Unbelievable Advances in Cord Blood Processing: 4 Market Leaders You Need to Know

Introduction to Automated Cord Blood Processing

This post considers the four key processing technologies that are operating within the global cord blood marketplace. It provides a framework of understanding for current market options and the technologies that are being used by industry leaders.

Automated processing systems have many benefits, including speed, processing efficiency, and cost-savings. However, automated processing systems have not always dominated the cord blood industry. In 2006, the AutoXpress® System was launched by Thermogenesis, a company which then merged with TotipotentRX Corporation in February 2014 to create Cesca Therapeutics.[1]

The AutoXpress® (AXP®) technology was the first automated, functionally closed, sterile system to obtain stem cells from cord blood through an efficient and high yield process, allowing for the automated processing of cord blood samples. The AXP® Platform brought unprecedented automation and precision to cord blood stem cell processing. By 2007, Cord Blood Registry, the world’s largest private cord blood bank, had fully incorporated the AXP® platform into its cord blood operations, showing the willingness of company management to invest in new processing technology.

Automated processing systems efficiently recover mononuclear cells (MNC) in cord blood collections. One of the other major benefits to automated processing systems is found in the replaced need for additives and human manipulation. As the first automated processing technology to enter the cord blood market, the AXP® Platform uses optical sensor technology to formulate precision separation and retention of almost all the target mononuclear cell population. When this process is automated, there is a reduced chance of contamination and an increased reliability of results.

Four Market Leaders in Automated Cord Blood Processing

There are now four key processing technologies operating within the cord blood banking market that allow for automation of the traditional process of manual cord blood processing, each with distinct advantages and disadvantages, as described below.

1. AutoXpress® Platform (“AXP®”) and BioArchive System (By Thermogenesis, a Division of Cesca Therapeutics in Rancho Cordova, California, USA)

As mentioned, in 2006, the AutoXpress® System was launched by Thermogenesis, a company that was acquired by Cesca Therapeutics in February of 2014. It was announced as the first automated, functionally closed, sterile system to obtain stem cells from cord blood through an efficient and high yield process.

The system can reduce a unit of cord blood to an exact volume selected by an individual processer, using a closed processing set and individual collection bags for buffy coat, plasma, and red blood cells.[2] Together, the system reliably collects all fractions. One of the key benefits of the AXP® Platform is the high success rate of cell yield, an important metric because transplant survival rates improve when higher numbers of stem cells are used in cell therapy.

In addition, the system enables the tracking of data for each unit of cord blood processed. An advantage of the AXP® platform is that cord blood units processed with AXP® are richer in mono nuclear cells (MNC) than units processed by traditional means, and the CD34+ stem cell recovery is greater than 97%.[3] The system also has an in-line clot filter and multiple sampling ports to ensure quality results.

Shortly after launch of the AXP® technology, the world’s largest private cord blood bank by total units stored, Cord Blood Registry, incorporated the AXP® platform into its business operations. In addition to serving the private cord blood sector, the technology has entered the public cord blood banking sector. The National Cord Blood Program of the New York Blood Center (NYBC), the largest public cord blood bank in the world, has also adopted AXP® processing. Since its inception, the National Cord Blood Program has publicly stored over 60,000 cord blood units. In December 2013, ThermoGenesis Corp. also entered into a major deal with Bebevida, a cord blood stem cell bank in Portugal, to provide the AXP® AutoXpress® System for their service, a contract which allowed them to replace a competitor’s automated processing system and expand the reach of the AXP® system within Europe.

2.  Sepax (By Biosafe, in Eysins, Switzerland)

The Sepax system, similar to the AXP® system, is a fully-automated system that allows for efficient processing of umbilical cord blood, in a bag processing set, through centrifugation and the eventual separation into different components.

The Sepax system separates cellular components by utilizing a light beam to identify the density gradient between various cell layers, after cellular separation has been achieved through centrifugation of the full blood sample. The system uses a rotating syringe technology that provides both separation and component transfer through displacement of the syringe piston. The bag system is a single-use, sterile, fully-closed system.

