Landmark Events in Stem Cell Development Shift Industry Dynamics [Timeline]

Ushering in the Era of Regenerative Medicine

Stem cell research and experimentation have been driving progress in the area of regenerative medicine for decades. Despite major advances in stem cell knowledge, current medical approaches rely on single drug or single molecule treatments, occasionally supported by removal or alteration of biological tissues by a surgeon’s scalpel.

There is irony in the term “modern” medicine, as the central focus in modern medicine has largely been to contain damage and to limit symptoms: “Diabetic? No problem, we can regulate your insulin.” Under our current framework for medicine, regeneration has not played a central role in treatment. Rather than welcome in regenerative treatments, fears of novel cell-based treatments have been perpetuated and an emphasis on drug-based treatments has been continued.

In contrast, the next decade will be ushering in an era of “futuristic” medicine, centered on remedying underlying health conditions and resolving states of health.  Under this new model, what we currently consider “modern” medicine will soon be considered “archaic” medicine.

Life extension will also become a recognized area of medicine, referencing medical techniques that will allow for the extension of the average lifespan by 30-40 years. As Peter Diamondas, head of a Life Extension Company called Human Longevity, Inc, says, their vision is to “Make 100 the new 60.” In large part, progress in the area of regenerative medicine will be driven by cell-based therapies, with emphasis on delivering stem cells to sites of damage.

Exponential Growth of Stem Cell Technologies

The incorporation of stem cell technologies into modern medicine has been surprisingly slow.  However, this makes sense when you recognize that (as with all areas of technology) advances with stem cells are following an exponential, and not linear, path of progress. Past accomplishments are only a small indicator of future progress that will be achieved.

Regardless, to become educated about the potential for future growth in stem cell technologies, it is valuable to educate yourself about historical events that have accompanied the discovery and evolution of stem cells.  Both companies developing stem cell products and investors entering the stem cell sector can achieve improved decision-making through understanding technological advances that have driven breakthrough discoveries with stem cells to date.

Timeline of Landmark Events

The timeline below presents major accomplishments in stem cell research and development from 1860 to present (approximately a 150 year historical analysis). Enjoy!

