Lonza’s Cocoon will soon make dozens of stem cell therapies all at once – Innovation Origins

The name Lonza comes from the river in Switzerland near where the company was originally founded more than a hundred years ago, As such, it has nothing to do with the biomedical products and services that Lonza provides.

Lonza is active around the world and has around 15,000 employees with branches in the Netherlands as well. Such as the one on the Brightlands Chemelot Campus in Geleen. where approximately 250 people work there. This company division started as a start-up in Maastricht in 2005 and developed a production facility for stem cell and gene therapy to combat diseases. It became part of Lonza in 2018.

The reason that Lonza is on the Chemelot campus is due to its strategic location. This is very convenient for having access to all kinds of industry-related services that are already available there, says Willem Dullaers. He is the senior manager of quality control at Lonza in Geleen. Security is well organized, and we use a number of other facilities so that as a company you dont need to arrange these yourself.

The interesting thing about the Lonza production facility in Geleen is that the company isolates living cells and is even able to manipulate them on behalf of pharmaceutical groups. These companies then supply them to hospitals for the treatment of patients, primarily those suffering from forms of cancer. So what does Lonza do exactly and what does it ultimately deliver to those hospitals? is the question for Dullaers. This is not so easy to explain.

We work in cleanrooms at Lonzas premises in Geleen with the aim of selecting body cells from a sample of the patient taken in the hospital via a blood transfusion or bone marrow puncture. For example, body cells that are selected have the ability to fight cancer cells by virtue of their specific properties. If these cells are selected and reproduce in number after being cultured, it can be useful to add DNA to them so that they are able to attack the cancer cells even more effectively. Modification is done using a piece of deactivated virus that is used as a vector to introduce DNA into the selected cells.

Once that process is completed, the number of cells, which is usually very small, is cultivated to a larger quantity so that after various quality checks and the preparation for transport (cooled or frozen) are carried out, the cells are introduced into the patient. It is very common that patients are successfully treated afterward, says Dullaers. He refers to a report that made the world news last year. An Italian two-year-old boy with a rare immune disease (HLH) who was initially given up by doctors, Alex Montresor, was cured after stem cell therapy.

About 30 people are currently working on the production process for cell and gene therapy to treat people, Dullaers adds. The tasks that the biomedical doctors have to perform take time and require careful attention. They have to enter the cleanroom themselves to put the cells through the process to be transformed into stem cell therapies. They have to wear protective, hermetically sealed suits under the strictest safety conditions. That is to safeguard their own safety but also to prevent any potential contamination of the cells. Patients for whom this therapy is intended are often severely debilitated. They are not allowed to get sick as a result of a bacterium or particulate matter that has entered the cultured cells. A check always takes place to make sure that the product is completely clean. If this is not the case, it must be remade as a last resort.

At the moment, Lonza is working on a method to fully automate the culture process of the cells in the cleanroom. A pilot is currently underway at the Sheba Medical Center in Israel. It has a test setup with a so-called cocoon. The cocoon looks like an egg-shaped module of white plastic that is about one meter long. Inside the egg there is a small factory that automates all operations, from cell selection to DNA insertion and preparation for transport and administration.

Over the coming years, this innovative culture method for cell and gene therapy must be approved through clinical trials and by medicinal regulatory agencies such as the U.S. FDA and the European EMA. Only then can this robotized method be applied on a large scale.

I hope it will be achievable within five to ten years, says Dullaers. That will change a lot in terms of affordability and supply options for cell and gene therapy. Because it is such a cumbersome treatment, the costs are high right now. The production also takes a lot of time. Depending on the complexity of the process, the duration varies from a few days to sometimes more than two months, Dullaers notes.

If the entire process can be robotized, fewer people will be needed to do the work. I think that whereas we now work with 150 people, you will be able to do it with 15. However, you will need a different set of employees: People with a software background and an understanding of the machinery.

