Optimizing dose and delivery route in mesenchymal stromal cells (MSCs)-based therapy: A systematic review of their implications for clinical efficacy

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

• Level A · Stronger Clinical Evidence
• Level B · Emerging clinical evidence with positive signals
• Level C · Early human research exploring benefits
• Level D · Scientific groundwork from lab and animal studies
• Emerging · Emerging topic under active research

Abstract (original English)

Mesenchymal stromal cell (MSC)-based therapies have demonstrated broad therapeutic potential across inflammatory, degenerative, and neurological disorders; however, clinical outcomes remain highly variable, largely due to heterogeneity in cell source, dosing strategies, routes of administration, treatment timing, and patient-specific factors. This review evaluates how MSC dose and delivery route influence clinical efficacy and safety, and whether specific administration routes require tailored dosing strategies. A systematic literature search of PubMed, Scopus, Web of Science, and the Cochrane Library (2015-2025) identified 29 eligible clinical trials employing intravenous (n = 13), intrathecal (n = 10), intramuscular (n = 4), intranasal (n = 1), and multi-route (n = 1) administration, with doses ranging from 2 × 10 5 cells/kg body weight to fixed doses exceeding 1 × 10 8 cells. Intravenous delivery was predominantly used for systemic indications but was limited by pulmonary first-pass sequestration, whereas intrathecal and intranasal routes enhanced central nervous system targeting and intramuscular administration supported prolonged local persistence and paracrine activity. Although MSC therapy was generally well tolerated across studies, substantial outcome variability underscores the need for harmonized frameworks for dose selection, route optimization, and manufacturing co

Evidence level

Relatively higher-quality human studies compared with other topics in this database, e.g. multiple RCTs or systematic reviews. This does not mean it is standard or approved care.

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