Category Archives: Regenerative Medicine

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With the promise of regenerative medicine comes the risk of widening health care disparities. Sometimes the newest discoveries, such as regenerative interventions, are out of reach for people in diverse ethnic or socioeconomic groups or they may not understand or trust new options for healing.

Mayo Clinicis trying to overcome those barriers by launching community outreach and a bioethics study aimed at improving access to regenerative medicine among underserved groups.

Regenerative medicine sometimes could look like a science fiction movie. It is important to learn from the community about how things could be better explained to them or how we can erase any doubts that they have about what we do, says Jorge Mallea, M.D., a pulmonologist at Mayo Clinic in Florida. Listening to their concerns, and explaining what we know, the things still we dont have solutions for, and what we are trying to accomplish could improve understanding and engagement.

Regenerative medicine is an emerging field of practice that is shifting the focus of health care from fighting disease to rebuilding health, with an emphasis on repairing, replacing or restoring diseased cells and tissues. Mayo ClinicsCenter for Regenerative Medicineis at the vanguard of this movement, supporting the concept of regeneration for all. Dr. Mallea chairs the centers Equity, Inclusion and Diversity Advisory Committee.

More diverse clinical trials

To ensure that regenerative therapies go beyond selected or priority groups, Mayo Clinic is expanding the recruitment for clinical trials to include more diversity in race, age and socioeconomic status. For example, a dermatology study in Rochester is exploring how certain regenerative interventions might affect ethnic groups with different skin tones.

We want to learn more about diverse groups to ensure the therapies we apply would work for people of different genders, races and genetics, says Dr. Mallea. Its important to have representation from diverse groups. We could learn in our clinical trials that certain groups need different doses or distinct ways of applying the interventions.

In other research,Zubin Master, Ph.D., a bioethicist in Mayo ClinicsBiomedical Ethics Research Program, is leading a bioethics study that seeks to understand possible economic, social and ethnic barriers toplatelet-rich plasma platelets spun from a persons own blood and containing growth factors as an orthobiologic treatment for kneeosteoarthritis. Platelet-rich plasma is a new regenerative intervention that shows healing potential. However, the Food and Drug Administration has not yet approved it. Therefore, patients must pay out of pocket for it.

Mohamed Addani, aMayo Clinic Graduate School of Biomedical Sciencesstudent within Dr. Masters team, will interview patients across Mayo Clinic who choose platelet-rich plasma as an intervention for knee osteoarthritis and those who opt instead for standard care. The team will compare those responses to a more demographically diverse group of patients whove made similar care choices at Detroit Medical Center. Researchers will examine race, ethnicity, socioeconomic and demographic variables, beliefs, attitudes, and understanding of regenerative medicine.

This study will provide the first scientifically based data on whether health disparities exist among patients seeking next-generation regenerative interventions such as platelet-rich plasma, says Dr. Master. The results will give us the unique opportunity to identify factors that are creating barriers to regenerative care and proactively address ways to overcome them.

The project seeks to improve access and make regenerative medicine more equitable among diverse and underserved groups.

Showcasing the cool stuff

Attracting a more diverse pool of regenerative medicine scientists and practitioners is another strategy to boost inclusivity. Mayo Clinic is taking regenerative medicine on the road to high schools and colleges near its destination locations in Arizona, Florida and Minnesota, showcasing what Dr. Mallea describes as the cool stuff in research and development. The hope is that it might inspire students, particularly those from underrepresented and disadvantaged communities, to consider a career in regenerative medicine.

We are sharing examples of our research, such as bioprinting of organs and developing new medicines from living organisms like cells to fight different diseases and cancers, says Dr. Mallea. We hope to plant a seed in their minds that regenerative medicine holds promise not only as a future therapy, but also a future career.

In addition, Mayo is using the Community Scientist Program to open its doors to scientists from the community who want to learn more. This program pairs community scientists with regenerative medicine researchers. Mayo hopes these strategies will improve the interaction and understanding needed to ensure access to new regenerative therapies as they are introduced in the practice.

Envision yourself working for a global leader in an industry fueled by innovation and growth. Mayo Clinic has opportunities for you. Join us at Floridas No. 1 hospital by visiting https://jobs.mayoclinic.org/. For more information on health care topics please visit Mayo Clinic Jacksonville at mayoclinic.org.

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Addressing Diversity Barriers to Regenerative Medicine Free Press of Jacksonville - Jacksonville Free Press

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With the unwinding of the high-growth/tech trade of the past two years, many biotechnology names suffered equally in nasty selloffs this year.

