Dublin, Aug. 02, 2018 (GLOBE NEWSWIRE) -- The "Global Induced Pluripotent Stem Cell (iPS Cell) Industry Report 2018-19" report has been added to ResearchAndMarkets.com's offering.

Groundbreaking experimentation in 2006 led to the introduction of induced pluripotent stem cells (iPSCs). These are adult cells which are isolated and then transformed into embryonic-like stem cells through the manipulation of gene expression, as well as other methods. Research and experimentation using mouse cells by Shinya Yamanaka's lab at Kyoto University in Japan was the first instance in which there was a successful generation of iPSCs.

In 2007, a series of follow-up experiments were done at Kyoto University in which human adult cells were transformed into iPSCs. Nearly simultaneously, a research group led by James Thomson at the University of Wisconsin-Madison accomplished the same feat of deriving iPSC lines from human somatic cells.

Since the discovery of 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. While it is clear that iPSCs represent a lucrative product market, methods for commercializing this cell type are still being explored, as clinical studies investigating iPSCs continue to increase in number.

iPS Cell Therapies

2013 was a landmark year in Japan because it saw the first cellular therapy involving the transplant of iPS cells into humans initiated at the RIKEN Center in Kobe, Japan. Led by Masayo Takahashi of the RIKEN Center for Developmental Biology (CDB). Dr. Takahashi was investigating the safety of iPSC-derived cell sheets in patients with wet-type age-related macular degeneration.

Although the study was suspended in 2015 due to safety concerns, in June 2016 RIKEN Institute announced that it would resume the clinical study using allogeneic rather than autologous iPSC-derived cells, because of the cost and time efficiencies.

In a world-first, Cynata Therapeutics received approval in September 2016 to launch the world's first formal clinical trial of an allogeneic iPSC-derived cell product, called CYP-001. The study involves centers in the UK and Australia. In this trial, Cynata is testing an iPS cell-derived mesenchymal stem cell (MSC) product for the treatment of GvHD.

On 16 May 2018, Nature News then reported that Japan's health ministry gave doctors at Osaka University permission to take sheets of tissue derived from iPS cells and graft them onto diseased human hearts. The team of Japanese doctors, led by cardiac surgeon Yoshiki Sawa at Osaka University, will use iPS cells to create a sheet of 100 million heart-muscle cells. From preclinical studies in pigs, the medical team determined that thin sheets of cell grafts can improve heart function, likely through paracrine signaling.

Kyoto University Hospital in Kobe, Japan also stated it would be opening an iPSC therapy center in 2019, for purposes of conducting clinical studies on iPS cell therapies. Officials for Kyoto Hospital said it will open a 30-bed ward to test the efficacy and safety of the therapies on volunteer patients, with the hospital aiming to initiate construction at the site in February of 2016 and complete construction by September 2019.

iPS Cell Market Competitors

In 2009 ReproCELL, a company established as a venture company originating from the University of Tokyo and Kyoto University was the first to make iPSC products commercially available with the launch of its human iPSC-derived cardiomyocytes, which it called ReproCario.

Cellular Dynamics International, a Fujifilm company, is another major market player in the iPSC sector. Similar to ReproCELL, CDI established its control of the iPSC industry after being founded in 2004 by Dr. James Thomson at the University of Wisconsin-Madison, who in 2007 derived iPSC lines from human somatic cells for the first time ever (the feat was accomplished simultaneously by Dr. Shinya Yamanaka's lab in Japan).

A European leader within the iPSC market is Ncardia, formed through the merger of Axiogenesis and Pluriomics. Founded in 2001 and headquartered in Cologne, Germany, Axiogenesis initially focused on generating mouse embryonic stem cell-derived cells and assays. After Yamanaka's groundbreaking iPSC technology became available, Axiogenesis was the first European company to license and adopt Yamanaka's iPSC technology in 2010.

Ncardia's focus lies on preclinical drug discovery and drug safety through the development of functional assays using human neuronal and cardiac cells, although it is expanding into new areas. Its flagship offering is its Cor.4U human cardiomyocyte product family, including cardiac fibroblasts.

