Toronto centre solving cell manufacturing challenges to benefit patients and global industry CCRM and Cytiva, formerly part of GE Healthcare Life…

TORONTO and MARLBOROUGH, Mass., June 02, 2020 (GLOBE NEWSWIRE) -- With Health Canada and the Food and Drug Administration beginning to approve and reimburse cell and gene therapies in significant numbers, the demand for cell and viral vector manufacturing will continue to grow. Consequently, the industrialization challenges associated with the variability of cell and gene therapies, and with manufacturing them on a commercial scale, must be overcome. CCRM and Cytiva, formerly part of GE Healthcare Life Sciences, have renewed their Collaboration Agreement for continued operation of the Centre for Advanced Therapeutic Cell Technologies (CATCT), which was created to accelerate the development and adoption of cell manufacturing technologies for novel regenerative medicine-based therapies.

Together, CCRM and Cytiva have established a commercialization hub where great minds, state-of-the-art equipment and a spirit of innovation meet, says Michael May, President and CEO of CCRM. Continuing to partner in the operation of CATCT will enable us to move the cell and gene therapy industry closer to fulfilling its promise of creating cures, and enabling treatments to get to patients.

By creating an innovative platform and approach to tackle the issues facing commercialization of living therapies, we are supporting the viability of the regenerative medicine industry, says Catarina Flyborg, Vice President, Cell & Gene Therapy, Cytiva. In CATCT, we are creating the technologies, processes and equipment that will enable our customers, and the broader industry, to achieve its goals and help patients.

Established in 2016, CATCT is a partnership between CCRM and Cytiva, with initial funding from the Federal Economic Development Agency for Southern Ontario (FedDev Ontario). Its staff of 40 works in a 10,000 ft (~930 m) process development facility, located in the MaRS Discovery District, next to Torontos world-leading hospitals and the University of Toronto.

The global regenerative medicine market was valued at US$23.8 billion (2018), and it is anticipated to grow to US$151 billion by 2026 with an annual growth rate of 26.1 per cent.i Operating CATCT allows CCRM and Cytiva to address the manufacturing bottlenecks that would otherwise have the potential to impede the industrys growth.

CATCTs key areas of expertise are:

The work conducted in CATCT can be categorized as follows: the first is fee-for-service development projects that advance customers therapeutic technologies towards industrialization; second, the teams New Product Introductions (NPIs) efforts provide core biological expertise in Cytivas product development process; finally, internal technology development builds additional capabilities and innovative solutions for cell and gene therapies.

A recent success stemming from the work being done in CATCT is the involvement of CCRM and Cytiva in a consortium led by iVexSol Canada, with conditional funding from Next Generation Manufacturing Canada (NGen), to build an advanced manufacturing platform for lentiviral vectors. As core partners in this consortium, which was announced in August 2019, CCRM will provide supporting manufacturing infrastructure and downstream processing capabilities, and Cytiva will share expertise of manufacturing processes, and access to and use of specialized tools and technology.

The new collaboration agreement between CCRM and Cytiva has a three-year term and it became effective on October 15, 2019. The funding will be a combination of in-kind contributions, milestone payments, reinvested fee-for-service revenue and any successful grant opportunities. FedDevs funding of CATCT was for a three-year term and ended in December 2018.

About CCRM CCRM, a Canadian not-for-profit organization funded by the Government of Canada, the Province of Ontario, and leading academic and industry partners, supports the development of regenerative medicines and associated enabling technologies, with a specific focus on cell and gene therapy. A network of researchers, leading companies, strategic investors and entrepreneurs, CCRM accelerates the translation of scientific discovery into new companies and marketable products for patients, with specialized teams, funding, and infrastructure. CCRM is the commercialization partner of the Ontario Institute for Regenerative Medicine and the University of Torontos Medicine by Design. CCRM is hosted by the University of Toronto. Visit us at ccrm.ca.

About CytivaCytiva is a 3.3 billion USD global life sciences leader with nearly 7,000 associates operating in 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients. Visit http://www.cytiva.com for more.

