Race/ethnicity and underlying disease influences hematopoietic stem/progenitor cell mobilization response: A single center experience

Abstract

Background Whether race/ethnicity plays a role in hematopoietic stem/progenitor cells (HSPC) mobilization in autologous donors has not been studied. We hypothesize that donor characteristic including race/ethnicity, age, sex, body mass index, and diagnostic groups influences HSPC mobilization. Diagnostic groups include healthy allogeneic donors, autologous multiple myeloma (MM) and non‐MM donors. Study Design and Methods Here, we conducted a single‐center retrospective study in 64 autologous patients and 48 allogeneic donors. Autologous donors were patients diagnosed with MM or non‐MM. All donors were grouped as African American (AA), White (W), or “Other”(O). Results Multivariate analysis demonstrated diagnostic group differences for CD34+ cell yields between race/ethnicity. Specifically, non‐MM patients had the lowest CD34+ cell yields in AA and O, but not in W. For pre‐apheresis peripheral blood (PB) CD34+ cell numbers, race/ethnicity had a significant effect both in bivariate and multivariate analyses. Non‐MM patients had the lowest, and AA patients had the highest PB CD34+ cells. The results support the view that past therapies used in MM are likely more conducive of recovery of HSPC. Conclusions Our study shows that race/ethnicity and diagnostic group differences influenced CD34+ cell mobilization response across donor types. Interestingly, autologous MM donors with the aid of plerixafor displayed comparable CD34 yields to allogeneic donors. Even though both MM and non‐MM donors received plerixafor, non‐MM donors had significantly lower CD34 yields among AA and O donors but not in W donors. Larger studies would be required to validate the role of diagnostic groups and race/ethnicity interactions.

Cryopreserved hematopoietic stem/progenitor cells stability program‐development, current status and recommendations: A brief report from the AABB‐ISCT joint working group cellular therapy product stability project team

“…If the cryopreservation technique is identical (autologous vs. allogeneic) separate metrics may not be warranted. The source material derived from autologous (sick patients) 4 and allogeneic (healthy volunteers) donors may be different enough to warrant separating certain metrics, such as viable post‐thaw CD34+ cells recovery.…”

“…HSPC viability and potency are also influenced by factors independent of primary manufacturing and cryopreservation such as follows: cell source (e.g., bone marrow, peripheral blood, and umbilical cord blood), collection methodology, donor factors (e.g., age, past exposure to chemotherapy for autologous donors); cell concentration at the collection; granulocyte fraction within the graft; and length of time between collection to cryopreservation. [1][2][3][4] Since each step from collection to infusion may impact the intended therapeutic function of HSPC, well-controlled and validated processes are recommended to maintain optimal target cell recovery and functional potency. Ultimately, stability programs should periodically evaluate key manufacturing steps (i.e., Critical Process Parameters or CPPs) via Critical Quality Attributes/Elements (CQAs, CQEs), with sufficient sample size, using a variety of standardized and validated assays, to mitigate the loss of viable cell recovery and function in the HSPC product.…”

“…Most HSPCs ‐ autologous, umbilical cord blood, and some allogeneic HSPC grafts ‐ require cryopreservation for weeks to years prior to administration to patients, depending on the patient need and more recently for logistical reasons (i.e., COVID‐19 pandemic). HSPC viability and potency are also influenced by factors independent of primary manufacturing and cryopreservation such as follows: cell source (e.g., bone marrow, peripheral blood, and umbilical cord blood), collection methodology, donor factors (e.g., age, past exposure to chemotherapy for autologous donors); cell concentration at the collection; granulocyte fraction within the graft; and length of time between collection to cryopreservation 1–4 . Since each step from collection to infusion may impact the intended therapeutic function of HSPC, well‐controlled and validated processes are recommended to maintain optimal target cell recovery and functional potency.…”