends and clinicians) are encouraged to report adverse medical events after receiving the product and the health care provider must clearly explain the specific steps for doing so, such as filling in patient-friendly forms to report the matter. Such reports will enable the FDA to get a complete picture of the range of dubious activities.

Finally, patients enrolled in the clinical trial should receive a summary of results after the clinical trial. Transparency, it is felt, will engender trust.

Interestingly, the authors state that medical professionals, including primary care physicians and nurses, are in the best position to assist patients in identifying whether the particular regenerative medicine treatment is appropriate for them to pursue. It is doubtful whether this represents an accurate position as there may be a wide range of knowledge and awareness of stem cell interventions even among the doctors.

The article, written amid a pandemic when the FDA is occupied with other pressing matters, reiterates the agency's obligation to its fundamental mission. Collectively, this piece and the recent escalation in warnings, as well as untitled letters sent by FDA to clinics proffering unapproved stem cell treatments, may indicate that these companies may not be granted more time to comply with the requirements. The remaining months may provide some inkling into what the enforcement situation is likely to be as the FDA's enforcement discretion period finishes in November 2020.

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Unproven stem cell therapies, and now, strong words from the FDA - BioNews

HKUMed reveals pathogenic gene of carpal tunnel syndrome providing new directions for prevention and treatment – Mirage News

By adminJuly 27, 2020Stem Cell Treatment

The LKS Faculty of Medicine of The University of Hong Kong (HKUMed), in collaboration with China-Japan Union Hospital of Jilin University, Mainland China, Harvard University and National Institutes of Health (NIH), U.S., have discovered that genetic mutation is one of the key risk factors of carpal tunnel syndrome (CTS). The study revealed a previously unrecognized mechanism in CTS pathogenesis and provided new insight into the development of new preventive and therapeutic strategies. The findings are now published in the leading multidisciplinary science journal Nature Communications [link to the publication].

Background

CTS, sometimes also known as mouse hand, is a fairly common condition in people, who have repeated and forceful movements of the hand and the wrist in their work and daily life, such as I.T. professionals, construction workers, cleaners and housewives. CTS is characterized by pain, numbness, tingling and weakness in the hand and the wrist due to excessive pressure on the median nerve within the carpal tunnel, which is often caused by swelling and thickening of soft connective tissues surrounding the median nerve.

CTS is a progressive disorder that can worsen without appropriate treatment, leading to nerve damage, permanent muscle atrophy, or loss of hand function. It is estimated to affect 1-5% of the general population[1] and is a leading cause of work disability. It is more common in people older than 40, and women are more likely to develop the condition than men; and more than one-half of cases will experience bilateral symptoms. According to the 0.1-0.3% incidence of CTS in U.S., the number of new cases in Hong Kong is estimated to be at least 7,000 per year[2].

In the past, most people believed that environmental factors, such as repetitive use of hands and wrists, were the main causes of CTS. However, familial occurrence of CTS in 1739% of cases[3] [4], a number of CTS families reported over the world and a large twin study that found an approximate 46% genetic contribution[5], suggest that genetic factors significantly influence CTS susceptibility. Nevertheless, so far, no causal genes were identified.

Research findings

It is challenging to study the pathogenesis of complex human diseases due to their multifactorial and polygenic nature, but Mendelian forms of common diseases have proven invaluable in identifying disease genes and elucidating pathogenic mechanisms. In this study, the research team analyzed two large pedigrees of CTS (nearly 100 cases) by using clinical, genetic, histological and biochemical methods. They discovered that mutations in a gene called COMP caused CTS in these two families.

COMP is highly expressed in the soft connective tissues surrounding the median nerve. The mutant COMP induced cellular stress response, leading to an accumulation of fibrotic and adipogenic cells. Eventually, fibrotic connective tissues in the human carpal tunnel become thickened and swollen, thus compressing the median nerve in causing CTS. Scientists further generated a CTS animal model, which recapitulated the progressive phenotype of human patients, and found that injury could significantly accelerate CTS onset.

Our findings provide solid evidence that genetic mutations can cause CTS, and COMP is the first identified causative gene. We also revealed cellular stress response as a novel mechanism underlying the pathogenesis of CTS, which lays the foundation for the future development of new treatments by inhibiting such response, said Dr Gao Bo, Assistant Professor of the School of Biomedical Sciences, HKUMed, who led the research.

