Cord Blood Re-imagined The use of cord blood stem cells for clinical applications and medical innovations

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1 GE Healthcare Proceedings of the Symposium Cord Blood Re-imagined The use of cord blood stem cells for clinical applications and medical innovations 12 th Annual Meeting of the International Society for Cellular Therapy Berlin, Germany May 7 th, 2006 Symposium sponsored by GE Healthcare imagination at work

2 Cord blood banking: meeting the challenges of increasing efficiency and regulations Dr Koen Theunissen, Stem Cell and Transplantation Unit, Department of Hematology, University of Leuven, Belgium Overview Umbilical cord blood stem cells can provide many advantages to patients who require hematopoietic stem cell transplantation, but who cannot find a matched related or unrelated donor. However there are challenges to overcome if cord blood stem cell use is to become more widespread. One specific challenge is finding a more efficient means of processing high yields of stem cells with high viabilities. I shall share with you a validation study of the new AutoXpress (AXP ) platform which shows great promise in meeting this challenge. The benefits of cord blood stem cells Cord blood stem cells are immunologically naïve, allowing up to two human leukocyte antigen (HLA) mismatches. They can therefore provide a stem cell source for those patients without a matched donor, which is one patient in three in our transplantation unit. Cord blood stem cells have very high proliferative activity, show no teratoma formation, have low risk of infectious disease transmission, and can be cryopreserved for at least 15 years. Cord blood stem cells also have disadvantages: screening for inborn errors is limited; total processing and storage costs are at least 750 Euro for one unit. Importantly, a single unit contains only enough cells for a patient of 40 kg or less. Challenge: Minimal experience from cord blood transplantations in adults Whilst cord blood now accounts for 20% of all transplant patients under 20 years of age, due to the low number of cells, its use in adults is minimal. For the ageing population cord blood could provide a valuable stem cell source. Challenge: The need for selection criteria other than TNC To produce a more efficient system for banking and selecting cord blood, a standard method is needed for enumerating and appropriately characterizing cord blood cells. However, due to high variability between

3 labs in enumerating CD34+ cells in cord blood, so far no strong correlation between CD34+ dose and engraftment has been shown. So, whilst more specific criteria like mononuclear cell (MNC) count are used for bone marrow and CD34+ for peripheral blood, the current criteria for cord blood selection is based solely on total nucleated cell (TNC) count. The drawbacks of this selection criterion will become apparent when I discuss the results of the AXP validation study. Challenge: How to effectively process and store more units The current worldwide cord blood inventory of some units in public banks needs to be increased in order to meet increasingly stringent HLA matching criteria, and ensure that rare haplotypes are represented. Furthermore, higher cell doses per unit are needed for adult patients. As more units need to be processed and stored, more effective means of volume reduction are required. The ideal cord blood processing system should reduce cell volume reduction with no loss of progenitors. Compliant with NETCORD and other safety guidelines, it should be a functionally closed system, independent of level of operator expertise. It should not require the addition of reagents. The system should be cost-effective. A new system: The AutoXpress (AXP) platform In our search for a more efficient volume reduction process we have recently evaluated the AutoXpress (AXP) platform developed by ThermoGenesis and distributed by GE Healthcare. This automated, functionally closed, sterile system harvests the buffy coat from cord blood, reducing a unit of cord blood to a precise volume determined by the operator. The AXP platform uses the following four-step method: (1) cord blood is transferred to the processing set; (2) the bag sets are loaded into the device; (3) up to six units of stem cells are harvested through a 20 min centrifuge run; (4) the stem cell units are removed from the bag set. This process takes about 30 min and can be performed with or without HESpan. The AXP platform includes XpressTRAK software that captures and documents each cord blood unit s processing data, to which other data can be added. The software contains a QC program to ensure that each device is operating correctly. All data are stored in a database which can be sorted and searched, and from which reports can be produced.

