Regenerative medicine encompasses innovative therapies that allow the body to repair or regenerate aging cells, tissues, and organs. The skin is a particularly attractive organ for the application of novel regenerative therapies due to its easy accessibility. Among these therapies, stem cells and platelet-rich plasma (PRP) have garnered interest based on their therapeutic potential in scar reduction, antiaging effects, and treatment of alopecia.

Stem cells possess the cardinal features of self-renewal and plasticity. Self-renewal refers to symmetric cell division generating daughter cells identical to the parent cell.1 Plasticity is the ability to generate cell types other than the germ line or tissue lineage from which stem cells derive.2 Stem cells can be categorized according to their differentiation potential. Totipotent stem cells may develop into any primary germ cell layer (ectoderm, mesoderm, endoderm) of the embryo, as well as extraembryonic tissue such as the trophoblast, which gives rise to the placenta. Pluripotent stem cells such as embryonic stem cells have the capacity to differentiate into any derivative of the 3 germ cell layers but have lost their ability to differentiate into the trophoblast.3 Adults lack totipotent or pluripotent cells; they have multipotent or unipotent cells. Multipotent stem cells are able to differentiate into multiple cell types from similar lineages; mesenchymal stem cells (MSCs), for example, can differentiate into adipogenic, osteogenic, chondrogenic, and myogenic cells.4 Unipotent stem cells have the lowest differentiation potential and can only self-regenerate. Herein, we review stem cell sources and their therapeutic potential in aesthetic dermatology.

Multipotent stem cells derived from the bone marrow, umbilical cord, adipose tissue, dermis, or hair follicle bulge have various clinical applications in dermatology. Stem cells from these sources are primarily utilized in an autologous manner in which they are processed outside the body and reintroduced into the donor. Autologous multipotent hematopoietic bone marrow cells were first successfully used for the treatment of chronic wounds and show promise for the treatment of atrophic scars.5,6 However, due to the invasive nature of extracting bone marrow stem cells and their declining number with age, other sources of multipotent stem cells have fallen into favor.

Umbilical cord blood is a source of multipotent hematopoietic stem cells for which surgical intervention is not necessary because they are retrieved after umbilical cord clamping.7 Advantages of sourcing stem cells from umbilical cord blood includes high regenerative power compared to a newborns skin and low immunogenicity given that the newborn is immunologically immature.8

Another popular source for autologous stem cells is adipose tissue due to its ease of accessibility and relative abundance. Given that adipose tissuederived stem cells (ASCs) are capable of differentiating into adipocytes that help maintain volume over time, they are being used for midface contouring, lip augmentation, facial rejuvenation, facial scarring, lipodystrophy, penile girth enhancement, and vaginal augmentation. Adipose tissuederived stem cells also are capable of differentiating into other types of tissue, including cartilage and bone. Thus, they have been successfully harnessed in the treatment of patients affected by systemic sclerosis and Parry-Romberg syndrome as well in the functional and aesthetic reconstruction of various military combatrelated deformities.9,10

Adipose tissuederived stem cells are commonly harvested from lipoaspirate of the abdomen and are combined with supportive mechanical scaffolds such as hydrogels. Lipoaspirate itself can serve as a scaffold for ASCs. Accordingly, ASCs also are being utilized as a scaffold for autologous fat transfer procedures in an effort to increase the viability of transplanted donor tissue, a process known as cell-assisted lipotransfer (CAL). In CAL, a fraction of the aspirated fat is processed for isolation of ASCs, which are then recombined with the remainder of the aspirated fat prior to grafting.11 However, there is conflicting evidence as to whether CAL leads to improved graft success relative to conventional autologous fat transfer.12,13

The skin also serves as an easily accessible and abundant autologous source of stem cells. A subtype of dermal fibroblasts has been proven to have multipotent potential.14,15 These dermal fibroblasts are harvested from one area of the skin using punch biopsy and are processed and reinjected into another desired area of the skin.16 Autologous human fibroblasts have proven to be effective for the treatment of wrinkles, rhytides, and acne scars.17 In June 2011, the US Food and Drug Administration approved azficel-T, an autologous cellular product created by harvesting fibroblasts from a patients own postauricular skin, culture-expanding them in vitro for 3 months, and reinjecting the cells into the desired area of dermis in a series of treatments. This product was the first personalized cell therapy approved by the US Food and Drug Administration for aesthetic uses, specifically for the improvement of nasolabial fold wrinkles.18

In adults, hair follicles contain an area known as the bulge, which is a site rich in epithelial and melanocytic stem cells. Bulge stem cells have the ability to reproduce the interfollicular epidermis, hair follicle structures, and sebaceous glands, and they have been used to construct entirely new hair follicles in an artificial in vivo system.19 Sugiyama-Nakagiri et al20 demonstrated that an entire hair follicle epithelium and interfollicular epidermis can be regenerated using cultured bulge stem cells. The cultured bulge stem cells were mixed with dermal papilla cells from neonatal rat vibrissae and engrafted into a silicone chamber implanted on the backs of severe combined immune deficient (SCID) mice. The grafts exhibited tufts of hair as well as a complete interfollicular epidermis at 4 weeks after transplantation.20 Thus, these bulge stem cells have the potential to treat male androgenic alopecia and female pattern hair loss. Bulge stem cells also have been shown to accelerate wound healing.21 Additionally, autologous melanocytic stem cells located at the hair follicle bulge are effective for treating vitiligo and are being investigated for the treatment of hair graying.22

Read more:
Regenerative Medicine in Cosmetic Dermatology | MDedge ...

G-CON Awarded Korea Bioprocessing Award for Innovative Bioprocessing Technology

COLLEGE STATION, Texas (PRWEB) October 29, 2020

IMAPAC, the organizer of Biologics Manufacturing Korea, recently awarded G-CON Manufacturing with the 2020 Korea Bioprocessing Excellence Award in Innovative Bioprocessing Technology. The award honors outstanding experts, institutions, and technologies in the field of bioprocessing and cell/gene therapy. G-CON is honored to be in the company of the many distinguished organizations and individuals who have been considered for this award in the past.

G-CON received the award for its BERcellFLEX prefabricated modular cleanroom infrastructure for the manufacturing of autologous cell therapies. BERcellFLEX is part of the iCON product line developed by G-CON and IPS-Integrated Project Services, LLC and represents a line of gene/cell therapy products that operating companies can buy today, ready- to-order with little to no engineering time.

Its with great pride and gratitude, that G-CON has accepted this award on behalf of the entire iCON team said Dennis Powers, Vice President of Business Development and Sales Engineering for G-CON Manufacturing. Being recognized for our innovative platform approach to facility design and construction further reinforces the growing need in our industry that IPS and G-CON recognized three years ago when we launched iCON."

Available in both 12-foot and 24-foot wide POD configurations, the BERcellFLEX processing suites enable faster and more predictable project schedules for new facility construction and a standardized solution to meet speed to market requirements filling all major needs in the cell therapy arena. Multiple units can be installed to scale up/out from phase 1 clinical production to commercial manufacturing.

About G-CON ManufacturingG-CON Manufacturing designs, builds, and installs prefabricated G-CON POD cleanrooms. G-CONs POD portfolio provides cleanrooms in a number of dimensions for a variety of uses, from laboratory environments to personalized medicine and production process platforms. G-CON POD cleanroom units surpass traditional cleanroom structures in scalability, mobility and the possibility of repurposing the PODs once the production process reaches its lifecycle end. For more information, please visit G-CONs website at https://www.gconbio.com.

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G-CON Manufacturing Honored with the Korea Bioprocessing Excellence Award - PR Web

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

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

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

Segmentation by Product Type

Segmentation by End User

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

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

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

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The Stem Cell-Derived Cells market to be in conjunction to growth from 2020 to 2030 - PRnews Leader

This article was reviewed by Russell N. Van Gelder, MD, PhD

Neuronal cell replacement therapies remain a challenge in retinal diseases. Some fish and salamanders have the innate ability to regenerate retinal tissue after injuries and, as Russell N. Van Gelder, MD, PhD, pointed out, if researchers could harness this ability in humans, the possibilities would be great for repairing or replacing damaged tissue in a wide variety of retinal diseases. Stem cells are the key to cell replacement therapies.

Stem cells are cells that have not terminally differentiated and still have the potential to become many types of terminal cells, said Van Gelder, from the Department of Ophthalmology at the University of Washington in Seattle. We all started as embryonic stem cells in the earliest phases of development.

Related: Retinal pathologies challenging to image with current technologies

Van Gelder went on to explain that there are now methods to create equivalently totipotent stem cells from individual induced progenitor stem cells derived from an individuals blood or epithelial cells.

The overarching goal is to create a cell type that needs replacement from a stem cell precursor, he said.

A major achievement in this quest for regenerative ability occurred in 2014 when an entire eye cup was grown from progenitor stem cells.

