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Coronavirus: assistant parish priest in Sharjah dies from complications of the disease – The National
Posted: May 18, 2020 at 11:46 am
An assistant parish priest in the UAE has died after suffering from multiple complications arising from Covid-19.
Father Youssef Sami Youssef, 62, served the Arabic-speaking community at St Michaels Church Sharjah.
The outgoing and lively priest had been receiving treatment, including ventilation and stem-cell therapy, at Sheikh Khalifa Medical City, Ajman.
But his condition continued to deteriorate and he died on Sunday as a result of multiple organ failure.
Fr Youssef was under treatment for almost three weeks at the multi-speciality hospital and received expert care, ventilation and stem cell therapy, the Apostolic Vicariate of Southern Arabia said.
However since he already had some underlying medical conditions, he soon started to develop critical multiple organ failure.
The vicariate said his outgoing and lively personality would be sorely missed by all who knew him, especially the Arabic and French-speaking Catholics in the vicariate, where he served several churches throughout his career.
More than 700 parishioners paid tribute to Fr Youssef on the vicariates Facebook page, where his death was announced to his congregation.
May his soul rest in peace. I used to attend his Masses when he served in Abu Dhabi, wrote one.
Father Youssef was a humble man, I heard that he lived a difficult life, as he lost so many family members in the Lebanese war, yet he kept the faith.
He is without a doubt in the Lord's heavens. A good humble man he was, a faithful priest and a caring soul. May God have mercy on your soul Father. We will miss you.
Another wrote he would remember his smile.
Even though I never interacted with him so much ... but he was one person I came across with a smile when I used to see him before the Sunday 8pm Mass. Rest in peace, Father.
Born in Lebanon in 1957, Father Youssef joined the Order of Friars Minor Capuchin of the General Custody of the Near East in 1977, and was ordained to the priesthood 11 years later.
He had been a missionary in the Gulf region since 1993, and served several UAE communities, including St Marys Church in Dubai, St Josephs Cathedral Abu Dhabi and St Marys Church Al Ain.
He was also stationed in Doha and Manama for a time between 2004 and 2011. But since 2016, he served St Micheals Church Sharjah.
Details of his burial and memorial Mass have yet to be made public.
Updated: May 18, 2020 03:31 PM
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Coronavirus: assistant parish priest in Sharjah dies from complications of the disease - The National
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Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Review Study,Indepth Analysis is Available in Recent Research Report During…
Posted: May 18, 2020 at 11:46 am
Los Angeles, United StatesThe report offers an all-inclusive and accurate research study on the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market while chiefly focusing on current and historical market scenarios. Stakeholders, market players, investors, and other market participants can significantly benefit from the thorough market analysis provided in the report. The authors of the report have compiled a detailed study on crucial market dynamics, including growth drivers, restraints, and opportunities. This study will help market participants to get a good understanding of future development of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. The report also focuses on market taxonomy, regional analysis, opportunity assessment, and vendor analysis to help with comprehensive evaluation of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market.
Key companies operating in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market include : , Orange County Hair Restoration Center, Hair Sciences Center of Colorado, Anderson Center for Hair, Evolution Hair Loss Institute, Savola Aesthetic Dermatology Center, Virginia Surgical Center, Hair Transplant Institute of Miami, Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies
Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :
Segment Analysis
The segmental analysis will help companies to focus on high-growth areas of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. In order to broaden the overall understanding of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry, the report has segregated the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies business into varied segments comprising product type, application, and end user. This examination has been carried out based on parameters like size, CAGR, share, production, and consumption. Also, region-wise assessment, wherein lucrative prospects that a region or country is likely to offer has been explored.
Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Segment By Type:
, Platelet Rich Plasma Injections, Stem Cell Therapy Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies
Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Segment By Application:
, Platelet Rich Plasma Injections, Stem Cell Therapy Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies
Competitive Landscape:
It is important for every market participant to be familiar with the competitive scenario in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies industry. In order to fulfill the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.