Shares of Mesoblast Ltd(ASX: MSB) have taken a hit in 2022 having slipped more than 42% into the red this year to date.

Shares of the regenerative medicine player are currently at 84 cents apiece in early trading on Thursday, gaining the 3% they lost in yesterdays session.

It was a busy period in the last financial year for Mesoblast, especially in its liaison with the US Food and Drug Administration (FDA).

Mesoblast has made, and is set to make, a host of submissions to the FDA regarding its lead drug candidates, Remestemcel-L and Rexlemestrocel-L.

It intends to resubmit a biologics license application (BLA) with the FDA this quarter for the approval of Remestemcel-L in treating children with steroid-resistant acute graft-versus-host-disease (SR-aGVHD). It is aiming for this approval in early 2023.

Meanwhile, Mesoblast also plans to meet with the FDA in the next quarter under its existing regenerative medicine advanced therapy (RMAT) designation to discuss Rexlemestrocel-L.

They will look over data from the companys recent phase 3 trial of 565 patients with heart failure condition HFrEF.

Rexlemestrocel-L also gained alignment with the FDA last period on key metrics for a pivotal phase 3 clinical trial in patients with chronic low back pain (CLBP) associated with disc pathology.

This follows on from the first phase 3 trial covering the same condition and Mesoblast hopes to replicate favourable results produced there.

The company also plans to have received clearance from the FDA by the end of 2022 so it can commence the pivotal trial.

As such, it will be a busy few months for Mesoblast as it looks to progress through this next round of trials in both of its leading drug segments.

In the last 12 months, the Mesoblast share price has faltered 54% into the red.

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- Successful biopharma entrepreneur with 25 years of experience growing leading healthcare firms -

LONDON, Ontario, Sept. 07, 2022 (GLOBE NEWSWIRE) -- Sernova Corp. (TSX:SVA) (OTCQB:SEOVF) (FSE/XETRA:PSH), a clinical-stage company and leader in regenerative medicine cell therapeutics, today announcedthe appointment of Daniel Mahony, Ph.D. to its Board of Directors, effective September 30th, 2022. Dr. Mahony is Entrepreneur-in-Residence at Evotec and is also responsible for managing Evotecs equity investment portfolio.

Dr. Mahony brings over 25 years of global healthcare investment, management and research experience covering biotechnology, medical technology, and healthcare service sectors. Prior to joining Evotec, he served as the Co-head of Healthcare at Polar Capital where he launched the firms healthcare investment business in 2007 and grew it to over $4 billion of assets under management. Prior to Polar Capital, he was head of European healthcare research at Morgan Stanley, an analyst at ING Barings Furman Selz in New York, and a postdoctoral research scientist at DNAX Research Institute in California.

We are delighted to welcome Dr. Mahony to Sernovas Board of Directors, said Frank Holler, Executive Chair of Sernova. Dan has a unique background, starting as a research scientist, then moving into healthcare research and capital markets and finally into the pharmaceutical industry. This background gives him deep insights into the healthcare business and capital markets which will be very valuable for Sernova.

Dr. Mahony stated, Sernova is uniquely well positioned with its Cell Pouch System to become a leading player in regenerative medicine. I am thrilled to be joining its Board of Directors and look forward to working with the other directors and the management team to advance potential functional cures for some of the most challenging chronic diseases.

Dr. Mahony holds multiple industry leadership positions. He currently chairs the board of the BioIndustry Association (BIA), the industry trade association for UK life sciences,andholds non-executive directorships at the Wellcome Sanger Institute, Trellus Health, Celmatix, Keepabl, and Apian. Dr. Mahony also acts as a mentor for the NHS Clinical Entrepreneur Training Programme, which supports junior doctors and healthcare professionals in developing entrepreneurial aspirations during their clinical training. Dr. Mahony was awarded a first-class, honours degree in biochemistry from Oxford University and received his doctorate degree from Cambridge University. Dr. Mahony will replace Dr. Dohrmann as Evotecs representative on the Sernova board.