4 Validation study of the AXP platform Our unit at the University of Leuven performed a validation study of the AXP platform. We followed our standard criteria for banking: processing within 48 hours of cord blood collection, and collecting a minimum volume of 80 ml of cord blood. We performed the procedure without HESpan to avoid potential contamination. We evaluated 21 procedures, finding a consistent buffy coat end volume of 22 ml. We found an average recovery of 92% of MNC, 99% of CD34+ and 87% of granulocyte-macrophage colony-forming units (CFU-GM). As expected in a procedure excluding HESpan, the recovery of TNC was lower at 77%. This lower figure is probably due to the loss of granulocytes, which may be an advantage as granulocytes can cause problems upon thawing the unit. To conclude this validation study, the AXP system gives consistent volume reduction with very good recoveries of MNC and CD34+. The lower TNC recovery was as expected with the absence of HESpan. The system was quick and easy-to-use and the XpressTRAK software was a useful tool that secured tracking, monitoring and data recording required to comply with the regulations. AXP platform highlights drawbacks of selection criteria based on TNC count The results of the AXP platform validation raise the question of the validity of the current criteria for selection of cord blood units, which is based solely on TNC count. With a TNC recovery of 77%, the units processed in this AXP validation study would not be readily selected for transplantation under the current criteria. Yet these units had a 92% recovery of MNC and 99% of CD34+ cells. As with bone marrow grafts and peripheral blood stem cells, it is now time for the cord blood stem cell banking community to produce more appropriate standards to enumerate and characterize cord blood stem cell units. Question and answer session Question: How is the recovery of TNCs affected when HESpan is added? Answer: There is good recovery of TNCs when HESpan added to the process. Question: Is it correct that you were finding a haematocrit of around 26%? Answer: Yes, I was positively surprised, but the haematocrit was 26%.

5 The biological and medical potential of unrestricted somatic stem cells from placental cord blood Professor Peter Wernet University Medical Center, Heinrich-Heine University, Düsseldorf, Germany Overview Transplantation of placental cord blood already offers major clinical benefits. Now a new stem cell line derived from cord blood shows promise of significant biological and medical potential. I want first to outline how the cord blood banking community is currently working together internationally to optimize the provision and selection of cord blood units for hematopoietic transplantation. I then want to describe a rare pluripotent stem cell that we identified, and hint at possible future clinical applications. Cord blood bank organization in Europe At our institute we have now processed and cryopreserved over units of cord blood, and around 300 units have been selected for transplantation. Our institute is part of an international network of cord banks called the NETCORD Foundation. NETCORD collaborates with the Foundation for the Accreditation of Cellular Therapy (FACT) to establish quality standards on the collection, cryopreservation, storage and release of cord blood units. NETCORD also collaborates with EUROCORD, which focuses on dissemination of results and quality control. The cord blood banks within NETCORD share a joint inventory by internet, using a common algorithm for the selection of units. At present there is debate amongst the cord blood banking community around the issue of whether to select matched or unmatched units. The appropriate selection choice may turn out to be dependent on the type of disease. The advantages of unrestricted somatic stem cells Turning to research at our Institute, we have identified a rare cell type in human cord blood (1) termed unrestricted somatic stem cells (USSCs). These USSCs do not have specific surface markers that are absolute predictors for the cell type, but instead show plasticity over a range of surface markers (2).