The onset time and symptoms of familial patients are usually earlier and stronger than sporadic patients because the major risk factor is intrinsic (e.g. genetic) rather than extrinsic (e.g. life style, occupation). But sporadic CTS more likely result from combined effects of genetic susceptibility and environmental factors. When consulting a doctor, the patient should inform whether there are other affected members in his/her family, which will assist in diagnosis. I would also suggest, when introducing CTS to the public, the Hospital Authority should include genetic predisposition as one of the important risk factors of CTS, Dr Gao said.

About the Research Team

In collaboration with multiple institutions, the research was led by Dr Gao Bo, Assistant Professor of the School of Biomedical Sciences, HKUMed. Dr Li Chun-yu, China-Japan Union Hospital of Jilin University, Mainland China and Dr Wang Ni, Research Associate, School of Biomedical Sciences, HKUMed are co-first authors. Key international collaborators include Professor Yang Ying-zi, Harvard University, U.S.; Professor Cui Shu-sen, China-Japan Union Hospital of Jilin University, Mainland China and Dr Alejandro Schaffer, National Institutes of Health, U.S.. Other HKU scientists contributing to the research include Professor Danny Chan, S Y and H Y Cheng Professorship in Stem Cell Biology and Regenerative Medicine, Interim Director of School of Biomedical Sciences, HKUMed and Assistant Dean (Research postgraduate studies), HKUMed; Dr Wang Jin, Post-doctoral Fellow, School of Biomedical Sciences, HKUMed; Dr Wang Cheng, former Post-doctoral Fellow, School of Biomedical Sciences, HKUMed; and Ms Vanessa Choi Nga-ting, Technician, School of Biomedical Sciences, HKUMed.

The work was supported in part by Health and Medical Research Fund (Project #05160946) in Hong Kong.

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HKUMed reveals pathogenic gene of carpal tunnel syndrome providing new directions for prevention and treatment - Mirage News

Cancer Biological Theraphy Market Size, Share Global Opportunities, Trends, Regional Overview, Global Growth, Leading Company Analysis, And Key…

By adminJuly 27, 2020Gene Therapy Clinics

Global Cancer Biological Theraphy Market Report Focuses on the key Cancer Biological Theraphy Market manufacturers, to study the sales, value, market share and development plans in the future. It is Define, describe and forecast the Cancer Biological Theraphy Market by type, application, and region to Study the global and key regions market potential and advantage, opportunity and challenge, restraints and risks. Know significant trends and factors driving or inhibiting the Cancer Biological Theraphy Market growth opportunities in the market for stakeholders by identifying the high growth segments. Strategically it examines each submarket with respect to individual growth trend and their contribution to the Cancer Biological Theraphy Market

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Biological therapy treatment is done with the help of living organisms, parts of living organisms or laboratory manufactured version of such content. There are various types of biological therapies, which inhibit specific molecules involved in development and growth of cancer tumor. Such therapies known as; cancer targeted therapies. The global cancer biological therapy market is expected to reach USD 82,276.8 million by 2023 at a CAGR of 4.7% during the forecasted period. The global cancer biological therapy market is segmented on the basis of phases, types, end users and regions. On the basis of phases, the market is segmented into phase I, phase II and phase III. In stage I & II the real impact of these therapies is seen and giving a success rate of 35% in Phase 1 and 20% in Phase II. The success rate of phase I is 35%.On the basis on types, the global cancer biological therapy market is segmented into monoclonal antibodies, cancer growth blockers, interferons, interleukins, gene therapy, targeted drug delivery, colony stimulating factor, cancer vaccines and others. Monoclonal antibodies accounted for the largest market share of the global cancer biological therapy market. Colony stimulating factor is the fastest growing market at a CAGR of 5.2% during the forecasted period.On the basis on end users, hospitals & clinics dominates the global cancer biological therapy market. Registering USD 26,790.6 million in 2016 and expected to reach at USD 38,471.9 million by 2023 at the rate of 4.4 % from 2016-2023. On the basis of regions, the market is segmented into North America, Europe, Asia-Pacific and the Middle East & Africa. North America has the dominating market for cancer biological therapy. The cancer biological therapy market for North America is estimated at USD 19,481.2 million in 2016 and expected to reach by USD 29,516.9 million by 2023 at a fastest CAGR of 5.10%.

