Is It Better to Mobilize Hematopoietic Stem Cells With Pegfilgrastim in Healthy Donors During Allogeneic Hematopoietic Stem Cell Transplantation?

Li, Jiali; Wang, Sanbin; Zhang, Yicheng; Lou, Shifeng; Liu, Yao; Kong, Peiyan; Zhang, Cheng; Gao, Lei; Peng, Xiaoyong; Wang, Ping; Deng, Xiaojuan; Gao, Li; Zhang, Xi

doi:10.3389/fonc.2020.01598

Cited by 7 publications

(4 citation statements)

References 36 publications

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“…12,13 In our study, the peak of CD34 + cells in the peripheral blood was reached on day 5 (step 1, step 2, and step 4). This finding is consistent with that reported by Kroschinsky et al 11 and Li et al 27 Therefore, day 5 appeared to be the best time to conduct apheresis procedure in healthy donors after pegfilgrastiminduced mobilization.…”

Section: Discussionsupporting

confidence: 92%

Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study

Goto,

Sugita,

Hasegawa

et al. 2023

Transplantation

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Background. Pegfilgrastim, a long-acting form of granulocyte-colony stimulating factor, with a convenient single-injection dosage, is being investigated for peripheral blood stem cell (PBSC) mobilization in healthy volunteers. However, data on the adequate dose of pegfilgrastim for PBSC mobilization are limited. This phase 2, single-arm study evaluated the efficacy and safety of pegfilgrastim for PBSC mobilization in healthy volunteers. Methods. The study comprised 2 phases: pilot (steps 1–3, dose escalation, a single subcutaneous dose of 3.6, 7.2, and 10.8 mg pegfilgrastim, respectively) and evaluation (step 4, efficacy and safety assessments). The primary endpoint was the proportion of subjects who achieved mobilization of ≥20 × 106/L cluster of differentiation 34 positive (CD34+) cells. Results. Thirty-five subjects (6 each in steps 1 and 2 and 23 in step 4) were included. In the pilot phase, step 3 with a 10.8 mg dose was not conducted due to favorable outcomes in step 2 (desired CD34+ cell count), at 7.2 mg pegfilgrastim, which was identified as the optimal dose for the evaluation phase. In the evaluation phase, successful CD34+ mobilization was achieved in all 23 subjects. The mean peripheral blood CD34+ cells count peaked on day 5. Back pain, thrombocytopenia, transient elevations of alkaline phosphatase, and lactate dehydrogenase were the most common adverse events. All adverse events were mild, and none led to study discontinuation. Conclusions. A single-dose pegfilgrastim successfully mobilized an optimal number of CD34+ cells and was well tolerated. Pegfilgrastim could be an alternative option for PBSC mobilization in healthy volunteers. The trial was registered at www.clinicaltrials.gov (NCT03993639).

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Section: Discussionsupporting

confidence: 92%

Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study

Goto,

Sugita,

Hasegawa

et al. 2023

Transplantation

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“…The mobilization of CD34 + CD38 − HSPCs using G-CSF or GM-CSF [99][100][101] has been instrumental in establishing peripheral blood HSPC autologous transplantation as an effective therapeutic practice, demonstrating efficiency comparable to bone marrow transplants. 102 Since HSPC are responsible for producing blood and immune cells in response to immunological stress, they represent a promising strategy for treating sepsis. A recent study demonstrated that sepsis induced by Group A Streptococcus in mice results in the depletion of bone marrow HSPCs and mortality.…”

Section: Looking Forward To Ther Apeuti C P Otentialmentioning

confidence: 99%

“…The most commonly used stem cell‐based therapy is bone marrow transplantation. The mobilization of CD34 + CD38 − HSPCs using G‐CSF or GM‐CSF 99–101 has been instrumental in establishing peripheral blood HSPC autologous transplantation as an effective therapeutic practice, demonstrating efficiency comparable to bone marrow transplants 102 . Since HSPC are responsible for producing blood and immune cells in response to immunological stress, they represent a promising strategy for treating sepsis.…”

