Scaradavou
Cord blood beyond transplantation: can we use the experience to advance all cell therapies?
Andromachi Scaradavou,
Corresponding Author
Andromachi Scaradavou
Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering (MSK) Kids, MSK Cancer Center, New York, NY, USA
Correspondence: Andromachi Scaradavou, Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering (MSK) Kids, MSK Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
E-mail: [email protected]
Search for more papers by this authorAndromachi Scaradavou,
Corresponding Author
Andromachi Scaradavou
Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering (MSK) Kids, MSK Cancer Center, New York, NY, USA
Correspondence: Andromachi Scaradavou, Stem Cell Transplantation and Cellular Therapies, Memorial Sloan Kettering (MSK) Kids, MSK Cancer Center, 1275 York Avenue, New York, NY 10065, USA.
E-mail: [email protected]
Search for more papers by this authorSummary
Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, ‘off-the shelf’ treatments. Such strategies will allow broader patient access and wide product utilisation.
Conflict of interest
Andromachi Scaradavou was the Medical Director of the NCBP until 01/2020. Andromachi Scaradavou is a member of the Scientific Advisory Board of ExCellThera (06/2020).
References
- 1Rubinstein P, Rosenfield RE, Adamson JW, Stevens CE. Stored placental blood for unrelated bone marrow reconstitution. Blood. 1993; 81: 1679–90.
- 2Wagner JE. Cord blood 2.0: State of the art and future directions in transplant medicine. Blood Res. 2019; 54: 7–9.
- 3 US Food and Drug Administration. Guidance for Industry: Biologics License Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. March 2014. Available at: https://www.federalregister.gov/documents/2014/03/05/2014-04813/guidance-for-industry-biologics-license-applications-for-minimally-manipulated-unrelated-allogeneic. Accessed December 2020.
- 4Kurtzberg J. The view for cord blood is “cup half full” not “cup half empty”. Stem Cells Transl Med. 2020; 9: 1–3.
- 5Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, et al. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017; 35: 3547–57.
- 6Abraham AA, John TD, Keller MD, Cruz CRN, Salem B, Roesch L, et al. Safety and feasibility of virus specific T cells derived from umbilical cord blood in cord blood transplant recipients. Blood Adv. 2019; 3: 2057–68.
- 7Prockop S, Doubrovina E, Suser S, Heller G, Barker J, Dahi P, et al. Off-the-shelf EBV-specific T cell immunotherapy for rituximab-refractory EBV-associated lymphoma following transplantation. J Clin Invest. 2020; 130: 733–47.
- 8Liu E, Marin D, Banerjee P, Macapinlac HA, Thompson P, Basar R, et al. Use of CAR-transduced natural killer cells in CD19-positive lymphoid tumors. N Eng J Med. 2020; 382: 545–53.
- 9Dunbar C, High KA, Joung K, Kohn DB, Ozawa K, Sadelain M. Gene therapy comes of age. Science. 2018; 359: 175–85.
- 10Zhao J, Lin Q, Song Y, Liu D. Universal CARs, universal T cells and universal CAR T cells. J Hematol Oncol. 2018; 11: 132–41.
- 11Zhou H, Rao MS. Can cord blood banks transform into induced pluripotent stem cell banks? Cytotherapy. 2015; 17: 756–64.
- 12Alvarez-Palomo B, Vives J, Casaroli-Marano RP, Gomez SG, Gomez LR, Edel MJ, et al. Adapting Cord Blood Collection and Banking Standard Operating procedures for HLA-Homozygous Induced Pluripotent Stem Cell Production and Banking for Clinical Application. J Clin Med. 2019; 8: 476. https://doi.org/10.3390/jcm8040476
- 13Liedtke S, Korschgen L, Korn J, Duppers A, Kogler G. GMP-grade CD34+ selection from HLA-homozygous licensed cord blood units and short-term expansion under European ATMP regulations. Vox Sang. 2020 [Online ahead of print]. https://doi.org/10.1111/vox.12978
- 14 US Food and Drug Administration. Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products. U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. January 2011. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-tests-cellular-and-gene-therapy-products. Accessed December 2020.
- 15Inglesias-Lopez C, Agusti A, Oback M, Vallano A. Regulatory framework for advanced therapy medicinal products in Europe and United States. Front Pharmacol. 2019; 10: article 921.