Year DESCRIPTION OF EVENT
1860-1920 “Stem cells” inferred from analysis of embryo development and microscopy of bone marrow. (Germany)
1948-1958 Stem cell mechanisms deduced for sperm development and intestinal epithelium replacement. (Canada)
1958 First bone marrow transplants performed in human patients. (USA)
1958 Dr. Johgn Gurdon of Oxford University reported cloning a tadpole with genetic characteristics of the original frog. He used a “nuclear transfer” approach in which scientists use the nucleus of a mature skin cell to replace the nucleus of an embryonic cell. (United Kingdom)
1959 Experiments in mice prove the existence of resident blood stem cells in marrow. (England)
1961 Dr. James Till and Dr. Ernest McCulloch of the Ontario Cancer Institute proved that stem cells exist. Stem cells are important because they can develop into any kind of tissue in the body. (Canada)
1968 First allogeneic human marrow transplants achieved avoiding lethal rejection reactions. (USA)
1969 First application of cell separation technology to dissect marrow stem cell hierarchy. (Canada)
1974 Dr. Rudolf Jaenisch of the Salk Institute and Dr. Beatrice Mintz of the Fox Chase Institute created the first transgenic mammals” by inserting a virus that does not normally infect race into mouse embryos and watching the virus’s genes integrate into the embryonic cells as they developed into adult mice. This landmark creation of genetically modified mice set the stage for the use of viruses to create animal models of human diseases. (USA)
1978 Transplantable stem cells are discovered in human cord blood. (USA)
1981 Dr. Gail Martin of the University of California, San Francisco, isolated stem cells from mice embryos. (USA)
1981 Drs. Marlin Evans and Matthew Kaufman of the University of Cambridge reported growing mouse embryonic stem cells in a petri dish. (United Kingdom)
1982 Marrow stem cells measured by regenerative capacity in vivo are shown to be distinct from progenitors measured by colony methods. (Australia, USA)
1982-1986 First methodology developed for targeted genetic modification in embryonic stem cells. (UK, USA)
1984 Blood stem cells measured by colony formation in vivo are first extensively purified. (Holland)
1990 Mouse marrow regenerating stem cells are first completely separated from in vivo colony-forming cells. (USA)
1992 Neural stem cells identified in the adult human brain. (Canada)
1993 Pluripotency of embryonic stem cells is proven through the generation of entirely embryonic stem cell-derived mice. (Canada)
1994 First separation of cancer stem cells from the majority of cells in a cancer. (Canada)
1994 Patients with damaged corneas are successfully treated with corneal stem cells. (Taiwan)
1995 First derivation of primate embryonic stem cell lines. (USA)
1996 Dr. Ian Wilmut of the Roslin Institute used Dr. Gurdon’s nuclear transfer method (see Dec. 1962) to clone a mammal (Dolly, the sheep), replacing the nucleus of a fertilized embroyo with the nucleus from an adult mammary gland cell. (United Kingdom)
1998 Dr. James Thomson of the University of Wisconsin isolated human embryonic stem cells. (USA)
2000 Retinal stem cells identified in mice. (Canada)
2001 First collaborative stem cell research network – the Stem Cell Network – is formed. (Canada)
2001 Dermal stem cells identified in adult skin tissue. (Canada)
2002 First complete purification from mice of multipotent marrow stem cells capable as single injected cells of extended marrow regeneration in vivo. (Canada)
2002 The International Society for Stem Cell Research is formed. (Global)
2002 Creation of the International Stem Cell Forum (ISCF) to encourage international collaboration, and with the overall aim of promoting global good practices and accelerating progress in biomedical science. (Global)
2003 Cancer stem cells isolated in human brain tumours. (Canada)
2003 Rare human breast cancer stem cells identified. (USA)
2004 First derivation of dopaminergic cells from human embryonic stem cells, a hope for Parkinson’s disease treatment. (USA)
2004 International Consortium of Stem Cell Networks (ICSCN) is initiated, which aims to unify international efforts to make stem cell therapy a reality for a broad range of debilitating diseases. (Global)
2005 First evidence for human bone cancer stem cells. (USA)
2005 James Till and Ernest McCulloch win the Lasker Prize for experiments that first identified stem cells and set the stage for all current research on adult and embryonic stem cells. (Canada)
2006 Normal mammary stem cells demonstrated in adult mice. (Australia, Canada, US)
2006 Drs. Shinya Yamanaka and Kazutoshi Takahashi at Kyoto University generated “embryonic stem – likes cells” by introducing four genes (later known as the Yamanaka factors) into mouse fibroblasts (a type of connective-tissue cell, which in this case where skin cells). They named the cells “induced pluripotent stem cells” or iPS cells. (Japan)
2007 Mario Capecchi, Martin Evans and Oliver Smithies win the Nobel Prize for Physiology for Medicine for discoveries enabling germline gene modification in mice. (United Kingdom, Global)
2007 First physical identification and localization of mammalian intestinal stem cells. (Holland)
2007 First evidence for human colon cancer stem cells. (Canada)
2007 Dr. Yamanaka and Takahashi repeated the same feat with human cells, reprogramming human adult skin cells into iPS cells (see 2006) that are comparable to human embryonic stem cells. (Japan)
2007 Dr. Yamanaka described a modified protocol for the generation of human iPS cells from adult skin cells without the c-Myc retrovirus – a retrovirus capable of forming tumors. (Japan)
2007 Dr. James Thomson of the University of Wisconsin reported a method for converting human skin cells in cells that closely resemble embryonic stem cells. (USA)
2007 Dr. Rudolf Jeanie of the Whitehead Institute applied iPS technology to treat a human disease in a mouse model, showing that reprogrammed iPS cells obtained from healthy skin cells could improve the symptoms of sickle cell-like anemia in mice. (USA)
2008 Sam Weiss is awarded the Gairdner Prize for the discovery of neural stem cells. (Canada)
2008 Dr. Jaenisch showed that iPS cells reprogrammed into neurons could improve symptoms in an animal model of Parkinson’s disease. (USA)
2008 Drs. Yamanaka and Keisuke Okita used a modified iPS protocol developed in 2007 to generate virus-free iPS cells. (Japan)
2009 John Gurdon and Shinya Yamanaka win the Lasker Prize for discoveries in nuclear reprogramming. Yamanaka is also awarded the Gairdner Prize. (Global)
2009 iPS cells created with minimal residual genomic alteration. (Canada)
2010 Adult cells reprogrammed directly to neurons, cardiac muscle and blood cells. (Canada, USA)
2010 iPS cells created by transfection of mRNA. (USA)
2010 First clinical trial of human embryonic-derived stem cells for treatment of spinal cord injury. (USA)
2010 Dr. Marius Wernig of Stanford University converted mouse skin cells into functional neurons in a petri dish. (USA)
2010 Dr. Deepak Srivastava of the Gladstone Institutes directly reprogrammed mouse non-muscle cells into beating heart cells. (USA)
2010 Dr. Mick Bhatia of McMaster University converted human skin cells directly into human blood cells. (Canada)
2010 Dr. Sheng Ding of Scripps Research Institute used only one factor and a cocktail of pharmaceutical chemicals to reprogram skin cells into iPS cells. (USA)
2011 Isolation of multipotent human blood stem cells capable of forming all cells in the blood system. (Canada)
2011 Dr. Sheng Ding, now of Gladstone Institutes, reveled methods of directly reprogramming adult skin cells into neurons that can transmit brain signals. (USA)
2012 John Gurdon and Shinya Yamanaka win the Nobel Prize in Physiology or Medicine for the discovery that mature cells can be reprogrammed to become pluripotent. (United Kingdom, Japan)
2012 Dr. Srivastava showed that scar tissue that formed after a heart attack can be directly reprogrammed into beating heart cells in living animals, significantly improving heart function and strength. (USA)
2012 Dr. Steven Finkbeiner of the Gladstone Institutes, along with the International Huntington’s Disease (HD) consortium, reprogrammed skin cells from HD patients to iPS Cells, developing the first-ever human cell-culture model of HD. (USA)
2012 Japanese researchers announced plans for the first human clinical trails using iPS cells to treat age-related macular degeneration – a leading cause of blindness. (Japan)
2012 Dr. Yadong Huang of Gladstone Institute transformed skin cells – with a single genetic factor – into neural stem cells that developed on their own into an interconnected functional network of mature brain cells. (USA)
2012 Dr. Yamanaka, laboratory at the Gladstone Institutes discovered that environmental factors critically influence the growth of IPS cells, taking an important step towards understanding how these cells develop – and towards the ability to use stem cell based therapies combat disease. (USA)
2013 Induced pluripontent stem cells (iPSCs) enter the first ever clinical trial in humans, led by Masayo Takahashi of the RIKEN Center in Japan. The trial investigates the safety of iPSC-derived cell sheets for use in patients with macular degeneration. (Japan)
2014 A historic patent challenge occurs between a group called “BioGatekeeper” and Drs. Yamanaka and Takahashi, who hold a U.S. patent claiming a method for creating iPSCs (U.S. Patent No. 8,058,065).  (Global)

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2-Minute Overview: Stimulus-Triggered Acquisition of Pluripotency (STAP) Cells

There has been a lot of clamour and hype surrounding stimulus-triggered acquisition of pluripotency (STAP) cells since their introduction to the research community in 2014. However, it is difficult to find a good, succinct summary of the scientific controversy. In this post, we provide a brief overview of the cell type, bringing you quickly up to speed on the key points you need to know, in two-minutes flat. Enjoy

What are STAP Cells?

