Guidelines for Cord Blood Unit Thaw and Infusion

Scaradavou, Andromachi; Avecilla, Scott T.; Tonon, J.; Politikos, Ioannis; Horwitz, Mitchell E.; Kurtzberg, Joanne; Milano, Filippo; Barker, Juliet N.

doi:10.1016/j.bbmt.2020.06.018

Cited by 8 publications

(4 citation statements)

References 6 publications

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“…Finally, because multiple components of CBT contribute to the high rates of engraftment and PFS, such studies should adhere to optimal CBT practices to ensure favorable outcomes. 13 To assist with this, the American Society of Transplantation and Cellular Therapy CB Special Interest Group has developed guidelines outlining current standards of care for unit selection, 58 thaw, and infusion, 59 and guidelines for multiple other aspects of CBT are in preparation.…”

Section: Discussionmentioning

confidence: 99%

High progression-free survival after intermediate intensity double unit cord blood transplantation in adults

et al. 2020

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Cord blood transplantation (CBT) after high intensity or nonmyeloablative conditioning has limitations. We investigated cyclosporine-A/mycophenolate mofetil–based intermediate intensity (cyclophosphamide 50 mg/kg, fludarabine 150 mg/m2, thiotepa 10 mg/kg, total body irradiation 400 cGy) unmanipulated double-unit CBT (dCBT) with prioritization of unit quality and CD34+ cell dose in graft selection. Ninety adults (median age, 47 years [range, 21-63]; median hematopoietic cell transplantation comorbidity index, 2 [range, 0-8]; 61 [68%] acute leukemia) received double-unit grafts (median CD34+ cell dose, 1.3 × 105/kg per unit [range, 0.2-8.3]; median donor-recipient human leukocyte antigen (HLA) match, 5/8 [range 3-7/8]). The cumulative incidences of sustained CB engraftment, day 180 grade III-IV acute, and 3-year chronic graft-versus-host disease were 99%, 24%, and 7%, respectively. Three-year transplant-related mortality (TRM) and relapse incidences were 15% and 9%, respectively. Three-year overall survival (OS) is 82%, and progression-free survival (PFS) is 76%. Younger age and higher engrafting unit CD34+ cell dose both improved TRM and OS, although neither impacted PFS. Engrafting unit-recipient HLA match was not associated with any outcome with a 3-year PFS of 79% in 39 patients engrafting with 3-4/8 HLA-matched units. In 52 remission acute leukemia patients, there was no association between minimal residual disease (MRD) and 3-year PFS: MRD negative of 88% vs MRD positive of 77% (P = .375). Intermediate intensity dCBT is associated with high PFS. Use of highly HLA mismatched and unmanipulated grafts permits wide application of this therapy, and the low relapse rates support robust graft-versus-leukemia effects even in patients with MRD.

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Section: Discussionmentioning

confidence: 99%

High progression-free survival after intermediate intensity double unit cord blood transplantation in adults

et al. 2020

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“…Whereas, the above mentioned mismatch reduces the risk of recurrence [56,113,114,116]. Low levels of matching by 6 HLA loci were associated with poorer post-transplant survival in one group of CB transplantation studies [30,57,63,116], but were not detected in other studies [65,70,113,114,117,118]. According to some authors, the negative impact of HLA mismatch on post-transplant survival is limited to children [69].…”

Section: Minimal Required Hla Matching In the Donor/recipient Pair Hla Matching By 6 Loci: Antigen-level Typing For Hla-a Hla-b Allele-lementioning

confidence: 99%

Optimization of the criteria for cord blood unit selection for transplantation in recipients of the different age groups: current view and prospects in Ukraine

