Libmeldy TM Receives Positive CHMP Opinion for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD); U.S. IND Application on Track for Year End 2020

Cash and Investments of More Than $200M and Runway into 2022

Frontotemporal dementia (FTD) and Crohns Disease Preclinical Programs to be Featured in Virtual R&D Event on November 13, 2020

BOSTON and LONDON, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today reviewed recent business accomplishments and reported financial results for the quarter ended September 30, 2020.

The positive CHMP opinion we received last month for Libmeldy in the EU represents a proud moment for Orchard and offers a potentially transformative therapy for early-onset MLD patients and their families, said Bobby Gaspar, M.D., Ph.D., chief executive officer, Orchard Therapeutics. We are looking forward to many exciting developments for this program and the rest of our pipeline in the coming months, including our November investor event which will highlight our work in conditions with larger patient populations such as FTD and Crohns disease.

Recent Corporate Achievements

Planned Corporate Milestones

Seek regenerative medicine advanced therapy (RMAT) designation and file an investigational new drug (IND) application in U.S. by year-end 2020

Third Quarter 2020 Financial Results

Revenue from product sales of Strimvelis were $2.0 million for the third quarter of 2020 compared to $1.9 million in the same period in 2019, and cost of product sales were $0.7 million for the third quarter of 2020 compared to $0.6 million in the same period in 2019.

Research and development (R&D) expenses were $14.7 million for the third quarter of 2020 compared to $28.5 million in the same period in 2019. R&D expenses include the costs of clinical trials and preclinical work on the companys portfolio of investigational gene therapies, as well as costs related to regulatory, manufacturing, license fees and milestone payments under the companys agreements with third parties, and personnel costs to support these activities. The decline in R&D expenses is primarily attributable to the companys U.K. research and development tax credits, which are recorded as an offset to R&D expense. During the third quarter of 2020, the company recorded tax credits of $10.1 million as compared to $2.7 million in the same period in 2019. Further, the company has realized savings associated with an updated strategy and corporate restructuring previously announced in May 2020, including the consolidation of its R&D sites.

Selling, general and administrative expenses were $13.0 million for the third quarter of 2020 compared to $14.2 million in the same period in 2019. The decline was primarily due to lower administrative and corporate expenses as compared to the prior period, primarily resulting from the May 2020 corporate restructuring.

Net loss was $20.3 million for the third quarter of 2020 compared to $36.7 million in the same period in 2019. The lower net loss compared to the same period in 2019 is a result of the higher U.K. research and development tax credits, the savings associated with an updated strategic plan and corporate restructuring, and $5.5 million in other income primarily attributable to unrealized foreign currency gains in the quarter. The company had 97.7 million ordinary shares outstanding as of September 30, 2020.

Cash, cash equivalents and investments as of September 30, 2020, were $201.3 million compared to $325.0 million as of December 31, 2019. The decrease was primarily driven by cash used to fund operations for the nine months ended September 30, 2020. In the third quarter of 2020, the company received approximately $13.6 million of cash from R&D tax credits related to 2018 as a result of qualifying activities under the tax code in the U.K. The company expects that its existing cash, cash equivalents and investments will fund its anticipated operating and capital expenditure requirements into 2022. This excludes the $50 million expected to be available under the companys credit facility and any non-dilutive capital received from potential future partnerships or priority review vouchers.

Our European commercial team is in place and have executed the activities necessary to launch Libmeldy (if approved) on a country-by-country basis in the first half of 2021, said Frank Thomas, president and chief operating officer. In addition, we will be leveraging cross border reimbursement channels for the treatment of patients from other parts of the world based on our past experience with Strimvelis.

Webcast Information for November 13 R&D Investor Event

The company will be webcasting a virtual R&D investor event starting at 9:00 am ET on Friday, November 13, 2020. The event can be accessed under "News & Events" in the Investors & Media section of the company's website at http://www.orchard-tx.com, and a replay will be archived on the Orchard website following the event.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us onTwitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, plans, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, including its plans and expectations for the regulatory approval and commercialization of Libmeldy, the therapeutic potential of Orchards product candidates, including Libmeldy and the other product candidates referred to in this release, Orchards expectations regarding the timing of regulatory submissions for approval of its product candidates, including the product candidates referred to in this release, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, the likelihood that such data will be positive and support further clinical development and regulatory approval of these product candidates, the likelihood of approval of such product candidates by the applicable regulatory authorities, and Orchards financial condition and cash runway into 2022. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that any one or more of Orchards product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates, including Libmeldy, will be insufficient to support regulatory submissions or marketing approval in the US and EU or that long-term adverse safety findings may be discovered; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates, including the risk that our marketing authorization application submitted for Libmeldy may not be approved by the European Commission when expected, or at all, or the receipt of restricted marketing approvals; the inability or risk of delays in Orchards ability to commercialize its product candidates, including Libmeldy, if approved, including the risk that Orchard may not secure adequate pricing or reimbursement to support continued development or commercialization of Libmeldy; the risk that the market opportunity for its product candidates, including Libmeldy, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter ended September 30, 2020, to be filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts)(unaudited)

Condensed Consolidated Balance Sheet Data(In thousands)(unaudited)

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaChristine Harrison VP, Corporate Affairs+1 202-415-0137media@orchard-tx.com

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Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results - GlobeNewswire

Bone Marrow Stem Cells Comments Off on Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results – GlobeNewswire | November 3rd, 2020

U.S. biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shownpositive results inseverely ill patients

Vancouver, WACytoDyn Inc. (CytoDyn) a late-stage biotechnology companydeveloping leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announcedit is currently accepting only 155 more candidates across the country for its Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19.

CytoDyn is currently enrolling COVID-19 patients in its Phase 2b/3 clinical trial in at least 13 hospitals in nine states (California, Georgia, Massachusetts, New Jersey, New York, North Carolina, Ohio, Oregon and Texas). Please visit the Companys website atwww.cytodyn.com. The sites currently enrolling patients are listed on the home page under Clinical Trial Enrollment, then click on COVID-19 Severe or Critical in the drop-down screen. Please visit the website frequently, as the list of hospitals is updated on a regular basis.

CytoDyn has already enrolled 235 patients in its trial, and the Data Safety Monitoring Committee (DSMC) recently recommended CytoDyn continue its study without modification to achieve its primary endpoint, based on the results the DSMC observed so far.

The DSMC also added that it will look at the unblinded data again, once an additional 58 patients are enrolled.

We are very encouraged the DSMC recommended we continue our trial without modification, said Nader Pourhassan, Ph.D., President and CEO of CytoDyn.We believe this result, combined with the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients, is an indicator of positive data.

Its our hope this means our study is not only proving to be safe, but effective. If it wasnt, the DSMC would have stopped our trial or requested modifications.But instead, the DSMC recommended we continue our study without modification, and indicated it would look at the unblinded data once we are 75% enrolled.This, to us, is a very strong signal of positive data, added Pourhassan.

The recovery of a young woman in California provides some hopeful evidence of the effectiveness of leronlimab, Pourhassan said. She had contracted COVID-19 and was in the hospital on a ventilator. Within 24 hours after receiving a single injection of leronlimab, the amount of oxygen she needed started to drop, and 2 days later, she was able to be removed from her ventilator and later, sent home. She believes our drug saved her life.

We are optimistic and look forward to the completion of our study, or possible early evaluation to warrant an Emergency Use Authorization (EUA) from the FDA, Pourhassan concluded.

About Coronavirus Disease 2019

CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.

CytoDyn is currently enrolling patients in its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in at least 13 hospitals and clinics across the U.S., which are identified in this press release and on the Companys website under the Clinical Trial Enrollment section of the homepage.

About Leronlimab (PRO 140)

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn

CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking Statements

This release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict.Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, including for patients with COVID-19, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain emergency use authorization or regulatory approval for leronlimab for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results,(ii) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (iii) the market for, and marketability of, any product that is approved, (iv) the sufficiency of the Companys cash position, (v) the Companys ability to raise additional capital to fund its operations, (vi) the Companys ability to meet its debt obligations, if any, (vii) the Companys ability to enter into partnership or licensing arrangements with third parties, (viii) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (ix) the Companys ability to achieve approval of a marketable product, (x) the design, implementation and conduct of the Companys clinical trials, ((xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this release.

