Evidence map›Paper›PMID 40635295›Full record

ArticleTransfusion2025

Healthy volunteer stem cell donors followed up 10 years after stimulation with biosimilar filgrastim.

Jens Heyn, Susanne Bräuninger, Petra Becker, Niklas Stoeckmann, Christian Seidl, Sebastian Howe, Simon Daubert, Daniel Fürst, Hubert Schrezenmeier, Halvard Bonig

Registry-linked trialAbstract read
In one paragraph

Article in Transfusion, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07376460 (Biological and Proteomic Characterisation of Platelet-rich Plasma), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07376460 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Biological and Proteomic Characterisation of Platelet-rich Plasma (PRP) Before and After Mobilisation of Haematopoietic Stem Cells in Peripheral Blood From Women With Low Ovarian Response (Low Responders) and in Vitro Evaluation in Human Ovarian Cell Models

TypeobservationalSponsorInstituto Valenciano de Infertilidad, IVI AlicanteRan2026 to 2026Enrolled10ConditionsPoor Ovarian Response, Ovarian ReactivationArmsPlatelet Rich Plasma + BMDSCs mobilization
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jens HeynHexal AG (a Sandoz Company), Holzkirchen, Germany.
Susanne BräuningerGerman Red Cross Blood Service Baden-Württemberg-Hessen, Institute Frankfurt, Frankfurt, Germany.ORCID https://orcid.org/0000-0003-0038-385X
Petra BeckerGerman Red Cross Blood Service Baden-Württemberg-Hessen, Institute Frankfurt, Frankfurt, Germany.
Niklas StoeckmannHexal AG (a Sandoz Company), Holzkirchen, Germany.
Christian SeidlGerman Red Cross Blood Service Baden-Württemberg-Hessen, Institute Frankfurt, Frankfurt, Germany.
Sebastian HoweHexal AG (a Sandoz Company), Holzkirchen, Germany.ORCID https://orcid.org/0009-0008-1321-3108
Simon DaubertHexal AG (a Sandoz Company), Holzkirchen, Germany.
Daniel FürstInstitut für Klinische Transfusionsmedizin und Immungenetik Ulm (IKT), Ulm, Germany.
Hubert SchrezenmeierInstitut für Klinische Transfusionsmedizin und Immungenetik Ulm (IKT), Ulm, Germany.
Halvard BonigGerman Red Cross Blood Service Baden-Württemberg-Hessen, Institute Frankfurt, Frankfurt, Germany.ORCID https://orcid.org/0000-0003-0088-2675

Funding

HEXAL AG (a Sandoz Company)
6 · The paper itself

Abstract

backgroundThe application of granulocyte colony-stimulating factors (G-CSF) for mobilizing hematopoietic stem and progenitor cells in healthy donors is considered safe. However, only limited safety information is available about long-term adverse events (AEs) in this setting. To determine the long-term effect of health consequences to stem cell donors, 244 G-CSF-mobilized donors were tracked prospectively for 10 years. STUDY DESIGN AND

methodsA total of 244 adult healthy unrelated stem cell donors who received at least one dose of Sandoz biosimilar filgrastim were enrolled in this prospective long-term surveillance study. Safety, mental health, and physical health were followed up over a period of 10 years.

resultsNinety-five percent of the donors experience at least one AE during the stem mobilization period; beyond this period, the onset of the first AE was 3.86 [3.45-4.27] years in females and 4.02 [3.68-4.35] years in males. The risk of reporting an AE was significantly lower in the youngest tertile of donors, when compared to the oldest (p = 0.026). Females were more likely to report AEs than males (0.40 vs. 0.21 AEs/year, rate ratio: 1.87 [CI: 1.32-2.64]; <0.001). No clinically relevant permanent changes occurred up to 10 years from mobilization in physical or mental health. DISCUSSION: No new or excessive AEs were identified during a 10-year follow-up of mobilized stem cell donors and therefore reassure about the overall safety of stem cell mobilization with G-CSF in healthy volunteers.

Indexed as

Biosimilar PharmaceuticalsFilgrastimGranulocyte Colony-Stimulating FactorHematopoietic Stem Cell MobilizationTissue DonorsAdultFemaleFollow-Up StudiesHealthy VolunteersHumansMaleMiddle AgedProspective StudiesYoung AdultBiosimilar PharmaceuticalsFilgrastimGranulocyte Colony-Stimulating Factordonorsstem celltransfusion practices (oncology–hematology)transplantation

Identifiers

PMID40635295
PMCPMC12315617

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.