ABOUT SERNOVA CORP. AND THE CELL POUCH SYSTEM PLATFORM FOR CELL THERAPY

Sernova Corp. is a clinical-stage biotechnology company that is developing regenerative medicine therapeutic technologies for chronic diseases, including diabetes, thyroid disease, and blood disorders including hemophilia A. Sernova is currently focused on developing a functional cure for diabetes with its regenerative cell therapy platform technologies, including its proprietary Cell Pouch. On implantation, the Cell Pouch forms a natural vascularized tissue environment in the body for long-term survival and function of therapeutic cells that release necessary proteins or factors missing from the body to treat chronic diseases. Sernovas Cell Pouch System has already shown it can potentially provide a functional cure to people with type 1 diabetes in an ongoing Phase 1/2 clinical study at the University of Chicago. Sernova is also advancing its proprietary conformal coating technology in collaboration with the University of Miami to cloak the therapeutic cells from the immune system attack with the goal to eliminate the need for chronic immunosuppressives. In May 2022, Sernova and Evotec entered into a global strategic collaboration to develop an implantable off-the-shelf iPSC-based (induced pluripotent stem cells) beta cell replacement therapy. This collaboration potentially provides Sernova an unlimited supply of insulin-producing cells to treat millions of patients with insulin-dependent diabetes (type 1 and type 2). Sernova is also gearing up to be in the clinic in two additional programs that utilize its Cell Pouch System an implantable cell therapy for benign thyroid disease resulting from thyroid gland removal and an ex-vivo lentiviral factor VIII gene therapy for hemophilia A.

FOR FURTHER INFORMATION, PLEASE CONTACT:

Corporate: Christopher Barnes VP, Investor Relations Sernova Corp. christopher.barnes@sernova.com Tel: 519-902-7923 http://www.sernova.com

Investors: Corey Davis, Ph.D. LifeSci Advisors, LLC cdavis@lifesciadvisors.com Tel: 212-915-2577

Media: Elizabeth Miller, M.D. LifeSci Communications emiller@lifescicomms.comTel: 646-791-9705

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Sernova Announces the Appointment of Daniel Mahony, Ph.D. to its Board of Directors - GlobeNewswire

HAIFA, Israel, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR) (Pluri or the Company) (formerly known as Pluristem Therapeutics, Inc.), a leading biotechnology company, today announced that a 7.5 million non-dilutive grant from the European Unions Horizon Europe program has been awarded to PROTO (Advanced PeRsOnalized Therapies for Osteoarthritis), an international collaboration led by Charit, Berlin Institute of Health Center for Regenerative Therapies. The goal of the PROTO project is to utilize Pluris PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA). The project is currently under grant agreement preparation number 101095635. Final approval of the grant is subject to completion of the consortium and Horizon Europe grant agreements. The funds from the grant are expected to be allocated between Pluri and other members of the consortium in accordance with budget and work packages which will be determined by the consortium.

The Phase I/IIa study will be carried out by Charit, Pluri and other members of the international consortium under the leadership of Professor Tobias Winkler, Principal Investigator (PI) at the Berlin Institute of Health Center for Regenerative Therapies, Julius Wolff Institute and Center for Musculoskeletal Surgery. Professor Winkler was also the lead PI in the Phase II and Phase III muscle regeneration studies using Pluris PLX-PAD cells.

Having evaluated PLX-PAD in other advanced-stage clinical studies, we see clear potential for this cell-based product to treat OA, Professor Winkler said. The immunomodulatory properties of PLX-PAD appear well suited to address the significant chronic inflammatory components that underly OA pathophysiology, and we are eager to advance the product candidate into a clinical study for this indication. Financial support from Horizon Europe may accelerate this critical process.

This award underscores the vast potential of our PLX-PAD cells to treat chronic disease with regenerative medicine, said Yaky Yanay, Pluris CEO and President. We are proud to expand our collaboration with Professor Winkler and Charit and receive support from Horizon Europe for our platform technology and cell product candidates, as we advance Pluris clinical pipeline and seek new cell-based solutions to longstanding health challenges.

OA is one of the most common chronic articular diseases, with a global prevalence of 16% in the adult population1. OA is the third most rapidly growing disease associated with disability2, showing an increase of 30% over the past decade, currently affecting more than 500 million people worldwide and about 50 million in Europe3. Globally, symptomatic OA affects ~10% of men and 18% of women over 60 years of age, with knee being most the commonly affected joint4. OA also represents a huge healthcare burden with U.S. indirect costs amounting to 1% of the gross national product5.

There is currently no effective disease-modifying treatment for OA, only symptomatic treatment at a late stage. OA increases the risks of joint inflammation, pain, stiffness, swelling, disability, morbidity and mortality, and it reduces quality of life and work performance. OA might lead to reduced mobility and chronic disability and is associated with cardiovascular and metabolic co-morbidities.

PLX-PAD is an innovative anti-inflammatory allogeneic placental cell therapy product candidate to treat patients with mild to moderate knee OA as a direct approach to reduce inflammation and cartilage degeneration.

