Evidence map›Paper›PMID 29204274›Full record

ArticleAnnals of medicine and surgery (2012)2017

Clinical use of adipose-derived stem cells: European legislative issues.

Edoardo Raposio, RosaGemma Ciliberti

Open access · diamondAbstract read
In one paragraph

Article in Annals of medicine and surgery (2012), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 3 pooled it
2.0field-weighted citation impact, top 13% 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

38 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  3. Comparing mechanical and enzymatic isolation procedures to isolate adipose-derived stromal vascular fraction: A systematic review.Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
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  12. Role of Adipose-Derived Mesenchymal Stem Cells in Bone Regeneration.International journal of molecular sciences · 2024
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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

2 authors at 2 institutions in 1 country.

Edoardo RaposioDepartment of Medicine and Surgery, Plastic Surgery Section, University of Parma, Italy.
RosaGemma CilibertiDepartment of Sciences of Health (DISSAL), Forensic and Legal Medicine Section, University of Genova, Italy.
University of Genoa · ITUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveWith this study we analyse the current European legislation in order to provide guidance for regenerative medicine professionals on correct Adipose-derived Stem Cells (ASCs) isolation and use protocols for clinical applications. MATERIALS AND

methodsThe European Medicines Agency (EMA) considers that ASCs does not fall within the definition of an advanced therapy medicinal product if the cells have not been subjected to a substantial manipulation, and the mode of action of the cells (contribute to and enhance tissue renewal and turnover of the subcutaneous tissue) is considered to be homologous to the donor fat tissue.

resultsCollagenase digestion, as well as cell culturing, is considered to be a substantial manipulation. Only transplantation of a non-manipulated tissue to another location in the same anatomical or histological environment is considered to be homologous.

conclusionsAccording to these considerations, ASCs should be not-cultured, isolated mechanically and used only in the subcutaneous tissue.

Indexed as

Adipose-derived stem cellsClinical applicationsEuropean legislation

Identifiers

PMID29204274
PMCPMC5709339
OpenAlexW2767961847

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.