For more information, please contact:

Stacey JohnsonDirector, Communications and Marketing, CCRM416-946-8869stacey.johnson@ccrm.ca

Colleen ConnollySenior Communications Manager, Cytiva774-245-3893Colleen.Connolly@cytiva.com

ihttps://www.fortunebusinessinsights.com/industry-reports/regenerative-medicine-market-100970

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Toronto centre solving cell manufacturing challenges to benefit patients and global industry CCRM and Cytiva, formerly part of GE Healthcare Life...

Professor Wolf Reik appointed acting director of the Babraham Institute – Cambridge Independent

Professor Wolf Reik has been appointed acting director of the Babraham Institute.

It follows the death of Professor Michael Wakelam, who died from suspected a Covid-19 infection on March 31.

Prof Reik has been the institutes associate director since 2004 and has headed up its epigenetics research programme since 2008.

Prof Peter Rigby, chair of the institutes board of trustees, said: Prof Reik is a world-class scientist, internationally renowned for his work in epigenetics, who has been at the Institute for over 30 years.

The Biotechnology and Biological Sciences Research Council (BBSRC), which funds the institute, approved of the move, he said.

The BBSRC fully support the board's appointment, which will ensure the institute continues to be strongly led, building on the excellent work of Prof Michael Wakelam. I know that Wolf will provide much needed leadership and stability during the uncertain times that we all face, said Prof Rigby.

Prof Reik added: I am really honoured by this appointment; I look forward to working with everyone at the Institute, the campus and with BBSRC.

After Michaels sad death, my primary aim is to bring us back to our labs in a safe and considerate fashion, and to jointly tackle the opportunities and challenges for the science of the Institute going forward strongly into the future.

The study of epigenetics explores the set of instructions that alter how our genome behaves - by regulating gene expression - without changing our underlying DNA code.

Prof Reik explores the role of epigenetics in establishing cell fate and identity during mammalian development and also the process of epigenetic reprogramming.

From the earliest steps in human development, to how stem cells maintain their pluripotency - that is, their ability to change into different cells - Prof Reiks lab is interested in some fundamental questions.

It also explores how the identity of cells is established during the process of differentiation, through which they change into all the different types of cells in our bodies.

Recently, the lab has been studying how the epigenome degrades with age - and whether there are ways of reversing this decay.

New technologies for single cell multi-omics sequencing, which allows unprecedented insights into cell fate changes during development or ageing, have been developed by the lab.

Prof Reik has an interest in collaboration both inside and outside the institute and leads a Wellcome-funded consortium studying cell fate decisions during mouse gastrulation and organ development.

He obtained his MD in 1985 from the University of Hamburg, where he undertook thesis work with Rudolf Jaenisch before completing postdoctoral work with Azim Surani at the Institute of Animal Physiology, which is now the Babraham Institute. During this spell, he became a fellow of the Lister Institute of Preventive Medicine which, in 1987, provided funding for him to start his own independent research group.

He is honorary professor of epigenetics and affiliate faculty at the Stem Cell Institute at the University of Cambridge and associate faculty at the Wellcome Sanger Institute. A member of EMBO and the Academia Europaea, a fellow of the Academy of Medical Sciences and the Royal Society, he has also been a member of funding committees such as UKRI-Medical Research Council, Cancer Research UK and Wellcome Trust.

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Babraham Institute director Professor Michael Wakelam dies after suspected coronavirus infection

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Professor Wolf Reik appointed acting director of the Babraham Institute - Cambridge Independent

30,000-cell Study Maps the Development of Sound Sensing in the Mouse Inner Ear – Technology Networks

A team of researchers has generated a developmental map of a key sound-sensing structure in the mouse inner ear. Scientists at the National Institute on Deafness and Other Communication Disorders (NIDCD), part of the National Institutes of Health, and their collaborators analyzed data from 30,000 cells from mouse cochlea, the snail-shaped structure of the inner ear. The results provide insights into the genetic programs that drive the formation of cells important for detecting sounds. The study also sheds light specifically on the underlying cause of hearing loss linked to Ehlers-Danlos syndrome and Loeys-Dietz syndrome.