Stimulus-triggered acquisition of pluripotency (also known as STAP) is a process of creating pluripotent stem cells by subjecting ordinary cells to specific types of stress, such as the application of a bacterial toxin, submersion in a weak acid, or physical squeezing.[1]  It is a radically simpler method of stem cell generation than previously researched methods, because it does not require either nuclear transfer or the introduction of transcription factors.[2]  The technique for creating STAP cells in 2014 was discovered by Charles and Martin Vacanti and developed by Haruko Obokata at the Brigham and Women’s Hospital (BWH), and then later performed at the RIKEN Center for Developmental Biology in Japan. [3]

Background of STAP Cells

Interestingly, the concept grew out of an earlier discovery. In 2008, while working at Harvard Medical School, Obokata verified at the request of Charles Vacanti, that some of the cultured cells she was working with had shrunk to the size of stem cells after being squeezed through a capillary tube.[4]  She tested the outcome from imposing various stimuli on cells. After improving her technique, Obokata shared that she was able to demonstrate that white blood cells from newborn mice could be transformed into cells that behaved similarly to stem cells. She then repeated the process with other cell types, including skin, brain, and muscle cells, and generated the same result.[5]

When her findings were announced in January 2014 in the scientific journal Nature, they created enormous clamor within the scientific community. The technique is novel in that it has the potential to produce cheap, fast, and flexible cells for use in regenerative medicine, medical treatments, and cloning.

However, at this time, Obokata’s findings are both controversial and not validated, despite attempts by multiple researchers.  If the technique was able to be reproduced by other teams of scientists, then the discovery of STAP cells could represent the most significant stem cell discovery of 2014.  Unfortunately, the situation has not been this simple or straightforward.

The Controversy Over STAP Cells

On February 15, 2014, the RIKEN Center where Obokata conducts her stem cell research announced that an investigation had been opened to look into irregularities allegedly found in her two papers that were published in Nature.  The allegations against her questioned the use of what could be duplicated images within her papers.  Other allegations cited the failure of other prominent stem cell laboratories to reproduce her results.  Shortly thereafter, the journal Nature also announced that they were investigating the research papers.

To address that reproducibility has not been achieved in other laboratories, Obokata published technical ‘tips’ on the protocols on March 5, 2014, while promising that the full procedure will be published in due time.[6]  Despite this action, on March 11, 2014, Teruhiko Wakayama, one of the co-authors for the two articles, advised all the researchers involved to withdraw the articles, citing many “questionable points.”[7]  However, a United States based co-author of articles on STAP cell research, Charles Vacanti of Harvard Medical School, has publicly stated that he opposes their retraction and has posted information about how to generate STAP cells on his website.[8]

On March 14, 2014, RIKEN released an interim report of their investigation.  Among the six items being investigated, the committee concluded that there has been inappropriate handling of data for two of the items, but did not conclude that the mishandling had involved “research misconduct.”[9]  As such, the investigation of the remaining four items continues.

In the original research presenting the technique, STAP cells were produced by exposing CD45+ murine spleen cells to acidic medium with a pH of 5.7 for approximately a half-hour.[10]  After this treatment, the cells were confirmed to be pluripotent by observing increasing levels of Oct-4, a transcription factor expressed in embryonic stem cells.  This was tested over the following week using an Oct4-GFP-transgene.  On average, about 25% of cells survived the acid treatment, but over 50% of those that survived converted to Oct4-GFP+CD45- pluripotent cells.

The researchers also found that treatment with bacterial toxins or physical stress were conducive to the acquisition of pluripotent markers.[11]  Additionally, STAP cells injected into mouse embryos demonstrated pluripotency, growing into a variety of tissues and organs found throughout the body.  According to the researchers, the mice appeared “to be healthy, fertile, and normal” after one-to-two years of observation.[12]  Additionally, these mice produced healthy offspring, thereby demonstrating germline transmission, which is “a strict criterion for pluripotency, as well as genetic and epigenetic normality.”[13]

One of the most interesting reported traits of STAP cells is that they are supposedly able to differentiate into placental cells.  This totipotent capacity, the ability to turn into any cell in the body or placenta, could mean the cells are even more powerful than embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs).  Pluripotent cells, such as ESCs or iPSCs, can form any cell in an embryo but not in a placenta.  On the other hand, totipotent cells can form any cell in an embryo or a placenta, meaning they have the capacity to create life.  The only cells known to be naturally totipotent are in embryos that have undergone only the first couple of cell divisions immediately after fertilization.

Production of Human STAP Cells

Furthermore, research has been undertaken to attempt to generate stimulus-triggered acquisition of pluripotency (STAP) cells using human tissue.  Specifically, in February 2014 Charles Vacanti and Koji Kojima, Harvard researchers who were originally involved in the discovery and publication of STAP cells, claimed to have preliminary results of STAP cells generated from human fibroblasts.  On February 5, 2014, they provided images of the first human “STAP cell” experiments to the New Scientist.  However, they also cautioned that these preliminary results require further analysis and validation.[14]

In summary, STAP cells are of interest to the stem cell research community, in that if validated, they could represent an easier, faster, and more flexible method for generating totipotent cells.  However, there is currently substantial controversy surrounding the discovery and ongoing investigation seems to indicated that the technique may not be worthy of research attention. Rather, it may be a case of misrepresented findings. In particular, lack of reproducibility of Obokata’s findings continues to be a major issue.

Opportunities for Commercialization?

For companies interested in capitalizing on current interest in STAP cells, it may be viable to offer products that could aid in the investigation of these research protocols and methodologies. However, it is risky area for product development, because evidence suggests that STAP protocols may not be valid or reproducible. There are other more worthy stem cell types to target for commercialization, and all current evidence indicates you should stick to them.