Key companies operating in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market include : , Orange County Hair Restoration Center, Hair Sciences Center of Colorado, Anderson Center for Hair, Evolution Hair Loss Institute, Savola Aesthetic Dermatology Center, Virginia Surgical Center, Hair Transplant Institute of Miami, Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies
Key Questions Answered
Enquire for Customization in this Report: https://www.qyresearch.com/customize-request/form/1698362/covid-19-impact-on-global-stem-cell-and-platelet-rich-plasma-prp-alopecia-therapies-market
Table of Contents
1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue1.4 Market Analysis by Type1.4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size Growth Rate by Type: 2020 VS 20261.4.2 Platelet Rich Plasma Injections1.4.3 Stem Cell Therapy1.5 Market by Application1.5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Application: 2020 VS 20261.5.2 Dermatology Clinics1.5.3 Hospitals1.6 Coronavirus Disease 2019 (Covid-19): Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry Impact1.6.1 How the Covid-19 is Affecting the Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Industry
1.6.1.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business Impact Assessment Covid-19
1.6.1.2 Supply Chain Challenges
1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products1.6.2 Market Trends and Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Potential Opportunities in the COVID-19 Landscape1.6.3 Measures / Proposal against Covid-19
1.6.3.1 Government Measures to Combat Covid-19 Impact
1.6.3.2 Proposal for Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Global Growth Trends by Regions2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Perspective (2015-2026)2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Growth Trends by Regions2.2.1 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Share by Regions (2015-2020)2.2.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Growth Strategy2.3.6 Primary Interviews with Key Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Market Size3.1.1 Global Top Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Players by Revenue (2015-2020)3.1.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue Market Share by Players (2015-2020)3.1.3 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio3.2.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Revenue in 20193.3 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players Head office and Area Served3.4 Key Players Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Product Solution and Service3.5 Date of Enter into Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Historic Market Size by Type (2015-2020)4.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Type (2021-2026) 5 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Breakdown Data by Application (2015-2026)5.1 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020)5.2 Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)6.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in North America (2019-2020)6.3 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)6.4 North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 7 Europe7.1 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)7.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Europe (2019-2020)7.3 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)7.4 Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 8 China8.1 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)8.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in China (2019-2020)8.3 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)8.4 China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 9 Japan9.1 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)9.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Japan (2019-2020)9.3 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)9.4 Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)10.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)10.4 Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 11 India11.1 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)11.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in India (2019-2020)11.3 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)11.4 India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size (2015-2020)12.2 Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Key Players in Central & South America (2019-2020)12.3 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Type (2015-2020)12.4 Central & South America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Orange County Hair Restoration Center13.1.1 Orange County Hair Restoration Center Company Details13.1.2 Orange County Hair Restoration Center Business Overview and Its Total Revenue13.1.3 Orange County Hair Restoration Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.1.4 Orange County Hair Restoration Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020))13.1.5 Orange County Hair Restoration Center Recent Development13.2 Hair Sciences Center of Colorado13.2.1 Hair Sciences Center of Colorado Company Details13.2.2 Hair Sciences Center of Colorado Business Overview and Its Total Revenue13.2.3 Hair Sciences Center of Colorado Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.2.4 Hair Sciences Center of Colorado Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.2.5 Hair Sciences Center of Colorado Recent Development13.3 Anderson Center for Hair13.3.1 Anderson Center for Hair Company Details13.3.2 Anderson Center for Hair Business Overview and Its Total Revenue13.3.3 Anderson Center for Hair Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.3.4 Anderson Center for Hair Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.3.5 Anderson Center for Hair Recent Development13.4 Evolution Hair Loss Institute13.4.1 Evolution Hair Loss Institute Company Details13.4.2 Evolution Hair Loss Institute Business Overview and Its Total Revenue13.4.3 Evolution Hair Loss Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.4.4 Evolution Hair Loss Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.4.5 Evolution Hair Loss Institute Recent Development13.5 Savola Aesthetic Dermatology Center13.5.1 Savola Aesthetic Dermatology Center Company Details13.5.2 Savola Aesthetic Dermatology Center Business Overview and Its Total Revenue13.5.3 Savola Aesthetic Dermatology Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.5.4 Savola Aesthetic Dermatology Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.5.5 Savola Aesthetic Dermatology Center Recent Development13.6 Virginia Surgical Center13.6.1 Virginia Surgical Center Company Details13.6.2 Virginia Surgical Center Business Overview and Its Total Revenue13.6.3 Virginia Surgical Center Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.6.4 Virginia Surgical Center Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.6.5 Virginia Surgical Center Recent Development13.7 Hair Transplant Institute of Miami13.7.1 Hair Transplant Institute of Miami Company Details13.7.2 Hair Transplant Institute of Miami Business Overview and Its Total Revenue13.7.3 Hair Transplant Institute of Miami Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.7.4 Hair Transplant Institute of Miami Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.7.5 Hair Transplant Institute of Miami Recent Development13.8 Colorado Surgical Center & Hair Institute13.8.1 Colorado Surgical Center & Hair Institute Company Details13.8.2 Colorado Surgical Center & Hair Institute Business Overview and Its Total Revenue13.8.3 Colorado Surgical Center & Hair Institute Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Introduction13.8.4 Colorado Surgical Center & Hair Institute Revenue in Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Business (2015-2020)13.8.5 Colorado Surgical Center & Hair Institute Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details
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Family needs to raise 40k towards potentially life-changing treatment for mum with MS – Coventry Telegraph
Posted: May 18, 2020 at 11:46 am
A Coventry woman has set up a Go Fund Me page in the hope of raising money for treatment which has the potential to change her mother's quality of life.
Leyla Hassan and her family own a fish and chip shop in Tile Hill called the Station Plaice Fish Bar. They have owned the business for many years with her mum and dad running it on a daily basis.
However the Hassan family's lives got turned upside down when mother Dalga Hassan, 54, got diagnosed with Primary Progressive Multiple Sclerosis (MS) three years ago.
Sadly since the diagnosis, Dalga's condition has deteriorated, to the point where she can no longer walk or be independent.
Daughter, Layla, 31, has had to move back into the family home to help offer support to her mother as she has suffered with the illness.
Layla said: "My mum and dad run Station Plaice Fish Bar in Tile Hill, but three years ago my mum was diagnosed with MS.