Van Gelder also described a study1 in which green fluorescent proteinlabeled retinal precursors derived from embryonic stem cells were transplanted into the subretinal space of macaques. Three months after the procedure, the researchers demonstrated that the bolus of cells persisted and had outgrowth of axons that were seen going to the optic nerve and on to the brain.

This result establishes the validity of a stem cell-based approach for doing regenerative medicine in primates, he said.

Related: Persistent retinal detachment associated with retinoblastoma

Replacement therapy hurdlesAs of now, however, no stem cell-based replacement treatment has received FDA approval. The problems preventing establishment of a treatment have been technical in nature and include correct cellular differentiation as well as generating adequate numbers of cells for large transplantation experiments, establishing correct cell polarity and connectivity, and ensuring the safety of these approaches regarding tumor or hamartoma formation, Van Gelder explained.

Managing inflammatory responses is a problem after cell transplantation. He cited a Japanese study2 of individual progenitor cell-derived retinal progenitor cells transplanted subretinally in monkey models.

Even with an immune HLA-matched donor, there was still a marked inflammatory response at the site of the transplantation, Van Gelder said. This and other inflammatory responses will have to be managed for cell transplantation to be successful.Related: Intravitreally injected hRPCs improve vision in retinitis pigmentosa cases

There are regulatory hurdles to clear. The FDA Center for Biologics Evaluation and Research regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy.

Van Gelder recalled the well-publicized case of transplantation of fat-derived mesenchymal cells into patients eyes, resulting in loss of vision bilaterally. He pointed out that it is important to temper patient expectations regarding these therapies and to ensure that the work is being done with the highest degree of ethical integrity.

While great progress has been made in this field, significant barriers remain to the successful adoption in the clinical setting in the coming years, Van Gelder concluded. The barriers to cell replacement should be overcome.

Read more by Lynda Charters

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Russell N. Van Gelder, MD, PhDe: russvg@uw.edu Van Gelder has no financial interests in this subject matter. He serves on the advisory committee for the National Eye Institute Audacious Goals Initiative.

--

References

1. Chao JR, Lamba DA, Kiesert TR, et al. Transl Vis Sci Technol. 2017;6:4; doi:10.1167/tvst/6/3/4

2. Fujii S, Sugita S, Futatsugi Y, et al. A strategy for personalized treatment of iPS-retinal immune rejections assessed in cynomolgus monkey models. Int J Mol Sci. 2020;21(9):3077. doi:10.3390/ijms21093077

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Harnessing regeneration of retinal tissues: An option almost within reach - Ophthalmology Times

By Michael Brown, CP Op-Ed Contributor | Thursday, October 15, 2020

Have you heard the latest? Trump cannot be pro-life since he used and is promoting the anti-COVID drug Regeneron, which was allegedly developed with the help of fetal tissue. And pro-life organizations are being hypocritical by refusing to condemn the drug. Is there any truth to these charges?

As reported by the UK Metro, Trump faces hypocrisy allegations after it was revealed Regeneron is made from stem cells originally taken from an embryonic kidney. That kidney was taken during an elective abortion performed in the Netherlands during the 1970s.

More bluntly, the MIT Technology Review claimed, Trumps antibody treatment was tested using cells originally derived from an abortion.

The Trump administration has looked to curtail research with fetal cells. But when it was life or death for the president, no one objected.

As for pro-life organizations, a lengthy headline on Business Insider stated, Antiabortion groups say they stand behind Trump's use of a drug tested on cells derived from an aborted fetus because the president was not involved with that abortion.

How should pro-life Trump voters respond to these concerns?

Lets say that Regeneron was actually developed with the help of fetal tissue. Does anyone actually think that doctors came to Trump and said, Mr. President, we have an experimental drug that was tested and developed using tissue from an aborted baby from the 1970s. How do you feel about using this?

Only the most hardened anti-Trumper could imagine such a scenario. In the world of reality, the very thought of it is absurd. And, even if the fetal tissue charges are true, who knew about this? Was this something that any of the doctors would have been aware of? I very seriously doubt it, especially when, as we shall see, Regeneron itself denies the charge.

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It is therefore completely ridiculous to claim that Trump is being hypocritical in using Regeneron, as if he knew the alleged history of the drug.

But that leads us back to the big question: Did Regeneron use fetal tissue from a baby aborted in the 1970s?

Another headline on Business Insider stated, One of Trump's COVID-19 treatments was developed using tissue that originally came from an abortion. He's tried to ban this kind of research.

This is being widely reported as established fact. But is it true?

In an official statement for the pro-life Charlotte Lozier Institute, David Prentice, Ph.D. and Tara Sander Lee, Ph.D., wrote:

The Regeneron therapy given to the president was made in Velocimmune humanized mice, a novel platform that uses genetically modifiedmouse embryonic stem (ES)cells to generate antibodies describedhereandhere.Development of Regenerons antibody cocktail is detailed in the journalScience, describing how they identified their antibodies made from Velocimmune miceandblood from recovered patientspreviously infected with SARS-CoV-2.The final antibody pair used in theREGN-COV2 therapycocktail was then produced inChinese hamster ovary (CHO) cells.Results from Regenerons REGN-COV2 clinical trials to treat COVID-19 patients are reportedhere.

Mouseembryonic stem cells and genetic modifications to make such mice date back to 1981, have been extensively studied, and were instrumental in the discovery of induced pluripotent stem (iPS) cells, another fully ethical alternative to fetal material, as discussed in thisNaturereview.iPSCs are much easier to use thanhuman embryonic stem cells,more flexible in their uses, and are not ethically controversial. No one has ever advocated against using mouse embryonic stem cells for development of therapies only against destruction of human lives.

In a statement made to The Christian Post, Alexandra Bowie, a spokesperson for Regeneron, explained, We did not use human stem cells or human embryonic stem cells in the development of REGN-COV2. We did use the HEK293T cell line to test our antibodies ability to neutralize the SARS-CoV-2 virus (they were used to make pseudovirus that looks like the Spike protein).

HEK293s are considered immortalized cells and are a common and widespread tool in research labs. The cell line was originally derived by adenovirus transformation of human embryonic kidney cells in 1977.

After this, it was further transformed at Stanford in the 80s with SV40 T-antigen (hence the T). HEK293T wasnt used in any other way and fetal tissue was not used in this research.

Im not a medical doctor or a scientist, but it seems clear from these descriptions (and from what I could glean from Regenerons technical article published in the journal Science, also cited above) that there is hardly a direct connection between the drug and an aborted baby.

Still, there is so much misinformation going viral online that Dr. Tara Lee started a Twitter account just to rebut the misconceptions. (Lees Twitter bio identifies her as Researcher, Clinical Scientist, Science Policy Advisor. PhD. Senior Fellow & Director of Life Sciences @lozierinstitute. For LIFE in this world and the next.)

She summarized the evidence in simple and clear terms: NO human embryonic stem cells or human fetal tissue were used to produce the treatments President Trump received period.

So, Regeneron denies that it used embryonic cells and other scientists deny it. This completely undermines the charge that pro-life groups are being hypocritical for not condemning the use of the drug (and the presidents promotion of it).

That being said, some pro-life groups have, in fact, opined that, even if testing for the drug could be traced back to an abortion in the 1970s, Trump had nothing to do with any of this and is therefore not being hypocritical in promoting the drug.

Is there some hypocrisy in this response?

Thats a fair question, and its the type of question that ethicists debate. If you could save the lives of many people using a drug that was developed with the help of aborted fetal cells, is that justifiable?

My answer to those accusing the president with hypocrisy is threefold. First, as stated here, its unlikely in the extreme he had any idea of the alleged abortion connection. Second, scientists from Regeneron deny any connection to human fetal cells, and Trump would presumably take them at their word. Third, if Regeneron had been developed with the help of an aborted baby, there would then be a serious ethical debate as to its use.

Still, with all that being said, it is grasping at straws to question the pro-life commitment of these organizations (along with that of President Trump). Thats because we are comparing the willful killing of more than 60 million babies in the womb, often out of convenience, with the possible, distant connection of a life-saving drug to a baby aborted in the 1970s. Who would seriously make such a comparison?

When it comes to the question of the benefit of embryonic cells in the development of medical cures, Dr. Lee noted that, Fetal tissue from aborted babies is not required for medical advancements. After 100+ years of research, no therapies have been developed that needed aborted fetal tissue to begin with. Newer & better ethical alternatives are available & being used now to make humanized mice.

There is, therefore, no justification for using embryonic fetus cells in medical research, and the Regeneron drug does not contradict this at all.

Of course, as readers here know well, I have no problem identifying President Trumps many, evident shortcomings, some of which can be quite destructive. And I continue to shake my head over some of the things he says.

But to call him a hypocrite or to question his pro-life commitment because he used Regeneron is to reveal ones anti-Trump animus. It indicts the accuser far more than it indicts the accused.

Join over 250,000 others to get the top stories curated daily, plus special offers!

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Dr. Michael Brown(www.askdrbrown.org) is the host of the nationally syndicatedLine of Fireradio program. His latest book isEvangelicals at the Crossroads: Will We Pass the Trump Test?Connect with him onFacebook,Twitter, orYouTube.