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US biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shown positive results in severely ill...

Bone Marrow Stem Cells Comments Off on US biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shown positive results in severely ill… | November 3rd, 2020

Proposition 14 would authorize the sale of $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine, known as CIRM, for stem cell studies and trials.

Here is a rundown of the ballot measure:

In 2004, voters approved a bond measure to pay for stem cell research.

Now, with the money from that bond running out, supporters of the states stem cell agency are asking taxpayers for a new infusion of cash.

With interest, the bond could cost the state $260 million per year, or $7.8 billion over the next 30 years, according to the nonpartisan Legislative Analysts Office.

Proponents of Proposition 14 say the measure will help find new treatments and cures for chronic diseases and conditions, including cancers, spinal cord injuries, Alzheimers, Parkinsons and heart disease. They say the previous bond advanced research and treatments for more than 75 diseases, including two cancer treatments for fatal blood disorders that were approved by the U.S. Food and Drug Administration.

Without new funding to keep the program going, supporters of Proposition 14 say, groundbreaking medical discoveries and lifesaving research will be slowed or stopped.

Opponents say that the state shouldnt take on new debt while facing a pandemic-induced deficit and that medical advances attributed to the previous stem cell bond have been overstated. In addition, opponents say CIRM has been hampered by conflicts of interest and too little oversight, neither of which are remedied by the ballot measure.

The campaign to pass the 2004 ballot measure told voters that the bond would save millions of lives and cut healthcare costs by billions. Critics say thats not been the case to date, although supporters of this years measure note that they never intended those results within 16 years. While there is not much organized opposition, some newspaper editorial boards, including those at the Los Angeles Times and San Francisco Chronicle, have opposed it.

With Prop. 14, California voters will be asked for more borrowing to keep stem cell research going

Explaining Prop. 14

Times columnist George Skelton assesses Prop. 14

The California stem cell programs $5.5-billion funding request might be its downfall

Californias stem cell program faces an existential moment and a chance for reform

When it comes to disease, stem cells are a game-changer, scientists say. This is why

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California Prop. 14: What to know about the stem cell measure - Los Angeles Times

Spinal Cord Stem Cells Comments Off on California Prop. 14: What to know about the stem cell measure – Los Angeles Times | November 3rd, 2020

Professor Paul Glare at the Pain Management Research Institute.

Opioids are good for acute pain. With chronic pain they only work short to medium term, he says. But after about six months, you become tolerant and have to take bigger doses. Then theres the growing risk of accidental overdose, even accidental death.

For many people though, opioids seem like the only way to numb the pain that constantly attacks them. But do they in fact, numb the pain?

Most people who come off the long term use of opioids realise that the drugs werent doing that much, says Glare. Theyd already stopped working, so the pain without them is often no worse. In fact, the drugs were just messing with their heads. Still its a huge psychological step to let the drugs go.

Gently spoken and with a great sense of compassion for the people he works to help, Glare started his career in palliative care which took him into the area of cancer pain, then pain more generally. Because its difficult to tell people battling chronic pain that there is no satisfactory pharmaceutical answer at this time, the PMRI has a large and active pain education unit.

The Unit offers a Masters of Medicine Pain Management that is also conferred as a Masters of Science for non-medical graduates. It also runs cognitive behavioural therapy classes teaching strategies for rising above the pain.

The classes are challenging, says Glare. But many people who learn the self-management techniques can reduce or even stop their opioid use. Its about them not being afraid of their pain anymore.

Its the nature of chronic pain that the injury its warning you about, sometimes very loudly, isnt actually there. This can be seen in a persons posture as they sit and walk in a way that protects that non-injury. By gently confronting the pain, the person can eventually reclaim their normal posture and walk more confidently. Through that, they feel stronger within themselves and more in control of their pain.

The PMRI is now looking at digital support resources for people dealing with pain, Were developing an SMS based text messaging service and a more sophisticated chat-bot tool, to help people get over the hump of opioid tapering, says Glare. Its new in the pain world.

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How pain changes your brain - News - The University of Sydney

Spinal Cord Stem Cells Comments Off on How pain changes your brain – News – The University of Sydney | November 3rd, 2020

Central nervous system comprises brain and spinal cord, and is responsible for integration of sensory information. Brain is the largest and one of the most complex organs in the human body. It is made up of 100 billion nerves that communicate with 100 trillion synapses. It is responsible for the thought and movement produced by the body. Spinal cord is connected to a section of brain known as brain stem and runs through the spinal canal. The brain processes and interprets sensory information sent from the spinal cord. Brain and spinal cord serve as the primary processing centers for the entire nervous system, and control the working of the body. Neuroprosthetics improves or replaces the function of the central nervous system. Neuroprosthetics, also known as neural prosthetics, are devices implanted in the body that stimulate the function of an organ or organ system that has failed due to disease or injury. It is a brain-computer interface device used to detect and translate neural activity into command sequences for prostheses. Its primary aim is to restore functionality in patients suffering from loss of motor control such as spinal cord injury, multiple sclerosis, amyotrophic lateral sclerosis, and stroke. The major types of neuroprosthetics include sensory implants, motor prosthetics, and cognitive prosthetics. Motor prosthetics support the autonomous system and assist in the regulation or stimulation of affected motor functions.

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Similarly, cognitive prosthetics restore the function of brain tissue loss in conditions such as paralysis, Parkinsons disease, traumatic brain injury, and speech deficit. Sensory implants pass information into the bodys sensory areas such as sight or hearing, and it is further classified as auditory (cochlear implant), visual, and spinal cord stimulator. Some key functions of neuroprosthetics include providing hearing, seeing, feeling abilities, pain relief, and restoring damaged brain cells. Cochlear implant is among the most popular neuroprosthetics. In addition, auditory brain stem implant is also a neuroprosthetic meant to improve hearing damage.

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North America dominates the global market for neuroprosthetics due to the rising incidence of neurological diseases and growth in geriatric population in the region. Asia is expected to display a high growth rate in the next five years in the global neuroprosthetics market, with China and India being the fastest growing markets in the Asia-Pacific region. Among the key driving forces for the neuroprosthetics market in developing countries are the large pool of patients, increasing awareness about the disease, improving healthcare infrastructure, and rising government funding in the region.

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Increasing prevalence of neurological diseases such as traumatic brain injury, stroke and Parkinsons disease, rise in geriatric population, increase in healthcare expenditure, growing awareness about healthcare, rapid progression of technology, and increasing number of initiatives by various governments and government associations are some key factors driving growth of the global neuroprosthetics market. However, factors such as high cost of devices, reimbursement issues, and adverse effects pose a major restraint to the growth of the global neuroprosthetics market.

Innovative self-charging neural implants that eliminate the need for high risk and costly surgery to replace the discharge battery and controlling machinery with thoughts would help to develop opportunities for the growth of the global neuroprosthetics market. The major companies operating in the global neuroprosthetics market are Boston Scientific Corporation, Cochlear Limited, Medtronic, Inc., Cyberonics, Inc., NDI Medical LLC, NeuroPace, Inc., Nervo Corp., Retina Implant AG, St. Jude Medical, and Sonova Group.

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The Neuroprosthetics market to stand in a good stead from 2015 to 2021 - KYT24

Spinal Cord Stem Cells Comments Off on The Neuroprosthetics market to stand in a good stead from 2015 to 2021 – KYT24 | November 3rd, 2020

Global Neuroprosthetics Market by Type (Output (Cognitive, Motor Prosthetics), Input (Cochlear, Retinal Implant)), Techniques (Deep Brain, Vagus Nerve, Spinal Cord stimulation), Application (Epilepsy, Paralysis, Alzheimers Disease). The neuroprosthetics market is projected to reach USD 10.48 billion by 2022 from USD 5.84 billion in 2017, at a CAGR of 12.4%.

Neuroprostheses uses electrodes to interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. These devices can receive neural signals from the external environment & brain, and convert the signals to restore functions such as loss of hearing and vision.

They have applications in cognitive disorders, ophthalmic disorders, motor disorders, and auditory disorders.