The study data is shared on a unique platform open to any researcher, creating an unprecedented resource that could catalyze future research on hearing loss. Led by Matthew W. Kelley, Ph.D., chief of the Section on Developmental Neuroscience at the NIDCD, the study appeared online in Nature Communications(link is external). The research team includes investigators at the University of Maryland School of Medicine, Baltimore; Decibel Therapeutics, Boston; and Kings College London.

Unlike many other types of cells in the body, the sensory cells that enable us to hear do not have the capacity to regenerate when they become damaged or diseased, said NIDCD Director Debara L. Tucci, M.D., who is also an otolaryngology-head and neck surgeon. By clarifying our understanding of how these cells are formed in the developing inner ear, this work is an important asset for scientists working on stem cell-based therapeutics that may treat or reverse some forms of inner ear hearing loss.

In mammals, the primary transducers of sound are hair cells, which are spread across a thin ribbon of tissue (the organ of Corti) that runs the length of the coiled cochlea. There are two kinds of hair cells, inner hair cells and outer hair cells, and they are structurally and functionally sustained by several types of supporting cells. During development, a pool of nearly identical progenitor cells gives rise to these different cell types, but the factors that guide the transformation of progenitors into hair cells are not fully understood.

To learn more about how the cochlea forms, Kelleys team took advantage of a method called single-cell RNA sequencing. This powerful technique enables researchers to analyze the gene activity patterns of single cells. Scientists can learn a lot about a cell from its pattern of active genes because genes encode proteins, which define a cells function. Cells gene activity patterns change during development or in response to the environment.

There are only a few thousand hair cells in the cochlea, and they are arrayed close together in a complex mosaic, an arrangement that makes the cells hard to isolate and characterize, said Kelley. Single-cell RNA sequencing has provided us with a valuable tool to track individual cells behaviors as they take their places in the intricate structure of the developing cochlea.

Building on their earlier work on 301 cells, Kelleys team set out to examine the gene activity profiles of 30,000 cells from mouse cochleae collected at four time points, beginning with the 14th day of embryonic development and ending with the seventh postnatal day. Collectively, the data represents a vast catalog of information that researchers can use to explore cochlear development and to study the genes that underlie inherited forms of hearing impairment.

Kelleys team focused on one such gene, Tgfbr1, which has been linked to two conditions associated with hearing loss, Ehlers-Danlos syndrome and Loeys-Dietz syndrome. The data showed that Tgfbr1 is active in outer hair cell precursors as early as the 14th day of embryonic development, suggesting that the gene is important for initiating the formation of these cells.

To explore Tgfbr1s role, the researchers blocked the Tgfbr1 proteins activity in cochleae from 14.5-day-old mouse embryos. When they examined the cochleae five days later, they saw fewer outer hair cells compared to the embryonic mouse cochleae that had not been treated with the Tgfbr1 blocker. This finding suggests that hearing loss in people with Tgfbr1 mutations could stem from impaired outer hair cell formation during development.

The study revealed additional insights into the early stages of cochlear development. The developmental pathways of inner and outer hair cells diverge early on; researchers observed distinct gene activity patterns at the earliest time point in the study, the 14th day of embryonic development. This suggests that the precursors from which these cells derive are not as uniform as previously believed. Additional research on cells collected at earlier stages is needed to characterize the initial steps in the formation of hair cells.

In the future, scientists may be able to use the data to steer stem cells toward the hair cell lineage, helping to produce the specialized cells they need to test cell replacement approaches for reversing some forms of hearing loss. The studys results also represent a valuable resource for research on the hearing mechanism and how it goes awry in congenital forms of hearing loss.

The authors have made their data available through the gEAR portal(link is external) (gene Expression Analysis Resource), a web-based platform for sharing, visualizing, and analyzing large multiomic datasets. The portal is maintained by Ronna Hertzano, M.D., Ph.D., and her team in the Department of Otorhinolaryngology and the Institute for Genome Sciences (IGS)(link is external) at the University of Maryland School of Medicine.

Single-cell RNA sequencing data are highly complex and typically require significant skill to access, said Hertzano. By disseminating this study data via the gEAR, we are creating an encyclopedia of the genes expressed in the developing inner ear, transforming the knowledge base of our field and making this robust information open and understandable to biologists and other researchers.

This news release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process; each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge gained through basic research.

