Pickup and drop-off included
Background:Mesenchymal stromal cells (MSCs), also known as adult stem cells, are widely utilized in experimental clinical applications. While their potential for treating serious diseases is promising, the safety profile of these cells remains unclear. This systematic review aims to assess the safety of MSC therapy through an analysis of clinical trials.
Methods and Results:A comprehensive search was conducted in MEDLINE, EMBASE, and CENTRAL databases until June 2011. The review included clinical trials that used intravascular delivery (intravenous or intra-arterial) of MSCs in adult or mixed adult and pediatric populations. Studies involving differentiated MSCs or additional cell types were excluded. The primary outcomes were categorized into immediate events (acute infusion toxicity, fever), organ system complications, infections, and long-term adverse events (death, malignancy). A total of 2347 citations were reviewed, and 36 studies met the inclusion criteria, involving 1012 participants, including individuals with ischemic stroke, Crohn’s disease, cardiomyopathy, myocardial infarction, graft-versus-host disease, and healthy volunteers. Among the studies, eight were randomized controlled trials (RCTs) involving 321 participants. A meta-analysis of the RCTs found no significant associations between MSC therapy and acute infusion toxicity, organ system complications, infection, death, or malignancy. However, a significant association was found between MSC treatment and temporary fever.
Although no major adverse events were reported in other countries, the potential for serious risks remains uncertain.
Conclusion:Based on current clinical trial data, MSC therapy appears to be safe. However, to better understand the safety profile of MSCs, larger clinical trials with detailed reporting of adverse events are necessary.
Source: Lalu MM, McIntyre L, Pugliese C, Fergusson D, Winston BW, Marshall JC, Granton J, Stewart DJ; Canadian Critical Care Trials Group. "Safety of Cell Therapy with Mesenchymal Stromal Cells (SafeCell): A Systematic Review and Meta-Analysis of Clinical Trials." PLoS One. 2012;7(10)
. doi: 10.1371/journal.pone.0047559. Epub 2012 Oct 25.