You can simultaneously fill a room with dozens of cocoons where cell therapies are made. That means that productivity is bound to skyrocket. Consequently, it will also be possible to make more medication based on the cells of individual patients, which will also be cheaper since less staff is needed. The chance of making mistakes is smaller than with work that involves human hands, Dullaers points out.

Another alternative is for hospital laboratories to make the gene and cell therapies themselves. It is conceivable that they would like to have a cocoon in their own hospital that they can use to treat patients.

You can also read the earlier articles in this series here:

The Chinese and Americans are knocking on the Dutch town of Geleens door to test innovative chem tech

Xilloc: Requests from dozens of hospitals worldwide for 3D-printed implants

Dutch Arlanxeo: 85% less CO2 emissions thanks to rubber from sugar cane

Niaga: 100% recyclable mattresses, furniture and carpets have the future

See more here:
Lonza's Cocoon will soon make dozens of stem cell therapies all at once - Innovation Origins

Global Cell Therapy Market Report 2020: Market to Recover in 2023 – PRNewswire

DUBLIN, Dec. 31, 2020 /PRNewswire/ -- The "Cell Therapy Global Market Report 2020-30: COVID-19 Growth and Change" report has been added to ResearchAndMarkets.com's offering.

Cell Therapy Global Market Report 2020-30: COVID 19 Growth and Change provides the strategists, marketers and senior management with the critical information they need to assess the global cell therapy market.

Major players in the cell therapy market are Fibrocell Science Inc., JCR Pharmaceuticals Co. Ltd., PHARMICELL Co. Ltd., Osiris Therapeutics Inc., MEDIPOST, Vericel Corporation, Anterogen Co. Ltd., Kolon TissueGene Inc., Stemedica Cell Technologies Inc. and AlloCure.

The global cell therapy market is expected to decline from $7.31 billion in 2019 to $7.2 billion in 2020 at a compound annual growth rate (CAGR) of -1.54%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The entire supply chain has been disrupted, impacting the market negatively. The market is then expected to recover and reach $10.0 billion in 2023 at a CAGR of 11.55%.

The cell therapy market consists of sales of cell therapy and related services. Cell therapy (CT) helps repair or replace damaged tissues and cells. A variety of cells are used for the treatment of diseases includes skeletal muscle stem cells, hematopoietic (blood-forming) stem cells (HSC), lymphocytes, mesenchymal stem cells, pancreatic islet cells, and dendritic cells.

North America was the largest region in the cell therapy market in 2019. Asia Pacific is expected to be the fastest-growing region in the forecast period.

The cell therapy market covered in this report is segmented by technique into stem cell therapy; cell vaccine; adoptive cell transfer (ACT); fibroblast cell therapy; chondrocyte cell therapy. It is also segmented by therapy type into allogeneic therapies; autologous therapies, by application into oncology; cardiovascular disease (CVD); orthopedic; wound healing; others.

In August 2019, Bayer AG, a Germany-based pharmaceutical and life sciences company, acquired BlueRock Therapeutics, an engineered cell therapy company, for $1 billion. Through this transaction, Bayer AG will acquire complete BlueRock Therapeutics' CELL+GENE platform, including a broad intellectual property portfolio and associated technology platform including proprietary iPSC technology, gene engineering, and cell differentiation capabilities. BlueRock Therapeutics is a US-based biotechnology company focused on developing engineered cell therapies in the fields of neurology, cardiology, and immunology, using a proprietary induced pluripotent stem cell (iPSC) platform.

The high cost of cell therapy hindered the growth of the cell therapy market. Cell therapies have become a common choice of treatment in recent years as people are looking for the newest treatment options. Although there is a huge increase in demand for cell therapies, they are still very costly to try. Basic joint injections can cost about $1,000 and, based on the condition, more specialized procedures can cost up to $ 100,000. In 2020, the average cost of stem cell therapy can range from $4000 - $8,000 in the USA. Therefore, the high cost of cell therapy restraints the growth of the cell therapy market.

