CliniMACS® CD34 Product Line

CliniMACS
®
CD34 Product Line

The CD34 antigen is a single transmembrane glycoprotein that is mainly expressed on human hematopoietic stem and progenitor cells but is also present on endothelial progenitor cells.
The CD34 antigen is involved in cell adhesion and is thought to function as a signaling molecule.
The CliniMACS® CD34 Product Line consists of murine anti-CD34 monoclonal antibodies conjugated to superparamagnetic iron dextran particles.
One vial contains 7.5 mL sterile, non-pyrogenic solution.
The performance of the CliniMACS CD34 Product Line depends on the individual separation strategy. For information on respective capacities, refer to the CliniMACS User Manual or contact your local representative.
Please inquire about required CliniMACS System components and accessories.

Disclaimer

The CliniMACS
®
System components, including Reagents, Tubing Sets, Instruments, and PBS/EDTA Buffer, are designed, manufactured and tested under a quality system certified to ISO 13485.
In the EU, the CliniMACS System components are available as CE-marked medical devices for their respective intended use, unless otherwise stated. The CliniMACS Reagents and Biotin Conjugates are intended for in vitro use only and are not designated for therapeutic use or direct infusion into patients. The CliniMACS Reagents in combination with the CliniMACS System are intended to separate human cells. Miltenyi Biotec as the manufacturer of the CliniMACS System does not give any recommendations regarding the use of separated cells for therapeutic purposes and does not make any claims regarding a clinical benefit. For the manufacturing and use of target cells in humans the national legislation and regulations - e.g., for the EU the Directive 2004/23/EC ("human tissues and cells"), or the Directive 2002/98/EC ("human blood and blood components") - must be followed. Thus, any clinical application of the target cells is exclusively within the responsibility of the user of a CliniMACS System.
In the US, the CliniMACS CD34 Reagent System, including the CliniMACS Plus Instrument, CliniMACS CD34 Reagent, CliniMACS Tubing Sets TS and LS, and the CliniMACS PBS/EDTA Buffer, is FDA approved; all other products of the CliniMACS Product Line are available for use only under an approved Investigational New Drug (IND) application or Investigational Device Exemption (IDE).
CliniMACS MicroBeads are for research use only and not for human therapeutic or diagnostic use. Unless otherwise specifically indicated, Miltenyi Biotec products and services are for research only and not for therapeutic or diagnostic use.

Applications

The CliniMACS CD34 Product Line was developed for the enrichment of CD34
+
cells from human heterogeneous hematologic cell populations in combination with the CliniMACS System.

Referenced literature

CD34 enrichment of hematopoietic progenitor cells (HPC) is performed to provide an allogeneic stem cell graft highly purified for CD34
+
cells and depleted of unwanted cells.
Highly purified CD34
+
enriched stem cell grafts were reportedly used for HLA mismatched (MMUD/MMRD) and haploidentical hematopoietic stem cell transplantations (haplo-HSCT)
1-3
, as well as for HLA identical sibling (MRD) and matched unrelated donor (MUD) cell transplantations
4–7
. To overcome poor graft function (PGF) after HSCT CD34
+
selected stem cell boosts (SCB) were utilized in pediatrics and adults
8–11
. T cell depletion (TCD) facilitated by CD34
+
cell enrichment is also described in combination with reduced intensity conditioning (RIC)
12
and umbilical cord blood transplantation
13,14
. In addition outcomes of TCD in both malignant
1,4,6
and non-malignant diseases have been published
7,15
. Different methods of graft manipulation and future prospects of
ex vivo
TCD in allogeneic HSCT have been reviewed
27
.
In autologous transplantation CD34
+
progenitor cells can be enriched in order to passively remove tumor cells from the graft (tumor cell purging)
16,17
. Enriched CD34
+
cells have also been used to deplete auto-reactive cells from stem cell grafts for refractory autoimmune diseases, such as multiple sclerosis, severe scleroderma, systemic lupus erythematosus, and systemic sclerosis
18-22
. Genetically engineered hematopoietic stem cells for clinical gene therapy have been studied for over a decade and early limitations have been addressed
23
. The first
ex vivo
stem cell gene therapy for patients with ADA-SCID are commercially available autologous CD34
+
enriched cells transduced to express adenosine deaminase
24-26
.
  • Selected References

