Abstract
The hematopoietic progenitor cells present in the umbilical cord (HPC, Cord Blood) have the potential to engraft and differentiate in the bone marrow with subsequent trilineage hematopoiesis. The collection, processing and storage of HPC, Cord Blood should preserve the cell number and characteristics to protect their hematopoietic potential. Federal regulations establish guidelines for HPC, Cord Blood manufacturing and testing to ensure the safety, purity, potency and identity of the product. Accrediting organizations for cord blood banks, including the AABB and the Foundation for Accreditation of Cellular Therapy (FACT), provide a series of guidelines for developing safe processes and procedures in cellular therapy activities. Additionally, clinical data based on outcome analysis provide evidence to help in the process of unit selection for a given patient, based on compatibility, cell dose and potency of the product.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Harvath L. Food and Drug Administration’s proposed approach to regulation of hematopoietic stem/progenitor cell products for therapeutic use. Transfus Med Rev. 2000;14(2):104-11.
Food and Drug Administration. Proposed approach to regulation of cellular and tissue-based products (February 28, 1997). CBER Office of Communication, Training, and Manufacturers Assistance, Rockville, 1997.
Food and Drug Administration. Suitability determination for donors of human cellular and tissue-based products; proposed rule. Fed Regist. 1999;64:52696–723.
Food and Drug Administration. Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products; final rule. Fed Regist. 2004;69:29786–834.
Food and Drug Administration. Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling; final rule. Fed Regist. 2007;72:33667–9.
Food and Drug Administration. Current good tissue practice for manufacturers of human cellular and tissue-based products; inspection and enforcement; proposed rule. Fed Regist. 2001;66:1508–55.
Food and Drug Administration. Current good tissue practice for manufacturers of human cellular and tissue-based products; inspection and enforcement; final rule. Fed Regist. 2004;69:68612–88.
Food and Drug Administration. Guidance for Industry. Biologics License Applications for Minimally Manipulated, Unrelated Allogenic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System June 2013.
American College of Obstretics (Obstretricians), Gynecologists. ACOG committee opinion no. 560: medically indicated late-preterm and early-term deliveries. Obstet Gynecol. 2013;121:908–10.
Broxmeyer HE, Hangoc G, Cooper S, Ribeiro RC, Graves V, Yoder M, Wagner J, Vadhan-Raj S, Benninger L, Rubinstein P, et al. Growth characteristics and expansion of human umbilical cord blood and estimation of its potential for transplantation in adults. Proc Natl Acad Sci U S A. 1992;89:4109–13.
Bacigalupo A, Piaggio G, Podesta M, Figari O, Benvenuto F, Sogno G, Tedone E, Raffo MR, Grassia L, Ferrero R, et al. Influence of marrow CFU-GM content on engraftment and survival after allogeneic bone marrow transplantation. Bone Marrow Transplant. 1995;15:221–6.k
Masszi T, Gluckman E. Lack of correlation between the number of donor nucleated bone marrow cells or CFU-GM content and the rapidity of engraftment in allogeneic BMT. Acta Biomed Ateneo Parmense. 1993;64:221–6.
Page KM, Zhang L, Mendizabal A, Wease S, Carter S, Gentry T, Balber AE, Kurtzberg J. 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.
Eapen M, Klein JP, Ruggeri A, Spellman S, Lee SJ, Anasetti C, Arcese W, Barker JN, Baxter-Lowe LA, Brown M, Fernandez-Vina MA, Freeman J, He W, Iori AP, Horowitz MM, Locatelli F, Marino S, Maiers M, Michel G, Sanz GF, Gluckman E, Rocha V. Impact of allele-level HLA matching on outcomes after myeloablative single unit umbilical cord blood transplantation for hematologic malignancy. Blood. 2013. Epub ahead of print. doi:10.1182.
ViaCord. http://www.viacord.com/cord-banking/viacords-treatment-experience/. Accessed Dec 2013
Regan DM. Cord blood banking: the development and application of cord blood banking processes, standards, and regulations. In: Broxmeyer HE, editor. Cord Blood biology, transplantation, banking, and regulation (Chapter 35). Bethesda: AABB Press; 2011. pp. 633–44.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2014 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Pagano, M., Haley, N. (2014). Quality Control in Cord Blood Banking. In: Ballen, K. (eds) Umbilical Cord Blood Banking and Transplantation. Stem Cell Biology and Regenerative Medicine. Springer, Cham. https://doi.org/10.1007/978-3-319-06444-4_3
Download citation
DOI: https://doi.org/10.1007/978-3-319-06444-4_3
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-06443-7
Online ISBN: 978-3-319-06444-4
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)