Evidence map›Paper›PMID 35310384›Full record

ArticleBioactive materials2022

A regulatory perspective on recombinant collagen-based medical devices.

Wenbo Liu, Hai Lin, Peng Zhao, Lina Xing, Jie Li, Zehua Wang, Shan Ju, XinLi Shi, Yinghui Liu, Gang Deng and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Bioactive materials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing 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

26 citing papers in PubMed, 43 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

13 authors at 2 institutions in 1 country.

Wenbo LiuCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Hai LinNational Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China.
Peng ZhaoCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Lina XingCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Jie LiCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Zehua WangCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Shan JuCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
XinLi ShiCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Yinghui LiuCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Gang DengCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Guobiao GaoCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Lei SunCenter for Medical Device Evaluation, National Medical Products Administration, Beijing, China.
Xindong ZhangNational Engineering Research Center for Biomaterials, Sichuan University, Chengdu, China.
National Medical Products Administration · CNSichuan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

As a class of novel biomaterials manufactured by synthetic biology technologies, recombinant collagens are candidates for a variety of medical applications. In this article, a regulatory scientific perspective on recombinant collagens and their medical devices is presented with a focus on the definition, translation, classification and technical review. Recombinant collagens are categorized as recombinant human collagen, recombinant humanized collagen and recombinant collagen-like protein, as differentiated by specific compositions and structures. Based on their intended uses and associated risks, recombinant collagen-based medical devices are generally classified as Class Ⅱ or Ⅲ in China. The regulatory review of recombinant collagen-based medical devices aims to assess their safety and efficacy demonstrated by scientific evidences generated from preclinical and clinical evaluations. Taken together, opportunities as well as challenges for their future clinical translation of recombinant collagen-based medical devices abound, which highlights the essential role of regulatory science to provide new tools, standards, guidelines and methods to evaluate the safety and efficacy of medical products.

Indexed as

CollagenProduct translationRecombinant collagenRegulatory reviewSafety and efficacy

Identifiers

PMID35310384
PMCPMC8897173
OpenAlexW3211164322

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.