Risks Of Stem Cell Therapy
Background
Mesenchymal stromal cells (MSCs, referred to as "adult stem cells") are being extensively investigated as experimental therapeutics across a broad spectrum of clinical settings. Despite the burgeoning interest in leveraging these cells to treat severe and life-threatening diseases, their comprehensive safety profile remains insufficiently characterized. To address this clinical gap, we conducted a rigorous systematic review of clinical trials evaluating MSC interventions to definitively assess their safety and tolerability.
Methods and Results
Comprehensive literature searches were executed across MEDLINE, EMBASE, and CENTRAL (through June 2011). Eligible clinical trials evaluating the intravascular delivery (either intravenous or intra-arterial) of MSCs within adult or mixed adult-pediatric cohorts were enrolled, while investigations utilizing differentiated MSCs or co-transplantation with supplementary cell types were excluded. Primary safety endpoints were rigorously categorized into immediate events (e.g., acute infusion toxicity, pyrexia), organ-system complications, infectious complications, and long-term adverse outcomes (e.g., mortality, malignancy). Of the 2,347 citations screened, 36 distinct studies encompassing 1,012 participants met the strict inclusion criteria. This heterogeneous population comprised healthy volunteers alongside patients undergoing treatment for ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, and graft-versus-host disease (GvHD). Notably, eight of these investigations were randomized controlled trials (RCTs), accounting for 321 randomized participants.
While no major adverse events have been documented globally, potential long-term or structural risks may remain uncharacterized at this stage.
This review article focuses on the fundamental pathways underlying age-related stem cell dysfunction across various disorders. It further explores key mechanistic concepts driving this cellular decline. Finally, we provide a concise overview of emerging, next-generation therapeutic strategies aimed at reversing or mitigating age-associated stem cell deficiencies.
Citation// PLoS One. 2012;7(10):e47559. doi: 10.1371/journal.pone.0047559. Epub 2012 Oct 25.
Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials. Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ; Canadian Critical Care Trials Group.
