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Abstract
Mesenchymal stem cells (MSC) are widely studied for their immunomodulatory properties. Data from in vitro and pre-clinical models demonstrate that MSC suppress activated immune cells and ameliorate the severity of experimental immune disease. In complex human studies, the immunomodulatory efficacy of MSC therapy is not well established. We conducted a systematic review of clinical studies which used MSC with the purpose of immunomodulation and included at least 10 patients to investigate the efficacy of MSC therapy. Sixty-two studies comprising 10 different immune disorders were included in the analysis, of which 18 studies represented controlled trials. Although several of the studies reported an amelioration of disease severity, other studies failed to observe a beneficial effect of MSC. The low number of randomized controlled trials, small number of studies per disease category and limited immunological readout parameters made it difficult to draw a definitive conclusion on the efficacy of MSC immune therapy.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties.
No writing assistance was utilized in the production of this manuscript.
Mesenchymal stem cells (MSC) are under investigation as a therapy for a variety of immunological diseases.
The majority of the clinical trials with MSC are conducted on patients suffering from graft-versus-host disease or in hematopoietic stem cell transplantation recipients to prevent graft-versus-host disease.
In this systematic review, 62 studies examining the efficacy of MSC immune therapy in immunological diseases were included, of which 18 were controlled trials. The majority of the controlled studies scored high on the risk of bias assessment for at least one criterion.
The clinical study outcomes differed among the different studies and disease type due to the large variation in study design and patient population between studies and the small number of studies per disease category.
Immunological readout parameters measured by some studies varied per study and the outcome was inconclusive. Therefore, it is not possible to draw a conclusion on the immunological impact of MSC therapy.
Lack of control groups in most studies and the large differences in study design, patient population and outcome parameters between different studies made it difficult to draw decisive conclusions on the outcome. More large controlled studies are needed to establish whether there is a beneficial immunological effect of MSC therapy.