Have a personal or library account? Click to login
Labeling of cell therapy products: a review of the past and a look into the future Cover

Labeling of cell therapy products: a review of the past and a look into the future

By: N.R. Haley and  J.P. Miller  
Paid access
|Apr 2020

References

  1. Thomas ED, Buckner CD, Banaji M, et al. One-hundred patients with acute leukemia treated by chemotherapy, total body irradiation, and allogeneic marrow transplantation. Blood 1977; 49:511–33.10.1182/blood.V49.4.511.511
  2. Thomas ED, Storb R, Clift RA, et al. Bone marrow transplantation. N Engl J Med 1975;292:895–902.10.1056/NEJM197504242921706235092
  3. Philip T, Armitage JO, Spitzer G, et al. High-dose therapy and autologous bone marrow transplantation after failure of conventional therapy in adults with intermediate-grade or high-grade non-Hodgkin’s lymphoma. N Engl J Med 1987;316:1493–8.10.1056/NEJM1987061131624013295541
  4. Kessinger A, Armitage JO. The evolving role of autologous peripheral stem cell transplantation following high dose chemotherapy for malignancies. Blood 1991;77:211–3.10.1182/blood.V77.2.211.211
  5. Stroncek D, Bartsch G, Perkin HA, et al. The National Marrow Donor Program. Transfusion 1993;33:567–77.10.1046/j.1537-2995.1993.33793325052.x8333020
  6. Mavroudis D, Read EJ, Cuttler-Fox M, et al. CD34+ cell dose predicts survival, transplant morbidity, and rate of hematologic recovery after allogeneic marrow transplants for hematologic malignancies. Blood 1996;88:3223–9.10.1182/blood.V88.8.3223.bloodjournal8883223
  7. Szczepiorkowski ZM, ed. Standards for cellular therapy products and services. Bethesda: American Association of Blood Banks, 2004.
  8. Warkentin PI, ed. Standards for hematopoietic progenitor cell collection, processing and transplantation. 2nd ed. Omaha, NE: Foundation for the Accreditation of Cellular Therapy, 2002.
  9. Gluckman E, Broxmeyer HE, Auerbach AD, et al. Hematopoietic reconstitution in a patient with Fanconi’s anemia by means of umbilical cord blood from an HLA-identical sibling. N Engl J Med 1989;321:1174–8.10.1056/NEJM1989102632117072571931
  10. Kurtzberg J, Laughlin M, Graham ML, et al. Placental blood as a source of hematopoietic cells for transplantation into unrelated recipients. N Engl J Med 1996;335:157–66.10.1056/NEJM1996071833503038657213
  11. Kolb H, Mittermüller J, Clemm C, et al. Donor leukocyte transfusions for treatment of recurrent chronic lymphocytic leukemia in marrow transplant patients. Blood 1990;76:2462–5.10.1182/blood.V76.12.2462.2462
  12. Current Good Tissue Practice for Human Cellular and Tissue-Based Products and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement, 69 Federal Register 68611 (2004) (codified at 21 CFR Parts 16, 1270, and 1271). http://www.fda.gov/cber/rules/gtp.pdf.
  13. 21 CFR 1271.1 (b) (2)
DOI: https://doi.org/10.21307/immunohematology-2019-322 | Journal eISSN: 1930-3955 | Journal ISSN: 0894-203X
Language: English
Page range: 63 - 68
Published on: Apr 1, 2020
Published by: American National Red Cross
In partnership with: Paradigm Publishing Services
Publication frequency: 4 issues per year

© 2020 N.R. Haley, J.P. Miller, published by American National Red Cross
This work is licensed under the Creative Commons License.