Evidence map›Paper›PMID 36078137›Full record

ArticleCells2022

Manufacture and Quality Control of Human Umbilical Cord-Derived Mesenchymal Stem Cell Sheets for Clinical Use.

Juan Wang, Shuang Gao, Yufei Zhao, Taibing Fan, Mingkui Zhang, Dehua Chang

Abstract read
In one paragraph

Article in Cells, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing 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.

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

17 citing papers in PubMed.

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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

6 authors.

Juan WangBOE Regenerative Medicine Technology Co., Ltd., Beijing 100015, China.
Shuang GaoBOE Regenerative Medicine Technology Co., Ltd., Beijing 100015, China.ORCID 0000-0001-5785-7820
Yufei ZhaoBOE Regenerative Medicine Technology Co., Ltd., Beijing 100015, China.
Taibing FanChildren Heart Center, Fuwai Central China Cardiovascular Hospital, Zhengzhou 450018, China.
Mingkui ZhangHeart Center, First Hospital of Tsinghua University, Beijing 100016, China.
Dehua ChangDepartment of Cell Therapy in Regenerative Medicine, The University of Tokyo Hospital, Tokyo 113-8655, Japan.ORCID 0000-0003-1546-6906

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Human umbilical cord-derived mesenchymal stem cell (UC-MSC) sheets have attracted much attention in cell therapy. However, the culture media and coating matrix used for the preparation of UC-MSC sheets have not been safe enough to comply with current clinical drug standards. Moreover, the UC-MSC sheet preservation systems developed before did not comply with Good Manufacturing Practice (GMP) regulations. In this study, the culture medium and coating matrix were developed for UC-MSC sheet production to comply with clinical drug standards. Additionally, the GMP-compliant preservation solution and method for the UC-MSC sheet were developed. Then, quality standards of the UC-MSC sheet were formulated according to national and international regulations for drugs. Finally, the production process of UC-MSC sheets on a large scale was standardized, and three batches of trial production were conducted and tested to meet the established quality standards. This research provides the possibility for clinical trials of UC-MSC sheet products in the development stage of new drugs and lays the foundation for industrial large-scale production after the new drug is launched.

Indexed as

Mesenchymal Stem CellsUmbilical CordCulture MediaHumansQuality ControlCulture Medialarge-scale productionpreservationumbilical cord mesenchymal stem cell sheet

Identifiers

PMID36078137
PMCPMC9454431

What OpenQuestion holds

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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.