Abstract
ObjectiveThe aim of this study was to evaluate the safety of mesenchymal stem cell infusion in patients with autoimmune diseases.MethodsA total of 404 patients with autoimmune diseases who received mesenchymal stem cell infusion between 2007 and 2016 were included in this study. Adverse events in these patients were collected, mainly including infections and malignancies. Sources of information included hospitalization records and data from outpatient visits and each follow-up.ResultsThe mean follow-up period of all patients was 43.4 ± 25.9 months (range 1–109). Majority of stem cells were from the umbilical cord. The most common indications for mesenchymal stem cell infusion were systemic lupus erythematosus, Sjögren’s syndrome, and systemic sclerosis. The median age at infusion was 38.7 ± 15.7 years. The 5-year and 8-year survival rates were 90.4% and 88.9%, respectively. Median follow-up of survivors was 45.1 ± 25.7 months. The incidence rate of infections was 29.5% (119/404), and that of serious infections was 12.9% (52/404). Five patients (1.2%) experienced malignancies. Deaths occurred in 45 patients, and transplantation-related mortality was 0.2%. The most common causes of deaths in our study were disease relapse and complications associated with the underlying disease.ConclusionAutoimmune disease is an emerging indication for mesenchymal stem cell infusion. Our data shows that mesenchymal stem cell infusion is a safe therapy for patients with autoimmune diseases. The incidences of adverse events, whether infections or malignancies, are acceptable in these patients.Trial registrationClinaicalTrials.gov, NCT00698191. Registered 17 June 2008—Retrospectively registered
Highlights
Mesenchymal stem cell infusion (MSCI) has been described as a promising cell-based therapy, mainly because the cells display potent immunomodulatory and immunoprivilege properties and remarkable reparative capacities [1,2,3,4,5,6,7]
Other possible adverse events (AEs) may be caused by cell infusion itself, such as pulmonary cytolytic, venous thromboembolism, fever, and graft versus host disease, which are often reported in systematic reviews and meta-analyses about hematopoietic stem cell transplantation (HSCT) [13,14,15]
The median age of patients submitted to MSCI was 38.7 ± 15.7 years, and the mean follow-up of all patients was 43.4 ± 25.9 months
Summary
Mesenchymal stem cell infusion (MSCI) has been described as a promising cell-based therapy, mainly because the cells display potent immunomodulatory and immunoprivilege properties and remarkable reparative capacities [1,2,3,4,5,6,7]. MSCI has been applied to treat a variety of autoimmune diseases (AID), including. Liang et al Stem Cell Research & Therapy (2018) 9:312 of soluble factors [11, 12]. These immune cells play key roles in host defense against viral infections and immune surveillance against cancer. MSCs can inhibit protein production and gene expression of tumor necrosis factor-α (TNF-α), which plays a critical role in protection against many infections. Some unfavorable consequences might arise when applying MSCs as cell therapy in AID patients. The risk of infection and carcinogenesis might increase associated with dysfunction of specific effector cells or decreased TNF-α in AID patients receiving cell infusion. Other possible adverse events (AEs) may be caused by cell infusion itself, such as pulmonary cytolytic, venous thromboembolism, fever, and graft versus host disease, which are often reported in systematic reviews and meta-analyses about hematopoietic stem cell transplantation (HSCT) [13,14,15]
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