- 16 NetCord-FACT International Cord Blood Standards. Seventh Edition. Available at: http://www.factwebsite.org/cbstandards/. Accessed December 2020.
- 17Scaradavou A. Cord Blood Banking. In: B Shaz, C Hilly, M Gil, eds, Transfusion Medicine and Hemostasis: Clinical and laboratory aspects, 3rd edn. Philadelphia, PA: Elsevier, 2019: 519–529.
10.1016/B978-0-12-813726-0.00085-4 Google Scholar
- 18 U.S. Food and Drug Administration. Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). U.S. Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research. August 2007. Available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/eligibility-determination-donors-human-cells-tissues-and-cellular-and-tissue-based-products. Accessed December 2020.
- 19Scaradavou A. HLA-mismatched, non-inherited maternal antigen-matched unrelated cord blood transplantations have superior survival: how HLA typing the cord blood donor’s mother can move the field forward. Biol Blood Marrow Transplant. 2012; 18: 1773–5.
- 20Scaradavou A. Cord Blood Graft Assessment and Selection Criteria for Transplantation. In: J Schwartz, B Shaz, eds, Best Practices in Processing and Storage for Hematopoietic Cell Transplantation. New York, NY: Springer, 2018: 113–136.
10.1007/978-3-319-58949-7_10 Google Scholar
- 21Dobrila L. Cord Blood Processing: Different Bags and Automation. In: J Schwartz, B Shaz, eds, Best Practices in Processing and Storage for Hematopoietic Cell Transplantation. New York, NY: Springer, 2018: 97–112.
10.1007/978-3-319-58949-7_9 Google Scholar
- 22Purtill D, Smith K, Devlin S, Meagher R, Tonon J, Lubin M, et al. Dominant unit CD34+ cell dose predicts engraftment after double-unit cord blood transplantation and is influenced by bank practice. Blood. 2014; 124: 2905–12.
- 23 New York Blood Center, Inc. HEMACORD (HPC, Cord Blood) Package Insert 2011. Available at: https://hemacord.info/pub/Prescribing%20Information%20and%20Instructions.pdf. Accessed December 2020.
- 24Rubinstein P, Carrier C, Scaradavou A, Kurzberg J, Adamson J, Migliaccio AR, et al. Outcomes among 562 recipients of placental-blood transplants from unrelated donors. N Engl J Med. 1998; 339: 1565–629.
- 25Barker JN, Kempenich J, Kurtzberg J, Brunstein CG, Delaney C, Milano F, et al. CD34+ cell content of 126 341 cord blood units in the US inventory: implications for transplantation and banking. Blood Adv. 2019; 23: 1267–71.
- 26Keeney M, Chin-Yee I, Weir K, Popma J, Nayar R, Sutherland DR. Single platform flow cytometric absolute CD34+ cell counts based on the ISHAGE guidelines. International Society of Hematotherapy and Graft Engineering. Cytometry. 1998; 34: 61–70.
10.1002/(SICI)1097-0320(19980415)34:2<61::AID-CYTO1>3.0.CO;2-F CAS PubMed Web of Science® Google Scholar
- 27Barker JN, Kurtzberg J, Ballen K, Boo M, Brunstein C, Cutler C, et al. Optimal practices in unrelated donor cord blood transplantation for hematologic malignancies. Biol Blood Marrow Transplant. 2017; 23: 882–96.
- 28Politikos I, Davis E, Nhaissi M, Wagner JE, Brunstein CG, Cohen S, et al. American Society for Transplantation and Cellular Therapy Cord Blood Special Interest Group. Guidelines for Cord Blood Unit Selection. Biol Blood Marrow Transplant. 2020; 26: 2190–6.
- 29Migliaccio AR, Adamson JW, Stevens CE, Dobrila NL, Carrier CM, Rubinstein P. Cell dose and speed of engraftment in placental/umbilical cord blood transplantation: graft progenitor cell content is a better predictor than nucleated cell quantity. Blood. 2000; 96: 2717–22.
- 30Prasad VK, Mendizabal A, Parikh SH, Szabolcs P, Driscoll TA, Page K, et al. Unrelated donor umbilical cord blood transplantation for inherited metabolic disorders in 159 pediatric patients from a single center: influence of cellular composition of the graft on transplantation outcomes. Blood. 2008; 112: 2979–89.
