Evidence map›Paper›PMID 31930533›Full record

ArticleTransfusion2020

Preclinical safety assessment of pathogen reduced red blood cells treated with amustaline and glutathione.

Anne K North, Nina Mufti, Theresa Sullivan, Laurence Corash

Open access · hybridAbstract read
In one paragraph

Article in Transfusion, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.1field-weighted citation impact, top 64% 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

4 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. 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

4 authors at 1 institution in 1 country.

Anne K NorthCerus Corporation, Concord, California.
Nina MuftiCerus Corporation, Concord, California.
Theresa SullivanCerus Corporation, Concord, California.
Laurence CorashCerus Corporation, Concord, California.ORCID 0000-0002-8615-9869
Cerus (United States) · US

Funding

Cerus funded
6 · The paper itself

Abstract

backgroundThe nucleic acid targeted pathogen reduction (PR) system utilizing amustaline (S-303) and glutathione (GSH) is designed to inactivate blood-borne pathogens and leukocytes in red blood cell concentrates (PR-RBCC). Inactivation is attained after amustaline intercalates and forms covalent nucleic acid adducts preventing replication, transcription, and translation. After pathogen inactivation, amustaline spontaneously hydrolyzes to S-300, the primary negatively charged reaction product; amustaline is below quantifiable levels in PR-RBCC. GSH quenches free unreacted amustaline. STUDY DESIGN AND

methodsThe genotoxic and carcinogenic potential of PR-RBCC, the reaction by-products, and S-300 were assessed in accordance with the International Conference on Harmonization (ICH) guidelines and performed in compliance with the Food and Drug Administration (FDA) good laboratory practice standards, 21 CFR Part 58. in vitro bacterial reverse mutagenicity and chromosomal aberration assays were performed with and without exogenous S9 metabolic activation, and in in vivo clastogenicity and carcinogenic assays using validated murine models.

resultsPR-RBCCs were not genotoxic in vitro and in vivo and were non-carcinogenic in p53

conclusionsPR-RBCCs did not demonstrate genotoxicity in vitro or in vivo and were not carcinogenic in vivo. These studies support the safety of PR-RBCCs and suggest that there is no measurable genotoxic hazard associated with transfusion of PR-RBCCs.

Indexed as

AcridinesAnimalsBlood-Borne PathogensErythrocytesErythrocyte TransfusionFemaleGlutathioneHumansLymphocytesMaleMiceMicronucleus TestsNitrogen Mustard CompoundsTumor Suppressor Protein p53Virus InactivationAcridinesGlutathioneNitrogen Mustard Compounds(N,N-bis(2-chloroethyl))-2-aminoethyl-3-((acridin-9-yl)amino)propionateTrp53 protein, mouseTumor Suppressor Protein p53

Identifiers

PMID31930533
PMCPMC7027779
OpenAlexW2999877812

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.