________________1 Cui et al., 2020, PMID: 345058462 Hawker et al., 2019, PMID: 316215623 Hunter et al., 2020, PMID:331598514 A. Jaiswal et al., 20215 Kingsbury et al., 2014, PMID: 24489012

About Pluri Inc.Pluri is pushing the boundaries of science and engineering to create cell-based products for commercial use and is pioneering a biotech revolution that promotes global wellbeing and sustainability. The Companys technology platform, a patented and validated state-of-the-art 3D cell expansion system, advances novel cell-based solutions for a range of initiativesfrom medicine and climate change to food scarcity, animal cruelty and beyond. Pluris method is uniquely accurate, scalable, cost-effective, and consistent from batch to batch. Pluri currently operates in the field of regenerative medicine and food-tech and aims to establish partnerships that leverage the Companys 3D cell-based technology to additional industries that require effective, mass cell production. To learn more, visit us at http://www.pluri-biotech.com or follow us on LinkedIn and Twitter.

About Osteoarthritis and the ConsortiumOA is the most common form of arthritis worldwide. Chronic low-grade inflammation in the articular environment causes cartilage degeneration at an early disease stage, resulting in chronic pain, disability and loss of independence due to progressive joint destruction. To date, no disease modifying treatment is available to sustainably combat low-grade inflammation in early-stage OA patients. Biomechanical causes for intra-articular inflammation and OA development have been detected in specific patient groups. The PROTO consortium strives to implement new evidence- and patient-centered treatment strategies for early- and pre-disease stages. For the first time, early-stage knee OA patients will be treated with local PLX-PAD injections, a novel allogeneic cell therapy product with distinct anti-inflammatory capacities that may halt or revert disease progression. Secondly, patients recovering from anterior cruciate ligament reconstructions with pathological gait patterns leading to knee OA, will be treated with a personalized sensor-based digital training intervention. We intend to prevent health to disease transition by restoring physiological movement and reducing joint inflammation. To assess treatment success in early- and pre-stage OA, PROTO gathers scientific and clinical specialists who have genuinely shaped clinical, radiological and biomarker outcome parameters for OA in recent years. This will be the first time that these renowned experts join forces to analyze, stratify and compare fundamentally novel disease modifying treatment strategies for OA in one consortium. PROTO was developed with the help of patient organizations, industry partners and research societies. Restoring physiological joint homeostasis at an early disease stage may be the key to understanding health to disease progression in OA. Targeting this window of opportunity may fundamentally change the way OA is treated today and in the future.

Safe Harbor Statement This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluri is using forward-looking statements when it discusses the expected receipt of the grant from the Israel Innovation Authority, the potential for PLX-PAD to be used to treat OA, that the receipt of the grant may accelerate the clinical study of PLX-PAD, that the grant underscores the potential for PLX-PAD cells to treat chronic disease and that it is advancing its clinical pipeline and seeking new cell-based solutions to longstanding health challenges, that targeting the current window of opportunity may fundamentally change the way OA is treated today and in the future and the potential of the Companys products and solutions to promote global wellbeing and sustainability. These forward-looking statements and their implications are based on the current expectations of the management of Pluri only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements about Pluri: changes in technology and market requirements; Pluri may encounter delays or obstacles in launching and/or successfully completing its clinical trials, if necessary; its products may not be approved by regulatory agencies, its technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; it may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with its processes; its products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; its patents may not be sufficient; its products may harm recipients or consumers; changes in legislation with an adverse impact; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluri to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluri undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluri reference is made to Pluri's reports filed from time to time with the Securities and Exchange Commission.

Media Contacts

Investors: investor.relations@pluri-biotech.com

Israel Media: Shachar Yental at shacharye@gitam.co.il

U.S. Media: Nathan Miller at nathan@miller-ink.com / Meira Feinman at meira@miller-ink.com

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7.5 Million Granted to Collaborative PROTO Project led by Charit to Study Pluri's PLX-PAD Cells for Osteoarthritis Treatment - GlobeNewswire

Global regenerative medicine market was valued at USD 27.29 Billion in 2020. It is expected to increase at a compound annual rate (CAGR of 11.27%) between 2021 and 2027. Tissue Engineering is the segment expected to see the greatest growth in the Global Regenerative Medicine Market. Biomaterials currently hold the largest market share in global regenerative medicine.