Here is List of Top Cancer Biological Theraphy Market Key-Manufactures:

Global Cancer Biological Theraphy market 2020 research provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Global Cancer Biological Theraphy market analysis is provided for the international markets including development trends, competitive landscape analysis, and key regions development status. Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

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The overviews, SWOT analysis and strategies of each vendor in the Cancer Biological Theraphy market provide understanding about the market forces and how those can be exploited to create future opportunities. Major points like Competitive Situation and Trends, Concentration Rate Mergers & Acquisitions, Expansion which are vital information to grow/establish a business is also provided.

Key Factors Involved in the Report:

Cancer Biological Theraphy Market Forecast by regions, type and application, with sales and revenue, from 2020 to 2020.

Cancer Biological Theraphy Market Share, distributors, major suppliers, changing price patterns and the supply chain of raw materials is highlighted in the report.

Cancer Biological Theraphy Market Size (sales, revenue) forecast by regions and countries from 2020 to 2020 of Cancer Biological Theraphy industry.

The global Cancer Biological Theraphy market Growth is anticipated to rise at a considerable rate during the forecast period, between 2020 and 2020. In 2020, the market was growing at a steady rate and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Cancer Biological Theraphy Market Trend for Development and marketing channels are analysed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Cancer Biological Theraphy Market Report also mentions market share accrued by each product in the Cancer Biological Theraphy market, along with the production growth.

The study objectives of this report are:

Target Audience

Production Analysis: SWOT analysis of major key players of Cancer Biological Theraphy industry based on a Strengths, Weaknesses, companys internal & external environments, Opportunities and Threats. It also includes Production, Revenue, and average product price and market shares of key players. Those data are further drilled down with Manufacturing Base Distribution, Production Area and Product Type.

Regional analysis

Geographically, the global Cancer Biological Theraphy market is divided into global regions like Europe, North America, Asia- Pacific, Middle East, LATAM, and Africa.

Key Features of Cancer Biological Theraphy Market Research Report:

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Total Chapters in Cancer Biological Theraphy Market Report are:

Chapter 1 Overview of Cancer Biological Theraphy Market

Chapter 2 Global Market Status and Forecast by Regions

Chapter 3 Global Market Status and Forecast by Types

Chapter 4 Global Market Status and Forecast by Downstream Industry

Chapter 5 North America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 6 Europe Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 7 Asia Pacific Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 8 Latin America Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 9 Middle East and Africa Market Status by Countries, Type, Manufacturers and Downstream Industry

Chapter 10 Market Driving Factor Analysis of Low End Servers

Chapter 11 Cancer Biological Theraphy Market Competition Status by Major Manufacturers

Chapter 12 Cancer Biological Theraphy Major Manufacturers Introduction and Market Data

Chapter 13 Upstream and Downstream Market Analysis of Cancer Biological Theraphy Market

Chapter 14 Cost and Gross Margin Analysis of Cancer Biological Theraphy Market

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Global Ventilators Market Projections & Future Opportunities Recorded for the Period until 2027|ResMed., Medtronic, BD, Getinge AB., Drgerwerk AG…

By adminJuly 27, 2020Gene Therapy Clinics

Ventilators marketis expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 1662.48 million by 2027 growing at a CAGR of 7.60% in the above-mentioned forecast period. Increasing demand for homecare therapeutic devices and rising cases of pulmonary disorders are the factor which will affect the ventilators market in the forecast period of 2020 to 2027.

This persuasive ventilator market report endows with an exhaustive survey of key players in the market which is based on a range of objectives of an organization such as profiling, the product outline, the quantity of production, required raw material, and the financial health of the organization. This market report is an accurate study of the healthcare industry which gives estimations about new triumphs that will be made in the ventilator market in 2020-2027. The ventilator market document has been prepared to bring about comprehensive analysis of the market structure along with forecast of the different segments and sub-segments of the market.

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The major players covered in the ventilators market report areKoninklijke Philips N.V., ResMed., Medtronic, BD, Getinge AB., Drgerwerk AG & Co. KGaA,, Smiths Group, Hamilton Medical., GENERAL ELECTRIC COMPANY, Fisher & Paykel Healthcare Limited., Air Liquide., Asahi Kasei Corporation., Skanray Technologies Pvt. Ltd, WEINMANN Emergency Medical Technology GmbH + Co. KG, SCHILLER, Shenzhen Mindray Bio-Medical Electronics Co., Ltd, Airon Corporation, ZOLL Medical Corporation., among other domestic and global players. Market Share data is available for Global, North America, Europe, Asia-Pacific, Middle East and Africa and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Market Trends

On the basis of product type, the global ventilator market is segmented into intensive care ventilators, portable ventilators and neonatal ventilators. Intensive care ventilators are further sub-segmented into high-end ICU ventilators, basic ICU ventilators and mid-end ICU ventilators. In 2018, Intensive care ventilators segment is growing at the highest CAGR and expected to reach USD in the forecast period of 2018 to 2025.