Compared to the AXP® platform, the Sepax system generates a substantially better total nucleated cell (TNC) recovery.[4] It also has strong CD34+ cell recovery after cord blood unit volume reduction. Finally, the system is efficient in red blood cell depletion, but unlike the AXP® platform, it uses Hydroxyethyl Starch (HES) to accomplish this.[5]

One of the most commonly used automated processing systems within the cord blood industry, the Sepax system is used by many market leaders, including Cryo-Save, the largest private cord blood storage operator in Europe with samples stored from over 70 countries, across six continents. Cryo-Save also has processing and storage facilities in Belgium, Germany, Dubai, India, and South Africa, making this a large and important contract for BioSafe.

3.  PrepaCyte®-CB (By BioE in St. Paul, Minnesota, USA) 

Produced by BioE, the PrepaCyte®-CB system is a sterile, three-bag, closed system which is used to separate and obtain Total Nucleated Cells (TNC) including CD34+ stem cells and other stem cells from cord blood.[6] It is manufactured in accordance with current Good Manufacturing Practices (cGMA) regulations of the United States FDA. It is a simple system that allows for greater uniformity in processing.

This system of cord blood processing has the ability to provide greater yields of clinically relevant cells, most importantly stem cells, by removing approximately 99% of all unnecessary red blood cells from the final processed cord blood unit. It also minimizes risks of contamination during processing.

According to a multi-site in-vitro comparative study, when compared to traditional hetastarch-based cord blood processing techniques, the PrepaCyte®-CB process significantly improves the recovery of therapeutically important Total Nucleated Cells (TNC) and White Blood Cells (WBC) from human umbilical cord blood.[7] These are beneficial to cord blood banks for maximizing the yield of therapeutically beneficial cells they cryopreserve.

An associated benefit of of the PrepaCyte®-CB system is that since it is BioE’s first clinical product stemming from its patented PrepaCyte® technology platform, it can be used to produce a range of cellular products as other cell types become relevant for clinical applications.

4.  Cord Blood 2.0TM (By Americord, in New York, NY, USA)

Compared to traditional cord blood stem cell collections systems, the Cord Blood 2.0 TM can obtain substantially greater quantities of stem cells for preservation. The main advantage that results is that the cord blood units can be used for hematopoietic stem cell transplant in patients who are larger in size. Historically, the volume of stem cells preserved during traditional processing of a cord blood unit has only been sufficient to allow for the treatment of patients up to 60-70 pounds.

The Cord Blood 2.0TM process is a two-step process. The first step uses gravitational force to collect a large volume of cord blood from the umbilical cord and placenta following a live birth. In the second step, the collected cord blood is processed at the Americord laboratory. The proprietary process allows for higher volumes of stem cells to be extracted compared to currently available methods.[8] It is not known yet if Americord will sub-license this automated cord blood banking system to other cord blood banking operators.

Footnotes: 

[1]  Reuters.com, (2014). Cesca Therapeutics Inc (KOOL.O) Key Developments | Reuters.com. [online] Available at: http://www.reuters.com/finance/stocks/KOOL.O/key-developments/article/2925203 [Accessed 6 Nov. 2014].

[2] Cesca Therapeutics,Inc., C. (2014). Cesca Therapeutics Announces Approval of Its AXP(R) AutoXpress(R) System in Taiwan. [online] GlobeNewswire News Room. Available at: http://globenewswire.com/news-release/2014/09/29/668956/10100317/en/Cesca-Therapeutics-Announces-Approval-of-Its-AXP-R-AutoXpress-R-System-in-Taiwan.html#sthash.vSNATzkJ.dpuf [Accessed 2 Nov. 2014].

[3] Ibid.

[4] Pilar Solves, F. (2013). Qualitative and quantitative cell recovery in umbilical cord blood processed by two automated devices in routine cord blood banking: a comparative study. Blood Transfusion, [online] 11(3), p.405. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3729132/ [Accessed 2 Nov. 2014]

[5] Ibid.

