Evidence map›Paper›PMID 31727050›Full record

ArticleBiomedical engineering online2019

The assessment of xenogeneic bone immunotoxicity and risk management study.

Xiaoxia Sun, Chenghu Liu, Yanping Shi, Chunling Li, Likui Sun, Li Hou, Xin Wang

Open access · goldAbstract read
In one paragraph

Article in Biomedical engineering online, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

10 citing papers in PubMed, 17 citations in OpenAlex.

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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

7 authors at 2 institutions in 1 country.

Xiaoxia SunShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China. sun2x@163.com.ORCID http://orcid.org/0000-0002-9402-2977
Chenghu LiuShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Yanping ShiShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Chunling LiShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Likui SunShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Li HouShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Xin WangShandong Key Laboratory of Biological Evaluation for Medical Devices, Jinan, 250101, People's Republic of China.
Shandong Institute for Product Quality Inspection · CNNational Medical Products Administration · CN

Funding

National Key Research and Development Program of China 2016YFC1102503National Key Research and Development Program of China 2016YFC1103202National Key Research and Development Program of China 2016YFC1103205National Key Research and Development Program of China 2017YFB1104105
6 · The paper itself

Abstract

backgroundXenogeneic bone has been widely used in a variety of clinical bone-related disease to promote bone healing and restore bone defects. However, the adverse effects of immune system limit its application in the clinic. The aim of this study was to evaluate xenogeneic bone safety of immunotoxicity and explore the methods for immune risk supervision.

resultsXenogeneic bone, which is freeze-dried bovine cancellous bone, was implanted into the muscle of mice. On day 7, 14 and 28, the effects of xenogeneic bone were examined on humoral immunity and cellular immunity, including the levels of IgG, IgM, C3, inflammatory factors (TNF-α, IL-6), alkaline phosphatase (ALP) and the lymphocyte phenotype. The data showed that xenogeneic bone implantation had no potential to induce immune responses not only in humoral immunity but also in cellular immunity. To reveal the risk of immunogenicity, the residual DNA and the clearance of α-gal epitope were analyzed in 2 different bones (bone 1 is deproteinized bone, bone 2 is acellular and defatted bone). It was suggested that DNA of xenogeneic bone can be limited to < 50 ng per mg dry weight for the repair or regeneration with the acceptable immune risk. And α-gal clearance of xenogeneic bone could be an effective risk factor for improving xenograft quality management.

conclusionsThrough the detection of xenogeneic bone immunotoxicity, our findings indicated that the supervisions of risk factors could contribute to reduce the immune risk. And the risk factors under the acceptable limitation could decrease or replace animal experiment. However, it still needs to be studied on the limitation of α-gal epitope to predict rejection of xenogeneic bone more accurately.

Indexed as

AnimalsBone TransplantationCancellous BoneCattleCell ProliferationLeukocytes, MononuclearLymphocyte SubsetsMiceRisk AssessmentSafetyTransplantation, HeterologousImmune safetyImmunotoxicityRisk managementXenogeneic bone

Identifiers

PMID31727050
PMCPMC6857292
OpenAlexW2985990017

What OpenQuestion holds

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LicenceCC BY
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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.