6 USSCs produce functionally significant amounts of hematopoiesis-supporting cytokines. Compared to bone marrow mesenchymal stem cells (MSCs), USSCs show superior kinetics of ex vivo expansion in measures of total cells, total CFC, total BFU-E, total CFU-GM and total CD34+. Therefore USSCs present a more efficient stroma cell type than MSCs for hematopoiesis and may offer an advantage over MSCs in hematopoietic transplantation. This benefit is of practical importance because a major limitation in obtaining bone marrow MSCs for transplantation is that cell count rapidly declines with age of donor. USSCs grow adherently and can be expanded to high cell numbers cells without losing pluripotency. They do not spontaneously differentiate, but can be induced to differentiate by the use of appropriate protocols. After cell expansion, USSCs from cord blood have significantly longer telomeres than MSCs generated from bone marrow. However, these characteristically long telomere lengths shorten over time. In vivo animal studies with USSCs have shown no occurrence of tumor cells. In vitro studies have shown that USSCs can differentiate into osteoblasts, chondrocytes and adipocytes, as well as hematopoietic and neural cells. These neural cells include astrocytes and neurons that express neurofilament, sodium protein channel and various neurotransmitter phenotypes. When USSCs were stereotactically implanted into the intact adult rat brain, human Tau positive cells were identified at three months post-implantation. The implanted USSCs showed high migratory activity and a neuronal-like, highly differentiated morphology. Animal models showed in vivo mesodermal and endodermal differentiation of USSCs. Repair of critical size bone defects in the rat demonstrated the bone regeneration capacity of USSC transplantation. Chondrogenesis was demonstrated after transplanting USSCs into mice. USSCs differentiate into myocardial and hepatic cells in sheep Human USSCs have been transplanted into the uterus of the pre-immune sheep model developed by Prof Zajani in Reno, USA. Fourteen months after transplantation over 20% of the sheep s total liver cells consisted of human hepatocytes. These USSC derived hepatocytes were producing human albumin within the sheep.

7 Differentiation of human USSC into myocardial cells was also found in the chimeric sheep. In some cardiac areas, such as the atria and ventricles, the engrafted human cells were seen in patches surrounded by sheep cardiomyocytes. USSCs were also found engrafted in aggregates in the Purkinje fiber system. The results from this study suggest that the differentiation of USSCs is under the control of the biological niche in which they land. Thus USSCs landing in the liver will differentiate into hepatocytes, whilst those settling in the heart will develop into cardiomyocytes. Future directions for USSCs Because of their pluripotency and high capability for expansion, USSCs are a promising stem cell source for the future development of cellular therapy for tissue repair and regeneration. For example, the differentiation into both cardiomyocytes and Purkinje fiber cells in the pre-immune fetal sheep model suggests that USSCs could play a potential role in the in the repair and regeneration of the damaged human heart. Question and answer session Question: Are USSCs present in all cord blood units? Answer: In over several hundred attempts to initiate USSC cultures from cord blood we have been successful in 40% of cases. We don t know why we are unsuccessful in 60% of cases. It may be biological differences or it may be culture insufficiencies. Once initiated these cultures are easy to expand, freeze and thaw. References 1. Koegler, G. et al. J Exp Med (2004) 200: Koegler, G. et al. Exp Haematol (2005) 33:573-83

8 GE Healthcare Bio-Sciences AB Björkgatan Uppsala Sweden GE, imagination at work, and GE monogram are trademarks of General Electric Company. AXP, AutoXpress, and XpressTRAK are trademarks of ThermoGenesis Corp. All goods and services are sold subject to the terms and conditions of sale of the company within GE Healthcare which supplies them. GE Healthcare reserves the right, subject to any regulatory and contractual approval, if required, to make changes in specifications and features shown herein, or discontinue the product described at any time without notice or obligation. Contact your local GE Healthcare representative for the most current information General Electric Company All rights reserved. GE Healthcare Bio-Sciences AB, a General Electric Company. GE Healthcare Bio-Sciences AB Björkgatan 30, Uppsala, Sweden GE Healthcare Europe GmbH Munzinger Strasse 5, D Freiburg, Germany GE Healthcare UK Ltd Amersham Place, Little Chalfont, Buckinghamshire, HP7 9NA, UK GE Healthcare Bio-Sciences Corp 800 Centennial Avenue, P.O. Box 1327, Piscataway, NJ , USA GE Healthcare Bio-Sciences KK Sanken Bldg , Hyakunincho, Shinjuku-ku, Tokyo , Japan Asia Pacific T F Australasia T F Austria T 01 / F 01 / Belgium T F Canada T F Central & East Europe T F Denmark T F Eire T F Finland & Baltics T F France T F Germany T F Greater China T F Italy T F Japan T F Korea T F Latin America T F Middle East & Africa T F Netherlands T F Norway T F Portugal T F Russia, CIS & NIS T F Spain T F Sweden T F Switzerland T F UK T F USA T F imagination at work AA 09/2006

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