[6] WIRE, B. (2007). Clinical Study Finds BioE’s PrepaCyte-CB Significantly Improves Cell Recoveries from Cord Blood | Business Wire. [online] Businesswire.com. Available at: http://www.businesswire.com/news/home/20070509005094/en/Clinical-Study-Finds-BioEs-PrepaCyte-CB-Significantly-Improves#.VE8xDFeLO_J [Accessed 2 Nov. 2014].

[7] Ibid.

[8] Digitaljournal.com, (2014). Americord Launches Revolutionary Stem Cell Collection Process – Press Release – Digital Journal. [online] Available at: http://www.digitaljournal.com/pr/2282077 [Accessed 2 Nov. 2014].at

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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 prominent news outlets including the Wall Street Journal, Nature Biotechnology, Medical Ethics, CBS News, and the California Institute for Regenerative Medicine (CIRM).

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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 emerging trends and opportunities within 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

 

How to Assess Your Cord Blood Bank’s “Quality Guarantee”

The Cord Blood Registry (CBR) is the largest U.S. cord blood bank. To date, the Cord Blood Registry has stored 500,000 cord blood and cord tissue samples, while Viacord has stored 350,000 samples and Cryo-Cell has stored 240,000 samples. While these storage counts may include cord blood and tissue units collected by their international divisions, these three industry players are the clear market leaders within the U.S. private cord blood banking industry.

Current Market Leaders within U.S., Ranked by Number of Cord Blood & Tissue Units Stored

Another interesting company within the U.S. cord blood sector is Americord, who has had the most rapid growth rate of any U.S. cord blood bank over the past few years.[1]  To date, Americord has stored approximately 35,000 cord blood and tissue units, which represents only 7% as many units as the U.S. market leader, Cord Blood Registry. Meaning, while Americord it is a most assuredly a fast-growth company, it is not yet a market leader when assessed by units stored.

Qualities that Distinguish the Top Cord Blood Banks

As industry leaders emerge, it is valuable to examine which qualities set them apart from their competitors. There are a number of identifiable markers that separate the dominant players within the cord blood industry from the less dominant ones. For instance, Americord currently has a few characteristics that could explain its growth rate advantage over Cord Blood Registry, including substantially lower costs for collection and 20 years of storage (standard contract term), no cancellation fees, and a higher quality guarantee.

Another characteristic that can distinguish one cord blood bank from another is the amount of its quality guarantee. Currently, the top cord blood banks in America offer quality guarantee packages that range from $25,000 – $90,000.  The primary reason for this guarantee is to reassure prospects that banking their child’s cord blood is a protected investment, despite the relative “newness” of stem cell transplantation. Most quality guarantees ensure that if a cord blood unit is needed for medical purposes, then engraftment of it will be a success or a dollar value will be paid out to the client.  In the event that a client’s stem cells fail to engraft, a cord blood bank offering a guarantee would then pay out the amount of their guarantee toward procurement of an alternative source of stem cells or alternative medical treatment.

Inherently, there is risk to the company offering such a guarantee, as biological responses can vary and there is never a one-hundred percent guarantee that engraftment will occur.  However, offering substantial quality guarantee packages demonstrates that a cord blood bank trusts its collection and storage processes, as well as has the financial reserves to stand behind its services.

Comparison of Cord Blood Bank “Quality Guarantees”

Below, the quality guarantees offered by leading private cord blood banks within the United States are compared. A global comparison is not feasible given the differences in currencies, exchange rates, and income levels from country-to-country. However, the findings here represent a broad spectrum of guarantees offered by leading cord blood banks, with some banks using this metric as a market differentiator.

