Clinical use of adipose-derived stem cells: European legislative issues.
Raposio E., Ciliberti R.
Laboratory Study, published in Ann Med Surg (Lond) (2017) — 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
- Laboratory Study
- Journal
- Ann Med Surg (Lond) (2017)
- Country
- England
- Reported sample size
- —
- Source database
- PubMed
- PMID
- 29204274
- PMCID
- PMC5709339
- DOI
- 10.1016/j.amsu.2017.11.002
- Citations
- 43
Abstract (original English)
Objective With 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 methods The 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. Results Collagenase 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. Conclusions According to these considerations, ASCs should be not-cultured, isolated mechanically and used only in the subcutaneous tissue.
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • This is preclinical work; animal or laboratory results cannot be applied to humans.
Evidence level
Evidence from laboratory and animal studies provides groundwork for understanding mechanisms and potential before human studies continue.
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