Excerpt from:
Regeneron, Trump, and the alleged hypocrisy of the pro-life movement - Christian Post

In this report, the global Stem Cell-Derived Cells market is valued at USD XX million in 2019 and is projected to reach USD XX million by the end of 2025, growing at a CAGR of XX% during the period 2019 to 2025.

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Stem Cell-Derived Cells market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Stem Cell-Derived Cells market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Stem Cell-Derived Cells market to assist our clients arrive at beneficial business decisions.

The Stem Cell-Derived Cells market report firstly introduced the basics: definitions, classifications, applications and market overview; product specifications; manufacturing processes; cost structures, raw materials and so on. Then it analyzed the worlds main region market conditions, including the product price, profit, capacity, production, supply, demand and market growth rate and forecast etc. In the end, the Stem Cell-Derived Cells market report introduced new project SWOT analysis, investment feasibility analysis, and investment return analysis.

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Resourceful insights enclosed in the report:

The major players profiled in this Stem Cell-Derived Cells market report include:

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

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

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

Segmentation by Product Type

Segmentation by End User

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

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

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

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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The market report addresses the following queries related to the Stem Cell-Derived Cells market:

The study objectives of Stem Cell-Derived Cells Market Report are:

To analyze and research the Stem Cell-Derived Cells market status and future forecast in United States, European Union and China, involving sales, value (revenue), growth rate (CAGR), market share, historical and forecast.

To present the Stem Cell-Derived Cells manufacturers, presenting the sales, revenue, market share, and recent development for key players.

To split the breakdown data by regions, type, companies and applications

To analyze the global and key regions Stem Cell-Derived Cells market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends, drivers, influence factors in global and regions

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the Stem Cell-Derived Cells market.

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 - 2029 - Stock Market Funda

Nilanjan Ghosh, MD, PhD, a medical oncologist at Levine Cancer Institute, Atrium Health in Charlotte, NC, discussed the case of a 22-year-old patients with advanced Hodgkin lymphoma.

Targeted Oncology: What is your assessment of the patient?

GHOSH: The patients serum albumin is 4.2 g/dL, so thats an issue. The fact that she has stage IV disease, and that the white cell count was high, and the lymphocyte count was low are factors leading to an International Prognostic Score [IPS] of 4. The 5-year overall survival for high IPS, based on historical data, is not as good. I dont know if this would apply as much now, but this is what we have if we use the historical data. That suggests that she is a higher-risk patient. To be honest, the IPS has not affected treatment choice as much, at least in the United States, but well see if some of the newer treatments such as brentuximab vedotin [Adcetris] plus doxorubicin/vinblastine/dacarbazine [A+AVD] have any effect on that subgroup.

What do the National Comprehensive Cancer Network guidelines recommend for stage III or IV disease?

There are 2 treatment pathways that can be followed in patients who have stage III or IV.1 One focuses on a PET-adaptive pathway, which is ABVD [adriamycin, bleomycin, vinblastine, dacarbazine], followed by AVD [adriamycin, vinblastine, dacarbazine] or BEACOPP [bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, prednisone]. The non-PET adaptive therapy is the other pathway and uses brentuximab vedotin and AVD or escalated BEACOPP. Escalated BEACOPP is not usually used in North America.

Which regimen was chosen in this patient?

The patient was treated with brentuximab vedotin and AVD. Interim PET scan shows a Deauville score of 3; the patient tolerated this regimen well with G-CSF support. I think most people are certainly familiar with the Deauville scoring system, so just remembering that if the uptake is less than the liver, that is considered as grade 3 response. If its uptake is moderately above or markedly above, then thats considered progressive.

What are the key findings of the ECHELON-1 study (NCT01712490)2?

ECHELON-1 evaluated brentuximab and AVD versus ABVD. The standard of care is ABVD. The most important thing to note is the dose of brentuximab, which is 1.2 mg/kg, not 1.8 mg/kg, because this is given every 2 weeks. Its mirroring when ABVD is administered.

[This was a] large study with [more than] 1200 patients. It examined patients with stage III or IV classical Hodgkin lymphoma who had relatively good performance status. The investigators did allow patients to enroll if they had measurable disease and adequate liver and renal function. There was a PET scan at the end of cycle 2; however, this was not a PET-adaptive therapy. ABVD was given for 6 cycles. There is no decrease to AVD or escalation to BEACOPP

At 3 years, the progression-free survival [PFS] rate was 83% in the treatment arm and 76% in the control arm. This is highly significant, with a P value of .005, a hazard ratio of 0.7.

Overall, subgroup analysis favors brentuximab and AVD. But the confidence intervals do cross over in some categories, especially in the regional subgroup. For some reason, ABVD seems to do better in Asia. The study, though, is not powered to determine if 1 region is better than another. So, you have to take this kind of data with a grain of salt.

Now, remember this patient was young; shes in her early 20s. In a younger age group, the A+AVD did better than ABVD. She lives in North America, so thats a region where ABVD did better. And then looking at the IPS, she had a score of 4, and thats another group in which A+AVD did better.

In general, A+AVD would probably be favored in stage IV disease. Her symptoms are associated with having extranodal sites, and in our case, the patients extranodal site was associated with the bones. Her performance status is good.

Looking at the responses in ECHELON-1, the overall response rate was 86% versus 83%, so there are small differences.

Regarding adverse effects [AEs], remember that when we think about brentuximab, we think of peripheral neuropathy. In the study, peripheral neuropathy was 67% for the treatment arm versus 42% in the ABVD arm. For diarrhea, its 27% versus 18%, and abdominal pain was slightly higher in ABVD, as well. In terms of any AEs, theyre similar; grade 3 events were more for A+AVD versus ABVD.

I will mention that initially in the protocol there was no mandate for growth factor, so most patients were treated without growth factors. There were increasing incidences of neutropenia and neutropenic fevers in the A+AVD arm. Protocol amendments were performed later and G-CSF support was introduced. It was the middle part of the program. The guidelines recommend that A+AVD should be used with G-CSF support. But the protocol for the most part didnt initiate G-CSF support except toward the end. So, we see 83 patients who [received] G-CSF support and 579 who didnt.

In terms of serious AEs, there were more associated with A+AVD. The reason I bring that up is because the majority of that protocol was already carried out without the G-CSF support. The treatment group ended up seeing more AEs and clearly there are more incidences of neuropathy with A+AVD. Drug discontinuation, however, was about the same between the groups. Deaths during treatment [were] very low, and there were more hospitalizations observed with A+AVD.

Did investigators initiate any dose delays?

Most of the dose delays were initiated because of neutropenia and febrile neutropenia. For patients who discontinued more than 1 drug because of AEs, 7% were attributed to peripheral neuropathy, which is an important AE in this treatment.

Regarding pulmonary toxicity, we would expect a bleomycin-containing regimen would have higher pulmonary toxicity. It was seen in 7% of patients with ABVD and 2% with A+AVD,

and grade 3 or more pulmonary toxicity was low in A+AVD but observed in 3% of patients with ABVD.2

How were febrile neutropenia and any neutropenia addressed in the trial?

We see a difference between patients who [received] G-CSF support versus those who didnt, regarding febrile neutropenia versus any neutropenia. In patients who developed febrile neutropenia during treatment, 11% of those who received G-CSF support experienced the AE, and 21% who did not receive G-CSF support experienced the AE.

For neutropenia any grade, 73% of patients who did not receive GCSF versus 35% of patients who did receive G-CSF support developed it. Similarly, for grade 3 or more neutropenia, 70% who did not receive G-CSF versus 29% of patients who did developed it. To me, that is the most striking observation.

In the ABVD arm, there was neutropenia observed with ABVD, and we all have had patients with ABVD where the absolute neutrophil count is low, and we still go ahead and treat. That is done in standard practice.

In terms of serious AEs, there were more serious AEs with A+AVD compared [with] ABVD, 44% versus 28%. And there were no differences in deaths.

The A+AVD regimen can cause peripheral neuropathy. But if you look at complete resolution of peripheral neuropathy, you can see that 78% of patients treated with A+AVD had complete resolution and 83% of those on ABVD had complete resolution. Patients receiving ABVD also get neuropathy primarily because of vinblastine. Improvement in neuropathy also occurred in both groups; 17% of patients had improvement, not resolution, in the A+AVD arm versus 9% in the ABVD arm. The vast majority had resolution, but many had improvement as well.

However, for ongoing neuropathy that [was] grade 1 or 2, 25% of patients in the A+AVD arm and only 11% in the ABVD group experienced this. We have to be vigilant and monitor them throughout treatment so that it doesnt get too bad, so appropriate dose reductions can be made.

The bottom line here is most neuropathy is going to go away, but there will be patients where neuropathy can persist, and that can be an annoying thing, especially for a young person. For many in long-term follow-up, theyll experience improvement in neuropathy over time, which means things are getting better, but that doesnt mean its all resolved.