Currently, the top cord blood banks in America offer “Quality Guarantee” packages that range from $25,000 to $90,000, with Americord topping that list at $90,000. Quality guarantees ensure that if a cord blood unit is needed for medical purposes, then engraftment will be a success or the amount of their guarantee will be paid out toward procurement of an alternative source of stem cells or treatment. Americord raised its guarantee from $80,000 to $90,000 in mid-2014 to further separate itself from the competition and increase its trustworthiness in the eyes of its clients.[2]

The primary reason for private cord blood banks to offer a guarantee is to reassure prospects that banking their child’s cord blood is a protected investment. Inherently, there is risk to the company offering such a guarantee, as individual transplant responses can vary and there is never certainty that engraftment will occur. However, offering a substantial quality guarantee package demonstrates that a cord blood bank trusts its collection and storage processes, as well as has the financial reserves to stand behind its guarantee policy.

Different cord blood banks handle guarantees differently, and this provides a healthy, diverse choice for clients. Three of the leading banks, CorCell, PacifiCord, and Cord Blood Registry, provide the industry average of $50,000 dollars. This appears to be generally accepted as the “mid-line” on the spectrum of guarantees.

On the lower end of the spectrum, ViaCord ($25,000) and M.A.Z.E. Cord Blood (cost of reimbursement only) offer much less than the industry standard. ViaCord says on its website that they offer an amount to “defray the cost of procuring an alternative stem cell source.” M.A.Z.E. Cord Blood’s guarantee states only that they  “will reimburse you for the costs of collection and storage of these cells.”[3] The company qualifies this low amount by stating that they do not put out exceptions to their quality guarantees, while other companies include a variety of exclusions and exceptions in their guarantees.

Some U.S. cord blood banks choose not to offer a quality guarantee. For instance, FamilyCord AlphaCord, and New England Cord Blood Bank do not offer a quality guarantee.

At the high end of the spectrum, Cryo-Cell ($75,000) and Americord Registry ($90,000) offer much more than the industry standard. In fact, Americord offers the largest amount of all the leading banks, despite the fact that they charge some of the lowest banking prices in the industry.

For a summary of these findings, see the table below.

TABLE. COMPARISON OF LEADING PRIVATE CORD BLOOD BANKS IN THE USA (RANKED BY VALUE OF “QUALITY GUARANTEE”)
U.S. Cord Blood Bank Amount of “Quality Guarantee” Reference Link
AmeriCord Registry $90,000 http://cordadvantage.com/press-room/80-000-quality-guarantee-is-the-highest-in-the-cord-blood-banking-industry.html
Cryo-Cell $75,000 http://www.cryo-cell.com/cord-blood/benefits/cord-tissue-stem-cells
Cord Blood Registry $50,000 http://www.cordblood.com/best-cord-blood-bank/cord-blood-processing/cord-blood-services
CorCell $50,000 http://www.corcell.com/about-corcell/#.UvEAbPldXVE
PacifiCord $50,000 http://www.pacificord.com/2_6_Cord-Blood-Banking-Stem-Cell-Storage-California-Cost-Pricing.php
ViaCord $25,000 http://www.viacord.com/cord-banking/using-cord-blood/
M.A.Z.E. Cord Blood Guarantee only the “cost of collection and storage” http://www.mazecordblood.com/guarantee.php
New England Cord Blood Bank None https://cordbloodbank.com/processing-and-storage/
Family Cord None http://www.familycord.com/
AlphaCord None http://www.alphacord.com/
LifeBankUSA If banked stem cells do not engraft during transplant, LifebankUSA will search its donor inventory for a match and make the unit available for free. http://www.lifebankusa.com/the-lifebankusa-advantage/#.VFsSo_nF91U

Footnotes:

[1]  Umbilical Cord Blood Banking and Cord Tissue Banking,. ‘With Record Cord Blood Collections, Americord Aims For Inc. 500 | Americord’. N.p., 2015. Web. 5 Mar. 2015.

[2]  Prnewswire.com, (2014). Americord Backs Up Its Cord Blood Services With First Ever $90,000 Guarantee. [online] Available at: http://www.prnewswire.com/news-releases/americord-backs-up-its-cord-blood-services-with-first-ever-90000-guarantee-251940891.html [Accessed 6 Nov. 2014].

