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Cord Blood Processing – AutoXpress® (AXP), Sepax, PrepaCyte®, Cord Blood 2.0

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Automated cord blood processing systems, like Sepax, have many benefits, including speed, processing technology, and cost-savings. Automated the processing technology entered the cord blood sector in 2006, and since that time, a variety of systems have been developed. Cord blood processing systems are used to support cord blood banking, which is the long-term storage of the stem cells contained within umbilical cord blood for future therapeutic use.

Sepax | A Closer Look At Automated Cord Blood Systems

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Automated Cord Blood Processing

In the United States, most cord blood banks have incorporated automated cord blood processing technologies, but this is not the case in every region of the world.

Cesca’s AutoXpress (AXP) System

auto xpress | Automated Cord Blood Processing, AutoXpress® (AXP), Sepax, and More

In 2006, the AutoXpress® System (AXP) 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 stem cell processing, which in 2006 was important and cost-saving. Even though the 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.

Advantages of AutoXpress (AXP) System

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 of 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 result reliability increases.

Automated Cord Blood Processing | AutoXpress (AXP) Cellular Recovery

A key attribute of automated processing systems such as the AutoXpress® (AXP) 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% higher yield than the commonly used Hespan-based cord blood stem cell processing method, which achieved an MNC recovery rate of only 80.9% in the largest published Hespan study released in Cord Blood Transplantation.[2]

What is Hespan approach is it 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® System also gained traction because it creates lower and more desirable hematocrit levels than most previous methodologies. [4]

Shift Toward Automated Cord Blood Processing

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

As these automated platforms become more ingrained 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 the total number of cord blood banks operating within the country and in terms of the 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.

SepaxTM Cord Blood System

biosafe sepax | Automated Cord Blood Processing, AutoXpress® (AXP), Sepax, and More

Biosafe 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 of the AXP and Sepax comparison were as follows: [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.“

Cord Blood Processing with PrepaCyte®-CB and Cord Blood 2.0TM

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:

what is hespan | Automated Cord Blood Processing, AutoXpress® (AXP), Sepax, and More

Cord Blood Processing | TotiCyte by Cells4Life

Most recently, Cells4Life also launched TotiCyteTM, a processing method which “selectively removes the red blood cells in cord blood and yields over 95% recovery of the white cell fraction, 99.5% removal of the red cells, obviates the need for washing to remove DMSO and red cells, and exceptionally high post-thaw viable cell recovery.”[9]

(Click here to learn more about the companies producing these cord blood processing technologies.)

Summary of Cord Blood Processing

Innovation is part of the rapidly evolving field of cord blood banking. Embracing this and searching for more efficient and effective ways to procure stem cells from cord blood are 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.[10]

What are your thoughts on Sepax and other automated cord blood processing systems? Share them in the comments section.

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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]  “Future Technologies | Cells4life”. Cells4Life. N.p., 2017. Web. 29 Jan. 2017.
[10]  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.

To learn more, view the “Global Cord Blood Banking Industry Report.”

Introduction to Cord Tissue-Derived Mesenchymal Stem Cells (CT-MSCs)

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The past few years have seen major change within the global cord blood banking industry, with new trends emerging, shifts in public perception toward cord blood storage, improving techniques for the use of cord blood in cellular therapy, and more.

The post below discusses important trends in umbilical cord tissue storage and the degree to which these trends are impacting cord blood market participants.

How the Cord Tissue Banking Market Began

The storage of umbilical cord tissue has been a significant trend within the cord blood industry over the past few years. The reason to store both umbilical cord blood and tissue is that they contain different types of stem cells, each with the potential to treat different types of injury or disease. In cord tissue banking, 4-8 cm of the umbilical cord is collected, placed in the tissue collection kit, and transported to a cord blood bank for processing and storage. [Read more…]

Why Has Utilization of Umbilical Cord Blood for Transplantation Declined?

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In recent years, the rate of umbilical cord blood utilization has declined. To understand the dynamics behind this change, you need to understand cord blood registries and cord blood transplant statistics. Data about umbilical cord blood transplants from the donor registry of the CW Bill Young Cell Transplantation Program, including the National Cord Blood Inventory, are reported annually.[1]

The program’s donor registry, also called the Be The Match Registry®, is operated under Federal contracts by the National Marrow Donor Program® (NMDP).

The Be The Match Registry® is the world’s largest hematopoietic cell registry, listing more than 10.5 million individuals and approximately 185,000 cord blood units.[2]

Cord Blood Transplant Statistics | A Closer Look

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The National Marrow Donor Program

The National Marrow Donor Program is a contractor for the CW Bill Young Cell Transplantation Program operated through the U. S. Department of Health and Human Services, Health Resources and Services Administration, and Healthcare Systems Bureau. It is a non-profit organization launched in Minneapolis, MN, USA, in 1986.