Footnotes

[1] Cyranoski, D. 2014. Acid bath offers easy path to stem cells. Nature, 505 (7485), p. 596.

[2] Obokata, Haruko; et al. (2014-01-30). “Stimulus-triggered fate conversion of somatic cells into pluripotency”. Nature 505 (7485): 641–647. doi:10.1038/nature12968.PMID 24476887. Retrieved March 17, 2014.

[3] Grens, Kerry (29 January 2014). “New Method for Reprogramming Cells”. The Scientist. Retreived March 19, 2014.

[4] Sample, Ian (29 January 2014). “Simple way to make stem cells in half an hour hailed as major discovery”. The Guardian.

[5] Ibid.

[6] Haruko Obokata, Yoshiki Sasai and Hitoshi Niwa (March 2014). Essential technical tips for STAP cell conversion culture from somatic cells. Nature Protocols Discussion Forum.

[7] “Professor wants STAP findings withdrawn”. The Yomiuri Shimbun. 11 March 2014. Retrieved March 19, 2014.

[8] Charles A Vacanti (2014). Protocol for generating STAP cells from mature somatic cells. Center for Tissue Engineering and Regenerative Medicine. Retreived March 16, 2014.

[9] Press Release (March 14, 2014). “Interim report on the investigation of the Obokata et al. articles”. RIKEN. Retrieved March 20, 2014.

[10] Obokata, Haruko; et al. (2014-01-30). “Stimulus-triggered fate conversion of somatic cells into pluripotency”. Nature 505 (7485): 641–647. doi:10.1038/nature12968.PMID 24476887. Retrieved March 17, 2014.

[11] Sample, Ian (29 January 2014). “Simple way to make stem cells in half an hour hailed as major discovery”. The Guardian.

[12] Ibid.

[13] Obokata, Haruko; et al. (2014-01-30). “Stimulus-triggered fate conversion of somatic cells into pluripotency”. Nature 505 (7485): 641–647. doi:10.1038/nature12968.PMID 24476887. Retrieved March 17, 2014.

[14] Ibid.


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BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in stem cell industry data.

To learn more about the stem cell industry, view the global strategic report “Stem Cell Research Products – Opportunities, Tools, and Technologies” ” now.

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Induced Pluripotent Stem Cell News Round-Up| February 22 – 28, 2015

“Supreme Court Rules on Stem Cells, $100 Billion Proposed for International Stem Cell Collaboration, Japan to Launch iPSC Therapy Center, and More”

Induced pluripotent stem cells (iPSCs) are a rapidly evolving area of stem cell science. Since the discovery of the cell type in 2006, there have been several important market events, including the first ever clinical trial in humans which launched in August of 2013 to evaluate the capacity of iPSC-derived cell sheets for their ability to restore vision in patients with wet-type macular degeneration. More recently, the Supreme Court rejected the right of the Wisconsin Alumni Research Foundation (WARF) to control patents related to iPSC derivation in a landmark patent decision issued in February 2015.

Every month there are major events occurring in the iPSC sector that shift industry dynamics. For those of us interested in the iPSC industry, tracking shifting dynamics is of vital importance. For this reason, this post covers critical iPSC industry events for the week of February 22-28, 2015.

iPSC News Round-Up for February 22-28, 2015

1. $100 Billion for International Stem Cell Program? CIRM’s Klein proposes massive international collaboration [February 22, 2015]

The main architect of California’s groundbreaking 2004 stem cell initiative has proposed a $100 billion international bond program in life sciences, to speed up research and clinical testing of disease therapies. The program would be focused on stem cells and genomics.

Bob Klein, a real estate developer who spearheaded the creation of the California Institute for Regenerative Medicine, unveiled his proposal at last Thursday’s UCSD Moores Cancer Center symposium. The United States and a few other countries would jump-start the program and other countries would join.

Read More…

2. Supreme Court Rejects Stem Cell Patent Case [February 24, 2015]

A nine-year legal challenge to human embryonic stem cell patents ended Tuesday, when the Supreme Court declined to hear the case.  The decision means the Wisconsin Alumni Research Foundation, or WARF, will get to keep its patent rights for the cells, which were discovered in 1998 by University of Wisconsin – Madison scientist James Thompson.

However, the challengers succeeded in preventing WARF from gaining rights over induced pluripotent stem cells, said Jeanne Loring, a stem cell scientist at The Scripps Research Institute in La Jolla who was part of a coalition contesting the WARF patents.

Loring and two public interest groups, Consumer Watchdog and the Public Patent Foundation, challenged the patents in 2006, and in 2007 succeeded in narrowing WARF’s claims to exclude the IPS cells.

Read More…

3. Kyoto University Hospital in Japan to open iPS cell therapy center in 2019 [February 24, 2015]

Kyoto University Hospital in Japan says it will open a center to conduct clinical studies on induced pluripotent stem cell therapies in 2019 year.

Officials said the 30-bed ward will test the efficacy and safety of the therapies on volunteer patients. The hospital aims to break ground at the site next February and complete construction by September 2019.

Ongoing research on iPS cells at Kyoto University includes turning the cells into dopamine-releasing neurons for transplant into patients with Parkinson’s disease, and creating a formulation of platelets that helps blood to clot. Professor Shinya Yamanaka, who shared the 2012 Nobel Prize in medicine, leads the existing iPSC research center at Kyoto University.

Read More…

4. How Pluripotent Stem Cells Are Grown Affects Their Genetic Stability [February 25, 2015]

Human pluripotent stem cells, which include both human embryonic stem cells (hESCs) and adult stem cells like induced pluripotent stem cells (iPSCs), need large numbers for transplantation into patients but the process of translating their potential into effective, real-world treatments involves deciphering and resolving a host of daunting complexities, according to a new study.