"Over the past six or seven months she could walk but now she can't at all, she can't do anything for herself.
"My mum can't even go to the toilet on her own and she is desperate to do something on her own."
Dalga is a mother to three children and used to work in the family shop alongside her husband six days a week serving customers.
Now she sits at the back of the shop in the day, chatting to customers.
Leyla, who works in sales for car manufacturer BMW, continued: "Before the MS she used to work in the fish shop six days a week. Now, she will go down in the morning using her chairlift and sit in a chair at the back of the shop.
"It's so hard seeing someone that used to move and work at 100 miles an hour be like this. She always used to be cooking and cleaning for us and doing all sorts of things.
"However, our customers in the shop ask for my mum all the time and will always go and talk to her."
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The family are beginning to struggle with Dalga's condition and have been looking for different treatment methods that may be able to help.
"We have been asking the doctors here in the UK if she could take part in any trials, anything that might make her condition better but we just keep getting told no," Leyla said.
"So I did some research into different treatments across the world and stumbled on stem cell therapy. A lot of people that have MS and have had the treatment find their mobility becomes better as a result."
The family are attempting to raise 40,000 to send Dalga to Turkey to receive potentially life-changing stem cell treatment, which may improve her quality of life.
Leyla added: "The treatment is similar to chemotherapy, in the sense that it wipes out your immune system. That means my mum may loose her hair.
"So, if we reach the 40k mark and she is able to go, I'm going to shave my head so she doesn't have to go through it alone."
Leyla explains the family have also been in contact with Coventry City Council about getting a wet room fitted in place of their shower.
She said: "Someone came round to look at the flat and said we needed a wet room. They said it would be a six month wait but we have waited much longer than that.
"We appreciate the coronavirus situation has slowed everything down, but the week after someone came round to assess our bathroom, my mum fell out of the shower and I had to call an ambulance.
"I couldn't lift her on her own as it is like lifting a dead weight. It was really scary."
A spokesperson for Coventry City Council said: There is high demand for disabled adaptations in Coventry and as a result there is a waiting list. With the social distancing measures introduced as a result of Covid-19 this has extended the period further.
"There is a priority system in place for those with high level of risk and as some contractors are now returning to work these cases will be progressed.
So far, the Hassan family have raised around 3,000 of their 40,000 target.
"I really wanted to run some fundraising events. But given the current circumstances that just can't happen", Leyla said.
The family are desperate to send their mother to Turkey for treatment and say they are grateful for any donation.
If you would like to donate online, you can do so here.
Equally, the family are more than happy to take donations and speak to people at their chip shop located on Station Avenue in Tile Hill.
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Family needs to raise 40k towards potentially life-changing treatment for mum with MS - Coventry Telegraph
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The Week Ahead In Biotech: Aquestive Awaits FDA Decision, Earnings Flow Slows – Benzinga
Posted: May 18, 2020 at 11:46 am
Biotech stocks had another up week, with the American Society of Gene & Stem Cell Therapy virtual conference presentations and the ASCO abstracts made available onlineThursday calling the shots. Earnings news flow continued to taper.
Biopharma companies working on vaccines/therapies for COVID-19 continued to provide updates. Novavax, Inc. (NASDAQ: NVAX) shares more than doubled, thanks to an announcement concerning a $384 million grant from the Coalition for Epidemic Preparedness Innovations.
Here are the key catalysts for the unfolding week.
The FDA is due to rule on Aquestive Therapeutics Inc's (NASDAQ: AQST) NDA for apomorphine sublingual film (APL-130277), which is being evaluated for treating off episodes in Parkinson's disease patients. APL-130277 is being developed by Sunovion Pharmaceuticals, a subsidiary of Sumitomo Dainippon Pharma, in partnership with Aquestive.
Entera Bio Ltd (NASDAQ: ENTX) is scheduled to report on Thursday interim three-month top-line biomarker data for the first 50% of the patients enrolled in the Phase 2 osteoporosis clinical trial of EB613.
Oncolytics Biotech, Inc. (NASDAQ: ONCY) is due to present at the ESMO Breast Cancer Conference, interim biomarker data from the AWARE-1 early-stage breast cancer study that is evaluating its pelareorep along with Roche Holdings AG's(OTC: RHHBY) Tecentriq.
See Also: Results From Oxford University's Human Trial Of Coronavirus Vaccine Could Arrive In June; Where Inovio, Moderna Stand
Monday
Milestone Scientific Inc. (NYSE: MLSS) (before the market open)Adamis Pharmaceuticals Corp (NASDAQ: ADMP) (after the close)
Tuesday
Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (after the close)Ascendis Pharma A/S (NASDAQ: ASND) (after the close)
Wednesday
Mediwound Ltd (NASDAQ: MDWD) (before the market open)China Biologic Products Holdings Inc (NASDAQ: CBPO) (after the close)
Thursday
Entera Bio (before the market open)Medtronic PLC (NYSE: MDT) (before the market open)PAVmed Inc (NASDAQ: PAVM) (after the close)Xenon Pharmaceuticals Inc (NASDAQ: XENE) (after the close)
ORIC Pharmaceuticals Inc (NASDAQ: ORIC)
2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge – Endpoints News
Posted: May 18, 2020 at 11:46 am
Akin to cystic fibrosis (CF), scientists understand that certain mutations contribute to the development of the fatal neurological disorder amyotrophic lateral sclerosis (ALS). And much like CF drugmaker Vertex, a small Cambridge, Massachusetts-based biotech is forging a path to engineering precision therapies to treat the disease that killed visionary physicist Stephen Hawking.