References:

1. NCCN Clinical Practice Guidelines in Oncology. Hodgkin lymphoma, version 2.2020. Accessed August 26, 2020. http://bit.ly/2YAIYha

2. Connors JM, Jurczak W, Straus DJ, et al. Brentuximab vedotin with chemotherapy for stage III or IV Hodgkins lymphoma. N Engl J Med. 2018;378(4):331-344. doi:10.1056/NEJMoa1708984

Read the original post:
Ghosh Addresses Brentuximab Vedotin Use in Advanced Hodgkin Lymphoma - Targeted Oncology

A surface view of the organ of hearing (cochlea) from a mouse, using confocal microscopy. The sensory cells are named hair cells because of their apical projections (stereocilia) which move from stimulation by sound.

University of Maryland School of Medicine

Researchers at the University of Maryland School of Medicine (UMSOM) have conducted a study that has determined the role that a critical protein plays in the development of hair cells. These hair cells are vital for hearing. Some of these cells amplify sounds that come into the ear, and others transform sound waves into electrical signals that travel to the brain. Ronna Hertzano, MD, PhD, associate professor in the Department of Otorhinolaryngology Head and Neck Surgery at UMSOM and Maggie Matern, PhD, a postdoctoral fellow at Stanford University, demonstrated that the protein, called GFI1, may be critical for determining whether an embryonic hair cell matures into a functional adult hair cell or becomes a different cell that functions more like a nerve cell or neuron.

The study was published in the journalDevelopment, and was conducted by physician-scientists and researchers at the UMSOM Department of Otorhinolaryngology Head and Neck Surgery and the UMSOM Institute for Genome Sciences (IGS), in collaboration with researchers at the Sackler School of Medicine at Tel Aviv University in Israel.

Hearing relies on the proper functioning of specialized cells within the inner ear called hair cells. When the hair cells do not develop properly or are damaged by environmental stresses like loud noise, it results in a loss of hearing function.

In the United States, the prevalence of hearing loss doubles with every 10-year increase in age, affecting about half of all adults in their 70s and about 80 percent of those who are over age 85. Researchers have been focusing on describing the developmental steps that lead to a functional hair cell, in order to potentially generate new hair cells when old ones are damaged.

To conduct her latest study, Hertzano and her team utilized cutting-edge methods to study gene expression in the hair cells of genetically modified newborn mice that did not produce GFI1. They demonstrated that, in the absence of this vital protein, embryonic hair cells failed to progress in their development to become fully functional adult cells. In fact, the genes expressed by these cells indicated that they were likely to develop into neuron-like cells.

"Our findings explain why GFI1 is critical to enable embryonic cells to progress into functioning adult hair cells," said Hertzano. "These data also explain the importance of GFI1 in experimental protocols to regenerate hair cells from stem cells. These regenerative methods have the potential of being used for patients who have experienced hearing loss due to age or environmental factors like exposure to loud noise."

Hertzano first became interested in GFI1 while completing her MD, PhD at Tel Aviv University. As part of her dissertation, she discovered that the hearing loss resulting from mutations in another protein called POU4F3 appeared to largely result from a loss of GFI1 in the hair cells. Since then, she has been conducting studies to discover the role of GFI1 and other proteins in hearing. Other research groups in the field are now testing these proteins to determine whether they can be used as a "cocktail" to regenerate lost hair cells and restore hearing.

"Hearing research has been going through a Renaissance period, not only from advances in genomics and methodology, but also thanks to its uniquely collaborative nature among researchers," said Hertzano.

The new study was funded by the National Institute on Deafness and Other Communication Disorders (NIDCD) which is part of the National Institutes of Health (NIH). It was also funded by the Binational Scientific Foundation (BSF).

"This is an exciting new finding that underscores the importance of basic research to lay the foundation for future clinical innovations," said E. Albert Reece, MD, PhD, MBA, executive vice president for medical affairs, UM Baltimore, and the John Z. and Akiko K. Bowers Distinguished Professor and dean, University of Maryland School of Medicine. "Identifying the complex pathways that lead to normal hearing could prove to be the key for reversing hearing loss in millions of Americans."

- This press release was originally published on theUniversity of Maryland School of Medicine website

Originally posted here:
Researchers ID Role of Protein in Development of New Hearing Hair Cells - labmanager.com

The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies.

The Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to be adopted in October and published in November, according to Ana Hidalgo-Simon, MD, PhD, head of advanced therapies at EMA. She previewed the major changes at RAPS Convergence 2020.

There were an enormous number of comments on the document, Hidalgo-Simon said.The agency is also working on a Q&A document on principles of good manufacturing practices (GMP) for Advanced Therapy Medicinal Products (ATMP) starting material. There will likely be consultation on the document in 2021, she said. (RELATED: Regulation of advanced therapy medicinal products in the EU, Regulatory Focus, 16 July 2020.)

Major changesEMA chose to update the guidance to reflect the increase in clinical experience with these therapies, particularly chimeric antigen receptor-T (CAR-T) cells; to cover new categories of products, such as induced pluripotent stem (iPS) cells; and to allow for consideration of new tools for genetic modification of cells, such as genome editing technologies, she said.

The main quality updates are related to starting materials, the manufacturing process, and characterization and release. For example, the starting materials guidance will now include genome editing tools, while the manufacturing process includes a new section on comparability. The characterization and release portion of the guidance includes specific advice for CAR-T cells.

Additionally, the guidance calls for dose-finding studies to explore safety, toxicity, and anti-tumor activity at different dose levels, to define the threshold dose required for anti-tumor effect, and to define the recommended dose or range for Phase 2 studies. She said sponsors need to show a solid rationale for the criteria being used to find the dose.

The guidance also calls for Phase 3 confirmatory trials to follow a randomized controlled design, comparing the CAR-T cell therapy to a reference regimen, unless otherwise scientifically justified. Single-arm studies will continue to be allowed, but they will be the exception, Dr. Hidalgo-Simon said.

Be very careful with the design of the trials, she advised. The assumptions need to be really, very well backed.

When it comes to safety, the guidance calls for a 15-year follow period. While sponsors wont have all the answers at the time of submission, Hidalgo-Simon said they should have a plan that includes monitoring during the post-authorization period.

Hidalgo-Simon also advised sponsors to think beyond the approval process and consider what evidence will be needed to convince other stakeholders -- from patients to payers -- about the safety and efficacy of the therapy.

Avoiding development pitfallsRichard Dennett, PhD, the senior director of chemistry, manufacturing and controls regulatory affairs at PPD, also participated in the RAPS Convergence 2020 session on advanced therapies. He reviewed development points where companies can run into trouble with advanced therapies, particularly CAR-T cell products.Dennett recommended that product sponsors keep the end in mind when developing advanced therapies by focusing on the target product profile at the beginning of development. That profile includes the indication for which approval will be sought and the incidence of that indication; other considerations include mode of action, demographics, how much of the product needs to be produced, and market access and reimbursement considerations.

He also outlined several areas where developers should focus to create a watertight regulatory package, including sufficient product characterization, potency assay, impurities, formulation, stability, lack of sufficient development batches, and validation strategy.

Dennett urged developers to dive into the growing number of regulatory guidance documents for advanced therapies. In addition to the European guidance documents, developers should consultthe US Food and Drug Administrations Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), which was released in January 2020. (RELATED: Advanced therapies: Trip hazards on the development pathway, Regulatory Focus, 02 August 2020)

Live and breathe the guidances that are out there, Dennett advised. They allow us to understand what expectations we need to meet.

The key to success in advancing CAR-T cell therapies is the mitigation of risk, Dennett said: The biggest risk is the one that you havent thought of.RAPS 2020 Convergence

View original post here:
Convergence: EMA close to finalizing guidance for advanced therapies - Regulatory Focus

Stem Cells Market Report

The research study on the Global Stem Cells Market is a thorough investigation of the value and supply chain of the market and offers all-inclusive data about the industry. The report also covers insightful information about pricing, cost, value, capacity, gross revenue, and profit margins with reference to historical analysis and forecast estimation. The report also strives to identify demands and trends in different sectors of the Stem Cells market in major geographies of the world.

The Stem Cells market has witnessed dynamic changes in trends and demands owing to the ongoing COVID-19 pandemic. The report provides a detailed outlook on how the pandemic has affected the key segments of the Stem Cells industry. The report includes an in-depth impact analysis of the COVID-19 pandemic on the overall Stem Cells industry and covers a futuristic impact scenario.

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The report studies the market dynamics to identify and scrutinize the strategic initiatives and tactics undertaken by the industry players in order to gain a robust footing in the market and to achieve a substantial global position. It provides exhaustive analysis and imparts insightful data to help the readers understand the Stem Cells industry in detail and gain a competitive advantage over other players. The report also provides strategic recommendations to new and emerging players to help them formulate better entry and investment strategies.

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

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

The report offers a comprehensive analysis of the Stem Cells market inclusive of product portfolio, categories, applications, and a comprehensive analysis of the value chain structure. The study investigates several factors influencing the growth of the market and provides a competitive advantage to the readers.

