Towards Safety and Regulation Criteria for Clinical Applications of Decellularized Organ-Derived Matrices
van Hengel EVA., van der Laan LJW., de Jonge J., Verstegen MMA.
Narrative Review, published in Bioengineering (Basel) (2025) — summary generated from the PubMed abstract.
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Narrative Review
- Journal
- Bioengineering (Basel) (2025)
- Reported sample size
- —
- Source database
- Europe PMC
- PMID
- 40001655
- PMCID
- PMC11851377
- DOI
- 10.3390/bioengineering12020136
- Citations
- 17
Abstract (original English)
Whole-organ decellularization generates scaffolds containing native extracellular matrix (ECM) components with preserved tissue microarchitecture, providing a promising advancement in tissue engineering and regenerative medicine. Decellularization retains the ECM integrity which is important for supporting cell attachment, growth, differentiation, and biological function. Although there are consensus guidelines to standardize decellularization processes and ECM characterization, no specific criteria or standards regarding matrix sterility and biosafety have been established so far. This regulatory gap in safety, sterilization, and regulation criteria has hampered the clinical translation of decellularized scaffolds. In this review, we identify essential criteria for the safe clinical use of decellularized products from both human and animal sources. These include the decellularization efficacy, levels of chemical residue, preservation of ECM composition and physical characteristics, and criteria for the aseptic processing of decellularization to assure sterility. Furthermore, we explore key considerations for advancing decellularized scaffolds into clinical practice, focusing on regulatory frameworks and safety requirements. Addressing these challenges is crucial for minimizing risks of adverse reactions or infection transmission, thereby accelerating the adoption of tissue-eng
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • This is a narrative review: it collects no new patient data and does not systematically appraise evidence quality.
Evidence level
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
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