Regenerative medicine has the potential to treat chronic, incurable diseases such as Alzheimers disease, Parkinsons disease, diabetes, and other conditions. The Alliance for Regenerative Medicine estimates that around 1,028 clinical trials in regenerative medicine are currently underway. In 2018, regenerative medicine was funded with a total of USD 13.3 billion in global financing. The forecast period will see a significant increase in investment by market leaders in research and development of regenerative medicines.

Driving Factors

Growing prevalence of chronic diseases, genetic disorders, and cancer

Over the past few decades, the prevalence and incidence of chronic diseases like CVD, cancer and diabetes has increased dramatically around the world. Diabetes and obesity can lead to an increase in the number and complexity of wounds like infections, ulcerations (leg and foot ulcers), as well as surgical wounds. These will need treatment and may result in exorbitant medical costs.

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Restraining Factors

High cost of cell and gene therapies

The cell and gene therapies represent significant medical and scientific advancements for patients with serious and terminal illnesses. These therapies are changing the way diseases are treated and could even be cured. Injectable therapies will enable doctors and other medical professionals to infuse cells/genes through injectable methods, thereby avoiding multiple surgeries and the need for a number of drugs. Although these therapies can be life-saving and more effective than traditional treatments, demand is lower than anticipated. This is due to the high cost of these therapies as well as difficulties in obtaining coverage and reimbursements for them.

Market Key Trends

Recent development

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Regenerative Medicine Market to Garner Bursting Revenues [+USD 27.29 Billion] with Top Growing Companies During 2022-2029 - eTurboNews | eTN

WALTHAM, Mass.--(BUSINESS WIRE)--ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, today announced that it has partnered with the California Institute for Regenerative Medicine (CIRM) to advance the discovery and development of regenerative medicine as part of CIRMs Industry Alliance Program. Through the partnership, ElevateBio will provide access to high quality, well-characterized iPSC lines to academic institutions and biopharmaceutical companies that are awarded CIRM Discovery and Translational Grants. ElevateBio will also offer access to its viral vector technology, process development, analytical development, and Good Manufacturing Practice (GMP) manufacturing capabilities that are part of its integrated ecosystem built to power the cell and gene therapy industry.

This exciting partnership with CIRM reflects the novelty of our iPSC platform and recognition of our next-generation cell lines that address industry challenges and could potentially save time and costs for partners developing iPSC-derived therapeutics, said David Hallal, Chairman and Chief Executive Officer of ElevateBio. We are setting a new standard with iPSCs that can streamline the transition from research to clinical development and commercialization and leveraging our unique ecosystem of enabling technologies and expertise to help strategic partners harness the power of regenerative medicines.

With $5.5 billion in funding from the state of California, CIRM has funded 81 clinical trials and currently supports over 161 active regenerative medicine research projects spanning candidate discovery through phase III clinical trials. As part of CIRMs expansion of its Industry Alliance Program to incorporate Industry Resource Partners, this partnership will provide CIRM Awardees the option to license ElevateBios iPSC lines produced in xeno-free, feeder-free conditions using non-integrating technologies and have the ability to gain access to other enabling technologies, including gene editing, cell and vector engineering, and end-to-end services within ElevateBios integrated ecosystem, which are essential for driving the development of regenerative medicines.

About ElevateBio:

ElevateBio is a technology-driven company built to power the development of transformative cell and gene therapies today and for many decades to come. The company has assembled industry-leading talent, built state-of-the-art facilities, and integrated diverse technology platforms, including gene editing, induced pluripotent stem cells (iPSCs), and protein, vector, and cellular engineering, necessary to drive innovation and commercialization of cellular and genetic medicines. In addition, BaseCamp is a purpose-built facility offering process innovation, process sciences, and current Good Manufacturing Practice (cGMP) manufacturing capabilities. Through BaseCamp and its enabling technologies, ElevateBio is focused on growing its collaborations with industry partners while also developing its own portfolio of cellular and genetic medicines. ElevateBio's team of scientists, drug developers, and company builders are redefining what it means to be a technology company in the world of drug development, blurring the line between technology and healthcare.

ElevateBio is located in Waltham, Mass. For more information, visit us at http://www.elevate.bio, or follow Elevate on LinkedIn, Twitter, or Instagram.

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ElevateBio Partners with the California Institute for Regenerative Medicine to Accelerate the Development of Regenerative Medicines - Business Wire

Global cell therapy market value wasUSD 10.23 billionin 2021.This will continue to grow at a CAGR of13.3%over the 2023-2032 forecast period.

