RISK
Background:
Mesenchymal stromal cells (MSC “adult stem cells”) are widely used experimentally in various clinical situations. Although it is interesting to use these cells with serious diseases, the safety profile of these cells is not well known. We conducted a systematic review of clinical trials examining the use of MSC to evaluate the safety of MSC.
Methods and results:
MEDLINE, EMBASE, and CENTRAL (until June 2011) were searched. Clinical trials were conducted using intravascular delivery (Intravenous or intra-arterial) of MSCs in adult or mixed groups of adults and children. Studies using differentiated MSCs or additional cell types were excluded. The primary endpoint was classified according to immediate events (Acute infusion toxicity, fever), organ system complications, infections, and longer-term adverse events (Death, malignancy). The citation of 2347 was reviewed and 36 studies met the inclusion criteria. Among 1012 participants, volunteers of ischemic stroke, Crohn’s disease, cardiomyopathy, myocardial infarction, patients undergoing treatment for graft versus host disease, healthy volunteers were included. Eight studies were randomized controlled trials (RCT), with 321 participants. A meta-analysis of RCT did not detect association between acute infusion toxicity, organ system complications, infection, death or malignancy. There was a significant association between MSC and temporary fever.
Although no major adverse events have been reported in other countries, serious risks may not be clear.
Conclusion:
Based on current clinical trials, MSC therapy can be said to be safe. However, to further clarify the safety profile of MSCs, even larger clinical trials that strictly report adverse events are needed.
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.