Theneuroprosthetics marketis projected to reach USD 10.48 billion by 2022 from USD 5.84 billion in 2017, at a CAGR of 12.4%.

People suffering from diabetes may develop several foot problems, which cause damage to blood vessels and nerves. Diabetes can also damage the blood vessels in the retina, which can cause vision impairments or blindness.

As a result, the increasing incidence of diabetes is expected to support the growth of the retinal/bionic eye implants market. The top five countries with the highest diabetic population in 2013 (age group of 2079 years) were China, India, the US, Brazil, and the Russian Federation.

Dysvascular disorder- and diabetes-related amputations are expected to drive the demand for artificial limb replacements in the near future. The prevalence of diabetes has significant regional variation.

Since its burden is higher in the Asia Pacific region, this factor is expected to have a more substantial effect on the market in countries in Southeast Asia and the Indian subcontinent.

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Novel therapies, such as stem cell therapy, are showcasing a significant potential for the effective treatment of various neurological disorders. Stem cell therapy is an emerging branch of medicine that has the potential to restore organ and tissue function in patients suffering from serious injuries or chronic diseases.

These therapies offer advantages such as higher recovery rates and faster recovery periods for patients. Moreover, stem cells also have significant potential in the treatment of motor neuron disease, Parkinsons disease, and Alzheimers disease.

Furthermore, medicinal, physical, occupational, and speech therapies are available for the treatment of several neurological disorders. For instance, currently, the preference for drug therapies is higher among Parkinsons patients due to the lower cost and convenience of the treatment.

The availability of these alternative treatment options is one of the significant factors limiting the demand for and adoption of neuroprosthetic devices and implants among the target patient population.

Neuroprosthetic procedures involve minimally invasive techniques as opposed to alternate surgical procedures for treating tremors primarily associated with Parkinsons, which are invasive treatments. For instance, in a pallidotomy, the surgeon destroys a tiny part of the globus pallidus by creating a scar to reduce brain activity.

Doctors do not prefer this procedure and encourage the use of deep brain stimulation; instead, as it does not destroy brain tissue and has fewer risks as compared to pallidotomy.

The use of DBS in newer applications/indications, such as Alzheimers, epilepsy, and depression, is currently in clinical trials. Similarly, the treatment of heart failure, sleep apnea, obesity, and tinnitus through VNS (Vagus Nerve Stimulation); fecal incontinence by SNS (Sacral Nerve Stimulation); and tinnitus, migraine, and stroke by TMS (Transcranial Magnetic Stimulation) are also under clinical trials.

TMS is currently used to treat depression, SNS for urine incontinence, and VNS for epilepsy.

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North America is expected to command the largest share of the market during the forecast period.

Based on region, the neuroprosthetics market is segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). In 2017, North America is expected to command the largest share of the neuroprosthetics market.

The large share of this market can primarily be attributed to the high incidence of vision and hearing loss, rising prevalence of neurological disorders, and the strong presence of industry players in this region.

Key Market Players

Medtronic plc (Medtronic) (US), Cochlear Ltd. (Cochlear) (Australia), Abbott Laboratories (Abbott) (US), Boston Scientific (US), LivaNova, PLC (LivaNova) (UK), and Second Sight Medical Products, Inc.(Second Sight) (US).MED-EL (Austria), Retina Implant AG (Germany), Sonova (Switzerland), Neuropace (US), NDIE Medical, LLC (Canada) Nevro (US).

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Neuroprosthetics Market: Increasing Prevalence of Diabetes in Neuroprosthetics investigated in the latest research - WhaTech

Spinal Cord Stem Cells Comments Off on Neuroprosthetics Market: Increasing Prevalence of Diabetes in Neuroprosthetics investigated in the latest research – WhaTech | November 3rd, 2020

Stem cell-derived cells are ready-made human induced pluripotent stem cells (iPS) and iPS-derived cell lines that are extracted ethically and have been characterized as per highest industry standards. Stem cell-derived cells iPS cells are derived from the skin fibroblasts from variety of healthy human donors of varying age and gender. These stem cell-derived cells are then commercialized for use with the consent obtained from cell donors. These stem cell-derived cells are then developed using a complete culture system that is an easy-to-use system used for defined iPS-derived cell expansion. Majority of the key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

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The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

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North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

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The Stem Cell-Derived Cells market to go the astute way from 2019 to 2029 - TechnoWeekly

IPS Cell Therapy Comments Off on The Stem Cell-Derived Cells market to go the astute way from 2019 to 2029 – TechnoWeekly | November 3rd, 2020

The latest market report published by Reports and Data, titled Global Stem Cells Market, presents an accurate analysis of the estimated market size, share, revenue, and sales & distribution networks of the global Stem Cells market over the forecast period. The report offers an exhaustive overview of the market, along with a precise summary of the markets leading regions. Our team of analysts has studied the existing competitive landscape of the market inside out, focusing on the leading companies and their business expansion strategies. The report ends with conclusive data offering useful insights into the market growth on both regional and global levels.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Thermo Fisher Scientific, Agilent Technologies, Illumina, Inc., Qiagen, Oxford Nanopore Technologies, Eurofins Scientific, F. Hoffmann-La Roche, Danaher Corporation, Bio-Rad Laboratories, and GE Healthcare

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The report draws the focus of the reader on the grave impact of the ongoing COVID-19 pandemic on the Stem Cells industry and its vital segments and sub-segments. It elaborates on the adverse effects of the pandemic on the global economic scenario, as well as this particular business sphere. The report takes into account the key influencing factors influencing market performance in the present COVID-19 times. The market has been substantially affected by the pandemic, and significant changes have been observed in the market dynamics and demand trends. The report examines the major financial difficulties brought about by the pandemic and offers a future COVID-19 impact assessment.

The market intelligence study takes the reader through the key parameters of the Stem Cells market, including the strengths and weaknesses of the leading players, using analytical tools like the SWOT analysis and Porters Five Forces analysis. The report includes broad market segmentation based on the different product types, a wide application spectrum, the key regions, and the existing competition among players.

Product Outlook (Revenue, USD Billion; 2017-2027)

Technology Outlook (Revenue, USD Billion; 2017-2027)

Therapy Outlook (Revenue, USD Billion; 2017-2027)

Application Outlook (Revenue, USD Billion; 2017-2027)

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The investigative study further assesses the market on the basis of market reach and consumer base in the key geographical segments. Alongside reviewing the sales network, distribution channels, pricing analysis, profit margins, cost and demand volatility, import/export dynamics, gross revenue, and various other aspects of the market, the report studies several factors affecting market growth over the forecast period, such as drivers, restraints, limitations, growth prospects, and numerous macro- and micro-economic indicators.

Key Geographies Encompassed in the Report:

Key questions addressed in the report:

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Global Stem Cells Market 2020 Industry Demand, Share, Global Trend, Top Key Players Update, Business Statistics And Research Methodology By Forecast...

IPS Cell Therapy Comments Off on Global Stem Cells Market 2020 Industry Demand, Share, Global Trend, Top Key Players Update, Business Statistics And Research Methodology By Forecast… | November 3rd, 2020

Beathan Report has released the International report on The Autologous Stem Cell Based Therapies market, which is made up of advice about each of the essential parameters of this market like ingestion and the manufacturing patterns coupled with all the earnings patterns for the prediction period. Concerning creation aspect, the report provides complete detailed analysis about the manufacturing procedures combined with the gross financials accumulated by the very best most producers working within this business. The main facet of this Autologous Stem Cell Based Therapies market thats covered in the report helps the customers and the associations to better comprehend the company profile concerning drivers, restraints, challenges, and opportunities affecting and pertaining the market dynamics.

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Key market players

Major competitors identified in this market include Regeneus, Mesoblast, Pluristem Therapeutics Inc, US STEM CELL, INC., Brainstorm Cell Therapeutics, Tigenix, Med cell Europe, etc.