The company, christened QurAlis, now has $42 million in its coffers with three preclinical programs and 5 employees (including senior management) to combat an illness that has long flummoxed researchers, resulting in a couple of approved therapies over the course of decades, neither of which attacks the underlying cause of the rare progressive condition that attacks nerve cells located in the brain and spinal cord responsible for controlling voluntary muscles.
ALS garnered international attention when New York Yankees player Lou Gehrig abruptly retired from baseball in 1939, after being diagnosed with the disease. In 2014, ALS returned to the spotlight with the Ice Bucket Challenge, which involved people pouring ice-cold water over their heads, posting a video on social media, and donating funds for research on the condition.
QurAlis chief Kasper Roet, whose interest in ALS was piqued while he was working on his PhD at the Netherlands Institute for Neuroscience focusing on a treatment for spinal cord paralysis and moonlighting at the Netherlands Brain Bank as an ad-hoc autopsy team coordinator, saw an opportunity to combat ALS when Harvard scientists Kevin Eggan and Clifford Woolf pioneered some new stem cell technology.
Essentially, they found a way to take skin cells from a patient, turn them into stem cells, and turn those into the nerve cells that are degenerating. Thats the missing link, Roet said. So now we can finally use patients own cells to both do target discovery and develop potential therapeutics.
So Roet packed up his things and shifted base to Boston to learn more, with plans to head back to Europe to start a company. He never left. QurAlis was born in 2016, working out of a co-working space called LabCentral after winning a spot via an Amgen-sponsored innovation competition. The company was carved out of a collaboration with Eggans startup Q-State Biosciences, which developed laser technology to examine cell behavior examining how a neuron fires was imperative in the drug discovery process for ALS.
QurAlis, which counts Vertexs founding scientist Manuel Navia as an advisor, now has three preclinical programs. The furthest along is a therapy designed to target a specific potassium channel that is implicated in certain ALS patients the plan is to take that small molecule into the clinic next year, Roet said.
It has become really clear that if you understand why a specific tumor is developing you can develop very specific targeted therapies, he explained in an interview drawing a parallel between ALS and oncology. Thats exactly the same strategy that we are following for ALS. The genetics have shown that over 25 genes are causing the (ALS) mutations. Some of them work together, some of them are very dominant and work alone what we are doing is trying to get those specific proteins that are tied to very specific ALS populations, where we know that that specific target plays a very important and crucial role in the development of the disease.
In 2018, QurAlis scored seed funding from Amgen, Alexandria, and MP Healthcare Venture Management. The Series A injection was led by LS Polaris Innovation Fund, lead seed investor Mission BioCapital, INKEF Capital and the Dementia Discovery Fund, and co-led by Droia Ventures. Additional new investors include Mitsui Global Investment and Dolby Family Ventures, and existing investors Amgen Ventures, MP Healthcare Venture Management, and Sanford Biosciences also chipped in.
Roet is not sure how long these funds will last, particularly given the uncertainty of the coronavirus pandemic. But some of the capital will be used in hiring, given that the QurAlis team is comprised of a mere five people, including Roet.
Weve been very productive, he said. But we can definitely use some extra hands.
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Precision therapy approach secures small biotech $42M haul to combat disease that inspired the Ice Bucket Challenge - Endpoints News
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Global Stem Cell Therapy Market Forecast & Opportunities, 2025 – ResearchAndMarkets.com – Business Wire
Posted: May 14, 2020 at 7:42 pm
DUBLIN--(BUSINESS WIRE)--The "Global Stem Cell Therapy Market By Type (Allogeneic, Autologous, Syngeneic), By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood derived, iPSCs, Others), By Application, By End Users, By Region, Forecast & Opportunities, 2025" report has been added to ResearchAndMarkets.com's offering.
The Global Stem Cell Therapy Market is expected to grow at a formidable rate of around 12% during the forecast period. The industry is segmented based on type, source of stem cells, application, end-users, company and region.
The market is driven by the growing popularity and awareness pertaining to the use of stem cells for the prevention and cure of certain life threatening diseases. Additionally, increase in number of stem cell banks and growing investments by the government and private organizations for the development of stem cell preservation infrastructure is further propelling the market across the globe.
Based on type, the market can be categorized into allogeneic, autologous and syngeneic. The allogenic type segment is expected to register the highest growth during forecast period attributable to the rising commercialization of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easy production scale-up process, growing number of clinical trials related to allogeneic stem cell therapies, among others.
