Evidence map›Paper›PMID 27382281›Full record

ReviewInternational journal of nanomedicine2016

A comparison of immunotoxic effects of nanomedicinal products with regulatory immunotoxicity testing requirements.

Christina Giannakou, Margriet Vdz Park, Wim H de Jong, Henk van Loveren, Rob J Vandebriel, Robert E Geertsma

Open access · goldAbstract readComparative StudyReview
In one paragraph

Review in International journal of nanomedicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Article
  4. Review
  5. Review
  6. Regulatory aspects of a nanomaterial for imaging therapeutic cells.Drug delivery and translational research · 2023
    Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Article
  14. Immunotoxicity Considerations for Next Generation Cancer Nanomedicines.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2019
    Review
  15. Bridging communities in the field of nanomedicine.Regulatory toxicology and pharmacology : RTP · 2019
    Article
  16. Overview of the blood compatibility of nanomedicines: A trend analysis of in vitro and in vivo studies.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2019
    Review
  17. Mapping of the available standards against the regulatory needs for nanomedicines.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2019
    Review
  18. Review
  19. Review
  20. Safety Aspects of Bio-Based Nanomaterials.Bioengineering (Basel, Switzerland) · 2017
    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

6 authors at 1 institution in 1 country.

Christina GiannakouCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven; Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands.
Margriet Vdz ParkCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
Wim H de JongCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
Henk van LoverenCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven; Department of Toxicogenomics, Maastricht University, Maastricht, the Netherlands.
Rob J VandebrielCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
Robert E GeertsmaCentre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven.
National Institute for Public Health and the Environment · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Nanomaterials (NMs) are attractive for biomedical and pharmaceutical applications because of their unique physicochemical and biological properties. A major application area of NMs is drug delivery. Many nanomedicinal products (NMPs) currently on the market or in clinical trials are most often based on liposomal products or polymer conjugates. NMPs can be designed to target specific tissues, eg, tumors. In virtually all cases, NMPs will eventually reach the immune system. It has been shown that most NMs end up in organs of the mononuclear phagocytic system, notably liver and spleen. Adverse immune effects, including allergy, hypersensitivity, and immunosuppression, have been reported after NMP administration. Interactions of NMPs with the immune system may therefore constitute important side effects. Currently, no regulatory documents are specifically dedicated to evaluate the immunotoxicity of NMs or NMPs. Their immunotoxicity assessment is performed based on existing guidelines for conventional substances or medicinal products. Due to the unique properties of NMPs when compared with conventional medicinal products, it is uncertain whether the currently prescribed set of tests provides sufficient information for an adequate evaluation of potential immunotoxicity of NMPs. The aim of this study was therefore, to compare the current regulatory immunotoxicity testing requirements with the accumulating knowledge on immunotoxic effects of NMPs in order to identify potential gaps in the safety assessment. This comparison showed that immunotoxic effects, such as complement activation-related pseudoallergy, myelosuppression, inflammasome activation, and hypersensitivity, are not readily detected by using current testing guidelines. Immunotoxicity of NMPs would be more accurately evaluated by an expanded testing strategy that is equipped to stratify applicable testing for the various types of NMPs.

Indexed as

AnimalsDrug Delivery SystemsGuidelines as TopicHumansImmune SystemImmune ToleranceNanomedicineNanostructuresSpleenToxicity Testsimmunotoxicitynanomedicineregulatory requirementssafetytesting methods

Identifiers

PMID27382281
PMCPMC4922791
OpenAlexW2472550594

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.