On the basis of modality, the global ventilator market is segmented into non-invasive ventilation and invasive ventilation. Non-invasive ventilation is sub-segmented into volume-cycled ventilators, pressure-cycled ventilators, continuous positive airway pressure ventilators, bi-level positive airway pressure ventilators, flow-cycled ventilators and time-cycled ventilators. In 2018, Invasive ventilation segment is growing at a specific CAGR. However non-invasive ventilation segment is growing at the highest CAGR in the forecast period of 2018 to 2025.

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OPPORTUNITIES

Demand for Cost-saving Technologies

Mechanical ventilation is an integral and expensive part of the intensive care unit (ICU). Optimal application of mechanical ventilation could save costs and improve outcomes of patients. In the low economic countries such as India, shortages of ventilation can results into poor treatment of the patients. Increasing number of the patients with the chronic diseases associated with the respiratory issues demands more ventilation system; hence the demand of the low cost ventilators can enhance the ventilator market in coming year

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Segmentation: Global Ventilators Market

Ventilators market is segmented of the basis of mobility, interface, mode, end- users, and product type. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Based on mobility,

the ventilators market is segmented into intensive care ventilators and portable/transportable ventilators. Intensive care ventilators market is segmented into high-end ICU ventilators, mid-end ICU ventilators and basic ICU ventilators.

On the basis of interface,

the ventilator market is segmented into invasive ventilation and non- invasive ventilation.

Ventilators market on the basis of mode

is also segmented into combined- mode, volume mode ventilation, pressure- mode ventilation and other.

The end user segment of the ventilators market is segmented into hospitals & clinics, home care, ambulatory care centers and emergency medical services.

On the basis of product type,

the ventilators market is divided into Intensive care, portable and neonatal.

The ventilators market is also segmented on the basis of type. The type is segmented into adult, paediatrics and neonatal.

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Data bridge is an aftermath of sheer wisdom and experience which was formulated and framed in the year 2015 in Pune. We ponder into the heterogeneous markets in accord with our clients needs and scoop out the best possible solutions and detailed information about the market trends. Data Bridge delve into the markets across Asia, North America, South America, Africa to name few.

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Ligament Repair Procedures Market 2020 Global Industry Analysis By Size, Growth Rate, Share and Trends With Forecast To 2027 – Owned

By adminJuly 27, 2020Gene Therapy Clinics

Latest study released by Data Bridge Market Research on Global Ligament Repair Procedures Market Size, Share, Growth, Industry Research with more than 220 market data tables and figures spread through Pages are easy to understand TOC in Global Ligament Repair Procedures Market research, so you can get a variety of ways to maximize your profits. Ligament Repair Procedures business research report has market data and information which can answer several marketing problems in different functional areas of marketing such as consumer behaviour, product, sales, distribution channel, pricing, ad and physical distribution. The report provides data on patterns and improvements, and target business sectors and materials, limits and advancements. This report comprises a chapter on the global Ligament Repair Procedures market and all its associated companies with their profiles, which gives valuable data pertaining to their outlook in terms of finances, product portfolios, investment plans, and marketing and business strategies. Ligament Repair Procedures Market predicted until 2027.

Global Cruciate Ligament Repair Procedures Market is expected to rise to an estimated value of USD 17.42 billion by 2026, registering a healthy CAGR in the forecast period of 2019-2026.

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(Note-Our Free Complimentary Sample Report Accommodate a Brief Introduction of the research report, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology) Competitive Analysis:

The key players are highly focusing innovation in production technologies to improve efficiency and shelf life. The best long-term growth opportunities for this sector can be captured by ensuring ongoing process improvements and financial flexibility to invest in the optimal strategies. Company profile section of players such as Xiros, Medical Devices Business Services, Stryker, Corin, Smith+Nephew, Mathys Ltd Bettlach, GROUP FH ORTHO communication, Artelon, Zimmer Biomet, Colfax, CONMED, Bauerfeind, ?ssur Corporate, Ottobock, United Orthopedic Corp, Exactech, Wright Medical Group N.V., Breg, MicroPort Scientific, Fuse Medical among others.