Based on end-users, the market can be bifurcated into hospitals and clinics. The hospitals segment is expected to dominate the market during the forecast years. This can be accredited to the rising preference for stem cell therapies offered by hospitals proves beneficial for the business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On introduction and approval of any novel stem therapy, hospitals implement it immediately.
Regionally, the stem cell therapy market has been segmented into various regions namely Asia-Pacific, North America, South America, Europe, and Middle East & Africa. Among these regions, North America is expected to dominate the overall stem cell therapy market during the next five years on account of the increasing number of clinical trials for stem cell-based products and increasing public-private funding & research grants.
Major players operating in the Global Stem Cell Therapy Market include Osiris Therapeutics, Inc., MEDIPOST Co., Ltd., Anterogen Co., Ltd., Pharmicell Co., Ltd., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co., Ltd., NuVasive, Inc., RTI Surgical, Inc., AlloSource, Thermo Fisher Scientific and others. The companies are developing advanced technologies and launching new services in order to stay competitive in the market.
Years considered for this report:
Objective of the Study
Key Topics Covered
1. Product Overview
2. Research Methodology
3. Executive Summary
4. Voice of Customer
5. Global Stem Cell Therapy Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Type (Allogeneic, Autologous, Syngeneic)
5.2.2. By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood Derived, iPSCs, Others)
5.2.3. By Application (Musculoskeletal, Wound & Injury, Cardiovascular Disease (CVD), Surgery, Acute Graft-Versus-Host Disease, Drug Discovery & Development, Others)
5.2.4. By End Users (Hospitals v/s Clinics)
5.2.5. By Company (2019)
5.2.6. By Region
5.3. Product Market Map
6. Asia-Pacific Stem Cell Therapy Market Outlook
7. Europe Stem Cell Therapy Market Outlook
8. North America Stem Cell Therapy Market Outlook
9. South America Stem Cell Therapy Market Outlook
10. Middle East and Africa Stem Cell Therapy Market Outlook
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
13. Competitive Landscape
13.1. Osiris Therapeutics, Inc.
13.2. MEDIPOST Co. Ltd.
13.3. Anterogen Co. Ltd.
13.4. Pharmicell Co. Ltd.
13.5. Holostem Terapie Avanzate S.r.l.
13.6. JCR Pharmaceuticals Co. Ltd.
13.7. NuVasive, Inc.
13.8. RTI Surgical, Inc.
13.9. AlloSource
13.10. Thermo Fisher Scientific
14. Strategic Recommendations
For more information about this report visit https://www.researchandmarkets.com/r/hmawq6
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Global Stem Cell Therapy Market Forecast & Opportunities, 2025 - ResearchAndMarkets.com - Business Wire
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Stem Cell Therapy | Global Industry Review 2015-2019 and Forecast to 2025 – PRNewswire
Posted: May 14, 2020 at 7:42 pm
DUBLIN, May 13, 2020 /PRNewswire/ -- The "Global Stem Cell Therapy Market By Type (Allogeneic, Autologous, Syngeneic), By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood derived, iPSCs, Others), By Application, By End Users, By Region, Forecast & Opportunities, 2025" report has been added to ResearchAndMarkets.com's offering.
The Global Stem Cell Therapy Market is expected to grow at a formidable rate of around 12% during the forecast period. The industry is segmented based on type, source of stem cells, application, end-users, company and region.
The market is driven by the growing popularity and awareness pertaining to the use of stem cells for the prevention and cure of certain life threatening diseases. Additionally, increase in number of stem cell banks and growing investments by the government and private organizations for the development of stem cell preservation infrastructure is further propelling the market across the globe.
Based on type, the market can be categorized into allogeneic, autologous and syngeneic. The allogenic type segment is expected to register the highest growth during forecast period attributable to the rising commercialization of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easy production scale-up process, growing number of clinical trials related to allogeneic stem cell therapies, among others.
Based on end-users, the market can be bifurcated into hospitals and clinics. The hospitals segment is expected to dominate the market during the forecast years. This can be accredited to the rising preference for stem cell therapies offered by hospitals proves beneficial for the business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On introduction and approval of any novel stem therapy, hospitals implement it immediately.
Regionally, the stem cell therapy market has been segmented into various regions namely Asia-Pacific, North America, South America, Europe, and Middle East & Africa. Among these regions, North America is expected to dominate the overall stem cell therapy market during the next five years on account of the increasing number of clinical trials for stem cell-based products and increasing public-private funding & research grants.
Major players operating in the Global Stem Cell Therapy Market include Osiris Therapeutics, Inc., MEDIPOST Co., Ltd., Anterogen Co., Ltd., Pharmicell Co., Ltd., Holostem Terapie Avanzate S.r.l., JCR Pharmaceuticals Co., Ltd., NuVasive, Inc., RTI Surgical, Inc., AlloSource, Thermo Fisher Scientific and others. The companies are developing advanced technologies and launching new services in order to stay competitive in the market.