Based on the Region:

Asia-Pacific (China, Japan, South Korea, India and ASEAN)

North America (US and Canada)

Europe (Germany, France, UK and Italy)

Rest of World (Latin America, Middle East & Africa)

COVID-19 has affected the Overall worldwide companies and itll have a enormous time for the company recovery. Vast majority of the business sectors have realigned their company plans, priorities, and have amended their economic planning so as to stay in the company and keep their standing on the international platform. The thorough evaluation of this Autologous Stem Cell Based Therapies market will enable the brand new market entrants to acquire reliable market approaches and strategy powerful action plans for the prediction period.

Based on the Type:

Embryonic Stem Cell

Resident Cardiac Stem Cells

Umbilical Cord Blood Stem Cells

Based on the Application:

Neurodegenerative Disorders

Autoimmune Diseases

Cardiovascular Diseases

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Important highlights of this Autologous Stem Cell Based Therapies market report:

* COVID-19 effect on the earnings Streams of the Autologous Stem Cell Based Therapies market players.

* Statistics of the overall sales quantity And general market earnings.

* Business trends breakdowns.

* Estimated expansion rate of this Autologous Stem Cell Based Therapies Market.

* In-depth Information Regarding the important Distributors, traders, and dealers.

Key Benefits of the report:

-This report provides an extensive analysis of the current and emerging market trends and dynamics in the global Autologous Stem Cell Based Therapies market.

-In-depth analysis is conducted by constructing market estimations for the key market segments between 2020 and 2027.

-This report entails the detailed quantitative analysis of the current market and estimations through 2020-2027, which assists in identifying the prevailing market opportunities.

-Extensive analysis of the market is conducted by following key product positioning and monitoring the top competitors within the market framework

-Comprehensive analysis of all regions is provided that determines the prevailing opportunities in these geographies.

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Originally posted here:
Autologous Stem Cell Based Therapies Market to Witness Increase in Revenues by 2020-2026 - PRnews Leader

Cardiac Stem Cells Comments Off on Autologous Stem Cell Based Therapies Market to Witness Increase in Revenues by 2020-2026 – PRnews Leader | November 3rd, 2020

KING OF PRUSSIA, Pa., Nov. 2, 2020 /PRNewswire/ --Global biotherapeutics leader CSL Behring announced today that its investigational, plasma-derived hemopexin therapy (CSL889) received orphan drug designation from both the European Commission and the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development for the treatment of sickle cell disease (SCD). These designations grant special status to drugs and biological products intended to treat a rare disease, affecting less than 200,000 patients in the US or affecting not more than five in 10,000 people in the European Union.

CSL889 is a form of plasma-derived hemopexin, an important, naturally occurring protein produced in the body whose levels are decreased in patients with SCD. Low levels of hemopexin have been associated with increased symptoms in SCD, particularly acute vaso-occlusive crises (VOC). VOC, the most common manifestation in SCD, are severe, debilitating episodes characterized by severe pain. There is no approved treatment for acute VOC, so episodes can only be managed with supportive measures such as fluids and pain killers.

"Having treated hundreds of adults and children living with sickle cell disease over 30 years, I'm intensely aware of the need for novel and effective therapies, especially to relieve the tremendous pain from VOC," said Professor Greg Kato, who is leading the clinical development of CSL 889 at CSL Behring. "This newly granted orphan status recognizes the urgency for progressing new treatment options into the clinic."

CSL Behring has two Phase I SCD programs poised to evolve the treatment paradigm for patients: CSL889 hemopexin therapy for the treatment of VOC and CSL200 lentiviral stem cell gene therapy for long-term disease management.

About Sickle Cell Disease

Sickle Cell Disease is a hereditary blood disorder in which red blood cells contain an abnormal type of hemoglobin, causing some of the cells to become distorted into a crescent, or sickle-shape. These misshapen red blood cells have difficulty passing through small blood vessels, slowing and blocking blood flow to areas of the body, damaging tissue that isn't receiving a normal flow of blood. Sickle Cell Disease can lead to episodes of severe pain, strokes, kidney, lung and heart problems, slow growth, vision problems and infection vulnerability. While frequency of Sickle Cell Disease varies globally, it is estimated to impact 100,000 people in the US and 1 in 10,000 persons in the European Union.

About CSL Behring

CSL Behringis a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients' needs by using the latest technologies, we develop and deliver innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company's products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people, anddelivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.

SOURCE CSL Behring

See the original post here:
Orphan Drug Designation Granted for CSL Behring's Investigational Plasma-Derived Hemopexin Therapy for Sickle Cell Disease - PRNewswire

Cardiac Stem Cells Comments Off on Orphan Drug Designation Granted for CSL Behring’s Investigational Plasma-Derived Hemopexin Therapy for Sickle Cell Disease – PRNewswire | November 3rd, 2020

Waking up the dead science fiction or a Halloween night horror movie? No, thats the goal of Bioquarks ReAnima project. The project aims to restore neuronal activity in brain dead people by combining several techniques: stem cell injection, nerve stimulation, and laser.

Stem Cells

Stem cells are increasingly becoming a serious treatment option for many nervous disorders: Alzheimers, Parkinsons, brain injuries, etc. So why not repair the brains of the dead to bring them back to life? This idea, worthy of a science fiction (or horror) film, is the crazy project of a company based in Philadelphia: Bioquark.

Read Also: Old Human Cells Successfully Rejuvenated Via Stem Cell Technology

This is not the first time that the company wants to participate in such an experiment. In 2016, the ReAnima study was launched in Bangalore, India, together with Himanshu Bansal, an orthopedic surgeon at Anupam Hospital. His plan was to combine several techniques to revive 20 brain dead people.

ReAnima consisted of injecting patients with mesenchymal stem cells and peptides that help regenerate brain cells; these peptides were to be supplied by Bioquark. In addition to these injections, transcranial laser stimulation and nerve stimulation were planned. This project was stopped by the Indian authorities in November last year, as revealed then by Science magazine.

But the company did not admit defeat. This time, according to the company, they are close to finding a new location for their clinical trials. Ira Pastor, CEO of Bioquark, told the Stat website that the company would announce the process in Latin America in the coming months.

Read Also: HGH Improves Memory In Stroke Victims Study Shows

If the experiment follows the same protocol as planned in India, it may involve 20 people. The clinical trial would again involve the injection of the patients stem cells, fat, blood Then a mixture of peptides would be injected into the spinal cord to stimulate the growth of new nerve cells. This compound, called BQ-A, was tested on animal models with head trauma. In addition, the nerves would be stimulated by nerve stimulation and 15 days of laser therapy to stimulate the neurons to make nerve connections. Researchers could then monitor the effects of this treatment using electroencephalograms.

But such a protocol raises many questions: How would a clinical trial be conducted on officially deceased people? If the person recovers some brain activity, in what state would he be? Will families be given false hope with a treatment that may take a long time?

Read Also: UC San Diego: Adult Brain Cells Revert to Younger State Following Injury, Study Shows

There is no indication that such a protocol will work. The company has not even tested the entire treatment on animal models! The mentioned treatments, such as injection of stem cells or transcranial stimulation, were tested in other situations, but not in cases of brain death. In an article published in 2016, neurologist Ariane Lewis and bioethicist Arthur Caplan stressed that the experiment had no scientific basis and that it gave families false and cruel hopes of a cure.

Experiment to raise the dead blocked in India

Response to a trial on reversal of Death by Neurologic Criteria

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Original post:
Philadelphia Based Company Wants to Bring Back the Dead With Stem Cells - Gilmore Health News

Spinal Cord Stem Cells Comments Off on Philadelphia Based Company Wants to Bring Back the Dead With Stem Cells – Gilmore Health News | November 1st, 2020

How an Imaging Test Predicts Treatment Response

If youve already gone through a round of treatment for diffuse large B-cell lymphoma and it didnt work, or your cancer came back after treatment, your doctor might start talking to you about having an autologous stem cell transplant. This therapy involves getting high doses of chemotherapy to get rid of your cancer cells, followed by an infusion of stem cells taken from your blood or bone marrow before treatment, to replenish your bodys supply of healthy blood cells.

Related: What is Autologous Stem Cell Transplant?

A stem cell transplant can be a pretty grueling treatment that involves getting very high doses of chemotherapy, spending three to four weeks in the hospital, and enduring side effects like nausea, vomiting, mouth pain, infections, bleeding, and lung inflammation. And after all of that, you still may not get the results you want.

