Artikel
Efficacy and safety of allogeneic mesenchymal stem cells: a systematic review
Suche in Medline nach
Autoren
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Sarah Wolf
- Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Österreich
| Veröffentlicht: | 20. März 2019 |
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Gliederung
Text
Background/research question: Crohn’s disease (CD) is a chronic inflammatory condition characterised by transmural inflammation and skip lesions that can lead to (perianal) fistulas. In contrast to existing refractory therapies, allogeneic mesenchymal stem cells (MSCs) are assumed to prevent repeating surgeries and the need for a permanent stoma.
The aim of this systematic review was to evaluate the clinical effectiveness and safety of adult human MSCs of allogeneic origin in comparison to placebo, fibrin glue, or fistula plugs in CD-patients with complex perianal fistulas concerning quality of life (QoL), remission, response, and adverse events.
Methods: A systematic literature search was conducted in 4 databases (Cochrane, CRD, Embase, Medline). A methodological framework based on the EUnetHTA Core Model® was applied. The studies were systematically assessed for risk of bias (ROB) using the Cochrane RoB tool for RCTs and the Institute of Health Economics (IHE) checklist for single-arm case series. According to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scheme, the strength of evidence was synthesised on each selected outcome category. Overall, 590 citations were identified.
Results: Three studies were included for data extraction and further analysis (2 RCT [MSC vs. placebo] and 1 prospective single-arm study) after applying the inclusion criteria. Across the studies 255 patients were enrolled, of which 131 received adipose-tissue-derived MSCs and 15 bone-marrow-derived MSCs. Both RCTs reported improvements in remission, while only one RCT reported on response. Both RCTs showed contrasting results for QoL. No cases of peri-interventional mortality were reported in the studies, however, several severe adverse events were stated. One RCT showed a moderate RoB, the other RCT and the single-arm study resulted in a high RoB.
Conclusions: Due to the very low and low strength of evidence, no conclusions regarding the effectiveness and safety of the MSC-treatment can be made. Further evidence is necessary.