Nemtinov¹,

Ustymenko²,

Лобынцева³

et al. 2020

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Umbilical cord blood has been widely used to treat both malignant and non-malignant hematological diseases for over 30 years. During this time, more than 40,000 successful hematopoietic stem cell (HSC) transplantations of umbilical cord blood have been performed. However, today in Ukraine there is no public umbilical cord blood bank established for unrelated HSC transplantation to patients with oncohematological disorders (both children and adults). In this regard, the HSC units must be purchased abroad or the patients are sent to foreign clinics for high-cost treatment. The organization of a public umbilical cord blood bank in Ukraine would help in a short time to meet the needs of patients with oncohematological disorders for donor HSCs for unrelated transplantation and save significant funds for the treatment of patients abroad. According to the experience of the world's leading oncohematological centers, when it is impossible to find either a related or haploidentical donor or in all available registries – a unrelated transplant, the search continues in the registers of public cord blood banks and an umbilical cord blood unit that matches the criteria is usually found. The optimal choice of umbilical cord blood unit is crucial to maximize the likelihood of successful transplant engraftment and recipient survival after the transplantation, so the criteria for cord blood unit selection for unrelated transplantation are a bit broader than those used when matching donor-recipient pairs. The review presents the main criteria for cord blood unit selection according to the assessment of its quality, cell dose, HLA matching for unrelated transplantation to recipients of different age groups in accordance with international guidelines developed by the National Marrow Donor Program (NMDP), USA Center for International Blood and Brain Transplantation Research (CIBMTR), in collaboration with the NMDP Council Advisory Group, as well as in accordance with the American Society for Transplantation and Cellular Therapy (ASTCT) and the Seventh Edition of the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration.

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“…It has been suggested that cryopreserved HSPCs should be infused as soon as possible post thawing including the cryomedium, to preserve their optimal cell viability and function [ 42 ], but there is also literature recommending prior washing/removal of cryoprotectants, especially when patients are less than 20 kg of body weight [ 61 ].…”

Section: Hematopoietic Stem and Progenitor Cells (Hspcs)mentioning

confidence: 99%

Impact of Cryopreservation and Freeze-Thawing on Therapeutic Properties of Mesenchymal Stromal/Stem Cells and Other Common Cellular Therapeutics

et al. 2022

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Purpose of Review Cryopreservation and its associated freezing and thawing procedures–short “freeze-thawing”–are among the final steps in economically viable manufacturing and clinical application of diverse cellular therapeutics. Translation from preclinical proof-of-concept studies to larger clinical trials has indicated that these processes may potentially present an Achilles heel to optimal cell product safety and particularly efficacy in clinical trials and routine use. Recent Findings We review the current state of the literature on how cryopreservation of cellular therapies has evolved and how the application of this technique to different cell types is interlinked with their ability to engraft and function upon transfer in vivo, in particular for hematopoietic stem and progenitor cells (HSPCs), their progeny, and therapeutic cell products derived thereof. We also discuss pros and cons how this may differ for non-hematopoietic mesenchymal stromal/stem cell (MSC) therapeutics. We present different avenues that may be crucial for cell therapy optimization, both, for hematopoietic (e.g., effector, regulatory, and chimeric antigen receptor (CAR)-modified T and NK cell based products) and for non-hematopoietic products, such as MSCs and induced pluripotent stem cells (iPSCs), to achieve optimal viability, recovery, effective cell dose, and functionality of the cryorecovered cells. Summary Targeted research into optimizing the cryopreservation and freeze-thawing routines and the adjunct manufacturing process design may provide crucial advantages to increase both the safety and efficacy of cellular therapeutics in clinical use and to enable effective market deployment strategies to become economically viable and sustainable medicines.

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Guidelines for Cord Blood Unit Thaw and Infusion

Cited by 8 publications

References 6 publications

High progression-free survival after intermediate intensity double unit cord blood transplantation in adults

High progression-free survival after intermediate intensity double unit cord blood transplantation in adults

Optimization of the criteria for cord blood unit selection for transplantation in recipients of the different age groups: current view and prospects in Ukraine

Impact of Cryopreservation and Freeze-Thawing on Therapeutic Properties of Mesenchymal Stromal/Stem Cells and Other Common Cellular Therapeutics

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