Cord Blood Cell Wash/Infusion Bag Set

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For the thaw/washing and subsequent infusion of previously frozen cord blood stem cells as developed by the New York Blood Center.^{1, 2*} This two-bag set is designed to achieve a slow asymptotic reduction in osmotic pressure of the cryoprotected white cells to the appropriate level for transfusion. Set reduces the DMSO content of the final stem cell transfusion to less than one gram. Each sterile set consists of two transfer bags joined by integral tubing, and three connector lines (two spikes and one luer).

Designed specifically for use with the freezing bag of the Transfer/Freezing Bag Set (PN 791-02) and the Freezing Bag (PN 791-05). Components include:

Two 250 mL capacity transfer bags. One 250 mL transfer bag is used for thawing the frozen unit with a Dextran/albumin solution. The second 250 mL transfer bag receives supernatant from the concentrated stem cells.^{1, 2*}
Two multiple-use sampling sites.

Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.; Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.

Fraser, J.K.; Cairo, M.S.; Wagner, E.L.; McCurdy, P.R.; Baxter-Lowe, L.A.; Carter, S.L.; Kernan, N.A.; Lill, M.C.; Slone, V.; Wagner, J.E.; Wallas, C.H.; Kurtzberg, J. Cord Blood Transplantation Study (COBLT): Cord Blood Bank Standard Operating Procedures. Journal of Hematotherapy. 1998, 7(6):521-61.

*SOP available at the EMMES website: http://spitfire.emmes.com/study/cord/

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Application

For the thaw/washing and subsequent infusion of previously frozen cord blood stem cells as developed by the New York Blood Center.

Advanced Bag Designs Meet Rigorous Industry Standards

Cord blood stem cells have been effectively used in the treatment of more than 70 malignant and non-malignant diseases, including sickle cell, leukemia, non-Hodgkin’s lymphoma, other forms of cancer, life-threatening anemias, and autoimmune diseases. As a key supplier to the cord blood banking industry, Pall provides a full range of bag sets that are used to prepare the cord blood stem cells for treatment.

Pall’s collection and processing sets are manufactured to cGMP using validated manufacturing processes that ensure safe, consistent and reliable product performance. Each bag is 100% inspected prior to release and is fully traceable by lot number. Pall’s bag sets are uniquely designed to facilitate closed system processing of cord blood stem cells by the volume reduction method developed at the New York Blood Center.¹Volume reduction maximizes limited storage space while closed system processing minimizes sample loss and reduces the risk of contamination during handling. This method results in a high quality sample available for transplantation. SOP’s referencing Pall bag sets are available at the EMMES website: https://web.emmes.com/study/cord/sop.htm¹

Assessment of stem cell content and viability after long-term storage is a critical step prior to a successful transplantation. International standards recommend storing a cell sample attached to a unit of cord blood for quality control testing. Pall’s freezing bag includes sufficient tubing for the preparation of segments, enabling a sample aliquot to be cryopreserved with the final product. Using a tube segment for quality control testing prior to transplantation reduces the risk of contamination during the thawing process and provides critical information needed to predict treatment success.

For disease treatments or patient populations that require a higher cell dose to be transplanted, Pall’s advanced freezing bag design divides the sample into two compartments, facilitating transfusion of 80% of the stem cells while retaining 20% of the stem cells for ex vivo cell expansion. Scientific advances in our ability to amplify stem cells will greatly expand the applications for hematopoietic stem cells from cord blood.

^1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.;Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.


Product No.	791-03, 791-03U
Description	Cell Wash/Infusion Bag Set
Fill Volume Range	Up to 250 mL
Port Configuration	(2) in-line spikes; in-line luer; (2) multi-use sampling ports
Materials of Construction	Bags: Polyvinyl chloride (PVC) with tri (2-ethylhexyl) trimelliate (TEHTM) plasticizer; Tubing: Ethylene vinyl acetate
Bag Size(s)	17.53 cm length x 11.43 cm width (6.91 in. length x 4.5 in. width)
Sterilization	Gamma
Packaging	Individually packaged in a plastic pouch; 24/box
Shelf Life	3 years
Traceability	Lot number
Regulatory Status	FDA 510(k) cleared; CE marked
Compatible with Other Bags	791-02; 791-05

Product Code	Product Code (Europe)	Description	Packaging


791-03	791-03U	Cell Wash/Infusion Bag Set	24 units/case

Cord Blood Cell Wash/Infusion Bag Set

*SOP available at the EMMES website: http://spitfire.emmes.com/study/cord/

Application

Advanced Bag Designs Meet Rigorous Industry Standards

^1. Rubinstein, P.; Dobrila, L.; Rosenfield, R.E.; Adamson, J.W.; Migliaccio, G.; Migliaccio, A.R.;Taylor, P.E.; Stevens, C.E. Processing and Cryopreservation of Placental/Umbilical Cord Blood for Unrelated Bone Marrow Reconstitution. Proc Natl Acad Sci USA. 1995, Oct 24;92(22):10119-22.

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