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

Related: What is Autologous Stem Cell Transplant?

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

Read more:
Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? - SurvivorNet

Bone Marrow Stem Cells Comments Off on Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? – SurvivorNet | November 1st, 2020

Global Hematopoietic Stem Cell Transplantation Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Major Players in This Report Include,

Gilead Sciences Inc. (United States), Thermo Fisher Scientific (United States), PromoCell (Germany), CellGenix Technologie Transfer GmbH (Germany), Cesca Therapeutics Inc.(United States), R&D Systems (United States), Genlantis (United States), Lonza Group Ltd.(Switzerland), TiGenix N.V.(Belgium), ScienCell Research Laboratories (United States), Regen Biopharma Inc. (United States), China Cord Blood Corp (Hong Kong) and CBR Systems Inc. (United States).

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Analyst at AMA have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Hematopoietic Stem Cell Transplantation Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

Definition

Despite the increasing availability of smart antineoplastic therapies in recent years, Hematopoietic stem cell transplantation (HSCT) remains an optimal treatment modality for many hematologic malignancies. HSCT is one of a range of therapeutic options which is available to patients suffering from various diseases. It is a widely accepted treatment for many life-threatening diseases. The treatment is available to patients who suffer from refractory or relapsing neoplastic disease and non-neoplastic genetic disorders, as well as from chronic bone marrow failure. Hematopoietic stem cells are young or immature blood cells which are found to be living in bone marrow. These blood cells when matures in bone marrow very few enters into bloodstream.

Global Hematopoietic Stem Cell Transplantation Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.

Types of Products, Applications and Global Hematopoietic Stem Cell Transplantation Market Report Geographical Scope taken as the Main Parameter for Market Analysis. This Research Report Conducts an assessment of the industry chain supporting this market. It also provides accurate information on various aspects of this market, such as production capacity, available production capacity utilization, industrial policies affecting the manufacturing chain and market growth.

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In this research study, the prime factors that are impelling the growth of the Global Hematopoietic Stem Cell Transplantation market report have been studied thoroughly in a bid to estimate the overall value and the size of this market by the end of the forecast period. The impact of the driving forces, limitations, challenges, and opportunities has been examined extensively. The key trends that manage the interest of the customers have also been interpreted accurately for the benefit of the readers.

The Hematopoietic Stem Cell Transplantation market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

The report concludes with in-depth details on the business operations and financial structure of leading vendors in the Global Hematopoietic Stem Cell Transplantation market report, Overview of Key trends in the past and present are in reports that are reported to be beneficial for companies looking for venture businesses in this market. Information about the various marketing channels and well-known distributors in this market was also provided here. This study serves as a rich guide for established players and new players in this market.

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Current Scenario Analysis for Decision Framework

Key Strategic Developments in Hematopoietic Stem Cell Transplantation Market:

The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.

Key Market Features in Global Hematopoietic Stem Cell Transplantation Market

The report highlights Hematopoietic Stem Cell Transplantation market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Hematopoietic Stem Cell Transplantation market share and annualized growth rate (Y-o-Y) and Periodic CAGR.

Extracts from Table of Contents

Global Hematopoietic Stem Cell Transplantation Market Research Report

Chapter 1 Global Hematopoietic Stem Cell Transplantation Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Revenue (Value, Volume*) by Region

Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions

Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type

Chapter 7 Global Market Analysis by Application

.continued

This report also analyzes the regulatory framework of the Global Markets Hematopoietic Stem Cell Transplantation Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.

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Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button - Royal Sutton News

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button – Royal Sutton News | November 1st, 2020

The Autologous Stem Cell Based Therapies Market report makes available Today and Forthcoming technical and financial details of this industry. Few of those chief insights of this business report include; different analysis of the market drivers & restraints, major market players engaged like industry, detailed analysis of their market segmentation & aggressive evaluation. It quotes CAGR values in percentages which help to be familiar with increase or fall occurring in the market for particular product for the particular forecast period. Global Autologous Stem Cell Based Therapies Market report also encompasses tactical profiling of important players on the market, systematic analysis of the core competencies & brings a competitive landscape for the market.

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The Autologous Stem Cell Based Therapies Market report can be employed by both Conventional and new players from the market for whole knowhow of this marketplace. The business analysis report brings into consideration important industry trends, market size, market share estimates, and revenue volume that assist industry to speculate the strategies to increase return on investment (ROI). In addition, the market document holds a considerable significance as it is all about describing market definition, classifications, software and engagements. Together with the study of competitor analysis conducted in this Autologous Stem Cell Based Therapies Market report, industry can get fluency of these plans of key players on the market which includes new product launches, expansions, arrangements, joint ventures, partnerships, and acquisitions.

Market Evaluation: Global Autologous Stem Cell Based Therapies Market

Global Autologous Stem Cell Based Therapies economy is set to see a substantial CAGR Of XX percent in the forecasted period of 2019-2026. This increase in the market can be attributed because of improvement in autoimmune identification and technology advancement in the business.

The following players are covered in this report:

Regeneus

Mesoblast

Pluristem Therapeutics Inc

US STEM CELL, INC.

Brainstorm Cell Therapeutics

Tigenix

Med cell Europe

Autologous Stem Cell Based Therapies

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Breakdown Data by Type

Embryonic Stem Cell

Resident Cardiac Stem Cells

Umbilical Cord Blood Stem Cells

Autologous Stem Cell Based Therapies Breakdown Data by Application

Neurodegenerative Disorders

Autoimmune Diseases

Cardiovascular Diseases

Table of Contents : Autologous Stem Cell Based Therapies Market

Part 01: Executive Summary

Part 02: Scope Of The Report

Part 03: Research Methodology

Part 04: Market Landscape

Part 05: Pipeline Analysis

Part 06: Market Sizing

Part 07: Five Forces Analysis

Part 08: Market Segmentation

Part 09: Customer Landscape

Part 10: Regional Landscape

Part 11: Decision Framework

Part 12: Drivers And Challenges

Part 13: Market Trends

Part 14: Vendor Landscape

Part 15: Vendor Analysis

Part 16: Appendix

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Ready To Use Autologous Stem Cell Based Therapies Market Industry Analysis, Trend and Growth, 2020-2020 - Royal Sutton News

Cardiac Stem Cells Comments Off on Ready To Use Autologous Stem Cell Based Therapies Market Industry Analysis, Trend and Growth, 2020-2020 – Royal Sutton News | November 1st, 2020

Global Anti-Ageing Drugs Market Research report 2020 provides detailed analysis of industry status and outlook of major regions based on of key players, countries, product types, and end industries. This research report offers the overall analysis of the segments such as market opportunities, import/export details, market dynamics, key manufacturers, growth rate, and key regions. Global Anti-Ageing Drugs research report consist information according to the manufacturers, regions, type, and application.

In accordance with the Anti-Ageing Drugs is set to grow at a CAGR of xx% over the forecast period (2020-2025) and exceed a value of US$ XX by the end of 2025. The global Anti-Ageing Drugs offers the company profile of major key players including progress trends, competitive landscape breakdown, and key in regions development status.

Leading companies reviewed in the Anti-Ageing Drugs report are:Nu Skin, BIOTIME, Elysium Health, La Roche-Posay, DermaFix

Get a Free Sample PDF Report, Please [emailprotected]https://www.syndicatemarketresearch.com/sample/anti-ageing-drugs-market.html

Covid-19 pandemics create the negative impact on the majority of the developed and developing economies around the globe. Report covers the income impact investigation, interruptions and new open doors in the gracefully chain, overhauled merchant scene blend, new open doors mapping, and others. Also offers the various solutions and recovery options to solve this COVID-19 pandemic.

Global Anti-Ageing Drugs Segmentation by Type:Hormonal Therapy, Antioxidants, Enzymes, Stem Cells, Others

Global Anti-Ageing Drugs Segmentation by Applications:Skin, Hair, Others

Market Segmentation, By regions:North America (U.S., Canada, Mexico)South America (Cuba, Brazil, Argentina, and many others.)Europe (Germany, U.K., France, Italy, Russia, Spain, etc.)Asia (China, India, Russia, and many other Asian nations.)Pacific region (Indonesia, Japan, and many other Pacific nations.)Middle East & Africa (Saudi Arabia, South Africa, and many others.)