Years considered for this report:
Objective of the Study
Key Topics Covered
1. Product Overview
2. Research Methodology
3. Executive Summary
4. Voice of Customer
5. Global Stem Cell Therapy Market Outlook5.1. Market Size & Forecast5.1.1. By Value5.2. Market Share & Forecast5.2.1. By Type (Allogeneic, Autologous, Syngeneic)5.2.2. By Source of Stem Cells (Adipose Tissue, Bone Marrow, Neural, Embryo/Cord Blood Derived, iPSCs, Others)5.2.3. By Application (Musculoskeletal, Wound & Injury, Cardiovascular Disease (CVD), Surgery, Acute Graft-Versus-Host Disease, Drug Discovery & Development, Others)5.2.4. By End Users (Hospitals v/s Clinics)5.2.5. By Company (2019)5.2.6. By Region5.3. Product Market Map
6. Asia-Pacific Stem Cell Therapy Market Outlook
7. Europe Stem Cell Therapy Market Outlook
8. North America Stem Cell Therapy Market Outlook
9. South America Stem Cell Therapy Market Outlook
10. Middle East and Africa Stem Cell Therapy Market Outlook11. Market Dynamics11.1. Drivers11.2. Challenges
12. Market Trends & Developments
13. Competitive Landscape13.1. Osiris Therapeutics, Inc.13.2. MEDIPOST Co. Ltd.13.3. Anterogen Co. Ltd.13.4. Pharmicell Co. Ltd.13.5. Holostem Terapie Avanzate S.r.l.13.6. JCR Pharmaceuticals Co. Ltd.13.7. NuVasive, Inc.13.8. RTI Surgical, Inc.13.9. AlloSource13.10. Thermo Fisher Scientific
14. Strategic Recommendations
For more information about this report visit https://www.researchandmarkets.com/r/j7namd
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
Media Contact:
Research and Markets Laura Wood, Senior Manager [emailprotected]
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Cardio Stem Cell Therapy Used to Treat Critically Ill Covid-19 Patients – Physician’s Weekly
Posted: May 14, 2020 at 7:42 pm
Four of six patients in case series were weaned off respiratory support
An investigational allogeneic cell therapy using cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in a case series involving six patients treated at Cedars-Sinai Medical Center in Los Angeles.
All six patients treated with the intravenous allogeneic CDC formulation CAP-1002 (Capricor Therapeutics) as a compassionate therapy required respiratory support prior to treatment, with five on mechanical ventilation.
No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital as of late April.
The other two patients are still alive, but remain intubated, Cedars-Sinai cardiologist Raj Makkar, MD, confirmed to BreakingMED Wednesday, May 13.
While we are encouraged by these findings, it is important to point out that the only way that we can assess the efficacy of this treatment in a definitive way is with a randomized clinical trial, and that is what we intend to do, Makkar said.
He added that the clinical trial, which is in the planning stages, is likely to include Covid-19 patients who are not as critically ill as the six in the case series.
All of these patients required respiratory support and they were all on a downward trajectory when treated, he said. They were getting worse and we had nothing else to offer them.
Cardiosphere-derived cells are stromal/progenitor cells from heart tissue with a distinctive antigenic profile (CD105+, CD45-, CD90low).
In their case series, published in the journal Basic Research in Cardiology, Makkar and colleagues noted that the cells are entirely distinct from the controversial c-kit+ putative cardiac progenitors, which have been the subject of various retracted studies.
Since CDCs were first isolated in 2007, the cells have been tested in more than 200 patients in clinical trials for a variety of conditions with a good safety profile, including in young boys with Duchenne muscular dystrophy.
Makkar said the anti-inflammatory and antifibrotic properties of CDCs in animal models make them a possible target therapy for Covid-19.
The prior testing gave us reasonable confidence that this treatment was safe, he said, adding that there is also evidence of a favorable effect on the same type of proinflammatory cytokines that are up-regulated in Covid-19.
Comparisons to mesenchymal stem cells (MSCs) in pre-clinical models suggest that CDCs may also be more effective for paracrine factor secretion and myocardial remodeling.
Given the safety record of CDCs in humans, and the substantial body of evidence confirming relevant disease-modifying bioactivity, applicability to Covid-19 seemed compelling, particularly in the hyperinflammatory stage of the illness, the researchers wrote.
All six patients treated with the intravenous CDC formulation had severe, confirmed Covid-19 with respiratory failure and they were not receiving any other experimental agent, with the exception of hydroxychloroquine and tocilizumab.
Lack of clinical improvement or deterioration despite standard care was the primary reason for considering patients for treatment with CAP-1002. Exclusion criteria included known hypersensitivity to DMSO, which is a component of CAP-1002; prior stem cell therapy; pre-existing terminal illness; and need for mechanical circulatory support and dialysis.
In general, patients with multi-organ failure who were deemed to be too sick for any intervention were excluded from the study, Makkar and colleagues wrote.
All patients had acute respiratory distress syndrome (ARDS) prior to infusion, with decreased PaO2/FiO2 ratios (range 69-198; median 142), diffuse bilateral pulmonary infiltrates on chest imaging and evidence of preserved cardiac function on transthoracic echocardiography (LVEF range, 50-75%). SOFA scores ranged from 2 to 8 prior to stem cell treatment.
The six patients (age range, 19-75 years) had IV infusions of CAP-1002 containing 150 million allogeneic CDCs, and two of the six had a second dose of the treatment.
