Journal Article

Novel sponge formulation of mesenchymal stem cell secretome and hyaluronic acid: a safe and effective topical therapy for Psoriasis vulgaris

Valenzuela, Fernando, Lattus, José, Edwards, Natalie, Carrillo, Daniela, Elgueta, Estefanía, Casas, Bárbara, Catalán, Verónica, Pérez, Dan, Hartmann, Dan, Martínez, Constanza, Vergara, Luis, Oyarzun-Ampuero, Felipe, Palma, Verónica, Prieto, Catalina P.

2025

Overview

Background Psoriasis vulgaris is the most common form of psoriasis, yet current treatments often lead to significant side effects, resulting in a high rate of therapy desertion. Here, we explored a novel therapeutic approach using the secretome from Wharton Jelly-derived mesenchymal stem cells, biologically stabilized and enhanced with hyaluronic acid (HA), its presentation is an easy-to-apply topical sponge. This formulation had previously demonstrated efficacy in vitro and in experimental psoriasis mouse models. Methods In vitro characterization studies included dynamic light scattering, nanoparticle tracking analysis, optical/electronic microscopy, microbiological experiments, and angiogenic capacity (HUVEC cells). In vivo studies included angiogenic capacity in chicken embryo chorioallantoic membrane (CAM), safety (hypersensitive and healthy volunteers), and efficacy (double-blinded and randomized patients). Results We demonstrated the presence of spherical exosomes (164 ± 87 nm, PDI of 0.38, and 1.5 × 10⁷ particles/mL) within the selected secretomes, which exhibited significant proangiogenic activity in HUVEC cells and in a CAM assay. The secretome-containing sponges displayed distinct physicochemical properties, such as the absence of nitrogen and reduced carbon and oxygen content, resulting in a more cross-linked material with thinner fibers. These characteristics extended the dispersion time in aqueous media. Microbiological testing confirmed sterility in the packed, ready-to-use secretome-HA sponges after 3 months of storage. To assess safety, we selected doses (based on total protein content) that were applied to three patients with atopic dermatitis (42 µg of protein, patch test, 5 days) and four healthy volunteers (210 µg, 15 days) with no observed adverse topical or systemic effects. In a 30-day efficacy study, 12 patients with bilateral psoriasis exhibited up to a 33% reduction in mPASI scores and a 41% decrease in plaque size. Additionally, transepidermal water loss (TEWL) was reduced by up to 30%, while skin elasticity/flexibility improved by 43%. Conclusions These findings suggest that the topical application of the secretome-HA sponge is a safe and effective therapeutic option for alleviating symptoms of psoriasis vulgaris . Trial registration SSMN, SSMN047/2021. Registered 27 October 2021, https://www.ssmn.cl/comite_etica.php . Graphical abstract

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Administration, Topical / Adult / Angiogenesis / Animal models / Animals / Atopic dermatitis / Biomedical and Life Sciences / Biomedical Engineering and Bioengineering / Cell Biology / Cell culture / Chick Embryo / Chorioallantoic Membrane / Double-Blind Method / Erythema / Exosomes / Exosomes, hyaluronic acid, Psoriasis vulgaris / Female / Health aspects / Human Umbilical Vein Endothelial Cells / Humans / Hyaluronic acid / Hyaluronic Acid - administration & dosage / Hyaluronic Acid - chemistry / Hyaluronic Acid - pharmacology / Hyaluronic Acid - therapeutic use / Life Sciences / Light scattering / Male / Medical research / Medicine, Experimental / Mesenchymal stem cell / Mesenchymal Stem Cell (MSCs) and MSC-Derived Extracellular Vesicles: Roles in Regenerative Medicine and Beyond / Mesenchymal stem cells / Mesenchymal Stem Cells - cytology / Mesenchymal Stem Cells - metabolism / Middle Aged / Morphology / MSC-based therapy, cutometer / Nanoparticles / Neovascularization, Physiologic - drug effects / Physicochemical properties / Psoriasis / Psoriasis - drug therapy / Psoriasis - pathology / Psoriasis - therapy / Psoriasis vulgaris / Regenerative Medicine/Tissue Engineering / Secretome / Secretome - chemistry / Secretome - metabolism / Skin / Skin diseases / Stem Cells / Sterility / Topical application / Type 2 diabetes / Umbilical cord / Wharton Jelly - cytology