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Aim: This is the first analysis of both clinical trials and published studies that employ umbilical cord mesenchymal stromal cells, for the decade 2007–2017. Materials & methods: Searching international databases, we found 178 registered trials and 98 publications. Results: Among the registered clinical trials, 20% have resulted in publications so far. Among the publications, 18% report safety and 74% report some form of improvement. Between 36 and 45% of the publications do not report aspects of the cell manufacturing, including isolation method, culture medium or number of culture passages. Conclusion: Analyses that link trials with publications can elucidate factors that promote study completion and publication. More full disclosure of cell manufacturing is needed to evaluate the efficacy of mesenchymal stromal cell isolated from umbilical cord tissue (UC-MSC) products.

Aim: The first review of advanced cell therapy trials with perinatal cells. Materials & methods: We compiled 281 clinical trials of advanced cell therapy with perinatal cells that were registered in 2005–2015. Results: The most common cell source in these trials is cord blood, but the cell type that provides the mechanism of action in the majority of trials is mesenchymal stem/stromal cells. We analyze trends among the 15 parameters we compiled for these trials. Conclusion: Advanced cell therapy with perinatal cells is a new field that covers a wide range of diagnoses but where most of the trials are early Phase. Researchers in different countries tend to work with a preferred cell source and cell type.

Gene therapy and cell therapy have followed similar roller coaster paths of rising public expectations and disappointment over the past two decades. There is now reason to believe that momentum in the field has reached the point where the successes will be more frequent. The use of gene-modified cells has opened new avenues for engineering desired cell properties, for the use of cells as vehicles for gene delivery, and for tracking cells and controlling cell persistence after transplantation. Some notable recent clinical developments in cellular engineering by gene transfer offer lessons on how the field has emerged, and hint at additional future clinical applications.