Cell therapy is a technology that replaces damaged or dysfunctional cells with healthy functioning cells. Because stem cells can differentiate into the cells needed to repair damaged cells or tissue, they are the cells most often used in advanced therapies. Regenerative medicine is another area where cell therapy can be used. It involves the creation of multidisciplinary medicines that aim to maintain, improve or restore cell, tissue, or organ function. In cell therapy, many cells, including blood, bone marrow cells, mature and immature cells, adult stem, and embryonic cells, are used. Furthermore, transplanted cells, including induced pluripotent stem cells(iPSCs), embryonic and neural stem cells(NSCs), as well as mesenchymal and mesenchymal cells (MSCs), can be divided into two main groups: autologous and non-autologous.

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Cell therapy Market: Drivers

A rise in cell-based research and funding has resulted from the demand for new, better drugs for conditions like cancer and CVD. The Australian government published the Stem Cell Therapies Missionin November 2019. It is a 10-year strategy that will support stem cell research within Australia.The Medical Research Future Fund would fund the project with USD 102million (AU$150million) to support stem cell research and develop new medicines.Innovate UK (UKs innovation agency) was awarded USD 269670 (GBP 267,000) in September 2019 to fund the development of gel stabilization technologies. This was in response to Atelerixs first goal of increasing the shelf life of Rexgenero cell-based therapies that can be stored and transported at room temperature.

Cell therapy Market: Restraints

Despite technological developments and product advancements over the past decade, the industry has been hindered by a shortage of skilled personnel to operate complicated devices like multi-mode readers and flow cytometers. Technology-intensive devices such as spectrophotometers and flow cytometers can produce many data outputs that require skilled analysis and review. According to the National Accrediting Agency for Clinical Laboratory Sciences, there is a worldwide shortage of competent individuals (NAACLS). Over the next decade, Europe and the UK will likely face severe shortages in laboratory capabilities. The UKs medical laboratories will be the most severely affected.

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Cell therapy Market Key Trends:

Market Share is expected to be significant for the Allogeneic Therapies Segment of Cell Therapy

Allogeneic treatments rely on one source of cells to treat many patients. They can cause an immune response in patients and are often combined with immunosuppressive treatments. This is why physicians are increasingly inclined to use allogeneic therapies therapeutically. There is also a growing awareness of the therapeutic potential of cord cells and other tissues in various therapeutic areas. The benefits of allogenic cells are that they produce immune stem cells which kill any remaining cancer cells even after high-dose chemotherapy with cytotoxic drugs. This is called the graft-versuscancer effect. It is used for cancer relapse prevention and treatment. Over the forecast period, the market will be driven by the abovementioned factors.

The segment is expected to grow due to the increasing number of clinical trials needed to obtain regulatory approval for new medications. The segment has many growth opportunities, such as ALLO-501, Allo-501A, and ALLO-715.

Additionally, Allogene Therapeutics Inc. & SpringWorks Therapeutics Inc. have entered into a clinical collaboration agreement to evaluate and treat ALLO-715 in multiple myeloma patients.

This is due to the increasing number of research studies about allogenic therapy for cancer treatment and its associated benefits. The forecast period will see steady growth.

Recent development:

Immunocore was approved by the Food and Drug Administration (KIMMTRAK) in January 2022 to treat metastatic or unresectable uveal melanoma.

Novadip Biosciences was approved by the Food and Drug Administration in March 2021 for regenerative bone product NVD003 to treat rare bone diseases.

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The global cell therapy monitoring kits market is projected to reach a valuation ofUSD 4.29 Bnby 2032 at aCAGRof5.0%, fromUSD 2.63 Bnin 2022.

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The Automated Cell Culture Market is projected to reach a valuation ofUSD 526.22 Mnby 2032 at a CAGR of7.9%, fromUSD228Mnin 2021.

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328.7 Mn by 2030 at a CAGR of 4.8%.

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Global Cell Therapy Market to Reach a Capital Expenditure of USD 10.23 billion in 2021 - eTurboNews | eTN

Aug. 29, 2022 13:00 UTC

Company Continues Accelerated Development of Candidate Pipeline and Patent Portfolio in Respiratory Medicine Space as Phase III Trial Proceeds

ELK CITY, Idaho--(BUSINESS WIRE)-- Therapeutic Solutions International announced today data and filing of a patent covering the use of gene silencing in treatment of Acute Respiratory Distress Syndrome (ARDS), a leading cause of death in emergency rooms.

The Company currently is running a Phase III trial treating COVID-19 induced ARDS but has requested permission from the FDA to expand to ARDS caused by other precipitating factors.