Do enquire to get a strategic overview of the market reporthttps://www.syndicatemarketresearch.com/inquiry/anti-ageing-drugs-market

Important Points Covered by Report:

Report covers the various market dynamics of the industry. Business overview and business strategies of key players. SWOT analysis for all key players mentioned in the research report. Detailed information about drivers, opportunities, and restraints of the Anti-Ageing Drugs. Also covers PESTAL analysis and Potters Five Forces Report provides the detailed information of product life cycle. Covers the manufacturing process, cost and detailed information.

There are 13 Chapters to display the Global Anti-Ageing Drugs:

Chapter 1:Complete profiling and analysis of ManufacturersChapter 2:Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 3:Production by RegionsChapter 4:onsumption by RegionsChapter 5:Production, By Types, Revenue and Market share by TypesChapter 6:Consumption, By Applications, Market share (%) and Growth Rate by ApplicationsChapter 7:Market Overview, Drivers, Restraints and Opportunities, Segmentation overviewChapter 8:Market ForecastChapter 9:Market Competition by ManufacturersChapter 10:Marketing Strategy Analysis, Distributors/TradersChapter 11:Market Effect Factors AnalysisChapter 12:Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expensesChapter 13:Anti-Ageing Drugs Research Findings and Conclusion, Appendix, methodology and data source.

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Impact Of Covid 19 On Anti-Ageing Drugs 2020 Industry Challenges Business Overview And Forecast Research Study 2026 - Zenit News

Skin Stem Cells Comments Off on Impact Of Covid 19 On Anti-Ageing Drugs 2020 Industry Challenges Business Overview And Forecast Research Study 2026 – Zenit News | November 1st, 2020

Basel, October 30, 2020 Novartis today announced the receipt of marketing authorization from Japans Ministry of Health, Labor and Welfare (MHLW) for Foundation for Biomedical Research and Innovation at Kobe ("FBRI") to manufacture and supply commercial Kymriah (tisagenlecleucel) for patients in Japan. This approval makes FBRI the first and only approved commercial manufacturing site for CAR-T cell therapy in Asia.

Behind our efforts to reimagine medicine with CAR-T cell therapy lies a commitment to build a manufacturing network that brings treatment closer to patients, commented Steffen Lang, Global Head of Novartis Technical Operations. The expertise and infrastructure of FBRI, a world-leading manufacturing organization, allows us to bring CAR-T manufacturing to Asia. With the Japan MHLW commercial manufacturing approval, the recent capacity expansion in the US and our ongoing efforts to optimize and evolve our processes, we are well-positioned to deliver this potentially curative treatment option to more patients around the world.

Novartis has the largest geographical CAR-T cell therapy manufacturing network in the world, including seven CAR-T manufacturing facilities, across four continents. Commercial manufacturing for Kymriah now takes place at five sites globally including at the Morris Plains, New Jersey facility, where the US Food and Drug Administration (FDA) recently approved a further increase in manufacturing capacity.

Kymriah is the first-ever FDA-approved CAR-T cell therapy, and the first-ever CAR-T to be approved in two distinct indications. It is a one-time treatment designed to empower patients immune systems to fight their cancer. Kymriah is currently approved for the treatment of r/r pediatric and young adult (up to 25 years of age) acute lymphoblastic leukemia (ALL), and r/r adult diffuse large B-cell lymphoma (DLBCL)1. Kymriah, approved in both indications by the Japan MHLW in 2019, is currently the only CAR-T cell therapy approved in Asia. Clinical manufacturing began at FBRI in 2019 and will continue alongside commercial manufacturing.

Kymriah was developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, a strategic alliance between industry and academia, which was first-of-its-kind in CAR-T research and development.

About Novartis Commitment to Oncology Cell & Gene Novartis has a mission to reimagine medicine by bringing curative cell & gene therapies to patients worldwide. Novartis has a deep CAR-T pipeline and ongoing investment in manufacturing and supply chain process improvements. With active research underway to broaden the impact of cell and gene therapy in oncology, Novartis is going deeper in hematological malignancies, reaching patients with other cancer types and evaluating next-generation CAR-T cell therapies that focus on new targets and utilize new technologies.

Novartis was the first pharmaceutical company to significantly invest in pioneering CAR-T research and initiate global CAR-T trials. Kymriah, the first approved CAR-T cell therapy, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania, is the foundation of Novartis commitment to CAR-T cell therapy. Kymriah is currently approved for use in at least one indication in 26 countries and at more than 260 certified treatment centers, with the ambition for further expansion to help fulfill the ultimate goal of bringing CAR-T cell therapy to every patient in need.

The Novartis global CAR-T manufacturing footprint spans seven facilities, across four continents. This comprehensive, integrated footprint strengthens the flexibility, resilience and sustainability of the Novartis manufacturing and supply chain. Commercial and clinical trial manufacturing is now ongoing at Novartis-owned facilities in Stein, Switzerland, Les Ulis, France and Morris Plains, New Jersey, USA, as well as at the contract manufacturing sites at Fraunhofer-Institut for cell therapy and immunology (Fraunhofer-Institut fr Zelltherapie und Immunologie) facility in Leipzig, Germany, and now FBRI in Kobe, Japan. Manufacturing production at Cell Therapies in Australia and Cellular Biomedicine Group in China is forthcoming.

ImportantSafety information from the Kymriah SmPC

EU Name of the medicinal product:

Kymriah 1.2 x 106 6 x 108 cells dispersion for infusion

Important note: Before prescribing, consult full prescribing information.

Presentation: Cell dispersion for infusion in 1 or more bags for intravenous use (tisagenlecleucel).

Indications: Treatment of pediatric and young adult patients up to and including 25 years of age with B-cell acute lymphoblastic leukemia (ALL) that is refractory, in relapse posttransplant or in second or later relapse. Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Dosage and administration:

B-cell patients: For patients 50 kg and below: 0.2 to 5.0 x 106 CAR-positive viable T-cells/kg body weight. For patients above 50 kg: 0.1 to 2.5 x 108 CAR-positive viable T-cells (non-weight based).

DLBCL Patients: 0.6 to 6.0108 CAR-positive viable T-cells (non-weight based).

Pretreatment conditioning (lymphodepleting chemotherapy): Lymphodepleting chemotherapy is recommended to be administered before Kymriah infusion unless the white blood cell (WBC) count within one week prior to infusion is 1,000 cells/L. The availability of Kymriah must be confirmed prior to starting the lymphodepleting regimen.

Precautions before handling or administering Kymriah: Kymriah contains genetically modified human blood cells. Healthcare professionals handling Kymriah should therefore take appropriate precautions (wearing gloves and glasses) to avoid potential transmission of infectious diseases.

Preparation for infusionThe timing of thaw of Kymriah and infusion should be coordinated. Once Kymriah has been thawed and is at room temperature (20C 25C), it should be infused within 30minutes to maintain maximum product viability, including any interruption during the infusion.

Administration Kymriah should be administered as an intravenous infusion through latexfree intravenous tubing without a leukocyte depleting filter, at approximately 10 to 20mL per minute by gravity flow. If the volume of Kymriah to be administered is 20mL, intravenous push may be used as an alternative method of administration.

All contents of the infusion bag(s) should be infused.

Clinical assessment prior to infusion: Kymriah treatment should be delayed in some patient groups at risk (see Special warnings and precautions for use).

Monitoring after infusion: Patients should be monitored daily for the first 10 days following infusion for signs and symptoms of potential cytokine release syndrome, neurological events and other toxicities. Physicians should consider hospitalisation for the first 10 days post infusion or at the first signs/symptoms of CRS and/or neurological events. After the first 10 days following the infusion, the patient should be monitored at the physicians discretion. Patients should be instructed to remain within proximity of a qualified clinical facility for at least 4 weeks following infusion.

Elderly (above 65 years of age): Safety and efficacy have not been established in B-cell patients. No dose adjustment is required in patients over 65 years of age in DLBCL patients.