The authors say they have definitively shown that the culture conditions in which stem cells are grown and mass-produced can affect their genetic stability

Read More…

5. Scientists Complete First Steps Toward Making Sperm and Eggs From Skin Stem Cells [Feb 26, 2015]

Dr. Jacob (Yaqub) Hanna, from the Weizmann Institute of Science in Israel:   “Our research is focused on taking skin cell samples and converting them into embryonic-like stem cells (iPS cells) via direct reprogramming and without using embryo derived stem cell lines. Then we are focusing in differentiating these male or female iPS lines into sperm cells or oocytes, respectively. We have succeeded in the first and most important step of the process, where we succeed in reaching the progenitor cell state for sperm and egg… So we are now focusing on completing the second half of this process.”

Read More…

6. Neurons controlling appetite made from skin cells [February 27, 2015]

Researchers have for the first time successfully converted adult human skin cells into neurons of the type that regulate appetite, providing a patient-specific model for studying the neurophysiology of weight control and testing new therapies for obesity. The study, led by researchers at Columbia University Medical Center (CUMC) and at the New York Stem Cell Foundation (NYSCF), was published last month in the online issue of the Journal of Clinical Investigation.

In a separate study, which appeared in the February 10 issue of the journal Development, Kevin Eggan, PhD, Florian Merkle, and Alexander Schier of Harvard University have also succeeded in creating hypothalamicneurons from iPS cells. These neurons help to regulate behavioral and basic physiological functions in the human body, including, in addition to appetite, hypertension, sleep, mood, and some social disorders.

Read More…

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About Us

BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in stem cell industry data.

To learn more about the iPSC industry, view the “Complete 2013-14 Induced Pluripotent Stem Cell Industry Report” now.

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The Definitive Guide to Perinatal Stem Cells

The Beginning: Embryonic vs. Adult Stem Cells

When stem cells were first identified, only two types of stem cells were commonly discussed, adult stem cells and embryonic stem cells.  However, a diverse range of stem cell types now exist, because human embryonic stem cells have become further characterized, the diversity of adult stem cell types has substantially expanded, and induced pluripotent stem cells (iPSCs) have since been discovered.

Now, researchers debate the number of stem cells in existence, as the number depends on whether stem cells are characterized functionally (e.g. neural stem cells, mesenchymal stem cells, induced pluripotent stem cells) or characterized by source tissue (e.g cord blood stem cells, dental pulp stem cells, amniotic stem cells, etc.).

What is clear is that dozens of stem cell types now exist, all representing unique opportunities for your company. As such, substantial complexity has been added to the stem cell landscape.

An Introduction to Perinatal Stem Cells

In this post, we explore the interesting area of perinatal stem cell types, an often over-looked period of stem cell development that even many stem cell researchers can’t clearly define.  “Perinatal” is a term defining the short period right and after birth. As such, it encompasses both pre-natal and post-natal stem cells.

To best understand the difference between various embryonic, pre-natal, post-natal, and adult stem cells, it is helpful to define each:

  • Adult stem cells are all stem cells derived from living humans
  • Embryonic stem cells are stem cells derived from embryos
  • Pre-Natal stem cells are those derived from the fetus
  • Post-Natal stem cells are those derived from a recent newborn

Based on those definitions, the primary characteristic that separates embryonic versus perinatal versus adult stems cells is their source tissue. However, it is possible to further characterize each stem cell type by another characteristic, which is their differentiation capacity.  For instance, human embryonic stem cells (hESCs) can be further characterized by whether they represent a population of totipotentpluripotent, or multipotent cells, as described below.

Early human embryonic stem cells (hESCs) are derived from embryos that have been fertilized in vitro in fertilization clinics with informed donor consent.  Embryonic stem cells are typically harvested shortly after fertilization (within 4-5 days) by transferring the inner cell mass of the blastocyst into culture medium.

In mammals, the fertilized oocyte, zygote, 2-cell, 4-cell, 8-cell and morula resulting from cleavage of the early embryo are examples of totipotent cells.[1]   “Totipotent” cells are defined as those that have the capacity to form an entire organism.

5-6 four days post-fertilization, totipotent cells begin to specialize, at which point they become pluripotent or multipotent.  “Pluripotent” cells can give rise to most, but not all, tissues within an organism.  “Multipotent” cells are undifferentiated cells, but are limited to giving rise to specific populations of cells. For example, multipotent blood stem cells can differentiate into red cells, white cells and platelets in the blood.

While the precise point at which a stem cell switches from an embryonic stem cell to a pre-natal stem cell is blurry, pluripotent and multipotent stem cell types are often considered pre-natal stem cells instead of embryonic stem cells because of their more limited differentiation capacity.

Types of Perinatal Stem Cells

As mentioned, “perinatal” is a term describing the period right before (pre-natal) and after birth (post-natal).  These two categories of perinatal stem cells are explored in more depth below.

Pre-Natal Stem Cells

The first type of perinatal stem cells are pre-natal stem cells.  Pre-natal stem cells are similar to embryonic stem cells, in that they can be further distinguished by their pluripotency. Not surprisingly, as stem cells produced slightly later in development, prenatal stem cells are largely pluripotent stem cell populations, as described below.

1. Gonadal Ridge, 6 months (Pluripotent)

Primordial germ cells exist briefly in an embryo before they associate with somatic cells of the gonads and differentiate into germ cells.  Human embryonic germ cells (hEGCs) are stem cells that originate from the primordial germ cells of the gonadal ridge of 5- to 9-week old fetus. Since 1998, hEGCs have been successfully isolated and characterized.[2]

They are pluripotent, meaning they can develop into any of the three potential germ layers: ectoderm, mesoderm, and endoderm.