    1. Montoro, J. et al. (2016) Advances in haploidentical stem cell transplantation for hematologic malignancies. Leuk. Lymphoma 57(8): 1766-1775
    2. Teltschik, H. M. et al. (2016) Treatment of graft failure with TNI-based reconditioning and haploidentical stem cells in paediatric patients. Br. J. Haematol. 175(1): 115-122
    3. Martelli, M. F. et al. (2014) "Designed" grafts for HLA-haploidentical stem cell transplantation. Blood 123(7): 967-973
    4. Pasquini, M.C. et al. (2012)
      Comparative Outcomes of Donor Graft CD34
      +
      Selection and Immune suppressive therapy as graft-versus-host disease prophylaxis for patients with acute myeloid leukemia in complete remission undergoing HLA-matched sibling allogeneic hematopoietic cell transplantation.
      J. Clin. Oncol. 30(26): 3194-3201
    5. Shah, G. L. et al. (2018) Impact of Toxicity on Survival for Older Adult Patients after CD34 Selected Allogeneic Hematopoietic Stem Cell Transplantation. Biol. Blood Marrow Transplant. 24(1): 142-149
    6. Cho, C. et al. (2017)
      Long-term prognosis for 1-year relapse-free survivors of CD34
      +
      cell-selected allogeneic hematopoietic stem cell transplantation: a landmark analysis.
      Bone Marrow Transplant. 52(12): 1629-1636
    7. Mehta, P. A. et al. (2017) Radiation-Free, Alternative-Donor HCT for Fanconi Anemia Patients: Results from a Prospective Multi-Institutional Study. Blood 129(16): 2308-2315
    8. Chandra, S. et al. (2018)
      Post-Transplant CD34
      +
       Selected Stem Cell "Boost" for Mixed Chimerism after Reduced-Intensity Conditioning Hematopoietic Stem Cell Transplantation in Children and Young Adults with Primary Immune Deficiencies.
      Biol. Blood Marrow Transplant. Epub(DOI: 10.1016/j.bbmt.2018.03.013)
    9. Mainardi, C. et al. (2018)
      CD34
      +
      Selected Stem Cell Boosts can Improve Poor Graft Function after Paediatric Allogeneic Stem Cell Transplantation.
      Br. J. Haematol. 180(31): 90-99
    10. Ghobadi, A. et al. (2017)
      Fresh or Cryopreserved CD34
      +
      Selected Mobilized Peripheral Blood Stem and Progenitor Cells for the Treatment of Poor Graft Function after Allogeneic Hematopoietic Cell Transplantation.
      Biol. Blood Marrow Transplant. 23(7): 1072-1077
    11. Haen, S. P. et al. (2015)
      Poor Graft Function can be Durably and Safely Improved by CD34
      +
      -Selected Stem Cell Boosts after Allogeneic Unrelated Matched or Mismatched Hematopoietic Cell Transplantation.
      J. Cancer Res. Clin. Oncol. 141(12): 2241-2251
    12. Ciurea, S. O. et al. (2010) Reduced-Intensity Conditioning Using Fludarabine, Melphalan and Thiotepa for Adult Patients Undergoing Haploidentical SCT. Bone Marrow Transplant. 45(3): 429-436
    13. Tsai, S. B. et al. (2018) Reduced-Intensity Allogeneic Transplant for Acute Myeloid Leukemia and Myelodysplastic Syndrome Using Combined CD34-Selected Haploidentical Graft and a Single Umbilical Cord Unit Compared with Matched Unrelated Donor Stem Cells in Older Adults. Biol. Blood Marrow Transplant. 24(5): 997-1004
    14. van Besien, K. and Childs, R. (2016) Haploidentical Cord Transplantation - The Best of Both Worlds. Semin. Hematol. 53(4): 257-266
