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JOURNAL ARTICLE

First decade of clinical trials and published studies with mesenchymal stromal cells from umbilical cord tissue

Pedro S Couto, Gocha Shatirishvili, Alexey Bersenev, Frances Verter
Regenerative Medicine 2019 May 9
31070115
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.

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