2. Fetal Stem Cells (Pluripotent)

While early hESCs and gonadal ridge hESCs are derived from pre-implantation embryos, fetal stem cells are derived from primitive cells in the organs of fetuses. Specifically, neural crest stem cells, fetal hematopoietic stem cells and pancreatic islet progenitor cells are three types of stem cells that have been isolated from fetuses.[3]

Fetal stem cells are characterized by pluripotency, with neural stem cells taken from fetal brain tissue able to differentiate into both neurons and glial cells,[4],[5] and hematopoietic stem cells isolated from fetal blood and placenta able to differentiate into several blood cell types.

Post-Natal Stem Cells (Multipotent)

The second type of perinatal stem cells are post-natal stem cells. The most widely known of the post-natal stem cells are cord blood and cord tissue stem cells, although other more obscure types also exist.

1. Cord Blood Stem Cells (Multipotent)

The blood present in the newborn umbilical cord contains circulating stem cells. There are several important properties of umbilical cord blood, including that umbilical cord blood hematopoietic stem cells equal or exceed the frequency of those in bone marrow, they can produce large colonies in vitro, they have different growth factor requirements, and they can be expanded in long-term culture.[6]

Cord blood stem cells are characterized as multipotent, as they are capable of differentiating into numerous stem cell types, including neurons, hepatic cells, and circulating cell types.[7]

Typically, umbilical cord stem cells are most easily differentiated into cells found within the blood and lymph (immune) systems, such as red blood cells, which transport oxygen within the body; white blood cells, which combat bacterial and viral infection; and platelets, the “sticky” cells that aid in the clotting of blood.

The ability of cord blood stem cells to differentiate into cells of the blood and immune systems means that they hold significant potential for use in treatment of diseases that include heart disease, stroke, and neurological conditions like Alzheimer’s.

2. Cord Tissue Stem Cells (Multipotent)

While most research up to this point has focused on the blood present in umbilical cord tissue, the matrix cells that form umbilical cord tissue (known as “Wharton’s Jelly”) also contain stem cells.  Wharton’s Jelly has been a source of isolation for mesenchymal stem cells, which express typical stem cell markers (such as c-kit and high telomerase activity).  Mesenchymal stem cells derived from this source have been propagated for long population doubling times and can be induced to differentiate in vitro into neurons[8].

To date, this area of stem cell research has not produced FDA approved clinical applications, although several clinical trials are underway. Two particularly promising applications for this type of stem cell (among many other potential applications) are:

1) The ability of umbilical cord matrix stem cells to express hepatic markers and differentiate into hepatocyte-like cells[9],[10],[11]; and

2) The ability of umbilical cord matrix stem cells to differentiate into neurons and glia.[12],[13] ,[14]

Summary of Perinatal Stem Cells

In summary, embryonic stem cells, perinatal stem cells, and adult stem cells can all be sourced from humans, although the process for sourcing each and their differentiation capacity can vary.  For those operating in the stem cell research space, having a clear understanding of the characteristics of each stem cell type opens up new ideas and concepts for applied applications. It is often in over-looked stem cell types that commercial opportunity can exist.

Footnotes:

[1] Bongso A, Richards M. History and perspective of stem cell research.  Best Practice & Research Clinical Obstetrics & Gynaecology.  2004; 18(6): 827-842.

[2] Shamblott MJ, Axelman J, Wang S, et al. Derivation of pluripotent stem cells from cultured human primordial germ cells. Proc Natl Acad Sci USA. 1998; 95: 13726–13731.

[3] Beattie GM, Otonkoski T, Lopez AD, et al. Functional beta-cell mass after transplantation of human fetal pancreatic cells: Differentiation or proliferation?  Diabetes. 1997; 46: 244–248.

[4] Brustle O, Choudary K, Karram K, et al. Chimeric brains generated by intraventricular transplantation of human brain cells into embryonic rats. Nat Biotech. 1998; 16: 1040–1044.

[5] Villa A, Snyder EY, Vescovi A, et al. Establishment and properties of a growth factor dependent perpetual neural stem cell line from the human CNS. Exp Neuro. 2000; 161: 67–84.

[6] Rogers I, Casper RF. Umbilical cord blood stem cells. In Best Practice &Research Clinical Obstetrics&Gynaecology. 2004; 18(6): 893-908.

[7] Ilancheran, et al. Human fetal membranes: a source of stem cells for tissue regeneration and repair? Placenta. 2009; 30(1): 2-10.

[8] Bongso A, Lee EH.  E-textbook: Stem Cells: Their Definition, Classification and Sources.  http://www.worldscibooks.com/lifesci/etextbook/5729/5729_chap1.pdf. Retrieved March 20, 2014.

[9] Campard, et al. Native umbilical cord matrix stem cells express hepatic markers and differentiate into hepatocyte-like cells. Gastroenterology. 2008; 134 (3): 833-848.

[10]Sáez-Lara, et al. Transplantation of human CD34+ stem cells from umbilical cord blood to rats with thioacetamide-induced liver cirrhosis. Xenotransplantation. 2006; 13(6): 529-535.

[11] Wang, et al. Induction of umbilical cord blood-derived beta2m-c-Met+ cells into hepatocyte-like cells by coculture with CFSC/HGF cells. Liver Transpl. 2005; 11(6): 635-643.

[12] Mitchell, et al. Matrix Cells from Wharton’s Jelly Form Neurons and Glia. Stem Cells. 2003; 21: 50-60.

[13] McGuckin, et al. Culture of embryonic-like stem cells from human umbilical cord blood and onward differentiation to neural cells in vitro. Nat Protoc. 2008; 3(6): 1046-1055.

[14] Jomura, et al. Potential treatment of cerebral global ischemia with Oct-4+ umbilical cord matrix cells. Stem Cells. 2007; 25(1): 98-106.


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BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in stem cell industry data.

To learn more about emerging opportunities within stem cell industry, view the global strategic report “Stem Cell Research Products – Opportunities, Tools, and Technologies” ” now.

