Faculty of Regenerative Neuroscience and Neurology | Mesenchymal Stromal Cell and Extracellular Vesicle Therapies for Treatment-Resistant Depression: A Critical Narrative Review of Evidence and Clinical Translation

Abstract

Peer-reviewed critical narrative review from the IVURH Faculty of Regenerative Neuroscience and Neurology examining mesenchymal stromal cells (MSCs), extracellular vesicles (EVs), exosomes, and secretome-based approaches for treatment-resistant depression. The article critically evaluates preclinical mechanisms, human evidence, delivery, manufacturing, safety, biomarkers, and regulatory considerations, and proposes a translational framework separating product identity, biological activity, clinical benefit, and evidence of disease modification. Current evidence remains insufficient to establish efficacy or disease modification in unipolar treatment-resistant depression.