The Stem Cells market report is an investigative study that provides insights into opportunities, limitations, and barriers encountered by the companies that influence or hinder the growth of the industry. Overall the report provides valuable information and an overview of the market scenario to gain a better understanding of the market.

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

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

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

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

The report covers an extensive regional analysis and market estimation in each region and covers key geographical regions such as North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa.

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Stem Cells Market Report, History and Forecast 2020-2027, Data Breakdown by Manufacturers, Key Regions, Types and Application - News Degree

Concerning heart failure (HF), the current COVID-19 pandemic is having a dramatic effect on the daily life of each individual, ranging from social distancing measures applied in most countries to getting severely diseased due to the virus. Cardiovascular Disease (CVD) is among the most common conditions in people that die of the infection. The burden of CVD accounts for over 60 million people in the EU alone, therefore, it is the leading cause of death in the world.

Although COVID-19 shows us the direct impact of a potential treatment for peoples health, CVD is a stealthy pandemic killer. HF is a chronic disease condition in which the heart is not able to fill properly or efficiently pump blood throughout your body, caused by different stress conditions including myocardial infarction, atherosclerosis, diabetes and high blood pressure. Several measures are commonly used to treat heart disease, such as lifestyle changes and medications like beta-blockers and ACE inhibitors, yet these typically only slow down the progression of the disease.

Biomedical research is exploring new avenues by combining scientific insights with new technologies to overcome chronic diseases like HF. Among the most appealing and promising technologies are the use of cardiac tissue engineering and extracellular vesicles-mediated repair strategies.

Upon an initial cell loss post-infarction, it is appealing to replace this massive loss in contractile cells for new cells and thereby not treating patients symptoms, but repairing the cause of the disease. Cardiac cell therapy has been pursued for many years with variable results in small initial trials upon injection into patients. Different cell types have been used to help the myocardium in need, but the most promising approaches aim to use induced pluripotent cells (iPS) from reprogrammed cells from the patient themselves that can be directed towards contractile myocardial cells. These cells in combination with natural materials, in which the cells are embedded in the heart, can be used for tissue engineering strategies (1). Together with different international partners, Sluijters team are trying to develop strategies to use these iPS-derived contractile cells for myocardial repair via direct myocardial injection (H2020-Technobeat-66724) or to make a scaffold that can be used as a personalised biological ventricular assist device (H2020-BRAV-874827). A combination of engineering and biology to mimic the native myocardium aims to replace the chronically ill tissue for healthy and well-coupled heart tissue that can enhance the contractile performance of the heart.

Recently, a Dutch national programme started, called RegMedXB, in which the reparative treatment of the heart is aimed to be performed outside the patients body. During the time the heart is outside the body; the patient is connected to the heart-lung machine, and after restoring function, it will be re-implanted. The so-called Cardiovascular Moonshot aims to create a therapy that best suits the individual patient, by having their heart beating in a bioreactor, outside the body. Although it sounds very futuristic, many small lessons will be learned to feet novel therapeutic insights.

The initial injection of stem cells did result in a nice improvement of myocardial performance. We have now learned that rather than these delivered cells helping the heart themselves, the release of small lipid carriers called extracellular vesicles (EVs) (2) from these cells occur. These EVs carry different biological molecules, including nucleotides, proteins and lipids, and are considered to be the bodies nanosized messengers for communication. The use of stem cell-derived EVs are now being explored as a powerful means to change the course of the disease. Via these small messengers, natural biologics are delivered to diseased cells and thereby help them to overcome the stressful circumstances. EVs carry reparative signals that can be transferred to the diseased heart and thereby change the course of heart disease in some patients.

Within the EVICARE program (3) (H2020-ERC-725229), Sluijters team are using stem cell-derived EVs to change the response of the heart to injury. Also, to understand which heart cells and processes are being affected, they use materials to facilitate a slow release of biomaterials over an extended period rather than a single dose, which is probably essential for a chronic disease like HF. For now, improved blood flow is the main aim but the team have seen other effects as well, such as cardiovascular cell proliferation (4) by which the heart cells themselves start to repair the organ.

The use of EVs basically aims to enhance the endogenous repair mechanisms of the heart. These natural carriers can be mimicked with synthetic materials, or used as a hybrid of the two, thereby creating an engineered nanoparticle, that is superior in the intracellular delivery of genetic materials. The possibility of loading different biological materials allows a further tuning of its effectiveness and use in different disease conditions, creating a new off-the-shelf delivery system for nanomedicine to treat cancer and CVD (H2020-Expert-825828).

As is true of the current COVID-19 pandemic, HF is also a growing chronic disease that affects millions of people worldwide. The chronic damaged myocardium needs reparative strategies in the future to lower the social burden for patients, but also to keep the economic consequences affordable. New scientific insights with cutting edge technological developments will help to address these needs of CVD patients and their families.

References

(1) Madonna R, Van Laake LW, Botker HE, Davidson SM, De Caterina R, Engel FB, Eschenhagen T, Fernandez-Aviles F, Hausenloy DJ, Hulot JS, Lecour S, Leor J, Menasch P, Pesce M, Perrino C, Prunier F, Van Linthout S, Ytrehus K, Zimmermann WH, Ferdinandy P, Sluijter JPG. ESC Working Group on Cellular Biology of the Heart: position paper for Cardiovascular Research: tissue engineering strategies combined with cell therapies for cardiac repair in ischaemic heart disease and heart failure. Cardiovasc Res. 2019 Mar 1;115(3):488-500.

(2) Sluijter JPG, Davidson SM, Boulanger, CM, Buzs EI, de Kleijn DPV, Engel FB, Giricz Z, Hausenloy DJ, Kishore R, Lecour S, Leor J, Madonna R, Perrino C, Prunier F, Sahoo S, Schiffelers RM, Schulz R, Van Laake LW, Ytrehus K, Ferdinandy P. Extracellular vesicles in diagnostics and therapy of the ischaemic heart: Position Paper from the Working Group on Cellular Biology of the Heart of the European Society of Cardiology. Cardiovasc Res. 2018 Jan 1;114(1):19-34.

(3) https://www.sluijterlab.com/extracellular-vesicle-inspired-ther

(4) Maring JA, Lodder K, Mol E, Verhage V, Wiesmeijer KC, Dingenouts CKE, Moerkamp AT, Deddens JC, Vader P, Smits, AM, Sluijter JPG, Goumans MJ. Cardiac Progenitor Cell-Derived Extracellular Vesicles Reduce Infarct Size and Associate with Increased Cardiovascular Cell Proliferation. J Cardiovasc Transl Res. 2019 Feb;12(1):5-17.

Please note: this is a commercial profile.

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Original post:
Innovative treatments for heart failure - Open Access Government

The Japanese governments health ministry has given the go-ahead for a trial of human induced pluripotent stem cells to treat spinal cord injury, Reutersreports today (February 18).Researchers at Keio University plan to recruit four adults who have sustained recent nerve damage in sports or traffic accidents.

Its been 20 years since I started researching cell treatment. Finally we can start a clinical trial, Hideyuki Okano of Keio University School of Medicine told a press conference earlier today, The Japan Timesreports. We want to do our best to establish safety and provide the treatment to patients.

The teams intervention involves removing differentiated cells from patients and reprogramming them via human induced pluripotent stem cells (iPSCs) into neural cells. Clinicians will then inject about 2 million of these cells into each patients site of injury. The approach has been successfully tested in a monkey, which recovered the ability to walk after paralysis, according to the Times.

Its not the first time Japan has approved the use of iPSCs in clinical trials. Last year, researchers at Kyoto University launched a trial using the cells to treat Parkinsons disease. And in 2014, a team at the RIKEN Center for Developmental Biology led the first transplant of retina cells grown from iPSCs to treat a patients eye disease.

Read the original:
Japan Approves iPS Cell Therapy Trial for Spinal Cord ...

AMSBIO has announced new additions and certifications for its range of clinical grade, chemically defined cryopreservation excipient solutions STEM-CELLBANKER and HSC-BANKER.

STEM-CELLBANKER DMSO Free GMP grade is a new chemically defined freezing solution that does not contain DMSO as an anti-freezing agent. It was developed for customers who prefer not to use DMSO-containing cryopreservation solution due to the intended application of the samples. STEM-CELLBANKER DMSO Free GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines.

STEM-CELLBANKER is a chemically defined freezing media optimized for stem cells and iPS cells storage, as well as fragile primary cells. Published data supports its ability to cryopreserve organoids and tissues to allow the recovery of viable cells. STEM-CELLBANKER GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines. Free from animal derived components this popular cryopreservation medium contains only chemically defined USP, EP and JP grade ingredients. Available in both DMSO containing and DMSO-Free formulations, STEM-CELLBANKER is an optimal freezing solution for basic research and is finding widespread use in the clinical application of cell therapy products.