- 31Page KM, Zhang L, Mendizabal A, Wease S, Carter S, Gentry T, et al. Total colony-forming units are a strong, independent predictor of neutrophil and platelet engraftment after unrelated umbilical cord blood transplantation: a single-center analysis of 435 cord blood transplants. Biol Blood Marrow Transplant. 2011; 17: 1362–74.
- 32Albano MS, Rothman W, Watanabe C, Gora A, Scaradavou A, Rubinstein P. Hematopoietic colony forming unit: development of a high-throughput CFU assay strategy by the use of high-resolution digital images stored in a laboratory information system. Blood. 2008; 112: 2306
- 33Albano MS, Stevens CE, Dobrila LN, Scaradavou A, Rubinstein P. Colony-forming-unit (CFU) assay with high-resolution digital imaging: a reliable system for cord blood (CB) CFU evaluation. Biol Blood Marrow Transplant. 2009; 15(Suppl.): 45.
- 34Albano MS, Rothman W, Scaradavou A, Blass DP, McMannis JD, Rubinstein P. Automated counting of colony forming units (CFU): towards standardization of the measurement of potency in cord blood cell therapy products. Blood. 2011; 118: 485.
- 35Shoulars K, Noldner P, Troy JD, Cheatham L, Parrish A, Page K, et al. Development and validation of a rapid, aldehyde dehydrogenase-bright-based cord blood potency assay. Blood. 2016; 127: 2346–54.
- 36Galipeau J, Krampera M, Barrett J, Dazzi F, Deans RJ, Debruijn J, et al. International Society for Cellular Therapy perspective on immune functional assays for mesenchymal stromal cells as potency release criterion for advanced phase clinical trials. Cytotherapy. 2016; 18: 151–9.
- 37Weil B, Hanley PJ, Lowdell M. Proposal for the International Society for Cell and Gene Therapy position statement on assays for the quality control and potency assessment of adoptive cellular immunotherapies. Cytotherapy. 2019; 21: 367–75.
- 38Broxmeyer HE, Srour EF, Hangoc G, Cooper S, Anderson SA, Bodine DM. High-efficiency recovery of functional hematopoietic progenitor and stem cells from human cord blood cryopreserved for 15 years. Proc Natl Acad Sci USA. 2003; 100: 645–50.
- 39Scaradavou A, Dobrila L, Albano MS, Tarnawski M, Zhu T, Watanabe C, et al. Cord blood (CB) stability and potency evaluation: consistent, predictable recovery of hematopoietic progenitor cells (HPC) and high CD34+ cell viability in stored cord blood units (CBU) of the National Cord Blood Program (NCBP). Blood. 2016; 128: 2175.
- 40Rodrıguez L, Garcıa J, Querol S. Predictive utility of the attached segment in the quality control of a cord blood graft. Biol Blood Marrow Transplant. 2005; 11: 247–51.
- 41Masson Frenet E, Albano MS, Dobrila L, Tarnawski M, Zhu T, Watanabe C, et al. Pre-release quality/potency evaluation of 1241 cord blood units (CBU) by segment testing: CB banks need to interpret the segment results and provide recommendations to transplant centers (TC). Cytotherapy. 2019; 21: S53–4.
- 42Albano MS, Dobrila L, Tarnawski M, Sung D, Frenet E, Romeo C, et al. Cord blood units (CBU) selected for transplantation from a single CB bank over 10 years: high correlation of potency/quality among pre-cryopreservation and post-thaw segment measurements and time to engraftment. Blood. 2018; 132(Suppl. 1): 2062.
- 43Querol S, Gomez SG, Pagliuca A, Torrabadella M, Madrigal JA. Quality rather than quantity: the cord blood bank dilemma. Bone Marrow Transplant. 2010; 45: 970–8.
- 44Simard C, Bonnaure G, Fournier D, Neron S. An objective flow cytometry method to rapidly determine cord blod potency in cryopreserved units. Transfusion. 2019; 59: 2074–82.
- 45Wagner JE. Establishing the UCB graft potentiality. Blood. 2016; 127: 2272–4.