Reference: Kolla, L., Kelly, M. C., Mann, Z. F., Anaya-Rocha, A., Ellis, K., Lemons, A., Palermo, A. T., So, K. S., Mays, J. C., Orvis, J., Burns, J. C., Hertzano, R., Driver, E. C., & Kelley, M. W. (2020). Characterization of the development of the mouse cochlear epithelium at the single cell level. Nature Communications, 11(1), 116. https://doi.org/10.1038/s41467-020-16113-y

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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30,000-cell Study Maps the Development of Sound Sensing in the Mouse Inner Ear - Technology Networks

Stem Cell Therapy Market Analysis and Demand 2017 2025 – Cole of Duty

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Genetic features pave way for targeted BPDCN therapies – Dermatology Times

Researchers are learning more about genetic aberrations common in the rare but clinically aggressive hematological cancer blastic plasmacytoid dendritic cell neoplasm. There is one targeted therapy approved by the U.S. Food and Drug Administration: Elzonris (tagraxofusp-erzs, Stemline). However, more treatment options are needed to improve the cancers clinical outcome, according to a review published May 2020 in Critical Reviews Oncology/Hematology.1

Dermatologists might be the first providers to encounter patients with blastic plasmacytoid dendritic cell neoplasm because more than 70% of these patients have cutaneous lesions. Those lesions often are asymptomatic and vary in size. The skin lesions tend to have nodules, plaques or bruise-like areas, a brown to violet color and might be solitary or multifocal, according to the authors.

Blastic plasmacytoid dendritic cell neoplasm often originates from type 2 myeloid-derived resting plasmacytoid dendritic cell precursors. Recent research suggests providers can diagnose the cancer when patients express at least four of five plasmacytoid dendritic cell specific markers, CD4, CD56, CD123, TCL1 and BDCA-2, without expressing myeloid, T-cell or B-cell lineage markers.

Commonly, [blastic plasmacytoid dendritic cell neoplasm] is characterized by high CD123 expression, aberrant NF-B [nuclear factor-B] activation, dependence on TCF4-/BRD4-network, and deregulated cholesterol metabolism, they wrote.

Despite advancing knowledge about the cancer type, patients median overall survival remains at 12 to 14 months, according to the paper. Conventional treatment approaches include chemotherapy, radiotherapy and ultimately hematopoietic stem cell transplantation. The challenges with conventional therapies are while blastic plasmacytoid dendritic cell neoplasm is sensitive to some chemotherapy regimens, patient relapse is high at more than 60%. And many patients with blastic plasmacytoid dendritic cell neoplasm are too old or frail to have intensive chemotherapy or hematopoietic stem cell transplantation, according to the authors.

Recently, the most attractive agent for [blastic plasmacytoid dendritic cell neoplasm] is tagraxofusp, which is composed of the catalytic and translocation domains of diphtheria toxin (DT) fused to interleukin-3 (IL-3), the authors wrote.

Blastic plasmacytoid dendritic cell neoplasm cells overexpress interleukin-3 receptor subunit alpha (IL3RA, also called CD123). Elzonris, or tagraxofusp-erzs, is a CD123-directed cytotoxin given intravenously, which is used to treat blastic plasmacytoid dendritic cell neoplasm in adults and in pediatric patients 2 years and older.

Researchers reported in a study of 47 blastic plasmacytoid dendritic cell neoplasm patients published in 2019 in the New England Journal of Medicine that tagraxofusp led to clinical responses in untreated and relapsed patients.2 The overall response rate with tagraxofusp was 90% and the primary outcome of complete response and clinical complete response was 72% among the previously untreated patients. Overall response was 67% in the previously treated patients. Serious adverse events including capillary leak syndrome, hepatic dysfunction and thrombocytopenia were common, according to the NEJM paper.

More targeted therapies are needed to treat blastic plasmacytoid dendritic cell neoplasm, but many potential therapeutic agents are not advancing to clinical trials, according to authors of the paper in Critical Reviews Oncology/Hematology.

Common blastic plasmacytoid dendritic cell neoplasm characteristics are genetically heterogeneous and provide valuable drug targets, according to the authors.