Hematopoietic stem cell transplants from NMDP donors or umbilical cord blood units are used to treat patients with a variety of cancers and immune system conditions. To date, the NMDP had facilitated more than 55,000 transplants worldwide.[3]

Bone Marrow Donors Worldwide

Another group that exists is Bone Marrow Donors Worldwide (BMDW), an organization that coordinates the collection of the human leukocyte antigen (HLA) phenotypes of hematopoietic cell donors and cord blood units. BMDW participants currently include 48 cord blood banks from 32 countries worldwide.[4] Presently, more than 60,000 cord blood units are listed within its database.[5] This makes it the largest such database of its type in the world.

The Cooperation of NMDP and BMDW

The NMDP cooperates with BMDW in the Netherlands because BMDW coordinates communications between the world’s cord blood registries. Most national registries, including the NMDP’s Be The Match Registry®, have access to these worldwide volunteer donors, either through the BMDW or through individual terms and agreements.

Because of their wide reach, these organizations represent a method for assessing trends in cord blood banking storage and utilization, making them a valuable predictor of future trends. Specifically for this analysis, the CW Bill Young Cell Transplantation Program is used as a source of aggregated cord blood transplantation data.

Decline in Utilization of Cord Blood for Transplantation

Unfortunately, 2013 saw a decrease in the number of cord blood units used for transplant in the United States. In 2012, the CW Bill Young Cell Transplantation Program facilitated close to 1,200 transplants. In 2013, it facilitated approximately 1,100, a substantial year-over-year decline.[6]  See the image below.

umbilical cord transplant | Why Has Utilization of Umbilical Cord Blood for Transplantation Declined?

While the CW Bill Young Cell Transplantation Program did its last comprehensive analysis of registry data in 2014 using full-year 2013 data, it did release the following statement about FY 2014 data[7]:

“During 2014, cord blood units were used in 960 transplants. The National Cord Blood Inventory provided 544 cord blood units for these transplants.

Also, 1,225 transplants were performed using bone marrow and 4,068 transplants used peripheral blood stem cells.”

As mentioned previously, the registry facilitated close to 1,200 transplants in 2012, and approximately 1,100 in 2013.[8]  Therefore, 2014 again experienced a decline in cord blood utilization relative to the prior year, and peripheral blood stem cells again saw an increase in utilization. This information has been incorporated into the graph above.

From conversations with industry experts and independent analysis, BioInformant believes this trend is continuing.

However, this trend is primarily localized to the United States and Europe. Within the UK, the country’s National Health System (NHS) has been working toward building an established volume of publicly donated cord blood units to have as a national inventory for medical purposes. Furthermore, in other countries around the world, including the UK, China, Japan, Taiwan, and France, there have been increases in cord blood transplant rates compared to prior years.

Therefore, the growth or decline in cord blood transplant rates is a geographically dependent variable.

Why Has Cord Blood Transplantation Declined?

All of the information so far is interesting, but the important question here is, “Why has umbilical cord blood transplantation declined?”

The major reason for declining cord blood transplants in recent years is the increasing utilization of peripheral blood stem cells as an alternative for HSCT.

A much lesser reason is that there was declining utilization of bone marrow as a source of stem cells for HSCT from 1998 to 2005, but that trend corrected from 2005 to 2013, with the utilization of bone marrow slightly increasing over that period.

These answers are visually represented by the graph below.

bone marrow donors worldwide | Why Has Utilization of Umbilical Cord Blood for Transplantation Declined?

To learn more, view the “Global Cord Blood Banking Industry Report.“

What are your thoughts on cord blood transplant statistics and the decline in the utilization of umbilical cord blood for transplantation? Share them in the comments below.

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[1] “Donor Registry Transplant Data”. Home. [online]  Available at: Bloodcell.transplant.hrsa.gov. [Accessed 24 Apr. 2016].
[2] Bethematch.org. Home.  Available at: http://bethematch.org/ [Accessed 24 Apr. 2016].
[3] Ibid.
[4] Bmdw.org. BMDW: Home. Available at: http://bmdw.org/ [Accessed 25 Apr. 2016].
[5] Ibid.
[6]  “Donor Registry Transplant Data”. Registry Data. Available at: http://bloodcell.transplant.hrsa.gov/research/transplant_data/registry_tx_data/index.html. 2016. [Accessed 24 Apr. 2016].
[7]  “Blood Cell Transplantation”. Donor Registry Transplant Data. [online] Available at: http://bloodcell.transplant.hrsa.gov/ [Accessed 25 April 2016].
[8]  Bloodcell.transplant.hrsa.gov, (2014). Donor Registry Transplant Data. [online] Available at: http://bloodcell.transplant.hrsa.gov/research/transplant_data/registry_tx_data/index.html [Accessed 25 April 2016].

Top Stem Cell Video of the Year! (3 Minutes)

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This video published by the Harvard School of Medicine is incredible, winning our award for the “Best Stem Cell Video of the Year.”

It is a zebrafish animation that shows the discoveries made by the Stem Cell Research Program at Boston Children’s Hospital.

Using the zebrafish as a model, it takes you from the birth of a blood stem cell, along its travel through the body, to its site of engraftment.
[Read more…]

Cord Blood Banking Opinions Issued by Medical Societies

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When considering the value of cord blood banking, it is 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.
[Read more…]

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