RISK
Background:
Mesenchymal stromal cells (MSCs, or "adult stem cells") are widely used experimentally in various clinical settings. While there is interest in using these cells in serious diseases, their safety profile is not well understood. We conducted a systematic review of clinical trials that examined the use of MSCs to evaluate their safety.
Methods and Results:
MEDLINE, EMBASE, and CENTRAL (up to June 2011) were searched. Clinical trials were conducted using intravascular delivery (intravenous or intra-arterial) of MSCs in adult or mixed adult-pediatric groups. Studies using differentiated MSCs or additional cell types were excluded. Primary endpoints were classified according to immediate events (acute infusion toxicity, fever), organ system complications, infection, and longer-term adverse events (death, malignancy). 2347 citations were reviewed, and 36 studies met the inclusion criteria. Among the 1012 participants were patients being treated for ischemic stroke, Crohn's disease, cardiomyopathy, myocardial infarction, and graft-versus-host disease, as well as healthy volunteers. Eight studies were randomized controlled trials (RCTs) with 321 participants.
Although no major adverse events have been reported in other countries, serious risks may not be clear.
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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.
