Iranian Journal of Basic Medical Sciences

Iranian Journal of Basic Medical Sciences

Principles and regulatory pathways of exosome-based products in wound healing: Insights from the Iranian Food and Drug Organization Guideline

Articles in Press

Document Type : Review Article

Authors
Delnavaz Nazari 1
Banafsheh Heidari 2
Nazanin Akbari 3
Zahra Soleymani 1
1 Department of Veterinary Basic Sciences, SR.C., Islamic Azad University, Tehran, Iran
2 Department of Regenerative Medicine in Wound Healing, Medical Laser Research Center, Yara Institute, ACECR, Tehran, Iran
3 Department of Biology, Shahid Beheshti University, Tehran, Iran
10.22038/ijbms.2026.93213.20101
Abstract
Wound healing is a critical clinical challenge, particularly for chronic and refractory wounds complicated by infection, necrosis, amputation, and death. Recently, cell derivatives, particularly extracellular vesicles (EVs) from mesenchymal stem cells, have emerged as promising cell-free therapeutic agents in regenerative medicine. The review aims to introduce small extracellular vesicles (sEVs) as a next-generation therapeutic strategy and to describe different EV types according to the Global Regulatory Framework (GRF). We also compare techniques for isolating, purifying, and characterizing sEVs and evaluate sEV-based therapies in tissue engineering, focusing on their scope and limitations.A narrative review of the literature was conducted, focusing on preclinical and clinical studies investigating EV-based therapies in wound healing, along with an investigation of the GRF, particularly the Iranian Food and Drug Administration (IFDA) guideline on EVs. The IFDA has recently established a framework for categorizing extracellular particles and highlighting the structural complexity and functional diversity of EVs. sEVs demonstrate significant therapeutic potential for wound repair by promoting angiogenesis, enhancing epithelialization, modulating inflammation, and accelerating tissue remodeling. To enhance the stability and therapeutic lifespan of sEVs, advanced delivery systems, including hydrogels, nanofibers, and biomatrices, are used to preserve structural integrity, physicochemical stability, biological functionality, and morphological characteristics, and to control their release at the injury site. EV-based therapies represent a promising and versatile approach in regenerative medicine for wound healing. Despite challenges in isolation, characterization, scalable manufacturing, and regulatory approval, sEV-based therapeutics offer a biocompatible, cost-effective, and versatile platform that bridges nanotechnology and regenerative medicine.
Keywords
Biological products
Drug approval
Exosomes
Extracellular vesicles
Government regulation
Nanomedicine
Regenerative medicine
Wound Healing
Subjects
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Iranian Journal of Basic Medical Sciences

Articles in Press, Accepted Manuscript
Available Online from 27 July 2026