In summary, market leaders have emerged in all areas of iPSC development, including:

iPS Cell Commercialization

Key Findings

Key Topics Covered

1. SCOPE AND METHODOLOGY

2. EXECUTIVE SUMMARY

3. BACKGROUND - iPSC RESEARCH

4. MARKET ANALYSIS BY PRODUCT CATEGORY

5. MARKET ANALYSIS BY APPLICATION

6. MARKET ANALYSIS BY GEOGRAPHY

7. PATENTS

8. COMPANIES

9. COMPANY PROFILES

10. CONCLUSIONS

For more information about this report visit https://www.researchandmarkets.com/research/njhzjc/induced?w=12

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Induced Pluripotent Stem Cell (iPS Cell): 2018-2022 ...

14 hours ago This is Kevin Kit Parker, the Thomas D. Cabot Associate Professor of Applied Science and Associate Professor of Biomedical Engineering, and Harvard Stem Cell Institute Principal Faculty member, has identified standards making it possible to quantitatively judge and compare commercially available stem cell lines. Credit: Jon Chase/Harvard Staff Photographer

After more than a decade of incremental and paradigm shifting, advances in stem cell biology, almost anyone with a basic understanding of life sciences knows that stem cells are the basic form of cell from which all specialized cells, and eventually organs and body parts, derive.

But what makes a "good" stem cell, one that can reliably be used in drug development, and for disease study? Researchers have made enormous strides in understanding the process of cellular reprogramming, and how and why stem cells commit to becoming various types of adult cells. But until now, there have been no standards, no criteria, by which to test these ubiquitous cells for their ability to faithfully adopt characteristics that make them suitable substitutes for patients for drug testing. And the need for such quality control standards becomes ever more critical as industry looks toward manufacturing products and treatments using stem cells.

Now a research team lead by Kevin Kit Parker, a Harvard Stem Cell Institute (HSCI) Principal Faculty member has identified a set of 64 crucial parameters from more than 1,000 by which to judge stem cell-derived cardiac myocytes, making it possible for perhaps the first time for scientists and pharmaceutical companies to quantitatively judge and compare the value of the countless commercially available lines of stem cells.

"We have an entire industry without a single quality control standard," said Parker, the Tarr Family Professor of Bioengineering and Applied Physics in Harvard's School of Engineering and Applied Sciences, and a Core Member of the Wyss Institute for Biologically Inspired Engineering.

HSCI Co-director Doug Melton, who also is co-chair of Harvard's Department of Stem Cell and Regenerative Biology, called the standard-setting study "very important. This addresses a critical issue," Melton said. "It provides a standardized method to test whether differentiated cells, produced from stem cells, have the properties needed to function. This approach provides a standard for the field to move toward reproducible tests for cell function, an important precursor to getting cells into patients or using them for drug screening."

Parker said that starting in 2009, he and Sean P. Sheehy, a graduate student in Parker's lab and the first author on a paper just given early on-line release by the journal Stem Cell Reports, "visited a lot of these companies (commercially producing stem cells), and I'd never seen a dedicated quality control department, never saw a separate effort for quality control." Parker explained many companies seemed to assume that it was sufficient simply to produce beating cardiac cells from stem cells, without asking any deeper questions about their functions and quality.

"We put out a call to different companies in 2010 asking for cells to start testing," Parker says, "some we got were so bad we couldn't even get a baseline curve on them; we couldn't even do a calibration on them."

Brock Reeve, Executive Director of HSCI, noted that "this kind of work is as essential for HSCI to be leading in as regenerative biology and medicine, because the faster we can help develop reliable, reproducible standards against which cells can be tested, the faster drugs can be moved into the clinic and the manufacturing process."

The quality of available human stem cells varied so widely, even within a given batch, that the only way to conduct a scientifically accurate study, and establish standards, "was to use mouse stem cells," Parker said, explaining that his group was given mouse cardiac progenitor cells by the company Axiogenesis.

Continued here:
Establishing standards where none exist: Researchers define 'good' stem cells

Overview and Profile Axiogenesis is an innovative and productive biotechnology company located in Cologne, Germany. Its primary focus is to develop novel assays that use differentiated embryonic stem cell (ES) and induced pluripotent stem cell (iPS) derived cell types that display normal physiological behavior

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