Evidence map›Paper›PMID 40208547›Full record

ArticleMethods in molecular biology (Clifton, N.J.)2025

Quality Controls of Autologous Skin Products According to European GMP Guidelines.

Rocio García de la Cruz Valencia, Gloria Carmona Sánchez, Céline Auxenfans, Jean-François Brunet, Ana Fernández González, Vivienne Woodtli, Alexandra Karström, Marina Trouillas

Abstract read
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In one paragraph

Article in Methods in molecular biology (Clifton, N.J.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

8 authors.

Rocio García de la Cruz ValenciaPediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland.
Gloria Carmona SánchezAndalusian Network for the Design and Translation of Advanced Therapies (AND&TAT) - Fundación Pública Andaluza Progreso y Salud, Sevilla, Spain. gloria.carmona@juntadeandalucia.es.
Céline AuxenfansBanque de tissus et cellules, Plateforme de Biotherapies, Hospices Civils de Lyon, Lyon, France.
Jean-François BrunetCell Production Center, Service of Pharmacy, Lausanne University Hospital, Epalinges, Switzerland.
Ana Fernández GonzálezUnidad de Producción Celular e Ingeniería Tisular, Hospital Universitario Virgen de las Nieves, Granada. Red Andaluza de diseño y traslación de Terapias Avanzadas de la Fundación Progreso y Salud, Sevilla, Spain.
Vivienne WoodtliPediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Zurich, Switzerland.
Alexandra KarströmDepartment of Plastic and Maxillofacial Surgery, Uppsala University Hospital, Uppsala, Sweden.
Marina TrouillasInstitut de Recherche Biomédicale des Armées (IRBA), Unité de Thérapie Cellulaire et Tissulaire (U.TCT), Antenne Centre de Transfusion Sanguine des Armées, 1 rue du Lieutenant Raoul BATANY, CLAMART Cedex, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The production of Cultured Epithelial Autografts (CEAs), autologous keratinocyte-sprays, and tissue-engineered skin substitutes in hospital-based laboratories is considered an Advanced Therapy Medicinal Product (ATMP). The production of ATMPs in Europe has to follow GMP (Good Manufacturing Practice) conditions and is regulated by Regulation 1394/2007 and Commission Directive 2009/120/EC. European regulation establishes the need of carrying out a complex process of characterization and quality controls during production, in order to release these products for clinical use. They are carried out at each critical stage of production: reception of the skin biopsy, extraction of keratinocytes and/or fibroblasts, media change, cell growth, cell passaging, and on the finished products. Here, we describe the production for autologous skin products at each critical stage: harvesting and biopsy reception, isolation of keratinocytes and fibroblasts, cell culture, and preparation of the final product.

Indexed as

SkinSkin, ArtificialSkin TransplantationAutograftsBiopsyCell Culture TechniquesCells, CulturedEuropeFibroblastsHumansKeratinocytesQuality ControlTissue EngineeringTransplantation, AutologousAdvanced therapy medicinal productsEU guidelinesGood manufacturing practiceQuality controlsSkin substitutes

Identifiers

PMID40208547

What OpenQuestion holds

Textmetadata
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.