Highlights of the Report

The report offers a 360-degree overview of the Cruciate Ligament Repair Procedures Market, primarily emphasizing on growth drivers, restraints, market trends, size, share, growth, challenges, new recent developments and opportunities of the market.

It provides elaborative information about the competitive landscape of the market, names of market vendors, market segmentation on the basis of application, type, and others, and current logging-while-drilling market trends and industry developments.

The report also throws light on strategies such as company collaborations, mergers and acquisitions, production analysis, application niches and dominance, product approvals, product launches, geographical expansions, technological innovations and up-gradation of the older versions, investments in research and development, and other strategies adopted by the market players.

Browse Full Report with Details TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-cruciate-ligament-repair-procedures-market Market Drivers o Increasing incidence of accidents, sports injures may lead to the growth of the market o Advancement in the technique of surgery will drive the market growth o Increase in geriatric population with rising level of obesity and number of diseases will also augment the growth of this market in the forecast period o Increase research and development activities coupled with innovative therapies acts as a market driver Market Restraints o High cost associated with knee related surgery hampers the market growth o Dearth of skilled and trained physicians will impede the growth of the market o Poor quality of healthcare system in developing countries will also restrict the market growth

Global Cruciate Ligament Repair Procedures Market Detailed Segmentation:

By Type (PCL, ACL), Injury Type (Grade I, Grade II, Grade III), Product (Cemented Implants, Cement-Less Implants, Partial Implants, Revision Implants), Indication (Osteoarthritis, Rheumatoid Arthritis, Trauma, Others), Diagnosis (Imaging, Others) Treatment (Surgery, Therapies, Devices, Others)

By End-User (Hospitals, Orthopedic Clinics, ASC, Others)

By Country (U.S., Canada, Mexico, Germany, Italy, U.K., France, Spain, Netherland, Belgium, Switzerland, Turkey, Russia, Rest of Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific, Brazil, Argentina, Rest of South America, South Africa, Saudi Arabia, UAE, Egypt, Israel, Rest of Middle East & Africa)

List of the Leading Companies that are operating in the global Cruciate Ligament Repair Procedures Market are: Xiros, Medical Devices Business Services, Inc., Stryker, Corin, Smith+Nephew, Mathys Ltd Bettlach, GROUP FH ORTHO communication, Artelon, Zimmer Biomet, Colfax Corporation, CONMED Corporation, Bauerfeind, ?ssur Corporate, Ottobock, United Orthopedic Corp, Exactech, Inc., Wright Medical Group N.V., Breg, Inc., MicroPort Scientific Corporation, Fuse Medical among others.

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The Cruciate Ligament Repair Procedures Market report highlights the key players and the latest strategies including company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, new product launches, partnerships, joint ventures, product width and breadth, application dominance, technology lifeline curve, segmentation in terms of region and industry competition, profit and loss ratio, and investment ideas.

The Cruciate Ligament Repair Procedures report has been produced with the systematic gathering and analysis of information about individuals or organizations conducted through social and opinion research. With the studies, insights and analysis mentioned in the report, you get comprehensible idea about the marketplace with which you can take business decisions quickly and easily.

The worldwide Cruciate Ligament Repair Procedures advertise report comprises of all the organization profiles of the key players and brands. Market definition covered in this Cruciate Ligament Repair Procedures report studies the market drivers and market restraints with which businesses can get idea of whether to increase or decrease the production of a particular product.

Global Cruciate Ligament Repair Procedures Market Report includes Major Detailed Table of Content Points: Table of Content

1Introduction 2Market Segmentation 3 Market Overview 4 Executive Summaries 5 Premium Insights 6 Regulatory Procedure 7 Global Cruciate Ligament Repair Procedures Market, By Type 8 Global Cruciate Ligament Repair Procedures Market, by Product type 9 Global Cruciate Ligament Repair Procedures Market, By Deployment 10 Global Cruciate Ligament Repair Procedures Market, By End User 11 Global Cruciate Ligament Repair Procedures Market, By Distribution Channel 12 Global Cruciate Ligament Repair Procedures Market, By Geography 13 Global Cruciate Ligament Repair Procedures Market, Company Landscape 14 Company Profile Continued!!!

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