[3]  Viacord.com, (2014). Using Cord Blood | ViaCord. [online] Available at: http://www.viacord.com/cord-banking/using-cord-blood/ [Accessed 6 Nov. 2014].

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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 prominent news outlets including the Wall Street Journal, Nature Biotechnology, Medical Ethics, CBS News, and the California Institute for Regenerative Medicine (CIRM).

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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

 

Trending Now… Fully Automated Umbilical Cord Blood Processing

Introduction to Automated Cord Blood Processing

Automated processing systems have many benefits, including speed, processing technology, and cost-savings. While automated processing technology entered the cord blood sector in 2006, as of 2015 (ten years later), not all cord blood banks have yet been converted. In the United States, most cord blood banks have incorporated the technology, but in other regions of the world, the transition has been slower. Furthermore, there has also been a strategic advantage observed among to the companies that switched over sooner, as it has allowed for resources within these companies to gradually be reallocated toward other efforts, including toward relationship-building with Obstetricians, into the education of expectant parents, and toward sales and marketing budgets.

In 2006, the AutoXpress® System by Cesca Therapeutics was announced as the first automated, functionally closed, sterile system that procures stem cells from cord blood with efficient and high yield throughout. [1] The AXP Platform brought unprecedented automation and precision to the stem cell processing, which in 2006 was important and cost-saving. Even though automated processing technology for umbilical cord blood is becoming more and more standardized, automated processing systems are still fairly new. As of 2007, the AXP’s state of the art technology was being used by only one family cord blood bank, although market acceptance grew more substantially in 2008.

Since then, cord blood harvesting has made a dynamic shift to fully automated processing systems and other industry alternatives have also emerged. The greatest benefits to automated processing systems are found in the replaced need for additives and human manipulation. The AXP Platform uses optical sensor technology to formulate precision separation and retention of almost all the target mononuclear cell population. When this process is automated, there is a reduced chance of contamination and an increased reliability of results.

Benefits of Automated Processing Platforms

A key attribute of automated processing systems such as the AutoXpress® Platform is that they efficiently recover mononuclear cells in cord blood collections. In tested samples, the recovery percentage of these stem cells has been calculated at 99.3% efficiency, a 22.7 percent higher yield than the commonly-used Hespan-based cord blood stem cell processing method, which achieved an MNC recovery rate of only 80.9 percent in the largest published Hespan study released in Cord Blood Transplantation.[2]  The Hespan approach requires an additive to facilitate separation of cord blood into layers of plasma, red blood cells, the MNC population of white blood cells and stem cells. The MNCs are then collected by a laboratory technician, which is a manual (not automated) step of the process.[3]   The AXP® AutoXpress® System also gained traction because it creates lower and more desirable hematocrit levels than most previous methodologies. [4]

Not surprisingly, the shift toward fully automated processing systems has also occurred within the public cord blood banking sector. For instance, the New York Blood Center (NYBC), the largest public cord blood bank in the world, has adopted AXP processing. They have, since their inception, banked over 60,000 cord blood units. In addition, there have been more than 30,000 cord blood transplants performed worldwide, and NCBP has provided cord blood units for transplantation to more than 4,900 of those recipients, a pretty astounding accomplishment as their contribution represents nearly 20% of all cord blood transplants worldwide. [5] Again, the main benefit of the AXP® Platform cited by the National Cord Blood Program of the NYBC was the high success rate of cell yield.

Cell yield is important because transplant survival rates improve with the number of stem cells used in therapy. “Cell yield is an important measure of a cord blood collection’s transplant utility and stem cells are contained in the MNC population,” said Dr. David Harris, Ph.D., professor of immunology at the University of Arizona and scientific director for Cord Blood Registry. [6] Cord Blood Registry has had full production of the AXP®Platform since 2007.[7]

Expanding Market for Automated Cord Blood Processing Technologies

As these automated platforms become more engrained in the culture of cord blood banking, the market is expanding to other countries. While the United States leads the world in cord blood banking, both in terms of total number of cord blood banks operating within the country and in terms of total cord blood units stored, other countries are not far behind. Italy, Spain, and now Portugal are researching ways to innovate and create more efficient cord blood stem cell extractions.

