Off-label use of adipose-derived stem cells
Francesco Simonacci1,2, Nicolò Bertozzi1,2, Edoardo Raposio1,2
1Department of Medicine and Surgery, Plastic Surgery Division, University of Parma, Parma, Italy.
Annals of Medicine and Surgery (2012)
|November 11, 2017
Summary
Clinical trials using cultured adipose-derived stem cells (ASCs) may be considered off-label in Europe. For regulatory compliance, ASCs should be mechanically isolated and used in subcutaneous tissue.
Area of Science:
- Regenerative Medicine
- Tissue Engineering
- Stem Cell Biology
Background:
- Adipose-derived stem cells (ASCs) offer broad clinical potential due to ease of harvest and multi-lineage differentiation capabilities.
- Adipose tissue is an ideal stem cell source for tissue engineering applications.
- ASCs show promise in generating various tissue types.
Purpose of the Study:
- To review current European and US regulations regarding the clinical use of ASCs.
- To identify potential regulatory discrepancies in ASC-based clinical trials.
Main Methods:
- A comprehensive literature review was conducted.
- Publications on ASC applications were analyzed within the framework of European and US regulatory guidelines.
Main Results:
- A significant number of reported ASC clinical trials may be classified as off-label use under current regulations.
- Regulatory scrutiny is high for ASC applications.
Conclusions:
- European regulations suggest that clinical trials using cultured ASCs, collagenase-treated ASCs, or ASCs for non-homologous tissue applications are likely off-label.
- To ensure compliance, ASCs should ideally be non-cultured, mechanically isolated, and applied within subcutaneous tissue.