Key players in the market are strategically partnering and collaborating to expand the product portfolio and geographical presence of the company. For instance, in April 2018, Eli Lilly, an American pharmaceutical company entered into a collaboration agreement with Sigilon Therapeutics, a biopharmaceutical company that focused on the discovery and development of living therapeutics to develop cell therapies for type 1 diabetes treatment by using the Afibromer technology platform. Similarly, in September 2018, CRISPR Therapeutics, a biotechnological company that develops transformative medicine using a gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated on the discovery, development, and commercialization of allogeneic stem cell therapy for diabetes treatment.

The rising prevalence of chronic diseases contributed to the growth of the cell therapy market. According to the US Centers for Disease Control and Prevention (CDC), chronic disease is a condition that lasts for one year or more and requires medical attention or limits daily activities or both and includes heart disease, cancer, diabetes, and Parkinson's disease. Stem cells can benefit the patients suffering from spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis.

According to Cancer Research UK, in 2018, 17 million cancer cases were added to the existing list, and according to the International Diabetes Federation, in 2019, 463 million were living with diabetes. According to the Parkinson's Foundation, every year, 60,000 Americans are diagnosed with PD, and more than 10 million people are living with PD worldwide. The growing prevalence of chronic diseases increased the demand for cell therapies and contributed to the growth of the market.

Key Topics Covered:

1. Executive Summary

2. Cell Therapy Market Characteristics

3. Cell Therapy Market Size And Growth 3.1. Global Cell Therapy Historic Market, 2015 - 2019, $ Billion 3.1.1. Drivers Of The Market 3.1.2. Restraints On The Market 3.2. Global Cell Therapy Forecast Market, 2019 - 2023F, 2025F, 2030F, $ Billion 3.2.1. Drivers Of The Market 3.2.2. Restraints On the Market

4. Cell Therapy Market Segmentation 4.1. Global Cell Therapy Market, Segmentation By Technique, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.2. Global Cell Therapy Market, Segmentation By Therapy Type, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

4.3. Global Cell Therapy Market, Segmentation By Application, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

5. Cell Therapy Market Regional And Country Analysis 5.1. Global Cell Therapy Market, Split By Region, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion 5.2. Global Cell Therapy Market, Split By Country, Historic and Forecast, 2015-2019, 2023F, 2025F, 2030F, $ Billion

Companies Mentioned

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Global Cell Therapy Market Report 2020: Market to Recover in 2023 - PRNewswire

Induced Pluripotent Stem Cell Derived Human Lung Organoids to Map and Treat the SARS-CoV2 Infections In Vitro – DocWire News

This article was originally published here

Adv Exp Med Biol. 2021 Jan 1. doi: 10.1007/5584_2020_613. Online ahead of print.

ABSTRACT

COVID-19 is the current day pandemic that has claimed around 1,054,604 lives globally till date. Moreover, the number of deaths is going to increase over the next few months until the pandemic comes to an end, and a second wave has also been reported in few countries. Most interestingly, the death rate among certain populations from the same COVID-19 infection is highly variable. For instance, the European populations show a very high death rate, in contrast to the populations from Chinese ethnicities. Amongst all the closed cases with an outcome (total recovered + total died), the death rate in Italy is 13%, Iran is 6%, China is 5%, Brazil is 3%, The United States of America is 2%, India 2%, Israel is 1% as of October 08, 2020. However, the percentage was higher during the early phase of the pandemic. Moreover, the global death rate amongst all the patients with an outcome is 4%. Here we have reviewed virus-transmitted various respiratory tract infections and postulated a better understanding of SARS-CoV2 using lung stem cell organoids in vitro. Hence, here we propose the strategies of understanding first the infectivity/severity ratio of COVID-19 infections using various ethnicity originated induced pluripotent stem cell-derived lung stem cell organoids in vitro. The greater the infectivity to severity ratio, the better the disease outcome with the value of 1 being the worst disease outcome. This strategy will be useful for understanding the infectivity/severity ratio of virus induced respiratory tract infections for a possible betterment of community-based disease management. Also, such a strategy will be useful for screening the effect of various antiviral drugs/repurposed drugs for their efficacy in vitro.