- 46Cereb N, Kim HR, Ryu J, Yang SY. Advances in DNA sequencing technologies for high resolution HLA typing. Hum Immunol. 2015; 76: 923–37.
- 47Allen ES, Yang B, Garrett J, Ball ED, Maiers M, Morris GP. Improved accuracy of clinical HLA genotyping by next-generation DNA sequencing affects unrelated donor search results for hematopoietic stem cell transplantation. Hum Immunol. 2018; 79: 848–54.
- 48Hill CR, Butler JM, Vallone PM. A 26plex autosomal STR assay to aid human identity testing*. J Forensic Sci. 2009; 54: 1008–15.
- 49 American Association of Blood Banks (AABB). Standards for Cellular Therapy Services, 9th edition, 2019. Available at: https://www.aabb.org/aabb-store/product/standards-for-cellular-therapy-services-9th-edition-print-14253149. Accessed December 2020.
- 50Barker JN, Weisdorf DJ, DeFor TE, Blazar BR, McGlave PB, Miller JS, et al. Transplantation of 2 partially HLA-matched umbilical cord blood units to enhance engraftment in adults with hematologic malignancy. Blood. 2005; 105: 1343–7.
- 51van Besien K, Childs R. Haploidentical cord transplantation-The best of both worlds. Semin Hematol. 2016; 53: 257–66.
- 52Delaney C, Heimfeld S, Brashem-Stein C, Voorhies H, Manger RL, Bernstein ID. Notch-mediated expansion of human cord blood progenitor cells capable of rapid myeloid reconsitution. Nat Med. 2010; 16: 232–6.
- 53De Lima M, McMannis J, Gee A, Komanduri K, Couriel D, Andersson BS, et al. Transplantation of ex vivo expanded cord blood cells using the copper chelator tetraethylenepentamine: a phase I/II clinical trial. Bone Marrow Transplant. 2008; 41: 771–8.
- 54De Lima M, McNiece I, Robinsin SN, Munsell M, Eapen M, Horowitz M, et al. Cord-blood engraftment with ex vivo mesenchymal-cell coculture. New Engl J Med. 2012; 367: 2305–15.
- 55Wagner JE, Brunstein CG, Boitano AE, DeFor TE, McKenna D, Sumstad D. Phase I/II trail of Stem Regenin-1 expanded umbilical cord blood hematopoietic stem cells supports testing as a stand-alone graft. Cell Stem Cell. 2016; 18: 144–55.
- 56Horwitz ME, Wease S, Blackwell B, Valcarcel D, Frassoni F, Boelens JJ, et al. Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide. J Clin Oncol. 2019; 37: 367–74.
- 57Cohen S, Roy L, Lachance S, Delisle JS, Marinier A, Busque L, et al. Hematopoietic stem cell transplantation using single UM171-expanded cord blood: a single-arm, phase 1–2 safety and feasibility study. Lancet Haematol. 2020; 7: e134–45.
- 58Wagner JE, Brunstein CG, DeFor TE, Boitano AE, McKenna D, Sumstad D, et al. Phase 2 trials with MGTA-456, single cord blood units (CBU) expanded with an aryl hydrocarbon receptor (AHR) antagonist, demonstrate uniform engraftment and rapid hematopoietic recovery in patients following myeloablative or non-myeloablative conditioning. Blood. 2017; 130:(Suppl. 1): 662.
10.1182/blood.V130.Suppl_1.662.662 Google Scholar
- 59Orchard PJ, Raffel GD, Condon CEH, Braun JA, Shanley R, Lund TC, et al. Mgta-456 cell therapy in inherited metabolic disease (IMD) yields rapid and durable long-term improvement of disease-specific outcomes in a phase 2 trial. Biol Blood Marrow Transplant. 2020; 26: S19.
- 60Claveau JS, Cohen S, Ahmad I, Delisle JS, Kiss T, Lachance S, et al. Single UM171-expanded cord blood transplant can cure severe idiopathic aplastic anemia in absence of suitable donors. Eur J Haematol. 2020; 105: 808–11.
- 61Brunstein CG, McKenna DH, DeFor T, Sumstad D, Paul P, Weisdorf DJ, et al. Complement Fragment 3a Priming of Umbilical Cord Blood Progenitors: Safety Profile. Biol Blood Marrow Transplant. 2013; 19: 1474–9.
