Recommendations to Transplant Centres Performing Cord Blood Transplants. Why Choosing the Right Thaw Method Could Save a Patient s Life

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1 Recommendations to Transplant Centres Performing Cord Blood Transplants Vicki Antonenas Why Choosing the Right Thaw Method Could Save a Patient s Life Lynn O Donnell (USA) 1

2 The process of receiving, testing and preparing a CB unit for transplantation: 3) Transplant Center Laboratory 2) Transport 1) Cord Blood Banks 4) CB Infusion (which method?) 2

3 Receipt & Storage of incoming cord blood: The CB unit should be scheduled to arrive at the transplant centre at least 1 week prior to the patient commencing conditioning therapy Evidence of safe receipt of frozen CB unit after transportation Correct transport temperature in dry shipper The CB unit is stored at -150 C in the vapour phase of liquid nitrogen, until the time of transplant. Transport Temp Chart 3

4 Associated Problems we have experienced with our overseas CB units Tipped dry shipper Cracked Frozen Bag Arrival of a Thawed CB unit 4

5 Cryopreserved CB units come in different bags and vary in the type of processing performed prior to freezing. 1 bag Old bag Not RBC depleted before freezing 3 bags New bag Plasma and RBC depleted before freezing 5

6 Testing CB unit prior to transplant: Perform confirmatory TNC/Kg and CD34/Kg counts hours after delivery, but days before transplantation On segment (attached to CB bag) or pilot vial- both representing frozen CB cells Segment 0.1 ml Cryovial 0.5 ml 6

7 What if no pilot vial or segment is provided? Rely on the CBB s pre-freeze data and inform the BMT unit with actual cell counts on day of infusion Not an issue with Auscord Units! 7

8 How do the TNC s/kg correlate between CBBs and WMH BMT Lab? WMH BMT Lab n=112 r 2 = Median TNC recovery 84% CB Bank Report 8

9 What about the CD34/kg data? n=104 r 2 = Median CD34 recovery 61% WMH BMT Lab Number of X values 105 R square CB Bank Report 9

10 The variability was due to different CD34 assays used Enumerating viable CD34+ cells in CB units ISHAGE Gating Strategy (Single Platform & 7AAD) * Cord Blood Cells at time of Infusion Viability Marker Specific Gatings Viable CD34+ cells Trucount beads Dead Cells * Sartor M, Antonenas V, Bradstock KF. Bone Marrow Transplant Recovery of viable CD34+ cells from cryopreserved hemopoietic progenitor cell products. 10

11 History of our Lab Practice on CB units prior to Infusion: As of 2013, n=112 CB units for 90 patients washed all UCB units As described by Rubenstein et.al. Processing and Cryopreservation of placental/umbilical cord blood for unrelated bone marrow reconstitution. Proc. Natl.Acad.Sci. USA 1995: 92: CB units were routinely thawed with no washing and infused immediately No lab processing, infuse at bedside- as per marrow and apheresis infusions No cell loss CB infusions for Adults (single and double) But noticed serious adverse reactions for some paediatric patients and noticed thickness of thawed CB for some infusions present- CB units are routinely thawed and diluted prior to infusion As described by Barker et al, BBMT 2009;15(12): and As described by Regan, D et al, BBMT 2006 Washing was ONLY performed for: CB units that have NOT been volume / red blood cell reduced prior to freezing or For paediatric patient weights <20 Kg 11

12 The Thaw and Wash Method: Traditional wash method- developed by Rubenstein 1995 Because CB products were not red cell or plasma reduced, cryopreserved in large volumes, thus greater amounts of DMSO for paediatric infusions Wash solution: Dextran-40 and Albumex-4 solution (1:1) volumes Reduces DMSO toxicity and the free haemoglobin Restores osmolarity & extends cell viability 12

13 Thaw and Wash Method: After Centrifugation of a diluted RBC-depleted CB unit After Centrifugation of a diluted Non RBC-depleted CB unit 13

14 The Challenge of Washing CB units: Most labs are unfamiliar with the wash method Difficult to see the separated layers after centrifugation Some cell loss is associated 14

15 Ask for CORD BLOOD PRACTICE units from AUCORD: You have the right to request one or more practice units from the cord blood bank for this purpose FACT-JACIE standards(d ) 15