Manufactured to be completely free of serum and animal derived components, HSC-BANKER contains only European or US Pharmacopoeia graded ingredients making it suitable for storage of hematopoietic stem cells developed for cell therapy applications.

Recently the master files of HSC-BANKER were accepted by the Center for Biologics Evaluation and Research (CBER) within the US FDA (Food and Drug Administration). Master files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Beneficially they allow researchers to reference material without disclosing Master file contents to those parties.

HSC-BANKER is supplied ready-to-use and requires no special devices, such as a controlled rate freezer, in order to achieve consistently high viabilities following resuscitation from cryopreservation, even over extended long-term storage. HSC-BANKER significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability after freeze-thaw. Evaluated for endotoxins, pH, osmolarity and mycoplasma contaminants to ensure GMP equivalent quality. HSC-BANKER is part of the CELLBANKER range of cryopreservation media for cells, organoids and tissues.

Read more:
Optimized Freezing Solutions for Clinical Application of Cell Therapy Products - Technology Networks

The global Stem Cell-Derived Cells market study presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Stem Cell-Derived Cells market player in a comprehensive way. Further, the Stem Cell-Derived Cells market report emphasizes the adoption pattern of the Stem Cell-Derived Cells across various industries.

The Stem Cell-Derived Cells market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.

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key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

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

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

Segmentation by Product Type

Segmentation by End User

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

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

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

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Regional analysis includes

Report Highlights:

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The Stem Cell-Derived Cells market report offers a plethora of insights which include:

The Stem Cell-Derived Cells market report answers important questions which include:

The Stem Cell-Derived Cells market report considers the following years to predict the market growth:

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Why Choose Stem Cell-Derived Cells Market Report?

Stem Cell-Derived Cells Market Reportfollows a multi- disciplinary approach to extract information about various industries. Our analysts perform thorough primary and secondary research to gather data associated with the market. With modern industrial and digitalization tools, we provide avant-garde business ideas to our clients. We address clients living in across parts of the world with our 24/7 service availability.

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Stem Cell-Derived Cells Market Forecast to 2025: Global Industry Analysis by Top Players, Types, Key Regions and Applications - The Scarlet

Cell therapy is the administration of living cells to replace a missing cell type or to offer a continuous source of a necessary factor to achieve a truly meaningful therapeutic outcome. There are different forms of cell therapy, ranging from transplantation of cells derived from an individual patient or from another donor. The manufacturing process of cell therapy requires the use of different products such as cell lines and instruments. These cell therapies are used for the treatment of various diseases such as cardiovascular disease and neurological disorders.

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Key Players:

Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co., Inc. (FloDesign Sonics),NantWorks, LLC,Neurogeneration, Inc.,Novartis AG,Plasticell Ltd.,Regeneus Ltd,StemGenex, Inc.

Increase in the incidence of cardiovascular diseases, rise in the demand for chimeric antigen receptor (CAR) T cell therapy, increase in the R&D for the advancement in the research associated with cell therapy, increase in the potential of cell therapies in the treatment of diseases associated with lungs using stem cell therapies, and rise in understanding of the role of stem cells in inducing development of functional lung cells from both embryonic stem cells (ESCs) & induced pluripotent stem (iPS) cells are the key factors that fuel the growth of the cell therapy processing market.

Moreover, increase in a number of clinical studies relating to the development of cell therapy processing, rise in adoption of regenerative drug, introduction of novel technologies for cell therapy processing, increase in government investments for cell-based research, increase in number of GMP-certified production facilities, large number of oncology-oriented cell-based therapy clinical trials, and rise in the development of allogeneic cell therapy are other factors that augment the growth of the market. However, high-costs associated with the cell therapies, and bottlenecks experienced by manufacturers during commercialization of cell therapies are expected to hinder the growth of the market.

The cell therapy processing market is segmented into offering type, application, and region. By type, the market is categorized into products, services, and software. The application covered in the segment include cardiovascular devices, bone repair, neurological disorders, skeletal muscle repair, cancer, and others. On the basis of region, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (Germany, France, UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, India, and rest of Asia-Pacific), and LAMEA (Latin America, Middle East, and Africa).

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KEY MARKET SEGMENTS

By Offering Type Products Services Software

By Application Cardiovascular Devices Bone Repair Neurological Disorders Skeletal Muscle Repair Cancer Others

By Region

North Americao U.S.o Canadao Mexico Europeo Germanyo Franceo UK

Key question and answered in the report include:

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Cell Therapy Processing Market is Booming Worldwide to Show Significant Growth by 2026 Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co.,...

OneAZ Credit Union names Ken Bauer SVP

OneAZ Credit Union announced Ken Bauer as senior vice president, Credit Administration.

Bauer oversees OneAZs mortgage, business and commercial banking teams, emphasizing efficiency and excellence to help the organization succeed. He joined OneAZ Credit Union in 2020, bringing 20 years of experience in commercial banking with local and national banks and credit unions.

Established in 1951, OneAZ Credit Union is owned by its members and serves Arizona with 20 locations and more than 140,000 members

Spencer Fane LLP announced Kelly Mooney has joined the firm as of counsel. She will be part of the Tax, Trusts, & Estates practice group and work out of the firms Phoenix office.

Mooneys practice focuses on handling complex matters related to federal taxation, working with attorneys in other practice groups to structure transactions that comply with federal tax law, offer tax relief when applicable, and provide tax-efficient results for her clients. She regularly assists clients with tax planning and analysis for partnerships, LLCs, and corporations; real estate joint ventures organized as LLCs and general and limited partnerships; and individuals.

Spencer Fane understands that tax issues impact virtually every aspect of business, investment, and personal wealth management, said Andy Federhar, Spencer Fane office managing partner in Phoenix. We understand our clients needs to assist them with finding the best solutions to favorably handle their tax liability, and Kellys experience in handling these matters through collaborative analysis fits well with our firms approach to client service.

Mooney has an accomplished track record of representing clients before the Internal Revenue Service and other taxing authorities on ruling requests, civil controversy cases, and collection matters. Her work has included successfully negotiating the settlement of several complex and multiyear IRS examinations and cases involving the imposition of trust fund penalties and contested claims for refund.

The University of Arizona College of Nursing has announced key new appointments, promotions, honors, awards and other notable items in recent weeks, including:

After a national search, the UArizona College of Nursing has named Kelley Wilson, DNP, MSN, CMSRN, as the new program director of the colleges Master of Science for Entry to the Profession of Nursing (MEPN) program. Dr. Wilson joins the college from Georgetown Universitys School of Nursing and Health Studies, where she had been serving as program director for the schools Bachelor of Science in Nursing program. She assumed her new role on July 13.

Dr. Wilson brings a wealth of experience in teaching and developing courses and academic programs, said Connie Miller, DNP, RNC-OB, CNE, clinical associate professor and chair, General Nursing and Health Education Division. She has solid experience in mentoring and leading teams, in addition to proven track record of service and scholarship. We look forward to welcoming her to our MEPN team.

Aleeca Bell, PhD, RN, CNM, joined the College of Nursing in mid-July. Dr. Bell most recently was an associate professor at the University of Illinois at Chicago (UIC), College of Nursing, Department of Women Children and Family Health Science. At UIC, she also earned her masters degree in nursing in midwifery in 1998, practiced as a certified nurse midwife, and earned a doctorate in nursing in 2009. In addition, she was a postdoctoral fellow there from 2009-11.

Dr. Bells research in translational, multidisciplinary and biobehavioral clinical studies focuses on the intersection of perinatal mother-infant health outcomes and the underlying oxytocin system. Oxytocin is a hormone that acts on organs in womens bodies and as a chemical messenger in the brain, controlling key aspects of the reproductive system, including childbirth, lactation and some behavior. This includes womens childbirth experience, intrapartum medical interventions, the endogenous oxytocin system (hormonal, genetic and epigenetic), maternal postnatal mood/anxiety and caregiving attitudes, newborn behaviors and mother-infant interaction. Learn more.

Tracy E. Crane, PhD, a College of Nursing assistant professor, has focused much of her career on cancer survivorship. She is co-director of the Behavioral Measurements and Interventions Shared Resource at the UArizona Cancer Center and a member of the UArizona Data Science Institute. Shes also co-chair of the cancer prevention and control behavioral science working group for NRG Oncology, a research non-profit led by faculty at Columbia University, NYU Langone Health, the University of Michigan and UArizona.

With a research focus on improving adherence to healthy lifestyle behaviors in cancer survivors and their informal caregivers, Dr. Crane has developed interventions geared toward extending lifespans of post-treatment ovarian cancer survivors and telephone counseling to improve diet and physical activity in Latina cancer patients. In early 2020, Dr. Crane extended her expertise across the Atlantic when she helped researchers at Gustave Roussy, Europes largest cancer center, fine-tune a new cancer study, Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer (MEDEA).

In keeping with Dr. Cranes previous research, MEDEA aims to compare the effect of a personalized telephone-based health education weight-loss program based on motivational coaching, exercise and diet, compared with a standard health educational program control on fatigue of overweight or obese breast cancer patients. Learn more.

