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https://doi.org/10.4081/aiua.2026.15987

Intratesticular infiltration of platelet-rich plasma, polynucleotides, dermal and adipose cell in secretory azoospermia

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Received: 13 July 2026
Accepted: 31 July 2026
Published: 9 October 2026
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Platelet-rich plasma, Polynucleotides scaffolds, Dermal and adipose cells, Secretory azoospermia

Authors

Patrizio Vicini
patriziovicini@gmail.com
UniCamillus - Saint Camillus International University of Health Sciences, Rome, Italy.
Ilaria Ortensi
Criobiolab, Rome, Italy.
Silvana Campisi
Artemisia Lab, Rome, Italy.

To the Editor,

Regenerative medicine represents an innovative approach to treating chronic-degenerative pathologies. Mesenchymal stem cells (MSCs), particularly those derived from adipose tissue, are widely studied for their self-renewal, differentiation, and paracrine activities [...] 

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Ethics Approval

The use of PRP, polynucleotides, and dermal/adipose-derived cells for tissue regeneration in the EU is regulated according to origin, manipulation, and intended use. Autologous PRP, governed by Directive 2002/98/EC and Italian Legislative Decree 191/2007, is considered a non-transfusional blood component and may be used clinically when obtained through minimal manipulation with CE marked devices; substantial manipulation falls under the Advanced Therapy Medicinal Product (ATMP) framework of Regulation (EC) 1394/2007. Polynucleotides are regulated by the Medical Device Regulation (EU) 2017/745 and classified as Class III medical devices. Dermal and adipose-derived cells are regulated by Directive 2004/23/EC when minimally manipulated, whereas procedures involving enzymatic isolation or cell expansion constitute ATMPs, requiring GMP manufacturing and AIFA authorization or Hospital Exemption. This is an “off-label” procedure that is justifiable given the absence of valid, authorized therapeutic alternatives. The “off-label” treatment is supported by robust evidence documented in national and international scientific literature; it does not constitute unauthorized “experimentation,” but rather use in exceptional cases. So ethical approval is important but not mandatory. According to current laws and the applications carried out by others, we do not consider the intervention of the ethic committee mandatory because all the procedures performed are permitted and consolidated. In some cases, such as the use of PRP, communication to the relevant transfusion service is sufficient. The processing of preadipocytes is carried out with minimum permitted manipulation of filtration. Detailed informed consent from the patient and privacy were obtained

CRediT authorship contribution

All authors have contributed and approved the final version. All authors declare that this assignment is their own original work.

Supporting Agencies

No supporting agencies

Data Availability Statement

Data supporting this study are available from the corresponding author on reasonable request.

How to Cite



Intratesticular infiltration of platelet-rich plasma, polynucleotides, dermal and adipose cell in secretory azoospermia. (2026). Archivio Italiano Di Urologia E Andrologia. https://doi.org/10.4081/aiua.2026.15987
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