Intravenous infusion represents the most widely adopted delivery route for mesenchymal stromal cell (MSC) therapy in clinical trials, accounting for approximately 43% of registered clinical trials globally.1 Systemic administration offers a minimally invasive, reproducible method that has demonstrated particular promise in treating acute tissue injury syndromes, chronic degenerative disorders and inflammatory conditions.2,3 Understanding the clinical protocols, safety profile, and therapeutic mechanisms of stem cell infusion therapy is essential for healthcare professionals evaluating MSC-based interventions for their patients.
The growing body of clinical evidence supporting IV mesenchymal stem cell therapy reflects both the practical advantages of this delivery method and its therapeutic potential across multiple medical conditions.2,4 Regulatory frameworks based on the Declaration of Helsinki and the ICH E6 (R3) Guideline for Good Clinical Practice (GCP) from authorities like the FDA and EMA provide guidance for conducting cell therapy clinical trials.
For patients wondering how systemic stem cells are administered, the procedure typically involves a slow intravenous infusion of MSCs suspended in physiological solutions, with monitoring throughout the infusion process. Depending on the clinical trial or disease indication, the treatment protocol may vary from single to multiple infusions.
Research suggests that the majority of intravenously administered stem cells are initially trapped in the lungs, where they interact with the immune system through paracrine signalling and cell-to-cell interactions to promote tissue repair and modulate systemic inflammatory responses.5,6
A comprehensive 2021 meta-analysis analysing 62 randomized controlled trials encompassing 3,546 patients across approximately 20 different disease types demonstrated the robust safety profile of MSC therapy.7 All studies were deemed high quality, with no treatment-related serious adverse events such as death discovered across the included studies.7
The most commonly reported adverse events associated with MSC administration include transient fever, administration site reactions, fatigue, constipation and sleeplessness.7 Notably, MSC administration showed a trend toward reducing rather than increasing arrhythmia incidence, suggesting potential cardiovascular benefits.7
The analysis encompassed treatments using MSCs derived from bone marrow, adipose tissue, and umbilical cord sources, with local or systemic administration. The pooled analysis conclusively demonstrated that MSC administration was safe across different patient populations compared with placebo controls.7
Le Blanc et al. reported 69% overall response rates in steroid-resistant acute graft-versus-host disease following IV bone marrow MSC infusion, establishing this application as a recognized therapeutic option.6 Subsequent clinical studies have shown promising findings across various chronic inflammatory conditions, including Crohn's disease and multiple sclerosis.8
The clinical evidence supporting stem cell infusion therapy continues to expand, with hundreds of ongoing clinical trials registered on clinicaltrials.gov, though most remain in early-phase development. The favorable safety profile and promising clinical trial data make IV MSC administration an important consideration for treating systemic inflammatory diseases where conventional therapies have proven insufficient.
Future clinical development will likely focus on optimizing cell dosing, timing of administration, and patient selection criteria to maximize therapeutic outcomes while maintaining the excellent safety record established in current clinical trials.