PMID:33385178 | DOI:10.1007/5584_2020_613

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Induced Pluripotent Stem Cell Derived Human Lung Organoids to Map and Treat the SARS-CoV2 Infections In Vitro - DocWire News

Creative Medical Technology Holdings Announces Patent filing based on Preclinical Data in Model of Heart Attack using ImmCelz Regenerative…

PHOENIX, Dec. 31, 2020 /PRNewswire/ --(OTC CELZ) Creative Medical Technology Holdings Inc. announced today positive preclinical data using ImmCelz in treatment of a model of heart attack.

Patent application #63/132472, entitled "Treatment of Heart Failure and/or Post Infarct Pathological Remodeling by Ex Vivo Reprogrammed Immune Cells" covers data in which mice with restricted blood flow to the heart had significantly improved survival when treated with ImmCelz as compared to control mice.

"The role of the immune system in numerous aspects of regenerative medicine can not be overstated." Said Dr. Amit Patel, Board Member of the Company and co-inventor of the patent. "The data described today, while preliminary, supports the belief that ImmCelz, which is a "regenerative immunotherapy" can be applied across a broad range of conditions."

The ImmCelz product, based on decades of immunological research by Drs Thomas Ichim and Amit Patel, involves extraction of patient immune cells, "training" the immune cells to exhibit regenerative properties by incubation with regenerative cells outside of the body, followed by re-infusion of the patient's own cells. To date the Company has demonstrated that ImmCelz has therapeutic activity in stroke and liver failure.

"It is my honor that the work we initiated more than a decade ago is coming to fruition." Said Thomas Ichim, Ph.D, coinventor of the patent. "Ten years ago, Dr. Patel, myself and a team of colleagues described the potent synergies that occur when various cell types are utilized in combination for treatment of heart failure1. ImmCelz is the product of all these years of working and perfecting multi-cellular approaches to regenerative medicine."

"As we round out 2020, we have significantly expanded our Intellectual Property portfolio based on many years of collaborative research and development. Utilizing the ImmCelz technology for the treatment of heart failure is an excellent addition to this robust patent portfolio as it effects millions of patients in the U.S. alone. Patients with end stage heart failure in many cases have no options but heart transplantation, which is extremely limited." Said Timothy Warbington, President and CEO of the Company. "We are excited with the progress that the Company is making in advancing ImmCelz, which approaches regenerative medicine from a completely unique perspective. Given that the active cells in ImmCelz are derived from the same patient, we anticipate an accelerated path to FDA Investigational New Drug (IND) clearance."

"We encourage industry colleagues and other interested parties to review our early priority date patent filings to learn more about the ImmCelz technology and how it applies to multiple indications" Mr. Warbington further said.

About Creative Medical Technology Holdings

Creative Medical Technology Holdings, Inc. is a commercial stage biotechnology company specializing in stem cell technology in the fields of urology, neurology and orthopedics and trades on the OTC under the ticker symbol CELZ. For further information about the company, please visitwww.creativemedicaltechnology.com.

Forward Looking Statements

OTC Markets has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This news release may contain forward-looking statements including but not limited to comments regarding the timing and content of upcoming clinical trials and laboratory results, marketing efforts, funding, etc. Forward-looking statements address future events and conditions and, therefore, involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated in such statements. See the periodic and other reports filed by Creative Medical Technology Holdings, Inc. with the Securities and Exchange Commission and available on the Commission's website atwww.sec.gov.

Creativemedicaltechnology.com http://www.StemSpine.com http://www.Caverstem.com http://www.Femcelz.com

1 Ichim et al. Combination stem cell therapy for heart failure. Int Arch Med. 2010; 3: 5. Combination stem cell therapy for heart failure (nih.gov)

SOURCE Creative Medical Technology Holdings, Inc.

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Creative Medical Technology Holdings Announces Patent filing based on Preclinical Data in Model of Heart Attack using ImmCelz Regenerative...