16 Thaw and Dilution Method: Good method to follow for labs with limited experience in manipulating frozen CB products The CB unit is diluted with chilled Dextran-40 and Albumex-4 solution (1:1) volumes Frozen CB unit = 25 ml 12.5 ml Dextran, 12.5 ml Albumin Some labs perform higher dilutions than 1:2 ( for example 1:4, 1:6 or 1:8) No cell loss No centrifugation and no removal of supernatent Dilutes the concentration of haemoglobin and DMSO Maintains cell viability for up to 2 hrs after thawing 16

17 Thaw and Dilution Method Diluted CB unit ready to be released for infusion CB units are thawed and diluted by lab staff, in the cell processing laboratory 17

18 Cord Blood Ready for Infusion: The ward is notified in advance of time for infusion, which is 60 mins after thawing. We routinely use a 200 micron filter at time of infusion (for all HPC products including CB units) to remove any clumps or aggregates Staff return to lab with diluted CB sample in chilled tube for QC testing 18

19 Why Choosing the Right Thaw Method Could Save a Patient s Life Lynn O Donnell (USA) 19

20 NMDP-URGENT NOTICE: 2 As of March 2013, 8 serious Reports to NMDP, 2 fatalities, patients received nnnnnnnbbbbbb at least a non- RBC depleted unit, not washed prior to infusion Did we know of the 2 Reported Deaths?

21 Adult CB infusion resulting in Death (March 2013)-full clinical details on NMDP and WMDA websites Patient died of cardiac arrest within hours of bedside thaw of 2 non- RBC depleted CB units. M/39, CML transplant date March 2013 Background history of cardiac risk factors CB unit #1- non-rbc depleted unit (B+) to patient (O+) in 105 mls in 2 bags- infused directly CB unit #2- non-rbc depleted unit (O+), 75 ml in 1 bag-thawed and infused

22 Urgent change request for 6 th Edition Due 26 th July 2014 Chnnnnnnnnnnnnnnnnn

23 How should transplant centers treat CB units for infusion? Best and easy practice is to perform the thaw and dilution method on RBC-depleted CB unit We have seen a decrease in reported adverse reactions Wash all non RBC-depleted units Patients 20 kg should receive washed units 23

24 Recommendations: PLAN AHEAD. Very important the clinical BMT team and the lab review and discuss the thawing method of the CB unit and agree on the planned method before transplant. UPFRONT COMMUNICATION with the CBB s is essential -ask if unit was RBC depleted prior to cryopreservation. REQUEST for a pilot vial or confirm that a segment will be provided with shipment of the CB unit during CB workup with ABMDR. Essential for TCs to perform confirmatory testing. 24

25

26 Check the identity and integrity of the CB Unit: 1) Verify identity of product & recipient with paperwork 2) Bag(s) not compromised 3) Notify the Clinical BMT Unit of safe arrival with pending confirmatory cell counts 26

27 Preliminary CB Report: Is ed to the BMT team CB bag(s)- safely stored and not compromised The thawed TC results are satisfactory Based on Patients current weight (Kg)- child or adult Volume of CB and number of bags TNC/Kg Viable CD34/Kg RBC volume (<0.5 ml/kg) DMSO volume (<10 ml/kg) Method of CB processing before cryopreservation? Patient and CB blood groups- is it a major ABO incompatible infusion? Initiates discussion between the Laboratory and BMT team on appropriate CB thaw method Patient conditioning/chemo commences 27

28 Labs must be familiar with the Thermogenesis Bags for CB infusion 28

29 Routine Quality Control Testing performed on Day of Infusion Performed by the Transplant Center Laboratory (0.5 ml) Confirm volume of frozen CB unit The infused TNC/kg dose The infused viable CD34+ count/kg (and CD3) We do NOT perform- Rely on results from the CB Bank Report: ABO blood group testing of CB unit Colony Assays Sterility test (with pending results) Hematocrit for RBC volume Chimerism Analysis-Rinse of CB bag after infusion 29

30 Australia Total in 2012 = 64

31 Transplant Lab Cord Blood Worksheet: * CBB data typically represent TNC and CD34+ counts determined before freezing of CB units

32

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