GMP-grade CD34+ selection from HLA-homozygous licensed cord blood units and short-term expansion under European ATMP regulations.

Vox Sanguinis
Stefanie LiedtkeGesine Kogler

Abstract

Based on a synergistic consortium, the cord blood (CB) bank Düsseldorf was responsible for the selection of HLA-homozygous (HLA-h) donors, contacting/re-consenting the mothers, Good Manufacturing Practice (GMP)-grade CD34+ enrichment, followed by short-term expansion of CD34+ cells and qualification of the resulting CD34+ population as advanced therapy medicinal product (ATMP)-starting material. Among 20 639 licensed Düsseldorf cord blood units (CBUs), 139 potential HLA-h donors were identified with the most frequent 10 German haplotypes. 100% of the donors were contacted, and for 47·5%, consent was obtained. HLA-A, -B, -C, -DR, -DQ and -DP were determined by sequencing. Thawing/washing of the CBUs was performed in the presence of Volulyte/HSA with Sepax® , CD34+ selection by automated CliniMACS® -system (Miltenyi), expansion with qualified GMP-grade cytokines and media in the GMP facility. Here, we specify minimal criteria (≥5 x 105 viable CD34+ -count, ≥80% CD34+ -purity and ≥70% viability) and confirm that n = 10 CB units (max storage time 16 years) could be qualified for an ATMP starting material. The mean fold change expansion of isolated CD34+ cells at Day 3/4 (d3/4) was 3·38 ± 3·02 with a mean purity of 86·90 ± 10·38% an...Continue Reading

References

Oct 24, 1995·Proceedings of the National Academy of Sciences of the United States of America·P RubinsteinC E Stevens
Jan 9, 2003·Proceedings of the National Academy of Sciences of the United States of America·Hal E BroxmeyerDavid M Bodine
Jul 19, 2003·Science·Marie Kmita, Denis Duboule
Jul 21, 2004·The Journal of Experimental Medicine·Gesine KöglerPeter Wernet
Dec 30, 2004·Proceedings of the National Academy of Sciences of the United States of America·Julien Y BertrandAna Cumano
Jul 10, 2008·Nature Biotechnology·Norio NakatsujiKatsushi Tokunaga
Sep 13, 2008·Cell Stem Cell·Dirk HockemeyerRudolf Jaenisch
Oct 3, 2009·Cell Stem Cell·Alexandra HaaseUlrich Martin
Mar 25, 2010·Stem Cells and Development·Simone Maria KluthGesine Kögler
Jun 15, 2010·Experimental Hematology·Holm ZaehresPeter Wernet
Jul 14, 2010·Cell Stem Cell·Yuin-Han LohGeorge Q Daley
Jul 6, 2011·Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences·Keisuke Okita, Shinya Yamanaka
Jun 12, 2013·Biochimie·Ludovic ZimmerlinAlbert D Donnenberg
Aug 16, 2014·Journal of Immunology Research·Casimir de Rham, Jean Villard
Apr 23, 2015·Stem Cells Translational Medicine·Stefanie LiedtkeGesine Kogler
Sep 26, 2015·Science·Iñigo Martincorena, Peter J Campbell
Sep 29, 2015·Stem Cell Reports·Behnam Ahmadian BaghbaderaniMahendra S Rao
Sep 7, 2016·FEBS Letters·Emmanuelle JulienManuela Tavian
Mar 11, 2017·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Juliet N BarkerElizabeth Shpall
Sep 25, 2017·Journal of Tissue Engineering and Regenerative Medicine·Yeri Alice RimJi Hyeon Ju
May 4, 2018·Advances in Experimental Medicine and Biology·Vladimir KhristovSheldon Miller
Aug 14, 2018·Molecular Therapy. Methods & Clinical Development·Mor NgomRichard Keith Humphries
Dec 14, 2018·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Mitchell E HorwitzGuillermo Sanz
Apr 27, 2019·Annual Review of Immunology·Ana CumanoPablo Pereira
Aug 10, 2019·Methods in Molecular Biology·Huang Zhu, Dan S Kaufman
Sep 16, 2019·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Yasuo MorishimaJunya Kanda
Nov 14, 2019·International Journal of Hematology·Yuki Kageyama, Naoyuki Katayama

❮ Previous
Next ❯

Citations

Apr 21, 2021·British Journal of Haematology·Sergio QuerolAlejandro Madrigal

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.