- 62Cutler C, Multani P, Robbins D, Kim HT, Le T, Hoggat J, et al. Prostaglandin-modulated umbilical cord blood hematopoietic stem cell transplantation. Blood. 2013; 122: 3074–81.
- 63Popat U, Mehta RS, Rezvani K, Fox P, Kondo K, Marin D, et al. Enforced fucosylation of cord blood hematopoietic cells accelerates neutrophil and platelet engraftment after transplantation. Blood. 2015; 125: 2885–92.
- 64Farag SS, Srivastava S, Messina-Graham S, Schwartz J, Robertson MJ, Abonour R, et al. In vivo DPP-4 inhibition to enhance engraftment of single-unit cord blood transplants in adults with hematological malignancies. Stem Cells Dev. 2013; 22: 1007–15.
- 65Aljitawi OS, Paul S, Ganguly A, Lin TL, Ganguly S, Vielhauer G, et al. Erythropoietin modulation is associated with improved homing and engraftment after umbilical cord blood transplantation. Blood. 2016; 128: 3000–10.
- 66Xue E, Milano F. Are we underutilizing bone marrow and cord blood? Review of their role and potential in the era of cellular therapies. F1000Research. 2020; 9: 26.
- 67Mayani H, Wagner JE, Broxmeyer HE. Cord blood research, banking, and transplantation: achievements, challenges and perspectives. Bone Marrow Transplant. 2020; 55: 48–61.
- 68Berglund S, Magalhaes I, Gaballa A, Vanherberghen B, Uhlin M. Advances in umbilical cord blood cell therapy: the present and the future. Exp Opin Biol Ther. 2017; 17: 691–9.
- 69Hiwarkar P, Hubank M, Qasim W, Chiesa R, Gilmour KC, Saudemont A, et al. Cord blood transplantation recapitulates fetal ontogeny with a distinct molecylar signature that supports CD4+ T-cell reconstitution. Blood Adv. 2017; 1: 2206–16.
- 70Hiwarkar P, Qasim W, Ricciardelli I, Gilmour K, Quezada S, Saudemont A, et al. Cord blood T cells mediate enhanced antitumor effects compared with adult peripheral blood T cells. Blood. 2015; 126: 2882–91.
- 71Milano F, Gooley T, Wood B, Woolfrey A, Flowers ME, Doney K, et al. Cord-blood transplantation in patients with minimal residual disease. N Engl J Med. 2016; 375: 944–53.
- 72Barker J, Hanash A. Cord blood T cells are “completely different”. Blood. 2015; 126: 2778–9.
- 73Chaekal O, Scaradavou A, Masson Frenet E, Albano MS, Cushing M, Desai P, et al. Adoptive immunotherapy with CB following chemotherapy for patients with refractory myeloid malignancy: chimerism and response. Blood Adv. 2020; 4: 5146–56.
- 74Brunstein CG, Miller JS, McKenna DH, Hippen KL, DeFor TE, Sumstad D, et al. Umbilical cordblood-derived T regulatory cells to prevent GvHD: kinetiucs, toxicity profile, and clinical effect. Blood. 2016; 127: 1044–51.
- 75Kellner JN, Delemarre EM, Yvon E, Nierkens S, Boelens JJ, McNiece I, et al. Third party, umbilical cord blood derived regulatory T-cells for prevention of graft versus host disease in allogeneic hematopoietic stem cell transplantation: feasibility, safety and immune reconstitution. Oncotarget. 2018; 9: 35611–22.
- 76Pegram HJ, Purdon TJ, van Leeuwen DG, Curran KJ, Giralt SA, Barker JN, et al. IL-12-secreting CD19-targeted cord blood-derived T cells for the immunotherapy of B-cell acute lymphoblastic leukemia. Leukemia. 2015; 29: 415–22.
- 77Maus MV, Nikiforow S. The why, what, and how of the new FACT standards for immune effector cells. J. Immunotherapy Cancer. 2017; 5: 36–41.
- 78Cotten CM, Murtha AP, Goldberg RN, Grotegut CA, Smith PB, Goldstein RF, et al. Feasibility of autologous cord blood cells for infants with hypoxic-ischemic encephalopathy. J Pediatr. 2014; 164: 973–9.