The new data demonstrates feasibility of selectively silencing genes in the lung associated with mortality caused by ARDS, as well as a potent survival advantage in treated versus untreated mice. An approximately 70% reduction in mortality was observed in mice receiving siRNA specifically towards the target genes as compared to mice receiving scrambled siRNA in a TLR4 agonist induced model of ARDS.

The Company plans to continue development of this approach, which is attempted to synergize with the current regenerative medicine programs currently underway.

We are committed to making a significant impact in the lives of patients with ARDS. As part of that commitment, we need to constantly push the limits of medicine and science, said Dr. James Veltmeyer, Chief Medical Officer of the Company. Having previously demonstrated our ability to initiate and run clinical trials, as well as obtain Emergency IND approval, we are confident that we are in the position to accelerate this and other therapeutics in the area of respiratory medicine for which no curative therapeutic approaches exist.

The value of a biotechnology company is in its programs and intellectual property. As our ongoing Phase III continues, our team is brilliantly leveraging this waiting period to continually advance our science. This is what patients and investors count on use to do, said Timothy Dixon, President and CEO of the Company.

About Therapeutic Solutions International, Inc.

Therapeutic Solutions International is focused on immune modulation for the treatment of several specific diseases. The Company's corporate website is http://www.therapeuticsolutionsint.com.

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Therapeutic Solutions International Develops Gene Silencing Therapy for Acute Respiratory Distress Syndrome - BioSpace

An expert explains how we can reprogram cells, why the gut-brain connection is so exciting and what personalized medicine means for womens health.

Maryam Faizs path to neuroscience wasnt exactly a straight one. She considered architecture. She flirted with urban planning. She took a summer off from her PhD to intern at the BBC and spent another summer in Croatia tracking dolphins across the Adriatic. But a fascination with stem cellsand a meeting in Sweden with one of Canadas leading experts in regenerative medicinefinally drew her to the lab. When you see a neuron, its almost like spaceyou dont know exactly what it is, but its just so beautiful, says Faiz, a professor at the University of Torontos Faculty of Medicine. Theres a feeling of unmitigated possibility.

Her research now focuses on a promising class of star-shaped brain cells called astrocytes. Theyre a kind of glial cell, because glia is Greek for glue, and astrocytes were historically thought of as the sticky stuff that held the neurons of the brain together, Faiz says. Whoops: Turns out scientists were selling astrocytes short. They actually play a huge role in the brains circuitry, regulating blood flow and controlling how information travels across the brain. Not only thatas Faiz and her team are learning, astrocytes may also be harnessed for brain repair, offering the future possibility of custom-made therapeutics for people suffering from neurological injuries and diseases. Astrocytes are quite hot at the moment, in terms of things to study in neuroscience, she says with a laugh.

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Lots. Broadly speaking, the brain is not a regenerative organ, like the skin or even the liver. You dont generally regenerate neuronstheyre kind of fixed. So you can have changes in the way the brain develops, and that can lead to neurodevelopmental disorders. You can have an injury, like a stroke, and lose neuronal cells. And then there are neurodegenerative diseases, like Alzheimers and Parkinsons disease, where your neurons become under attack and start to die off.

I can give you a personal example. My younger sister had a traumatic brain injury, and she lost neurons in a region of the brain thats important for verbal communication. It was a small injury, and she was able to recoverbecause even though you lose neurons, the neurons around them can reconnect, which we broadly refer to as neuroplasticity. But my sister still has problems with speaking. The word school is problematic for her, because she cant connect the sounds to the letters, so shell say shul.

The human brain is so interesting because it has this innate ability to rewire, kind of like an electrical circuit. But even small changes in neuronal loss can lead to pretty big impairments in function. And so depending on the region of the brain, you can have different types of impairments, whether that be vision or motor or cognition.

My lab studies astrocytes, which are really important for proper brain function: They fine-tune neuronal information, so they can make that information transmit further, or they can dampen it down. But after injury or disease, some types of astrocytes can become pathological and even start to kill neurons. One example was work out of Harvard on progressive multiple sclerosisand this was preclinical, in mice, not in humans. It showed that if you just removed astrocytes in this end stage, you got improved function.

What we want to do in my lab is create new cells. Basically, you can take any mature cell and hit it with a bunch of genes that are important for its conversion to a new cell type. And so we started by reprogramming astrocytes into neurons. Again, this is preclinicalnothing to do with humansbut in mice after stroke, reprogramming improved mobility and gait to the level of an uninjured animal.