    15. Gilman, A. L. et al. (2017) Alternative Donor Hematopoietic Stem Cell Transplantation for Sickle Cell Disease. Blood Adv 1(16): 1215-1223
    16. Berger, M. D. et al. (2015)
      CD34
      +
      Selected versus Unselected Autologous Stem Cell Transplantation in Patients with Advanced-Stage Mantle Cell and Diffuse Large B-Cell Lymphoma.
      Leuk. Res. 39(6): 561-567
    17. Yahng, S. A. et al. (2014)
      Influence of ex vivo Purging with CliniMACS CD34
      +
      Selection on Outcome after Autologous Stem Cell Transplantation in Non-Hodgkin Lymphoma.
      Br. J. Haematol. 164(4): 555-564
    18. Sullivan, K. M. et al. (2018) Myeloablative Autologous Stem-Cell Transplantation for Severe Scleroderma. N. Engl. J. Med. 378(1): 35-47
    19. Oliveira, M. C. et al. (2016)
      Does ex vivo CD34
      +
      Positive Selection Influence Outcome after Autologous Hematopoietic Stem Cell Transplantation in Systemic Sclerosis Patients?
      Bone Marrow Transplant. 51(4): 501-505
    20. Keever-Taylor, C. A. et al. (2017)
      Manufacture of Autologous CD34
      +
      Selected Grafts in the NIAID-Sponsored HALT-MS and SCOT Multicenter Clinical Trials for Autoimmune Diseases.
      Biol. Blood Marrow Transplant. 23(9): 1463-1472
    21. Atkins, H. L. et al. (2016) Immunoablation and Autologous Haemopoietic Stem-Cell Transplantation for Aggressive Multiple Sclerosis: A Multicentre Single-Group Phase 2 Trial. Lancet 388(10044): 576-585
    22. Alchi, B. et al. (2013) Autologous Haematopoietic Stem Cell Transplantation for Systemic Lupus Erythe-matosus: Data from the European Group for Blood and Marrow Transplantation registry. Lupus 22(3): 245-253
    23. Psatha, N. et al. (2016) Optimizing autologous cell grafts to improve stem cell gene therapy. Exp. Hematol. 44(7): 528-539
    24. Stirnadel-Farrant, H. et al. (2018) Gene therapy in rare diseases: the benefits and challenges of developing a patient-centric registry for Strimvelis in ADA-SCID. Orphanent J Rare Dis 13(1): 49
    25. Aiuti, A. et al. (2009) Gene therapy for immunodeficiency due to adenosine deaminase deficiency. N. Engl. J. Med. 360(5): 447-458
    26. Cicalese, M. P et al. (2016) Update on the safety and efficacy of retroviral gene therapy for immunodeficiency due to adenosine deaminase deficiency. Blood 128(1): 45-54
    27. Saad, A. and Lamb, L. S. (2017) Ex vivo T-Cell Depletion in Allogeneic Hematopoietic Stem Cell Transplant: Past, Present and Future. Bone Marrow Transplant. 52(9): 1241-1248
  • Selected references

  • Certificates of Analysis (CoA)

    Please follow this
    link
    to search for certificates by lot number.
Product options: 5

Product information

Size
Order no.
Price

CliniMACS CD34 Reagent (171-01)

  • CE
7.5 mL
200-070-100
-

CliniMACS CD34 Complete Kit

  • CE-marked components
1
kit
200-074-012
-

CliniMACS CD34 Complete Kit with Accessories

  • CE-marked components
1
kit
200-074-014
-

CliniMACS CD34 Complete LS Kit

  • CE-marked components
1
kit
200-074-013
-

CliniMACS CD34 Complete LS Kit with Accessories

  • CE-marked components
1
kit
200-074-015
-

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