Apart from aberrant activation of NF-B signaling pathway, which is highly dependent on TCF4- and BRD4- transcriptional networks, cholesterol metabolism deregulation and CD123 expression, defects of DNA damage repair and mitosis are new, potential common features of the cancer. Corresponding therapies might be promising, the authors wrote.

Venetoclax, anti-CD123 CAR-T, XmAb14045 and IMGN632 are in clinical trials for blastic plasmacytoid dendritic cell neoplasm. But the authors noted that bortezomib, lenalidomide, 5-aza and pralatrexate could easily be pushed to the front line of the cancers treatment.

Disclosures:

The authors report no relevant disclosures.

References:

1. Zhang X, Sun J, Yang M, Wang L, Jin J. New perspectives in genetics and targeted therapy for blastic plasmacytoid dendritic cell neoplasm. Crit Rev Oncol Hematol. 2020 May;149:102928.2. Pemmaraju N, Lane AA, Sweet KL, et al. Tagraxofusp in Blastic Plasmacytoid Dendritic-Cell Neoplasm. N Engl J Med. 2019;380(17):1628-1637.

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Genetic features pave way for targeted BPDCN therapies - Dermatology Times

COVID-19 Impact on Stromal Vascular Fraction Market Marked US$ 76 Mn in forecast Years 2019 to 2029 – Cole of Duty

With the outbreak of COVID-19 in worldwide and stipulated lockdown, the healthcare sector is witnessing an unprecedented slowdown as per EY-FICCI study titled, COVID-19 impact assessment for healthcare sector and key financial measures recommendations for the sector. The study is predicated on an assessment of healthcare players within the country to assess the economic impact of the COVID-19 pandemic and provides recommendations on the fiscal stimulus measures it needs within the coming months.

Stromal vascular fraction is gaining significant importance in various fields, including internal medicine, orthopaedics, plastic and general surgery,and wound healing.

Ease of harvest, abundant availability, and stable phenotype are some factors increasing the demand for stromal vascular fraction. Also, stromal vascular fraction secretes several soluble factors with anti-inflammatory, immunomodulatory, and analgesic effects, which leads to an alternative treatment option for various diseases, significantly benefitting the growth of thestromal vascular fraction marketduring the forecast period.

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Delivery of stromal vascular fraction by intra-articular injection has advantages over surgical implantation, such as less invasiveness, better patient compliance, and lower cost.

The global stromal vascular fraction market was valued atUS$ 76 Mnin 2018, and is expected to witness a CAGR of around4%over the forecast period (2019-2029).

Key Takeaways of Stromal Vascular Fraction Market Study

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Stromal vascular fraction has emerged as an efficient alternative in the field of regenerative medication. However, better-structured and significant clinical investigations need to be carried out to demonstrate and define the therapeutic potential of stromal vascular fraction,says a PMR analyst.

Stromal Vascular Fraction Manufacturers Focusing on Innovative Methods to Optimize Tissue Recovery

Consistent up-gradation and innovation in methods to recover adipose tissue-derived mesenchymal stem cells (ATD-MSCs) for autologous use in regenerative medication applications are expected to offer significant opportunities for the stromal vascular fraction market.

For instance, LipoCell from Tissyou, is furnished with a semipermeable film that separates fat tissues from squander components with the assistance of continuous irrigation. The dialysis of the tissue limits the pressure and trauma to the cell and extracellular matrix, evacuating the blood and oil deposits, which are pro-inflammatory.

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More Valuable Insights on Stromal vascular fraction Market

Persistence Market Research brings a comprehensive research report on the forecasted revenue growth at global, regional, and country levels, and provides an analysis of the latest industry trends in each of the segments from 2014 to 2029.

The global stromal vascular fraction market is segmented in detail to cover every aspect of the market and present a complete market intelligence approach to the reader.

The study provide compelling insights on the stromal vascular fraction market on basis of product (SVF isolation products, SVF aspirate purification products, and SVF transfer products), application (cosmetic applications, orthopedic applications, soft tissue applications, and others), and end user (hospitals, ambulatory surgical centers, stem cell laboratories, and others), across six major regions.

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COVID-19 Impact on Stromal Vascular Fraction Market Marked US$ 76 Mn in forecast Years 2019 to 2029 - Cole of Duty