Paediatric patients: No formal studies have been performed in paediatric patients with B-cell ALL below 3 years of age. The safety and efficacy of Kymriah in children and adolescents below 18 years of age have not yet been established in DLBCL. No data are available.

Patients seropositive for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV): There is no experience with manufacturing Kymriah for patients with a positive test for HIV, active HBV, or active HCV infection. Leukapheresis material from these patients will not be accepted for Kymriah manufacturing.

Contraindications: Hypersensitivity to the active substance or to any of the excipients of Kymriah. Contraindications of the lymphodepleting chemotherapy must be considered.

Warnings and precautions: Reasons to delay treatment: Due to the risks associated with Kymriah treatment, infusion should be delayed if a patient has any of the following conditions: Unresolved serious adverse reactions (especially pulmonary reactions, cardiac reactions or hypotension) from preceding chemotherapies, active uncontrolled infection, active graft versus host disease (GVHD), significant clinical worsening of leukaemia burden or rapid progression of lymphoma following lymphodepleting chemotherapy. Blood, organ, tissue and cell donation: Patients treated with Kymriah should not donate blood, organs, tissues or cells.

Active central nervous system (CNS) leukaemia or lymphoma: There is limited experience of use of Kymriah in patients with active CNS leukaemia and active CNS lymphoma. Therefore the risk/benefit of Kymriah has not been established in these populations. Risk of CRS: Occurred in almost all cases within 1 to 10 days post infusion with a median time to onset of 3 days and a median time to resolution of8 days. See full prescribing information for management algorithm of CRS. Risk of neurological events: Majority of events, in particular encephalopathy, confusional state or delirium, occurred within 8 weeks post infusion and were transient. The median time to onset of neurological events was 8 days in B-cell ALL and 6 days in DLBCL; the median time to resolution was 7 days for B-cell ALL and 13 days for DLBCL. Patients should be monitored for neurological events. Risk of infections: Delay start of therapy with Kymriah until active uncontrolled infections have resolved. As appropriate, administer prophylactic antibiotics and employ surveillance testing prior to and during treatment with Kymriah. Serious infections were observed in patients, some of which were life threatening or fatal. After Kymriah administration observe patient and ensure prompt management in case of signs of infection Risk of febrile neutropenia: Frequently observed after Kymriah infusion, may be concurrent with CRS. Appropriate management necessary. Risk of prolonged cytopenias: Appropriate management necessary. Prolonged cytopenia has been associated with increased risk of infections. Myeloid growth factors, particularly granulocyte macrophage colony stimulating factor (GM CSF), not recommended during the first 3 weeks after Kymriah infusion or until CRS has been resolved. Risk of secondary malignancies: Patients treated with Kymriah may develop secondary malignancies or recurrence of their cancer and should be monitored lifelong for secondary malignancies. Risk of hypogammaglobulinemia or agammaglobulinemia: Infection precautions, antibiotic prophylaxis and immunoglobulin replacement should be managed per age and standard guidelines. In patients with low immunoglobulin levels preemptive measures such as immunoglobulin replacement and rapid attention to signs and symptoms of infection should be implemented. Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment was not studied. Vaccination with live virus vaccines is not recommended at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah. Risk of tumor lysis syndrome (TLS): Patients with elevated uric acid or high tumor burden should receive allopurinol or alternative prophylaxis prior to Kymriah infusion. Continued monitoring for TLS following Kymriah administration should also be performed. Concomitant disease: Patients with a history of active CNS disorder or inadequate renal, hepatic, pulmonary or cardiac function are likely to be more vulnerable to the consequences of the adverse reactions of Kymriah and require special attention. Prior stem cell transplantation: Kymriah infusion is not recommended within 4 months of undergoing an allogeneic stem cell transplant (SCT) because of potential risk of worsening GVHD. Leukapheresis for Kymriah manufacturing should be performed at least 12weeks after allogeneic SCT. Serological testing: There is currently no experience with manufacturing Kymriah for patients testing positive for HBV, HCV and HIV. Screening for HBV, HCV and HIV, must be performed before collection of cells for manufacturing. Hepatitis B virus (HBV) reactivation, can occur in patients treated with medicinal products directed against B cells and could result in fulminant hepatitis, hepatic failure and death. Prior treatment with anti CD19 therapy: There is limited experience with Kymriah in patients exposed to prior CD19 directed therapy. Kymriah is not recommended if the patient has relapsed with CD19 negative leukaemia after prior anti-CD19 therapy. Interference with serological testing: Due to limited and short spans of identical genetic information between the lentiviral vector used to create Kymriah and HIV, some commercial HIV nucleic acid tests (NAT) may give a false positive result. Sodium and potassium content: This medicinal product contains 24.3 to 121.5mg sodium per dose, equivalent to 1 to 6% of the WHO recommended maximum daily intake of 2g sodium for an adult. This medicinal product contains potassium, less than 1mmol (39mg) per dose, i.e. essentially potassium free. Content of dextran 40 and dimethyl sulfoxide (DMSO): Contains 11 mg dextran 40 and 82.5 mg dimethyl sulfoxide (DMSO) per mL. Each of these excipients are known to possibly cause anaphylactic reaction following parenteral administration. Patients not previously exposed to dextran and DMSO should be observed closely during the first minutes of the infusion period.

Interaction with other medicinal products and other forms of interaction

Live vaccines: The safety of immunisation with live viral vaccines during or following Kymriah treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during Kymriah treatment, and until immune recovery following treatment with Kymriah.

Fertility, pregnancy and lactation

Women of childbearing potential/Contraception in males and females: Pregnancy status for females of reproductive potential should be verified prior to starting treatment with Kymriah. Consider the need for effective contraception in patients who receive the lymphodepleting chemotherapy. There are insufficient exposure data to provide a recommendation concerning duration of contraception following treatment with Kymriah.

Pregnancy: There are no data from the use of Kymriah in pregnant women. It is not known whether Kymriah has the potential to be transferred to the foetus via the placenta and could cause foetal toxicity, including B cell lymphocytopenia. Kymriah is not recommended during pregnancy and in women of childbearing potential not using contraception. Pregnant women should be advised on the potential risks to the foetus. Pregnancy after Kymriah therapy should be discussed with the treating physician. Pregnant women who have received Kymriah may have hypogammaglobulinaemia. Assessment of immunoglobulin levels is indicated in newborns of mothers treated with Kymriah.

Breast feeding: It is unknown whether Kymriah cells are excreted in human milk, a risk to the breast fed infant cannot be excluded. Women who are breast feeding should be advised of the potential risk to the breast fed infant. Breast-feeding should be discussed with the treating physician.

Fertility: There are no data on the effect of Kymriah on fertility.

Effects on ability to drive and use machinesDriving and engaging in hazardous activities in the 8 weeks following infusion should be refrained due to risks for altered or decreased consciousness or coordination.

Adverse drug reactions:

B-Cell ALL patients and DLBCL patients:

Very common (10%): Infections - pathogen unspecified, viral infections, bacterial infections, fungal infections, anaemia, haemorrhage, febrile neutropenia, neutropenia, thrombocytopenia, cytokine release syndrome, hypogammaglobulinaemia, decreased appetite, hypokalaemia, hypophosphataemia, hypomagnesaemia, hypocalcaemia, anxiety, delirium, sleep disorder, headache, encephalopathy, arrhythmia, hypotension, hypertension, cough, dyspnoea, hypoxia, diarrhoea, nausea, vomiting, constipation, abdominal pain, rash, arthralgia, acute kidney injury, pyrexia, fatigue, oedema, pain, chills, lymphocyte count decreased, white blood cell count decreased, haemoglobin decreased, neutrophil count decreased, platelet count decreased, aspartate aminotransferase increased.