According to new research from College of Nursing Associate Professor Ruth Taylor-Piliae, PhD, RN, FAHA, tai chi can be beneficial to the psychological well-being for adults suffering from cardiovascular disease. Published in June in the European Journal of Cardiovascular Nursing, Dr. Taylor-Piliaes review and meta-analysis of more than a dozen studies on the topic found that the exercise eased stress, anxiety, depression and psychological distress for those who practiced the mind-body exercise that emphasizes concentration on posture, relaxation and breathing, using a soothing series of set movements. Go to the UArizona Health Sciences Connect website for a video on her research. Learn more.

Three cardiologists recently joined the University of Arizona Sarver Heart Center. Arka Chatterjee, MD, Talal Moukabary, MD, and Madhan Sundaram, MBBS, joined the faculty of the UArizona College of Medicine Tucson and are now seeing patients at Banner University Medical Center Tucson.

With the addition of Drs. Chatterjee, Moukabary and Sundaram we continue the rapid growth in cardiovascular medicine at the University of Arizona and Banner UMC Tucson and we enhance our ability to provide highly personalized and expert care in the most advanced cardiology procedures to our patients, said Nancy K. Sweitzer, MD, PhD, director of the UArizona Sarver Heart Center, professor of medicine and chief of the Division of Cardiology in the Department of Medicine at the college.

These three physicians not only bring experience in electrophysiology, coronary and peripheral interventions and minimally invasive valve replacement, but they will expand the research offerings of the Sarver Heart Center in important areas of cardiology. This will allow us to bring the latest advances in heart disease treatment to the people of Southern Arizona, added Dr. Sweitzer.

Drs. Chatterjee and Moukabary are associate professors and Dr. Sundaram is an assistant professor of medicine.

In addition, Dr. Chatterjee is associate director of the Structural Heart Program at Banner UMC Tucson. He is board certified in interventional cardiology, cardiovascular disease, internal medicine and echocardiography. Dr. Chatterjee is experienced in transcatheter therapies for valvular disease and other congenital/structural heart defects. He has completed more than 200 transcatheter aortic valve replacement (TAVR) procedures. He finds the best part of working in the structural heart team is the synergy that occurs when a multidisciplinary team of expert providers works together to identify the ideal treatment for each patients unique case. Dr. Chatterjees research interests include outcomes research after coronary, structural and adult congenital interventions, and advances in structural and device therapies for heart disease.

Dr. Moukabary is a cardiac electrophysiologist (a cardiologist specializing in heart rhythm disorders or arrhythmias). He is an expert in computer modeling of cardiac arrhythmia, imaging in the cardiac electrophysiology lab, cell-based arrhythmia therapy and clinical cardiac electrophysiology. He is board certified in clinical cardiac electrophysiology and internal medicine. Dr. Moukabarys research interests include use of stem cell and iPS (induced pluripotent stem) cell therapies for heart rhythm disorders.

Dr. Sundaram is director of the Banner UMC Tucson Cardiac Catheterization Lab and Endovascular Services. He is board certified in interventional cardiology, cardiovascular disease, echocardiography and internal medicine. His clinical interests include complex coronary interventions, chronic total occlusions, endovascular peripheral interventions, interventions for acute pulmonary embolism and structural heart disease interventions. His research interests include cardiac interventions in older adults and clinical trials in coronary artery disease, peripheral artery disease and pulmonary embolism.

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On the move at the OneAZ, Spencer Fane, UArizona - AZ Big Media

In a surgical procedure last month, neurosurgeons from Kyoto University implanted 2.4 million cells into the brain of a patient with Parkinsons disease. The cellsderived from peripheral blood cells of an anonymous donorhad been reprogrammed into induced pluripotent stem cells (iPSCs) and then into dopaminergic precursor cells, which researchers hope will boost dopamine levels and ameliorate the patients symptoms.

The procedure is the most recent attempt by clinicians to test whether iPSCs can treat disease. In recent years, Japanese scientists have launched several clinical studies to examine their efficacy in heart disease and macular degeneration of the eye. And other researchers around the globe are exploring ways to turn the cells into treatments for everything from endometriosis to spinal cord injury. The initial foray into clinical trials raises hopes that the technology will bear fruit 12 years after its Nobel Prizewinning discovery.

Im excited that theyre trying to move it to the clinical level, because the iPS field does at some point need to start demonstrating that [these cells] have regenerative potential, says Jalees Rehman of the University of Illinois at Chicago. But the move towards clinical work is also revealing the difficulties of developing therapies. Its a learning curve, he adds.

So far, only a handful of patients have undergone iPSC-based treatments. In 2014, a woman with macular degeneration of the eye received a transplant of iPSC-based retinal cells derived from her own cells. The woman treated showed no apparent improvement in her vision, but the safety of the iPSC-derived cells was confirmed, writes Jun Takahashi, a stem cell biologist at Kyoto University who helped derive the dopaminergic precursor cells implanted into the Parkinsons disease patient. It was his wife, Masayo Takahashi of the RIKEN Center for Developmental Biology, who created the retinal cells used in that trial.

Last year, five patients were treated for the same eye condition with iPSC-derived retinal cells, which were taken from different donors. One of them patients developed a serious, but non-lifethreatening, reaction to the transplant, forcing doctors to remove it, according to the Japan Times.

More clinical studies are underway: Next year, heart surgeons plan to implant sheets of iPSC-derived cardiomyocytes into the hearts of three patients with heart disease, and Takahashi hopes to treat six more patients with Parkinsons disease by 2022. These are all in the earliest phases of testing. It is too early to say something [about the cells efficacy] in our trial, he adds.

While some researchers are waiting for the results of clinical studies to determine whether iPSCs have regenerative potential, others are racing ahead with preclinical studies presenting ever more ways on how to use them therapeutically. For instance, April Pyle, a stem cell biologist at the University of California, Los Angeles, recently developed an approach she believes is promising in treating Duchenne muscular dystrophy, a devastating disease caused by a mutation in the gene encoding the muscle-strengthening protein dystrophin. She and her colleagues used CRISPR-Cas9 to repair the gene in human iPSCs, turned them into skeletal muscle cells, and injected them into the muscle of dystrophin-deficient mice. We [could] actually see that weve restored dystrophin in pockets of the muscle, she explains.

I think its really just the beginning, she says. I think that were finally seeing the payoff for all of the hard work . . . and there will be many more trials to follow from these initial studies.

By now, researchers have figured out how to coax iPSCs to grow into most known cell types, Rehman says. But to get these cells to take on the roles of mature cells in a new tissue environment is another issue. In the heart, for instance, researchers have found that new stem cells have to be electrically aligned with the other cells. Experiments on human iPSC-derived heart muscle cells in culture show that by subjecting them to electrically induced contractions as they develop, the cells mature faster, suggesting that they become more able to handle the adult workload in vivo. How to integrate the new cells so they will survive in injured or diseased tissue is another question. Do you need a special matrix, a gel, a patch, an organoid, to ensure the success of these cells long term? Rehman asks. These challenges are faced in all the organs.

Researchers have been relying on monkey models to evaluate the efficacy of engraftment procedures before testing them in human patients, explains Takahashi. Last year, his team demonstrated on monkeys that human iPSCderived dopaminergic neurons stably integrated into existing brain tissue, where they produced dopamine and ultimately improved Parkinsonian symptoms.

The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead.

Jalees Rehman, University of Illinois at Chicago

Another challenge with the implantation of iPSC-derived tissue is the ever-present risk that the cells might trigger cancer, because they stem from a cell type that is by nature highly proliferative. To avoid this, Takahashi and his colleagues filter the implanted cells to eliminate undifferentiated ones that are most prone to overgrowth, and also test the cell lines for tumorgenicity by implanting a sample into mice.

Still, we cannot completely eliminate the possibility of tumor formation, notes Tetsuo Maruyama, an associate professor of obstetrics and gynecology from Keio University School of Medicine. He thinks that such procedures should focus on non-essential organs, such as the eye or the uterus, for instance. He recently succeeded in deriving healthy uterine cells from iPSCs and plans to use these to study how endometriosis occurs, and also to generate human endometrium that could eventually be used clinically.

Another concern researchers have frequently raised are the immunosuppressive drugs that patients require if the iPSCs are derived from cells other than the patients own. Takahashis patient with Parkinsons, for instance, will be on immunosuppressants for a year, possibly making the patient less able to fight off infections and cancer. But despite the risks, many researchers have opted to use allogeneic stem cellsthose from a donorforemost because the approach will save time, cost, and labor when the time comes to scale up such treatments for commercialization. It is important when you think about industrialization, Takahashi writes in an email.

