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Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay.

Publication ,  Journal Article
Shoulars, K; Noldner, P; Troy, JD; Cheatham, L; Parrish, A; Page, K; Gentry, T; Balber, AE; Kurtzberg, J
Published in: Blood
May 12, 2016

Banked, unrelated umbilical cord blood provides access to hematopoietic stem cell transplantation for patients lacking matched bone marrow donors, yet 10% to 15% of patients experience graft failure or delayed engraftment. This may be due, at least in part, to inadequate potency of the selected cord blood unit (CBU). CBU potency is typically assessed before cryopreservation, neglecting changes in potency occurring during freezing and thawing. Colony-forming units (CFUs) have been previously shown to predict CBU potency, defined as the ability to engraft in patients by day 42 posttransplant. However, the CFU assay is difficult to standardize and requires 2 weeks to perform. Consequently, we developed a rapid multiparameter flow cytometric CBU potency assay that enumerates cells expressing high levels of the enzyme aldehyde dehydrogenase (ALDH bright [ALDH(br)]), along with viable CD45(+) or CD34(+) cell content. These measurements are made on a segment that was attached to a cryopreserved CBU. We validated the assay with prespecified criteria testing accuracy, specificity, repeatability, intermediate precision, and linearity. We then prospectively examined the correlations among ALDH(br), CD34(+), and CFU content of 3908 segments over a 5-year period. ALDH(br) (r = 0.78; 95% confidence interval [CI], 0.76-0.79), but not CD34(+) (r = 0.25; 95% CI, 0.22-0.28), was strongly correlated with CFU content as well as ALDH(br) content of the CBU. These results suggest that the ALDH(br) segment assay (based on unit characteristics measured before release) is a reliable assessment of potency that allows rapid selection and release of CBUs from the cord blood bank to the transplant center for transplantation.

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Published In

Blood

DOI

EISSN

1528-0020

Publication Date

May 12, 2016

Volume

127

Issue

19

Start / End Page

2346 / 2354

Location

United States

Related Subject Headings

  • Male
  • Leukocyte Common Antigens
  • Immunology
  • Humans
  • Hematopoietic Stem Cells
  • Flow Cytometry
  • Fetal Blood
  • Female
  • Cord Blood Stem Cell Transplantation
  • Antigens, CD34
 

Citation

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Shoulars, K., Noldner, P., Troy, J. D., Cheatham, L., Parrish, A., Page, K., … Kurtzberg, J. (2016). Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay. Blood, 127(19), 2346–2354. https://doi.org/10.1182/blood-2015-08-666990
Shoulars, Kevin, Pamela Noldner, Jesse D. Troy, Lynn Cheatham, Amanda Parrish, Kristin Page, Tracy Gentry, Andrew E. Balber, and Joanne Kurtzberg. “Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay.Blood 127, no. 19 (May 12, 2016): 2346–54. https://doi.org/10.1182/blood-2015-08-666990.
Shoulars 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 May 12;127(19):2346–54.
Shoulars, Kevin, et al. “Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay.Blood, vol. 127, no. 19, May 2016, pp. 2346–54. Pubmed, doi:10.1182/blood-2015-08-666990.
Shoulars K, Noldner P, Troy JD, Cheatham L, Parrish A, Page K, Gentry T, Balber AE, Kurtzberg J. Development and validation of a rapid, aldehyde dehydrogenase bright-based cord blood potency assay. Blood. 2016 May 12;127(19):2346–2354.

Published In

Blood

DOI

EISSN

1528-0020

Publication Date

May 12, 2016

Volume

127

Issue

19

Start / End Page

2346 / 2354

Location

United States

Related Subject Headings

  • Male
  • Leukocyte Common Antigens
  • Immunology
  • Humans
  • Hematopoietic Stem Cells
  • Flow Cytometry
  • Fetal Blood
  • Female
  • Cord Blood Stem Cell Transplantation
  • Antigens, CD34