Common (1 to 10%): Haemophagocytic lymphohistiocytosis, leukopenia, pancytopenia, coagulopathy, lymphopenia, infusion-related reactions, graft versus host disease, hypoalbuminaemia, hyperglycaemia, hyponatraemia, hyperuricaemia, fluid overload, hypercalcemia, tumor lysis syndrome, hyperkalaemia, hyperphosphataemia, hypernatraemia, hypermagnesaemia, dizziness, peripheral neuropathy, tremor, motor dysfunction, seizure, speech disorder, neuralgia, ataxia, visual impairment, cardiac failure, cardiac arrest, thrombosis, capillary leak syndrome, oropharyngeal pain, pulmonary oedema, nasal congestion, pleural effusion, tachypnea, acute respiratory distress syndrome, stomatitis, abdominal distension, dry mouth, ascites, hyperbilirubinaemia, pruritus, erythema, hyperhidrosis, night sweats, back pain, myalgia, muscolosceletal pain, influenza-like illness, asthenia, multiple organ dysfunction syndrome, alanine aminotransferase increased, blood bilirubin increased, weight decreased, serum ferritin increased, blood fibrinogen decreased, international normalized ratio increased, fibrin D dimer increased, activated partial thromboplastin time prolonged, blood alkaline phosphate increased, prothrombin time prolonged.

Uncommon: B-cell aplasia, ischaemic cerebral infarction, flushing, lung infiltration.

Packs and prices: Country-specific.

Legal classification: Country-specific.

DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as potential, can, will, plan, may, could, would, expect, anticipate, seek, look forward, believe, committed, investigational, pipeline, launch, or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AGs current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About NovartisNovartis is reimagining medicine to improve and extend peoples lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the worlds top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnewsFor Novartis multimedia content, please visithttps://www.novartis.com/news/media-libraryFor questions about the site or required registration, please contact media.relations@novartis.com

References

1.Kymriah (tisagenlecleucel) Summary of Product Characteristics (SmPC), 2018.

# # #

Novartis Media RelationsE-mail: media.relations@novartis.com

Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com

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Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia - GlobeNewswire

Cardiac Stem Cells Comments Off on Novartis expands Kymriah manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia – GlobeNewswire | October 31st, 2020

Is the United States a step closer to approving a form of stem cell transplantation as a treatment for multiple sclerosis? I believe it may be.

Thats because the National Multiple Sclerosis Society (NMSS) has slightly changed its view of autologous hematopoietic stem cell transplantation, or aHSCT.

aHSCT involves removing a patients own stem cells from the blood or bone marrow, using chemotherapy to kill off most of the immune system, and then injecting the stem cells back into the patient. Those stem cells regenerate the immune system, hopefully without any of the rogue immune cells that attack the nervous system and create MS symptoms.

In the past, the National MS Society has failed to make recommendations about how any form of stem cell treatment should be used, at least as far as my research can determine. Now, in an article in JAMA Neurology, a group of neurologists, including members of the NMSS National Medical Advisory Committee, are outlining parts of a stem cell protocol.

The NMSS is now being specific about who might be a candidate for aHSCT:

The National Multiple Sclerosis Society believes that AHSCT may be a useful treatment option for people with relapsing multiple sclerosis who demonstrate substantial breakthrough disease activity (ie, new inflammatory central nervous system lesions and/or clinical relapses) despite treatment with high-efficacy disease-modifying therapy or have contraindications to high-efficacy disease-modifying therapies.

That language seems more aggressive than what the NMSSwrote about an Italian study published earlier this year. In that commentary, the society suggested the procedure might be appropriate for people with secondary progressive MS, and it suggested further study with a larger group:

These results suggest that HSCT might be appropriate in a subgroup of people with SPMS that have significant inflammatory activity as measured by MRI. Further study in larger numbers are needed to understand who among those with secondary progressive MS might benefit from HSCT.

The new guidelines clearly outline which people with relapsing-remitting MS might benefit. They are younger than 50 and have lived with an MS diagnosis for less than 10 years.

The authors recommend that stem cell transplantation be performed in medical centers with substantial experience and expertise. A follow-up regime is proposed, along with the creation of a single database to track people who undergo the procedure. But the article cautions that more research is needed to establish best practices for handling the stem cells and other technical processes.

Some hospitals and clinics in Russia, Mexico, and other locations offer aHSCT to MS patients at a cost of about $50,000. aHSCT also is provided to some MS patients through the U.Ks National Health Service. A list of aHSCT facilities worldwide is available at http://www.hsctstopsms.com.

The authors of the JAMA Neurology article suggest a clinical trial may be the place for someone who wants their MS treated with a stem cell transplant right now. A well-known trial by Dr. Richard Burt shut down about a year ago. However, a trial called BEAT-MS has been enrolling patients at several locations in the U.S. You can find information about other studies at clinicaltrials.gov.

The authors note that joining a trial would assure the patient of quality care with an acceptable protocol and provide the personal satisfaction of knowing they are contributing to answering a very important question for people with MS.

That sounds like a pretty good suggestion to me since the U.S. likely has a long way to go before aHSCT for MS becomes common here, even with the NMSS backing. But its encouraging that finally it is gaining some traction.

Youre invited to follow my personal blog at http://www.themswire.com.

***

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Diagnosed with MS at age 32 in 1980, Ed has written the MS Wire column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. Hes won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. Hes the author of Were Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis. Ed and his wife split time between the Washington, D.C. suburbs and Floridas Gulf Coast.

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aHSCT Gets a Boost in US With NMSS Recommendations - Multiple Sclerosis News Today

Bone Marrow Stem Cells Comments Off on aHSCT Gets a Boost in US With NMSS Recommendations – Multiple Sclerosis News Today | October 31st, 2020

DetailsCategory: Small MoleculesPublished on Friday, 30 October 2020 17:39Hits: 249

- Enrollment to cease immediately; topline data anticipated in H1 2021-

TEL AVIV, Israel I October 30, 2020 I BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.

At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.

In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.

"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."

The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn

SOURCE: BioLineRx

Link:
BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small...

Bone Marrow Stem Cells Comments Off on BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small… | October 31st, 2020

The latest Stem Cell Banking market research report offers a top to bottom analysis of this business sphere in terms of potential industry size, supply chain, growth dynamics, opportunity analysis, and competitive landscape. Furthermore, it extends through abstracts on various industry segments, inclusive of a rundown of the business scenario across the various regional markets. Additionally, the study provide insights into to the impact of Covid-19 pandemic and recommends strategies that could maximize ROI amid these uncertain times.

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Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market to witness an impressive growth during the forecast pe – News by aeresearch | October 31st, 2020

Liposuction is a surgical procedure to remove extra fat from your body. It started in the 1980s and has become one of the most popular plastic surgeries in the US. An estimated 258,000 Americans got it in 2018.

Today, you can expect to pay around $3,500 for liposuction and most health insurance plans won't cover the cost. But if you're willing to pay the price, liposuction is a relatively safe and quick procedure that can help you shed fat that diet and exercise can't.

Some of the most common places to have fat removed are the belly, thighs, buttocks, arms, back, the upper neck just under the chin, and jawline/jowls.

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Then, surgeons will often inject into the area of operation a solution containing a mix of saline solution, a numbing medicine, and medicine the decreases bleeding. This is to help the skin and fat separate from important structures like muscles and blood vessels so they aren't damaged during the suctioning process.

After liposuction, your surgeon will likely recommend you wear a temporary band or brace over the area of operation to help the skin heal. The band or brace also helps prevent fluid from building up in the area of operation where the fat was removed, between the skin and deeper structures like muscles and blood vessels.

Whether you are awake or asleep during liposuction, you shouldn't feel any pain during the procedure, says Marco A. Pelosi II, MD, a cosmetic surgeon with experience performing liposuction procedures. The recovery, also, should be a relatively mild process.

Ongoing pain near the area where the cannula was inserted is a risk of liposuction, and if the pain grows or pain killers don't help, you should tell your surgeon.

According to the Cleveland Clinic, you should not use liposuction as a weight loss alternative. It recommends that if you want to lose weight, you should first try diet and exercise, then use liposuction to take care of more stubborn areas like the chin or belly fat.

There are some important safety tips to look for when choosing a liposuction provider.

Pelosi says that doctors should also do blood work testing and medical clearances before a liposuction procedure to ensure your safety. These tests are to make sure you can safely undergo general anesthesia without complication. If, for example, you have an infection or are pregnant, you may not qualify for the surgery.

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What is liposuction? How the procedure works and how painful it is - Business Insider India

Skin Stem Cells Comments Off on What is liposuction? How the procedure works and how painful it is – Business Insider India | October 31st, 2020