Stem Cell Research Products - Opportunities, Tools, and Technologies | Market Report

 

Medical Society Opinions: People Seeking Cord Blood Knowledge May Not Know This

When considering the value of cord blood banking, either for personal use or to assess an investment opportunity within the sector, it interesting to consider recommendations about cord blood banking issued by medical societies, associations, and ethics committees.

In most cases, medical societies have issued positive stances toward public cord blood banking, but have shown little support for the private sector. However, there are exceptions made for families that have a predisposition to a condition in which cord stem cells could be therapeutically applied.

Summary of Medical Society Opinions

The table below shows opinions issued by medical societies about cord blood banking. Interestingly, all of these recommendations are based on outdated transplant statistics, ranging from 2004 to 2009. As far as we are currently aware, no U.S. medical body has issued a renewed stance on cord blood banking over the past several years.

(Note: If you are a member of a medical society that has issued a more up-to-date stance, please comment below.)

This is somewhat surprising, as technology in the cord blood industry is rapidly advancing for processing technologies, storage techniques, transplant methodologies, and more.  Furthermore, none of these medical societies have included a consideration of emerging therapies while establishing their positions and guidelines.

The reason that emerging therapies are not considered in their current recommendations are they cannot easily be compared against current medical alternatives. Projected therapies that may one-day exist, including those that will arise within a timeline to allow currently stored cord blood samples to be utilized, are not considered at all, because they are speculative.

TABLE. CORD BLOOD BANKING OPINIONS ISSUED BY MEDICAL SOCIETIES

Medical Society Opinions of Cord Blood Banking*NOTE: Click on the table above to enlarge.

Summary of Findings

In summary, medical societies have largely issued positive stances toward public cord blood banking, and negative stances toward the private banking, with exceptions made for families who have a history of disease that could be addressed through cord blood stem cell transplant.

However, these opinions are largely outdated and it would be optimal for new stances to be published based on current processing technologies and medical applications.

Therefore, it is up to the individual consumer (expectant parents or investors entering the cord blood market) to learn about the advantages of cord blood transplant over other existing alternatives, such as bone marrow and peripheral blood transplant. You are then positioned to weight the value of private cord blood storage against the cost involved.  For public cord blood banking, the costs are covered by the public bank, which makes it an intelligent choice for most (if not all) families who can access the service.

View this post to further educate yourself about the technical advantages of cord blood.

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About Us

BioInformant is the only research firm that has served the cord blood sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in cord blood industry data.

To learn more about the cord blood banking industry, view the “Complete 2015-16 Global Cord Blood Banking Industry Report” now.

Complete 2015-16 Global Cord Blood Banking Industry Report

 

Induced Pluripotent Stem Cell News Round-Up| February 2015

The induced pluripotent stem cell (iPSC) industry is a rapidly evolving area.  Since the discovery of iPSCs in 2006, there have been a number of important market events that have occurred, including the first ever clinical trial in humans that was initiated in August 2013 to investigate iPSC-derived cell sheets for restoring vision, as well as large funding awards, major initial public offerings (IPOs), critical patent challenges, and more.

Every month there are major events occurring in the sector that shift industry dynamics. Often, these events are announcements of technical or scientific advancements.  Sometimes there are announcements of major industry alliances. Occasionally, there are announcements of a new industry competitor, a major milestone, or a significant funding award.

For those of us interested in the induced pluripotent stem cell (iPSC) industry, tracking these shifting dynamics is of paramount importance.  For this reason, this post covers the most significant iPSC industry news events as of February 2015.

Note that we will be covering major case law, patents, clinical trials, grant awards, and scientific advancements in separate articles, so sign-up for our email list below to be alerted as soon as this content is posted.

iPSC News Round-Up for February 2015

1. New partnership aims to create stem cell resource to study psychiatric disorders [February 20, 2015]

The New York Stem Cell Foundation (NYSCF) and the Stanley Center at the Broad Institute of MIT and Harvard are partnering to create a foundational stem cell resource to study psychiatric disorders through the production of induced pluripotent stem (iPS) cell lines from individuals with schizophrenia and other psychiatric disorders.

Read More…

2.  In vitro platform for antimalarial testing developed from stem cells [February 19, 2015]

Lab-grown liver cells derived from induced pluripotent stem cells may allow for personalized testing on antimalarial drugs and vaccines, according to recent data. “The platform can be used for testing candidate drugs that act against the parasite in the early liver stages, before it causes disease in the blood and spreads back to the mosquito vector,” says Sangeeta Bhatia, MD, PhD, of MIT and Brigham and Women’s Hospital. Bhatia and colleagues reprogrammed human skin cells to generate iPSC, which were then adapted to model cells from the liver using a 20-day in vitro differentiation protocol.

Read More…

* NOTE: Cellular Dynamics International (CDI) also published a press release about this iPSC news topic on February 11, 2015, titled “iCell Hepatocytes Enable Malaria-in-a-Dish Studies.” In this press release, CDI wrote  that their iCell® Hepatocytes, or human liver cells manufactured from iPSCs, had been used as a malaria-in-a-dish model to test anti-malarial drug candidates.

3.  Cynata Therapeutics achieves stem cell manufacturing breakthrough [February 19, 2015]

Cynata Therapeutics has achieved a breakthrough in the manufacture of stem cells and is set to scale up manufacturing of its mesenchymal stem cells derived from iPSCs for therapeutic use.

The company’s lead Cymerus™ stem cell manufacturing process has now been successfully validated through extensive trials at Waisman Biomanufacturing in Madison, Wisconsin. The trials confirmed this state-of-the-art stem cell manufacturing process is capable of producing MSCs for therapeutic application, consistently, efficiently and economically, in a Good Manufacturing Practice (GMP) production environment.

Importantly, the Cymerus™ process uses an effectively limitless starting material – a bank of induced pluripotent stem cells (iPSCs) – and a patent-protected process to derive MSCs for commercial use.

