Review · Volume 17, Issue 2 · pp. 174–190

Clinical Frontiers of Exosome Research: A Comprehensive Analysis of Human Trials in Diagnostics, Therapeutics, and Regenerative Medicine

Syam Mohan^1,2, Nizar A. Khamjan^3,4, Siddig Ibrahim Abdelwahab³, Manal Mohamed Elhassan Taha³, Jobran M. Moshi⁴, Abrar Fahad Alshahrani⁵, Jeraiby A. Mohammed⁶, Saeed Alshahrani⁷, Khaled A. Sahli⁸, Hatem Ahmed Salem Alqhtani⁹, Muhammad H. Sultan¹⁰, Marwa Qadri^3,11, Ali Ibrahim Ali Ashgar¹², Abdullah Farasani⁴, Hussain Ali I. Shobaili¹², Abdualmagid Mohammed Tobaiqi¹³, Tariq Idris Somily¹²

¹School of Health Sciences, University of Petroleum and Energy Studies, Dehradun, Uttarakhand, India.
²Center for Global Health Research, Saveetha Medical College and Hospital, Saveetha Institute of Medical and Technical Sciences, Saveetha University, Chennai, Tamil Nadu, India.
³Health Research Centre, Jazan University, Jazan, Kingdom of Saudi Arabia.
⁴Department of Medical Laboratory Technology, Faculty of Nursing and Health Sciences, Jazan University, Jazan, Kingdom of Saudi Arabia.
⁵Department of Clinical Nutrition, Faculty of Nursing and Health Sciences, Jazan University, Jazan, Kingdom of Saudi Arabia.
⁶Department of Basic Medical Science, College of Medicine, Jazan University, Jazan, Kingdom of Saudi Arabia.
⁷Department of Pharmacology and Toxicology, College of Pharmacy, Jazan University, Jazan, Kingdom of Saudi Arabia.
⁸General Directorate of Medical Services, Ministry of Interior, Riyadh, Kingdom of Saudi Arabia.
⁹King Fahad Central Hospital, Ministry of Interior, Jazan, Kingdom of Saudi Arabia.
¹⁰Department of Pharmaceutics, College of Pharmacy, Jazan University, Jazan, Kingdom of Saudi Arabia.
¹¹Department of Pharmacology and Toxicology, College of Pharmacy, Jazan University, Kingdom of Saudi Arabia.
¹²Emergency Medical Services Program, College of Nursing and Health Sciences, Jazan University, Jazan, Kingdom of Saudi Arabia.
¹³Department of Public Health, College of Nursing and Health Sciences, Jazan University, Jazan, Kingdom of Saudi Arabia.

Abstract

Background: Exosomes, key mediators of intercellular communication, transport functional biomolecules, making them promising tools for diagnostics and therapeutics across various human diseases. Objectives: To systematically review and analyze the clinical applications of exosomes, focusing on their sources, functions, therapeutic roles, and research trends through a bibliometric approach. Methodology: A comprehensive PubMed search was conducted using the term “exosomes” in titles and abstracts, limited to clinical studies, including Clinical Trials, Phase I–IV studies, and Randomized Controlled Trials. Ninety clinical trials were included. Bibliometric analysis using VOSviewer identified key terms, conceptual clusters, and emerging research topics. Results: Exosomes demonstrated diverse clinical applications in oncology, neurodegenerative diseases (e.g., Alzheimer’s), cardiovascular conditions, osteoarthritis, COVID-19, spinal cord injuries, transplant rejection, and skin regeneration. Predominant exosome sources included plasma, serum, urine, saliva, tears, ascites, adipose tissue, and stem cells. Functionally, exosomes served as diagnostic biomarkers, therapeutic agents, and molecular delivery systems. Key terms included miRNA, plasma, safety, efficacy, and trial, with conceptual clusters reflecting a shift from molecular exploration to clinical implementation. Emerging themes included precision medicine, biobank integration, and regenerative therapies using mesenchymal stem cell-derived or herbal-modified exosomes. Conclusion: Exosome-based interventions show promising safety and efficacy but face challenges in standardizing isolation methods, conducting large-scale randomized trials, and ensuring long-term follow-up. Future research should focus on integrating exosome platforms into precision medicine with robust clinical frameworks.

Keywords: Exosomes; clinical trials; biomarkers; therapeutics; bibliometric analysis

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