Exosomes and Signaling Nanovesicles from the Nanofiltration of Preconditioned Adipose Tissue with Skin-B® in Tissue Regeneration and Antiaging: A Clinical Study and Case Report

Author:

Svolacchia Fabiano1ORCID,Svolacchia Lorenzo2,Falabella Patrizia34ORCID,Scieuzo Carmen34ORCID,Salvia Rosanna34ORCID,Giglio Fabiana3ORCID,Catalano Alessia5ORCID,Saturnino Carmela3ORCID,Di Lascio Pierpaolo6,Guarro Giuseppe7ORCID,Imbriani Giusy Carmen8,Ferraro Giuseppe9,Giuzio Federica1011

Affiliation:

1. Department of Sense Organs, University of Rome “La Sapienza”, 00184 Rome, Italy

2. Department of General Surgery, University of Rome “La Sapienza”, 00184 Rome, Italy

3. Department of Sciences, University of Basilicata, 85100 Potenza, Italy

4. Spinoff XFlies S.R.L, University of Basilicata, Via Dell’Ateneo Lucano 10, 85100 Potenza, Italy

5. Department of Pharmacy-Drug Sciences, University of Bari “Aldo Moro”, 70126 Bari, Italy

6. Department of General Surgery AOR San Carlo, Basilicata, 85100 Potenza, Italy

7. Department of Plastic and Reconstructive Surgery, ASL Umbria 1, Umbria, 06127 Perugia, Italy

8. Department of Surgical Oncology, Aorn Sant’Anna e San Sebastiano, Campania, 81100 Caserta, Italy

9. Department of Medicine and Health Sciences “Vincenzo Tiberio”, University of Molise, 86100 Campobasso, Italy

10. Spinoff TNcKILLERS s.r.l., University of Basilicata, 85100 Potenza, Italy

11. U.O.C. Primary Care and Territorial Health, Social and Health Department, State Hospital, 47893 San Marino, Italy

Abstract

Background and Objectives: This three-year clinical trial aimed to demonstrate that only the signaling vesicles produced by ADSCa, containing mRNA, microRNA, growth factors (GFs), and bioactive peptides, provide an advantage over classical therapy with adipose disaggregate to make the tissue regeneration technique safer due to the absence of interfering materials and cells, while being extremely minimally invasive. The infiltration of disaggregated adipose nanofat, defined by the Tonnard method, for the regeneration of the dermis and epidermis during physiological or pathological aging continues to be successfully used for the presence of numerous adult stem cells in suspension (ADSCa). An improvement in this method is the exclusion of fibrous shots and cellular debris from the nanofat to avoid inflammatory phenomena by microfiltration. Materials and Methods: A small amount of adipose tissue was extracted after surface anesthesia and disaggregated according to the Tonnard method. An initial microfiltration at 20/40 microns was performed to remove fibrous shots and cellular debris. The microfiltration was stabilized with a sterile solution containing hyaluronic acid and immediately ultrafiltered to a final size of 0.20 microns to exclude the cellular component and hyaluronic acid chains of different molecular weights. The suspension was then injected into the dermis using a mesotherapy technique with microinjections. Results: This study found that it is possible to extract signaling microvesicles using a simple ultrafiltration system. The Berardesca Scale, Numeric Rating Scale (NRS), and Modified Vancouver Scale (MVS) showed that it is possible to obtain excellent results with this technique. The ultrafiltrate can validly be used in a therapy involving injection into target tissues affected by chronic and photoaging with excellent results. Conclusions: This retrospective clinical evaluation study allowed us to consider the results obtained with this method for the treatment of dermal wrinkles and facial tissue furrows as excellent. The method is safe and an innovative regenerative therapy as a powerful and viable alternative to skin regeneration therapies, antiaging therapies, and chronic inflammatory diseases because it lacks the inflammatory component produced by cellular debris and fibrous sprouts and because it can exclude the mesenchymal cellular component by reducing multiple inflammatory cytokine levels.

Publisher

MDPI AG

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