 The SepaxTM automated system has also been on the rise in the past few years, having different yet similarly viable results as the AXP’s system.  An interesting publication comparing the Sepax and AXP processing systems was released in July 2013, titled “Qualitative and quantitative cell recovery in umbilical cord blood processed by two automated devices in routine cord blood banking: a comparative study.”

The key findings were: [8]   

“Both the Sepax and AXP automated systems achieve acceptable total nucleated cell recovery and good CD34+ cell recovery after volume reduction of umbilical cord blood units and maintain cell viability. It should be noted that total nucleated cell recovery is significantly better with the Sepax system. Both systems deplete red blood cells efficiently, especially AXP which works without hydroxyethyl starch.”

Other automated processing alternatives to the SepaxTM and AXP® Platform are the PrepaCyte®-CB Processing System by BioE and Cord Blood 2.0TM by Americord, as shown below:

Automated Cord Blood Processing Systems

Summary of Findings

In summary, innovation is part of the rapidly evolving field of cord blood banking. Embracing this and searching for more efficient and effective ways of procuring stem cells from cord blood is extremely important. The quantity of total nucleated cells (TNCs), which is reported as a measure of the overall cell count found within a cord blood sample, correlates with improved transplant outcomes, higher patient survival rates, and better patient outcome.  It can also determine whether a sample can be used in a full-sized adult patient. While many studies have confirmed the importance of TNCs on patient outcomes, the importance of TNC count was recognized as early as 1998 when Dr. Rubinstein and his team released their research findings in the New England Journal of Medicine.[9]

Footnotes:

[1]  StreetInsider.com,. ‘Thermogenesis (KOOL) Says GE Healthcare Launches The Company’s AXP Autoxpress Platform’. N.p., 2015. Web. 5 Mar. 2015.

[2]  Registry, Cord. ‘Highest Recovery Of Cord Blood Stem Cells Achieved With New Automated Processing System, Study Shows’. Prnewswire.com. N.p., 2015. Web. 5 Mar. 2015.

[3]  Ibid.

[4]  Pilar Solves, Francisco Carbonell-Uberos. ‘Qualitative And Quantitative Cell Recovery In Umbilical Cord Blood Processed By Two Automated Devices In Routine Cord Blood Banking: A Comparative Study’. Blood Transfusion 11.3 (2013): 405. Web. 5 Mar. 2015.

[5]  Nybloodcenter.org,. ‘National Cord Blood Program | New York Blood Center’. N.p., 2015. Web. 5 Mar. 2015.

[6]  Registry, Cord. ‘Highest Recovery Of Cord Blood Stem Cells Achieved With New Automated Processing System, Study Shows’. Prnewswire.com. N.p., 2015. Web. 5 Mar. 2015.

[7]  Cordblood.com,. ‘Cord Blood Processing | Cord Tissue Processing | CBR®’. N.p., 2015. Web. 5 Mar. 2015.

[8]  Pilar Solves, Francisco Carbonell-Uberos. ‘Qualitative And Quantitative Cell Recovery In Umbilical Cord Blood Processed By Two Automated Devices In Routine Cord Blood Banking: A Comparative Study’. Blood Transfusion 11.3 (2013): 405. Web. 5 Mar. 2015.

[9]  Rubinstein P, Carrier C, et al. Outcomes among 562 recipients of placental-blood transplants from unrelated donors. N Engl Jour Med. 1998:339(24): 1565-1577.

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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 market research. BioInformant has been featured on news outlets including the Wall Street Journal, Nature Biotechnology, Medical Ethics, CBS News, and the California Institute for Regenerative Medicine (CIRM).