The possibility to create off the shelf iPSC therapies has also attracted industry, not just academics. For instance, Australia-based biotech company Cynata Therapeutics recently concluded a Phase I trial using iPSC-derived mesenchymal stem cells to treat graft-versus-host disease (GVHD). The condition occurs after bone marrow transplants when immune cells of the donor recognize cells in the recipients body as foreign and attack them, often resulting in death. But mesenchymal stem cells, which can mature into a variety of cell types, suppress the proliferation and activation of the donors T cells, explains Kilian Kelly, the companys vice president for product development. The company produced these cells by starting from iPSCs, reprogramming them in to an intermediary cell called a mesenchymoangioblast, and then directing them to become mesenchymal cells.

The trial, which the company claims is the worlds first to use iPSCs, administered the cells intravenously to 15 patients with GVHD who had previously failed to respond to steroid treatment and as such faced a grim prognosis. Although its too soon to evaluate efficacy, Kelly says, he sees it as a positive sign that 14 of them showed a notable improvement in their condition. And conveniently, immune rejection isnt an issue with mesenchymal stem cells because they dont express the donor-specific antigens that trigger rejection. So that means that we can use cells from a single iPS [cell] bank to treat essentially anybody, says Kelly.

Developing off-the-shelf treatments is also vastly more cost effective than maturing iPSC-derived cells for individual patients, adds Ross McDonald, the companys CEO. He points to personalized T-cell immunotherapiestwo of which have been recently FDA-approvedwhich can nearly$500,000 per patient. Its too soon to predict how much his product might cost, he adds.

This is one reason why several groups are developing banks of iPSCs that can be used to develop regenerative therapies at scale. For instance, the Japanese government decided to put around $250 million towards developing an iPSC stock for biomedical research. The donors from whom these cells are derived were carefully selected with immune compatibility in mind: the bank is designed to encompass a diverse set of commonly present human leukocyte antigen (HLA) types, so that they are broadly representative of the majority of the population. Then, implantation will require only a minimum amount of immune suppression. This is kind of a middle ground between using patient-specific cells and cells chosen at random, explains Amanda Mack, director of iPSC reprogramming at Fujifilm Cellular Dynamics, a Wisconsin-based company that grows human cells for biomedical research.

Together, the cells will be immunocompatible with almost 70 percent of the Japanese population, says Maruyama. This might be more difficult for countries such as the US, where the genetic makeup is more diverse, but similar efforts are also underway there. For instance, Macks company aims to develop a bank of iPSCs that are matched to a majority of the US population.

While efforts like these continue, researchers around the world are still figuring out the nuts and bolts of applying these cells therapeutically. The closer we get to [clinical] applications, the more we obviously realize the challenges that lie ahead, says Rehman. I think thats a very normal process for scientific discovery.

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Increasing Number of iPS Cell Therapies Tested in Clinical ...

Persistence Market Research recently published a market study that sheds light on the growth prospects of the global Stem Cell-Derived Cells market during the forecast period (20XX-20XX). In addition, the report also includes a detailed analysis of the impact of the novel COVID-19 pandemic on the future prospects of the Stem Cell-Derived Cells market. The report provides a thorough evaluation of the latest trends, market drivers, opportunities, and challenges within the global Stem Cell-Derived Cells market to assist our clients arrive at beneficial business decisions.

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The geographical reach of the Stem Cell-Derived Cells market has been meticulously segmented into United States, China, Europe, Japan, Southeast Asia & India, according to the report.

The research enumerates the consumption market share of every region in minute detail, in conjunction with the production market share and revenue.

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key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

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

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

Segmentation by Product Type

Segmentation by End User

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

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

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

The report covers exhaustive analysis on:

Regional analysis includes

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Some of the Major Highlights of TOC covers:

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 - Owned

DUBLIN, Aug. 11, 2020 /PRNewswire/ -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report" report has been added to ResearchAndMarkets.com's offering.

Since the discovery of induced pluripotent stem cells (iPSCs) a large and thriving research product market has grown into existence, largely because the cells are non-controversial and can be generated directly from adult cells. It is clear that iPSCs represent a lucrative market segment because methods for commercializing this cell type are expanding every year and clinical studies investigating iPSCs are swelling in number.

Therapeutic applications of iPSCs have surged in recent years. 2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPSCs into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB), it investigated the safety of iPSC-derived cell sheets in patients with macular degeneration. In another world-first, Cynata Therapeutics received approval in 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product (CYP-001) for the treatment of GvHD. Riding the momentum within the CAR-T field, Fate Therapeutics is developing FT819, its off-the-shelf iPSC-derived CAR-T cell product candidate. Numerous physician-led studies using iPSCs are also underway in Japan, a leading country for basic and applied iPSC applications.

iPS Cell Commercialization

Methods of commercializing induced pluripotent stem cells (iPSCs) are diverse and continue to expand. iPSC cell applications include, but are not limited to:

Since the discovery of iPSC technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. The main objectives of this report are to describe the current status of iPSC research, patents, funding events, industry partnerships, biomedical applications, technologies, and clinical trials for the development of iPSC-based therapeutics.

Key Topics Covered:

1. Report Overview

2. Introduction

3. History of Induced Pluripotent Stem Cells (IPSCS)

4. Research Publications on IPSCS

5. IPSCS: Patent Landscape

6. Clinical Trials Involving IPSCS

7. Funding for IPSC

8. Generation of Induced Pluripotent Stem Cells: An Overview

9. Human IPSC Banking

10. Biomedical Applications of IPSCS

11. Other Novel Applications of IPSCS

12. Deals in the IPSCS Sector

13. Market Overview

14. Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/kpc95y

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Opportunities in the Global Induced Pluripotent Stem Cell (iPS Cell) Industry - PRNewswire

Global Stem Cell-Derived Cells market Research presents a Comprehensive scenario Which can be segmented according to producers, product type, applications, and areas. This segmentation will provide deep-dive analysis of the Stem Cell-Derived Cells business for identifying the growth opportunities, development tendencies and factors limiting the development of the marketplace. This report features forecast market information based on previous and present Stem Cell-Derived Cells industry scenarios and growth facets. Each of the Essential regions coated in Stem Cell-Derived Cells report are North America, Europe, Asia-Pacific, South America, Middle East and Africa. The Stem Cell-Derived Cells market share and market prognosis of every region from 2020-2027 are presented within this report. A deep study of Stem Cell-Derived Cells marketplace dynamics will help the market aspirants in identifying the business opportunities that will lead to accumulation of earnings. This segment can efficiently determine the Stem Cell-Derived Cells hazard and key market driving forces.

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The Stem Cell-Derived Cells report is segmented to provide a clear and Precise view of this international Stem Cell-Derived Cells market statistics and market quotes. Stem Cell-Derived Cells report Information represented in the form of graphs, charts, and statistics will show the Stem Cell-Derived Cells growth rate, volume, goal customer analysis. This report presents the significant data to all Stem Cell-Derived Cells business aspirants which will facilitate useful business decisions.

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

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

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

Segmentation by Product Type

Segmentation by End User

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

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

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

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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The Stem Cell-Derived Cells report cover following data points:

Part 1: This part enlists the global Stem Cell-Derived Cells marketplace Overview, covering the simple market debut, market analysis by kind, applications, and areas. Stem Cell-Derived Cells industry states and prognosis (2020-2027) is presented in this part. Additionally, Stem Cell-Derived Cells market dynamics saying the chances, market risk, and key driving forces are studied.

Part 2: This part covers Stem Cell-Derived Cells manufacturers profile based On their small business overview, product type, and application. Additionally, the sales volume, Stem Cell-Derived Cells product price, gross margin analysis, and Stem Cell-Derived Cells market share of every player is profiled in this report.

Part 3 and Part 4: This part presents the Stem Cell-Derived Cells competition Based on earnings, earnings, and market share of each producer. Part 4 covers the Stem Cell-Derived Cells market scenario based on regions. Region-wise Stem Cell-Derived Cells sales and growth (2015-2019) is studied in this report.

America and Europes Stem Cell-Derived Cells industry by countries. Under this Stem Cell-Derived Cells revenue, market share of those nations like USA, Canada, and Mexico is provided. Under Europe Stem Cell-Derived Cells report contains, the countries such as Germany, UK, France, Russia, Italy, Russia and their sales and growth is coated.

Part 7, Part 8 and Part 9: These 3 sections covers Stem Cell-Derived Cells The earnings and expansion in these regions are presented in this Stem Cell-Derived Cells industry report.

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Part 10 and Part 11: This component depicts the Stem Cell-Derived Cells marketplace Share, earnings, sales by product type and application. The Stem Cell-Derived Cells sales growth seen during 2012-2020 is covered in this report.

Related to Stem Cell-Derived Cells market (2020-2027) for every region. The sales channels including indirect and direct Stem Cell-Derived Cells advertising, traders, distributors, and future trends are presented in this report.

Part 14 and Part 15: These components present Stem Cell-Derived Cells market key Research findings and judgment, research methodology, and data sources are covered.

Therefore, Global Stem Cell-Derived Cells report is a complete blend covering all The very important market aspects.

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Stem Cell-Derived Cells Market is Projected to Reach US$XX by the end of 2019 2029 - 3rd Watch News