Section: Looking Forward To Therapeutic Potentialmentioning

confidence: 99%

The potency of hematopoietic stem cell reprogramming for changing immune tone

Daman,

Cheong,

Berneking

et al. 2024

Immunological Reviews

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SummaryInnate immune memory endows innate immune cells with antigen independent heightened responsiveness to subsequent challenges. The durability of this response can be mediated by inflammation induced epigenetic and metabolic reprogramming in hematopoietic stem and progenitor cells (HSPCs) that are maintained through differentiation to mature immune progeny. Understanding the mechanisms and extent of trained immunity induction by pathogens and vaccines, such as BCG, in HSPC remains a critical area of exploration with important implications for health and disease. Here we review these concepts and present new analysis to highlight how inflammatory reprogramming of HSPC can potently alter immune tone, including to enhance specific anti‐tumor responses. New findings in the field pave the way for novel HSPC targeting therapeutic strategies in cancer and other contexts of immune modulation. Future studies are expected to unravel diverse and extensive effects of infections, vaccines, microbiota, and sterile inflammation on hematopoietic progenitor cells and begin to illuminate the broad spectrum of immunologic tuning that can be established through altering HSPC phenotypes. The purpose of this review is to draw attention to emerging and speculative topics in this field where we posit that focused study of HSPC in the framework of trained immunity holds significant promise.

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“…Unmanipulated BM (harvested on day 4 after G-CSF administration) and/or PB stem cells (harvested on days 4 and 5 after G-CSF administration) are infused into the recipient on the day of collection. A single dose of pegfilgrastim (12 mg subcutaneously on day 1) is used to mobilize PB; a single dose might avoid the pain of multiple injections [ 105 ]. An optimal number of CD34 + cells (≥ 4 × 10 6 kg) are collected in a single apheresis procedure on day 5.…”

Section: Recommendation: Donor Selection and Graft Sourcementioning

confidence: 99%

The consensus from The Chinese Society of Hematology on indications, conditioning regimens and donor selection for allogeneic hematopoietic stem cell transplantation: 2021 update

et al. 2021

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The consensus recommendations in 2018 from The Chinese Society of Hematology (CSH) on indications, conditioning regimens and donor selection for allogeneic hematopoietic stem cell transplantation (allo-HSCT) facilitated the standardization of clinical practices of allo-HSCT in China and progressive integration with the world. There have been new developments since the initial publication. To integrate recent developments and further improve the consensus, a panel of experts from the CSH recently updated the consensus recommendations, which are summarized as follows: (1) there is a new algorithm for selecting appropriate donors for allo-HSCT candidates. Haploidentical donors (HIDs) are the preferred donor choice over matched sibling donors (MSDs) for patients with high-risk leukemia or elderly patients with young offspring donors in experienced centers. This replaces the previous algorithm for donor selection, which favored MSDs over HIDs. (2) Patients with refractory/relapsed lymphoblastic malignancies are now encouraged to undergo salvage treatment with novel immunotherapies prior to HSCT. (3) The consensus has been updated to reflect additional evidence for the application of allo-HSCT in specific groups of patients with hematological malignancies (intermediate-risk acute myeloid leukemia (AML), favorable-risk AML with positive minimal residual disease, and standard-risk acute lymphoblastic leukemia). (4) The consensus has been updated to reflect additional evidence for the application of HSCT in patients with nonmalignant diseases, such as severe aplastic anemia and inherited diseases. (5) The consensus has been updated to reflect additional evidence for the administration of anti-thymocyte globulin, granulocyte colony-stimulating factors and post-transplantation cyclophosphamide in HID-HSCT.

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Is It Better to Mobilize Hematopoietic Stem Cells With Pegfilgrastim in Healthy Donors During Allogeneic Hematopoietic Stem Cell Transplantation?

Cited by 7 publications

References 36 publications

Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study

Efficacy and Safety of Single-dose Pegfilgrastim for CD34+ Cell Mobilization in Healthy Volunteers: A Phase 2 Study

The potency of hematopoietic stem cell reprogramming for changing immune tone

The consensus from The Chinese Society of Hematology on indications, conditioning regimens and donor selection for allogeneic hematopoietic stem cell transplantation: 2021 update

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