Evidence map›Paper›PMID 34724720›Full record

ReviewStem cells translational medicine2021

Development and investigational new drug application of mesenchymal stem/stromal cells products in China.

Qinjun Zhao, Zhibo Han, Jialun Wang, Zhongchao Han

Open access · goldAbstract readReview
In one paragraph

Review in Stem cells translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.1field-weighted citation impact, top 4% 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

21 citing papers in PubMed, 36 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

4 authors at 2 institutions in 1 country.

Qinjun ZhaoNational Engineering Research Center of Cell Products, AmCellGene Engineering Co. Ltd, Tianjin, People's Republic of China.
Zhibo HanNational Engineering Research Center of Cell Products, AmCellGene Engineering Co. Ltd, Tianjin, People's Republic of China.
Jialun WangBeijing Engineering Lab for Perinatal Stem Cells, Beijing Health & Biotech Co. Ltd, Beijing, People's Republic of China.
Zhongchao HanNational Engineering Research Center of Cell Products, AmCellGene Engineering Co. Ltd, Tianjin, People's Republic of China.
Sinovac Biotech · CNCell Technology (China) · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Mesenchymal stem/stromal cells (MSCs) have broad application prospects for regenerative medicine due to their self-renewal, high plasticity, ability for differentiation, and immune response and modulation. Interest in turning MSCs into clinical applications has never been higher than at present. Many biotech companies have invested great effort from development of clinical grade MSC product to investigational new drug (IND) enabling studies. Therefore, the growing demand for publication of MSC regulation in China necessitates various discussions in accessible professional journals. The National Medical Products Administration has implemented regulations on the clinical application of MSCs therapy. The regulations for MSCs products as drug have been updated in recent years in China. This review will look over the whole procedure in allogeneic MSC development, including regulations, guidance, processes, quality management, pre-IND meeting, and IND application for obtaining an approval to start clinical trials in China. The review focused on process and regulatory challenges in the development of MSCs products, with the goal of providing strategies to meet regulatory demands. This article describes a path for scientists, biotech companies, and clinical trial investigators toward the successful development of MSC-based therapeutic product.

Indexed as

Mesenchymal Stem CellsMesenchymal Stem Cell TransplantationCell DifferentiationChinaInvestigational New Drug ApplicationRegenerative Medicineadult stem cellscell transplantationcellular therapyclinical translationmesenchymal stem cells

Identifiers

PMID34724720
PMCPMC8560202
OpenAlexW3209772694

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.