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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 trends and opportunities within 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

 

Cord Blood Industry News Round-Up | March 2015

The cord blood banking industry is a rapidly evolving industry experiencing nearly constant innovation. Every month there are major events that shift industry dynamics. Often, these events are announcements of technical or scientific advancements.  Sometimes they are announcements of industry collaborations or alliances. Occasionally, they are announcements of a new industry competitor, a major milestone, or a significant grant award.

While it can be easy to track changes in your region, it can be quite difficult to track changes occurring globally, and it can be very time-consuming to stay on top of the latest science.

However, for those of us interested in the cord blood industry, tracking these shifting industry dynamics is of vital importance.  This post covers the most significant cord blood industry news as of March 2015.

Cord Blood News Round-Up for March 2015

1. Pluristem and Hadassah Medical Center Announce Significant Data Showing PLX-R18 Cells Improve Bone Marrow Transplantation

[March 3, 2015]  Pluristem Therapeutics Inc., a leading developer of placenta-based cell therapy products, announced positive data from a preclinical study of PLX-R18 cells to improve outcomes of bone marrow transplantation. PLX-R18 is being developed to treat a range of hematologic indications including complications associated with bone marrow and cord blood transplantation.

In the study, conducted in conjunction with Hadassah Medical Center, mice with damaged bone marrow who received intramuscular injections of PLX-R18 cells together with a bone marrow transplant had significantly faster recovery of blood cell production compared to those who received a placebo with the bone marrow transplant.

Alongside the study at Hadassah, a preliminary study was conducted by Hillard M. Lazarus, MD, a Professor of Medicine at Case Western Reserve University. The study was part of ongoing research there to test PLX-R18 for use in umbilical cord blood stem cell transplantation.

Read more…

@Pluristem #transplantation #hematologic #bonemarrow #preclinical

2.  News Release: Joanne Kurtzberg Chosen To Lead New Cord Blood Association

[March 3, 2015]  Joanne Kurtzberg, MD, director of the Carolinas Cord Blood Bank, Durham, N.C., has been chosen to be the first President of the new Cord Blood Association. The Cord Blood Association is an international nonprofit organization that promotes public and private banking and the use of umbilical cord blood and related tissues for disease treatment and regenerative therapies.

Dr. Kurtzberg, who received her medical degree at New York Medical College, has been active in the field of cord blood transplantation and banking since the beginning.  She founded the Pediatric Blood and Marrow Transplant Program at Duke University Medical Center in 1990, where cord blood transplants have been a focus. Her team at Duke performed the world’s first unrelated cord blood transplant in 1993 using a cord blood unit from the the New York Blood Center.

Others elected to office were Geoffrey Crouse as Vice President, Sue Armitage as Secretary, and Kenneth Giacin as Treasurer.

Read more…

#cordbloodassociation #foundingboard #collaboration #nonprofit

3. Potential biomarker identified for neonatal sepsis in preterm infants

[March 3, 2015]  Leena Mithal, MD, pediatric infectious diseases fellow at Ann and Robert H. Lurie Children’s Hospital of Chicago, discusses new research which found that acute phase reactants in cord blood of premature infants could be used in detection and risk stratification for early onset sepsis. While early onset sepsis in neonates continues to be a significant cause of morbidity and mortality, there are insufficient clinical and laboratory diagnostics available to apply necessary antibiotic prophylaxis.

To determine whether evaluation of acute phase reactant biomarkers in umbilical cord blood could improve early onset sepsis detection, Mithal and colleagues compared archived cord blood and placental data from preterm infants with confirmed early onset sepsis, presumed early onset sepsis, late onset sepsis as well as a control group without sepsis.

