- 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/
|Product No.||791-03, 791-03U|
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)|
|Packaging||Individually packaged in a plastic pouch; 24/box|
|Shelf Life||3 years|
|Regulatory Status||FDA 510(k) cleared : 791-02, 791-03, 791-05
CE marked: 791-02U, 791-03U, 791-05U
791-02U : Canadian medical device license # 101446
791-03U : Canadian medical device license # 91523
791-05U : Canadian medical device license # 101437
|Compatible with Other Bags||791-02; 791-05; 791-02U; 791-05U|
ApplicationFor 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 StandardsCord 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.1 Volume 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.
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.
- Cord Blood Collection Set: For the collection of up to 150 mL of umbilical cord blood.
- Transfer/Freezing Bag Set: For processing and freezing 25 mL of cryopreserved, concentrated cord blood stem cells.
- Freezing Bag: For the long-term storage of 25 mL of cryopreserved, concentrated blood components.
- Cord Blood Sterile Collection Bag: Safe and convenient cord blood collection for vaginal births and cesarean sections.
|Product Code||Product Code (Europe, Canada)||Description||Packaging|
|791-03||791-03U||Cell Wash/Infusion Bag Set||24 units/case|
To Order, Contact:
Pall Europe Ltd
Europa House, Havant Street
Portsmouth, PO1 3PD England
Tel: +44 (0)23 9230 3452
Fax: +44 (0)23 9230 3324
Pall Canada Ltd.
3450 Ridgeway Drive, Unit 6
Mississauga, ON L5L 0A2
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