I think the only way that reprogramming will work is if were able to generate really specific therapeutics. And thats where its important to understand the role that different astrocytes play in different types of diseases at different points in that disease. Imagine a scenario where weve identified Astrocyte Type A15, which happens at a certain time post-stroke and is really deleterious. We could go in, target it, change it into another type of cell and leave all the other cells that are important for recovery.

Over the last couple of yearsthis is so excitingtheres been a clear link between the gut and the brain. We know that the bacteria that colonize your gut are really important in brain development, and also really important for neurodegenerative diseases and even injury. So after a stroke, for example, the bacteria in your gut gets altered. And we think this bacteria feeds back onto the brain and can affect the neuroimmune response. We have some really nice dataagain, preclinicalthat shows that just by using probiotics after stroke, it actually improves motor function. Its wild. So one of the cool things weve started looking at is how different types of bacteria in the gut change the astrocyte response in the brain. We think that could be important for developing really novel therapeutics for brain treatment that you could administer in the gut.

Thats what our lab is all about. I think were in an era of personalized medicine. Especially in a system like the brain, which is so precise, you need to think about bespoke therapeutics. Youre not going to want to take out all astrocytes, which are so important, and youre not going to want to put back all types of neurons. This allows us to be really specific.

I mean, were humans, right? Theres so much variation that there can never be a one-size-fits-all response. I think a lot of clinical trials and drugs have failed in that respect. Even if you just think about womens health, 50 percent of our population was almost never tested. And so many of the drugs that have traditionally worked in men dont work in women. Even if we could just conquer that, I think it would be amazing. But with personalized medicine, you start to make discoveries that are going to work no matter where youre from, or what your background is, or your genetics or your sex or your age. Thats where the next 10 to 15 years are going to be really exciting.

Science tends to be quite incremental. But I do think, within 10 to 15 years, we could actually make a big difference with cellular reprogramming. And that helps us keep focused and on track to do the next experiment thats going to take us to the next step thats going to make the biggest difference in peoples lives.

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How Astrocytes May Be Able to Help With Brain Repair - Best Health Magazine

MILPITAS, Calif.--(BUSINESS WIRE)--Applied StemCell, Inc. (ASC), a leading cell and gene therapy CRO/CDMO focused on supporting the research community and biotechnology industry for their needs in developing and manufacturing cell and gene products, today announced the expansion of its Current Good Manufacturing (cGMP) facility. ASC has successfully carried out cell banking and product manufacturing projects in its current cGMP suite and is now set on building 4 additional cGMP cleanrooms, cryo-storage space, and a process development and QC/QA space. The expansion of the facility will increase its cell banking and cell product manufacturing capacity and allow ASCs team of experts to work simultaneously on multiple manufacturing projects such as iPSC generation, gene editing, differentiation, and cell bank manufacturing for safe and efficacious therapeutic products.

We are very excited to move forward with the expansion of our cGMP facility, said Dr. David Lee, Ph.D., Head of GMP and Quality. Our team has been working closely with our clients to ensure delivery of high-quality clinical grade products. We thank our customers for their support and trust. With the addition of 4 cGMP cleanrooms, we will be able to assist a greater number of researchers focused on cell and gene therapy.

President and CEO, Dr. Ruby Yanru Chen-Tsai, Ph.D. stated, We are committed to becoming a CDMO leader to support regenerative medicine and cell/gene therapy development and manufacturing. We aim to expand our bio-manufacturing capacity to meet the fast-growing demand in the cell and gene therapy industry. Our unique platform of GMP-grade allogeneic iPSC and TARGATTTM gene editing technology provides our partners great advantages, including shorter manufacturing timelines, non-viral gene editing, and genomic stability and safety.

Construction will begin within the next month, and the company has already begun the staff hiring process. ASC hopes to have the expansion completed and a team built that will be ready to take on as much as 4 times more new projects early next year.

About Applied StemCell, Inc.

ASC has a Drug Manufacturing License from the California Department of Public Health, Food and Drug Branch (FDB). It has a Quality Management System (ISO 13485 certified) and established cGMP-compliant protocols for cell banking and manufacturing, iPSC generation, genome editing, iPSC differentiation, and cell product manufacturing. With over 13 years of gene-editing and stem cell expertise, ASC offers comprehensive and customized cell and gene CRO/CDMO solutions. Its core iPSC and genome editing (CRISPR and TARGATTTM) technologies, facilitate site-specific, large cargo (up to 20kb) transgene integration and the development of allogenic cell products.

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Applied StemCell Announces the Expansion of its cGMP Manufacturing Facility to Support Cell and Gene Therapy - Business Wire