Following treatment, four patients (67%) were weaned from respiratory support and discharged from the hospital.
A contemporaneous control group of critically ill Covid-19 patients (n = 34) at our institution showed 18% overall mortality at a similar stage of hospitalization, the researchers wrote.
Ferritin was elevated in all patients at baseline (range of all patients 605.43-2991.52 ng/ml) and decreased in five of the six patients (range of all patients 252.891029.90 ng/ml).
Absolute lymphocyte counts were low in five of the six patients at baseline (range 0.260.82 103/l) but had increased in 3 of these five at last follow-up (range 0.231.02 103/l).
Administration of CAP-1002 as a compassionate therapy for patients with severe Covid-19 and significant comorbidities was safe, well tolerated without serious adverse events, and associated with clinical improvement, as evidenced by extubation (or prevention of intubation, the researchers wrote.
Stem cell therapy utilizing cardiosphere-derived cells (CDC) showed an acceptable safety profile with early evidence of efficacy in the treatment of very severe Covid-19 in an early case series involving 6 patients treated at Cedars-Sinai Medical Center, Los Angeles.
No adverse events related to the treatment were reported, and four of the six patients were successfully weaned from respiratory support and were discharged from the hospital.
Salynn Boyles, Contributing Writer, BreakingMED
Funding for this story was provided by the Smidt Family Foundation. The cell product, CAP-1002, was provided by manufacturer Capricor Therapeutics.
ResearcherEduardo Marban reported owning founders equity in Cariricor Therapeutics, and researcher Linda Marban reported being an employee and owning equity in the company.
Cat ID: 125
Topic ID: 79,125,254,930,287,728,932,570,574,730,933,125,190,926,192,927,151,928,925,934
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One year on, Capricor’s stem cell therapy appears to help DMD patients in small study, but investors balk at the data – Endpoints News
Posted: May 14, 2020 at 7:42 pm
Repeated setbacks aside, little Capricor has suggested it has generated some long-term data to support its pursuit to garner approval for its stem cell therapy for Duchenne muscular dystrophy, although some of the data appeared to underwhelmed investors.
The data from the small, placebo-controlled mid-stage study, HOPE-2, tracked the effects of the companys stem cell therapy CAP-1002, which is designed to temper the inflammation associated with DMD, in 8 boys and young men who are in advanced stages of DMD. The remaining 12 enrolled patients received the placebo.
The main goal of the study was a measure that evaluates shoulder, arm and hand strength in patients who are generally non-ambulant (performance of the upper limb (PUL) 2.0), as suggested by the FDA, Capricor said. It is one of several ways Capricor quantified skeletal muscle improvement in the trial.
The intravenous infusion of CAP-1002, given every 3 months, induced a statistically meaningful improvement of 2.4 points (p=0.05) versus the placebo group, in which patient declines were consistent with natural history data. However, on another measure of upper limb function, the trend was in favor of the Capricor drug, but did not hit statistical significance.
The companys shares $CAPR were down nearly 13% to $6.89 in morning trading.
Click on the image to see the full-sized version
Meanwhile, there were also some encouraging data on cardiac function the genetic condition is characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles.
As reflected above, CAP-1002 elicited an improvement across different measures of cardiac function, although the effect was not always statistically significant. In particular, the drug also caused a reduction in the levels of the biomarker CK-MB, an enzyme that is only released when there is cardiac muscle cell damage.
Armed with these data and an RMAT and orphan drug designation from the FDA, Capricor is now hoping to eke out a plan with the FDA for marketing approval.
LA-based Capricor initially set out to test the potential of technology that Eduardo Marbn, CEO Linda Marbns husband, developed at Johns Hopkins. But repeated setbacks clobbered the company, which in 2014 traded north of $14 a share. In 2017, J&J walked away from a collaboration on a stem cell therapy for damaged hearts after it flopped in the clinic.
In late 2018, the company voluntarily halted a DMD clinical trial, following a severe allergic reaction that occurred during infusion. In February 2019, the company said it is exploring strategic alternatives for one or more of its products and cutting 21 jobs to keep financially afloat, but had resumed dosing in its DMD trial.
The first batch of positive data on CAP-1002, which consists of progenitor cells derived from donor hearts and is designed to exude exosomes that initiate muscle repair by suppressing inflammation and driving immunomodulation, came last July when the company announced the drug had generated a positive effect at the interim analysis juncture of HOPE-2. Capricor is now working on to flexing its therapeutic muscle with CAP-1002 to fight the Covid-19 pandemic.
DMD is a rare muscle-wasting disease caused by the absence of dystrophin, a protein that helps keep muscle cells intact. It disproportionately affects boys and affects roughly 6,000 in the United States.
Patients are essentially treated with steroids. Sarepta Therapeutics now has two exon-skipping drugs designed to treat certain subsets of the disease, although the magnitude of their effect is controversial given that approvals were not based on placebo-controlled data. Meanwhile, Sarepta and others are also pursuing one-time cures in the form of gene therapies to replace the missing dystrophin gene in patients.