Read more…

#sepsis #neonates #biomarkers #cordblood #placenta

4.  BioLife Solutions CryoStor® Cell Freeze Media Used in Mayo Clinic Safety and Feasibility Study of Umbilical Cord Blood-Derived Cells for Pediatric Cardiac Regeneration

[March 3, 2015] BioLife Solutions, Inc., a developer, manufacturer and marketer of clinical grade hypothermic storage and cryopreservation freeze media and precision thermal shipping products, announced its CryoStor cell freeze media was utilized in a porcine animal study of umbilical cord blood-derived mononuclear cells (UBC-MNC) to evaluate the safety and feasibility of these cells for cardiac regeneration in pediatric congenital heart disease (CHD).

Thawed umbilical cord blood-derived mononuclear cells were administered to piglets via intramyocardial injections, with follow-up lasting three months. No mortality or toxicity in any study animal was observed.  The safety and feasibility study was performed at the Mayo Clinic in Rochester, Minnesota, with the results recently published in…

Read More…

@BioLifeSol #animalstudy #congentialheartdisease #pediatric

5. Study Shows Stem Cells Have Potential to Help Kids’ Hearts, Too

[February 27, 2015] Several studies showing the promise of stem cells for treating patients with heart failure have made headline news recently. However, all these studies targeted adult patients. New research appearing in this month’s STEM CELLS Translational Medicine demonstrates that stem cells may have the same potential to treat children with congenital heart diseases.

The study, undertaken by researchers at the Mayo Clinic in Rochester, MN, looked at the feasibility and long-term safety of injecting autologous umbilical cord blood cells directly into the heart muscle at the pediatric stage of heart development. The study was conducted on pigs, due to their hearts’ similarity to human hearts.

The team injected the stem cells directly into the right ventricle of groups of three- and four-week old healthy piglets, and then compared the results to a control group that did not receive any cells.

Read more…

@MayoClinic #cordblood #cardiacrepair  #pediatric 

6. ESPERITE (Euronext ESP) pioneers first treatment worldwide of Cerebral Palsy using two types of stem cells

[February 23, 2015] CryoSave, part of ESPERITE, is the only private cord blood bank sponsoring a GCP clinical trial according to GMP-ATMP international guidelines CryoSave leads and sponsors a multicentre clinical trial following GCP-ICH standards, for investigation of new treatment of Cerebral Palsy using dual infusion of two types of stem cells derived from umbilical cord blood and cord tissue processed by CryoSave.

The clinical trial aims to demonstrate safety and preliminary efficacy of sequential intravenous infusion of the ex vivo expanded mesenchymal stem cells (MSC) derived from cord tissue and the cord blood stem cells. The study will use, for the first time in clinical research, autologous MSC-derived from cryopreserved cord tissue.

Read more…

@CryoSave #clinicaltrial #cordtissue #MSC

7. Cesca Therapeutics Announces Approval of Its MarrowXpress(TM) System in India

[February 11, 2015]  Cesca Therapeutics Inc., an autologous cell-based regenerative medicine company, announced the Company has received approval from the India Drug Controller General (“DCGI”) for the import and commercialization of its MarrowXpressTM (“MXPTM“) System in India.  “We are very pleased to receive approval from the DCGI for our MXP System for bone marrow stem cell processing specifically for the preparation of intra-operative at the point-of-care or clinical laboratory preparation of bone marrow concentrate,” said Ken Harris, President and leader of Cesca’s clinical programs.

Cesca provides in-house GMP cell laboratory services, scientific support, and medical technology to Fortis’ cutting edge program at the Fortis Memorial Research Institute, including use of Cesca’s proprietary “CellWerks” approach that employs the MXP Platform. Cesca’s technology and services expand both pediatric and adult patient access to life saving cellular treatments by enabling a number of transplants that might otherwise not be an option for the patient, including cord blood processing and storage for double cord blood transplant.

Read more…

#cordblood #bonemarrow #processing #India

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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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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.

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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 emerging trends and opportunities within the iPSC industry, view the “Complete 2013-14 Induced Pluripotent Stem Cell Industry Report” now.

Complete 2013-14 Induced Pluripotent Stem Cell (iPSC) Industry Report