Read More…

4.  Cellular Dynamics Manufactures cGMP HLA “Superdonor” Stem Cell Lines to Enable Cell Therapy With Genetic Matching [February 9, 2015]

Cellular Dynamics International, Inc. (CDI) announced that it has manufactured, under current Good Manufacturing Practices (cGMP), stem cell lines from two HLA “superdonors.” HLA superdonors are individuals whose genetic HLA (human leukocyte antigens) profiles make their cells or tissues more compatible for donation to unrelated patients. As the first announced HLA superdonor master cell bank in the world, and the first produced under cGMP, these cell lines will enable a new area of cell therapy research using HLA matching.

CDI manufactured the HLA superdonor cell lines from blood samples collected from eligible anonymous donors.  The induced pluripotent stem cell (iPSC) lines made from the donor samples are pluripotent, meaning they can be used to produce virtually any cell type in the human body.

Read More…

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About Us

BioInformant is the only research firm that has served the stem cell sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in stem cell industry data.

To learn more about the iPSC industry, view the “Complete 2013-14 Induced Pluripotent Stem Cell Industry Report” now.

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Cord Blood Scientific Publications May Predict What Will Happen in 2015 and Beyond

Trend rate data is valuable for understanding current industry conditions, as well as for predicting future behavior within the cord blood industry.

In upcoming posts, we will be presenting a range of valuable trend rate data, pulled from diverse sources, including grant funding databases, patent databases, clinical trial databases, and more.

In this post, we will begin with an analysis of scientific publication rate data for cord blood industry, because it is an important way to gauge innovation and progress within the marketplace.

Scientific Publication Rate Analysis

PubMed is a service of the U.S. National Library of Medicine and the National Institutes of Health (NIH) that contains citations from MEDLINE and a diverse collection of other life science journals. The data below was generated using the PubMed database, because it is the largest, most comprehensive, and most up-to-date global meta-database available for scientific publications.[1]

It is also the most versatile tool for screening by multiple criteria.

For purposes of this analysis, the search term “Cord Blood” was used. It was chosen because it captures all longer-tail searches, including words like: “Umbilical Cord Blood,” “Cord Blood Banking,” “Cord Blood Transplant,” and more.

To compare growth rates for the related service of cord tissue storage, the search term “Cord Tissue” was also examined. Again, this phrase captures all longer-tail searches, including phrases such as: “Cord Tissue Stem Cells,” “Cord Tissue Banking,” and more. See data below.

TABLE. TREND RATE ANALYSIS FOR “CORD BLOOD” & “CORD TISSUE” SCIENTIFIC PUBLICATIONS, BY YEAR

Cord Blood Scientitic Trend Rate Analysis (Table)

* Note: For the “% Year-Over-Year Change” column, years with a positive change are in green
and years with a negative change as in red.
The 2014 figures are full-year estimates based on PubMed date for January 1 – November 1, 2014.

Trend Rate Analysis

In the first graph below, you can see rates of scientific publications containing the term “Cord Blood” over a trailing 10-year period. The key finding is that a relatively predictable, linear increase in publications is observable over this period of time.

Analysis of Scientific Publications Containing "Cord Blood"Next, fitting an exponential best-fit line to this data set (Rvalue of­­­­­ 0.9863[2]) , five-year projection data predicts that cord blood publications will reach nearly 1,600 per year by 2019. Note that an exponential best-fit line better describes this data set than a linear, logarithmic, power, polynomial, or moving average best-fit line.

See five-year future projection data below.

5 Year Projection Analysis of Scientific Publications Containing Cord Blood

In the next graph, the same trailing 10-year historical analysis is completed for scientific publications containing the term “Cord Tissue.”

Analysis of Scientific Publications Containing Cord Tissue

Unfortunately, a best-fit line does not fit well for this “Cord Tissue” data set. Indeed, an exponential best-fit line, which is more accurate than a linear, logarithmic, power, polynomial, or moving average best-fit line for this data set, provides only an Rvalue of­­­­­ 0.7307.[3]

If one chooses to ignore the poor fit of this trend line and extrapolate for purposes of creating five-year projection data, then it predicts that cord tissue publications will reach approximately 125 per year by 2019. However, actual numbers could vary substantially from this prediction, given the described limitation of this best-fit line and the smaller quantities involved within this data set.

See five-year future projection data below.

5 Year Projection Analysis of Scientific Publications Containing Cord Tissue

Summary

In summary, there have been consistent linear increases in scientific publications containing the term “Cord Blood” for the past 10 years. While past behavior is nota guarantee of future behavior, this consistent trend rate data suggests that accurate future predictions may be possible.

However, there have been less consistent trends observable for scientific publications containing the term “Cord Tissue.” As such, it is much more difficult to make accurate predictions in this area of stem cell medicine.

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Footnotes:                      

[1] Ncbi.nlm.nih.gov, (2014). Home – PubMed – NCBI. [online] Available at: http://www.ncbi.nlm.nih.gov/pubmed [Accessed 6 Nov. 2014].

[2]R² is a statistical term describing how good one term is at predicting another. If R² is 1.0 then given the value of one term, you can perfectly predict the value of another term. . If R² is 0.0, then knowing one term does not help you know the other term at all.

[3] Ibid.

About Us

BioInformant is the only research firm that has served the cord blood sector since it emerged. Our management team comes from a BioInformatics background – the science of collecting and analyzing complex genetic codes – and applies these techniques to the field of mark research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, CBS News, Medical Ethics, and the Center for BioNetworking. Serving Fortune 500 leaders that include GE Healthcare, Pfizer, Goldman Sachs, Beckton Dickinson, and Thermo Fisher Scientific, BioInformant is your global leader in cord blood industry data.

To learn more about the cord blood banking industry, view the “Complete 2015-16 Global Cord Blood Banking Industry Report” now.

Complete 2015-16 Global Cord Blood Banking Industry Report