Social: Linda Marbn, Capricor CEO (Twitter)
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One year on, Capricor's stem cell therapy appears to help DMD patients in small study, but investors balk at the data - Endpoints News
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Australia’s Mesoblast raises $90M to scale up stem cell therapy manufacturing to treat COVID-19 ARDS – BioWorld Online
Posted: May 14, 2020 at 7:42 pm
PERTH, Australia Australian stem cell company Mesoblast Ltd. completed a capital raising of AU$138 million (US$90 million) to scale up manufacturing of its allogeneic cell therapy, remestemcel-L, to treat COVID-19 acute respiratory distress syndrome (ARDS).
The Melbourne-headquartered company is currently enrolling patients in a randomized placebo-controlled phase II/III trial in up to 300 patients across 30 sites in the U.S. The trial is evaluating whether remestemcel-L can reduce the high mortality in COVID-19 patients with moderate to severe ARDS.
Patients are being dosed, and were really pleased how fast enrollment is growing, Mesoblast CEO Silviu Itescu told BioWorld. Were right on target and hope to update the market soon.
The phase II/III trial was initiated after promising results were seen with remestemcel-L under an emergency compassionate-use protocol in COVID-19 ARDS at Mount Sinai Hospital in New York, where nine of 12 (75%) ventilator-dependent patients were able to come off ventilators within 10 days.
Under the compassionate-use protocol, patients in intensive care units received standard-of-care treatment. Once they were intubated on a ventilator, they were treated within 72 hours with two infusions of Mesoblasts remestemcel-L cells within five days.
Once youre ventilated when you have acute respiratory distress syndrome in the lungs, your likelihood of coming off a ventilator is 9%, and your survival is 12%, Itescu said.
Whats exciting is that our patients in the same epicenter of this disease with the same treatment everyone else is getting, suddenly 75% are coming off of ventilators within 10 days, and weve got 83% survival, Itescu said.
The compassionate-use treatment experience informed the design of the phase II/III trial, and the FDA approved the same protocol, but it is powered so that results will be self-evident, Itescu said.
The phase II/III trial will randomize up to 300 ventilator-dependent patients in intensive care units to either remestemcel-L or placebo on top of standard of care, in line with guidance provided by the FDA. The primary endpoint is all-cause mortality within 30 days of randomization, with the key secondary endpoint being the number of days alive and off mechanical support.
What people are dying of is acute respiratory distress syndrome, which is the bodys immune response to the virus in the lungs, and the immune system goes haywire, and in its battle with the virus it overreacts and causes severe damage to the lungs, he said.
Capital raise allows scale up for COVID-19 and influenza
The capital raise consisted of a placement of 43 million shares to existing and new institutional investors at a price of AU$3.20 per share, representing a 7% discount to the five-day volume-weighted average price (VWAP) at the close of trading May 8. The placement was conducted with Bell Potter Securities as lead manager and underwriter. Settlement is expected to occur on Friday, May 15.
Most of the funds raised will be used to scale up manufacturing of remestemcel-L for the treatment of critically ill patients suffering with diseases causing ARDS, including COVID-19 and influenza.
Were in the middle of a pandemic, and people are talking about opening up, and theyre talking about a potential second wave, Itescu said. Its too early to talk about projections, but we need to at least be in a position to make more product in an additional facility, so that requires technology transfer and certain process improvements.
Remestemcel-L is Mesoblasts lead product, and it is currently being studied in multiple indications so the move to ramp up manufacturing is a good strategic move regardless of COVID-19, he said.
There are at least 125,000 patients every year in the United States with influenza-related acute respiratory distress syndrome in intensive care units, and those patients have got about a 40% fatality rate. Up to about 60,000 patients die per year due to influenza ARDS, so even if COVID-19 magically disappears, which we could only hope, influenza is here to stay despite vaccines being available, the CEO said.
This product would work in the same way for influenza-related ARDS as it would for COVID-19-related ARDS, he said.
The ability to build out manufacturing capacity is part of an FDA requirement to be able to demonstrate it can make product for patients in the U.S.
The company already has a manufacturing facility in Singapore, and the additional site in the U.S. would give the company the ability to provide product globally.
Were putting our strategic plan into play. You need to have multiple geographies, especially in this kind of environment, Itescu said.
Without the cash, we wouldnt have been able to deliver on this, but we now can execute.
Mesoblast's allogeneic candidates are based on mesenchymal lineage cells collected from the bone marrow of healthy adult donors.
Remestemcel-L is currently being reviewed by the FDA for potential approval in the treatment of children with steroid-refractory acute graft-vs.-host disease (aGVHD). The company submitted the final module of a rolling BLA in January. The FDA has set a PDUFA date of Sept. 30 for the product branded as Ryoncil.
The clinical data submitted with the BLA showed a survival rate of 79% compared to an expected 30% survival rate in the pediatric phase III trial in aGVHD.
Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing phase III trials in advanced heart failure and chronic low back pain.
Mesoblast shares (ASX:MSB) were down 1.45% on the news, trading at AU$3.39 per share by market close May 13. On Nasdaq (MESO), shares closed at $12.15.
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