Haywards Heath carer trying to raise funds for MS treatment – The Argus

A FORMER NHS care assistant is hoping the new year will see her raise 40,000 to fund groundbreaking treatment.

Joceline Colvert, 41, from Haywards Heath was diagnosed with multiple sclerosis (MS) at the age of 22.

During the last few years her condition has deteriorated and forced her to give up her job as a nursing assistant.

Haematopoietic stem cell transplantation, or HSCT, is available on the NHS but because Jocelines diagnosis was more than 15 years ago, she does not qualify for NHS treatment.

It means she has to fund treatment outside the UK.

READ MORE:'My MS relapse left me unable to walk or smile' - chef reveals devastating impact

She has raised 27,000 for the procedure at a specialist clinic in Russia, due to start in March next year.

The treatment involves removing the patients stem cells, followed by chemotherapy and then re-introducing the cleansed stem cells, effectively erasing the bodys memory of MS.

Joceline said: I am so excited about the difference the treatment could make to my life.

I bought my first wheelchair this year and decided I had to do everything to stop my mobility deteriorating any further.

I was devastated I didnt qualify for treatment on the NHS but rather than become despondent Ive put my energy into funding the treatment independently.

People have been so generous and I cant thank family, friends and complete strangers enough for their help so far.

Im hoping that I can reach the fundraising target so I can make the trip to Moscow.

Joceline Colvert hopes to halt the progress of her MS

The treatment has an 80 to 90 per cent success rate.

HSCT is not expected to cure MS, however in most cases it freezes it and stops it getting any worse and most patients see their mobility improve.

Joceline said: For years I have been dreading the future but for the first time I am excited about it and hopeful that I will be able to walk unaided again.

My dream is to be able to take my ageing dog for a proper walk in the future.

READ MORE:Mother refuses to be 'beaten' by MS after losing her son and husband

Although my husband takes her out, one of the hardest things is not being able to enjoy time outside with her.

The donations to Jocelines Gofundme page have reached two thirds of 40,000 needed to fund the treatment.

If you would like to donate and help Joceline make it to Russia, visit Jocelines GoFundMe page https://gf.me/u/y538k2

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Haywards Heath carer trying to raise funds for MS treatment - The Argus

Chronic graft-versus-host disease in children and adolescents with thalassemia after hematopoietic stem cell transplantation – DocWire News

This article was originally published here

Int J Hematol. 2021 Jan 1. doi: 10.1007/s12185-020-03055-w. Online ahead of print.

ABSTRACT

Data on chronic graft-versus-host disease (cGVHD) in patients with thalassemia after hematopoietic stem cell transplantation (HSCT) have not been specifically explored. The present study aimed to determine the incidence and clinical manifestations of cGVHD in children and adolescents with thalassemia who underwent HSCT and to compare healthcare utilization and medical cost between patients with and without cGVHD. We retrospectively analyzed the presentations, treatments, and outcomes of historical cGVHD (Seattle criteria), post-transplant admissions and direct medical cost for HSCT patients (n = 66). We used the 2014 NIH consensus criteria to reclassify the diagnosis of cGVHD (NIH cGVHD). Among 28 historical cGVHD patients, 13 (46.4%) fulfilled the NIH criteria. Reasons why the NIH criteria were unmet were reclassification as late acute GVHD and presence of distinctive signs without confirmatory tests. At 2 years after HSCT, the cumulative incidence of NIH cGVHD was 21.67% (95% CI, 12.31-32.74%). Lung cGVHD was associated with inferior survival with a hazard ratio of 13.6 (95% CI, 1.42-131.48). Patients with historical cGVHD had significantly increased frequency of inpatient admissions and medical cost. In conclusion, cGVHD was common in children with thalassemia receiving HSCT. Patients with cGVHD required prolonged immunosuppressive treatment and incurred high medical expenses.

PMID:33385291 | DOI:10.1007/s12185-020-03055-w

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Chronic graft-versus-host disease in children and adolescents with thalassemia after hematopoietic stem cell transplantation - DocWire News