- 79Sun JM, Grant GA, McLaughlin C, Allison J, Fitzgerald A, Waters-Pick B, et al. Repeated autologous umbilical cord blood infusions are feasible and had no acute safety issues in young babies with congenital hydrocephalus. Pediatr Res. 2015; 78: 712–6.
- 80Dawson G, Sun JM, Davlantis KS, Murias M, Franz L, Troy J, et al. Autologous cord blood infusions are safe and feasible in young children with autism spectrum disorder: results of a single-center phase i open-label trial. Stem Cells Transl Med. 2017; 6: 1332–9.
- 81Sun JM, Song AW, Case LE, Mikati MA, Gustafon KE, Simmons R, et al. Effect of autologous cord blood infusion on motor function and brain connectivity in young children with cerebral palsy: a randomized, placebo-controlled trial. Stem Cells Transl Med. 2017; 6: 2071–8.
- 82Damien P, Allan DS. Regenerative therapy and immune modulation using umbilical cord blood derived cells. Biol Blood Marrow Transplant. 2015; 21: 1545–54.
- 83Sun J, Mikati M, Troy J, McLaughlin C, Jasien J, Case L, et al. Sibling umbilical cord blood infusion is safe in children with cerebral palsy. Dev Med Child Neurol. 2017; 59: 115.
- 84Kang M, Min K, Jang J, Kim SC, Kang MS, Jiang SJ, et al. Involvement of immune responses in the efficacy of cord blood cell therapy for cerebral palsy. Stem Cells Dev. 2015; 24: 2259–68.
- 85Laskowitz DT, Bennet ER, Durham RJ, Volpi JJ, Wiese JR, Frankel M, et al. Allogeneic umbilical cord blood infusion for adults with ischemic stroke: clinical outcomes from a phase I safety study. Stem Cells Transl Med. 2018; 7: 521–9.
- 86Lee S, Huh JY, Turner DM, Lee S, Robinson J, Stein JE. Repurposing the cord blood bank for haplobanking of HLA-homozygous iPSCs and their usefulness to multiple populations. Stem Cells. 2018; 36: 1552–66.
- 87Okita K, Yamakawa T, Matsumura Y, Sato Y, Amano N, Watanabe A, et al. An efficient nonviral method to generate integration-free human-induced pluripotent stem cells from cord blood and peripheral blood cells. Stem Cells. 2013; 31: 458–66.
- 88Lomax GP, Hull SC, Isasi R. The DISCUSS project: revised points to consider for the derivation of induced pluripotent stem cell lines from previously collected research specimens. Stem Cells Transl Med. 2015; 4: 123–9.
- 89Mandai M, Watanabe A, Kurimoto Y, Hirami Y, Morinaga C, Daimon T, et al. Autologous induced stem-cell-derived retinal cells for macular degeneration. N Engl J Med. 2017; 376: 1038–46.
- 90Demirci S, Leonard A, Tisdale JF. Hematopoietic stem cells from pluripotent stem cells: Clinical potential, challenges, and future perspectives. Stem Cells Transl Med. 2020; 9: 1549–57.
- 91Themeli M, Rivière I, Sadelain M. New cell sources for T cell engineering and adoptive immunotherapy. Cell Stem Cell. 2015; 16: 357–66.
- 92Gee AP. GMP CAR-T cell production. Best Pract Res Clin Haematol. 2018; 31: 126–34.
- 93Ten Ham RM, Hovels AM, Hoekman J, Frederix GW, Leufkens HG, Klungel OH, et al. What does cell therapy manufacturing cost? A framework and methodology to facilitate academic and other small-scale cell therapy manufacturing costings. Cytotherapy. 2020; 22: 388–97.
- 94Barker JN, Boughan K, Dahi PB, Devlin SM, Maloy MA, Naputo K, et al. Racial disparities in access to HLA-matched unrelated donor transplants: a prospective 1312-patient analysis. Blood Adv. 2019; 3: 939–44.
- 95Kapinos KA, Briscombe B, Gracner T, Strong A, Whaley C, Hoch E, et al. Challenges to the Sustainability of the U.S. Public Cord Blood System. Santa Monica, CA: RAND Corporation; 2017.
10.7249/RR1898 Google Scholar
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