Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis
| العنوان: | Cell therapy with intravascular administration of mesenchymal stromal cells continues to appear safe: An updated systematic review and meta-analysis |
|---|---|
| المؤلفون: | Duncan J. Stewart, Mary Thompson, Keith R. Walley, Dianna Wolfe, Katrina J. Sullivan, Claudia C. dos Santos, Shane W. English, Emily Doxtator, Shirley H. J. Mei, Brian Hutton, Brent W. Winston, Lauralyn McIntyre, Dean Fergusson, John Granton, John Marshall, Manoj M. Lalu, Josee Champagne, Alies Maybee |
| المصدر: | EClinicalMedicine, Vol 19, Iss, Pp-(2020) EClinicalMedicine |
| بيانات النشر: | Elsevier, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | medicine.medical_specialty, Research paper, MEDLINE, Malignancy, 01 natural sciences, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, medicine, 030212 general & internal medicine, 0101 mathematics, Adverse effect, lcsh:R5-920, business.industry, 010102 general mathematics, General Medicine, medicine.disease, Confidence interval, 3. Good health, Clinical trial, Relative risk, Meta-analysis, Adverse events, Systematic review, Mesenchymal stem cells, Safety, business, lcsh:Medicine (General) |
| الوصف: | Background: Characterization of the mesenchymal stromal cell (MSC) safety profile is important as this novel therapy continues to be evaluated in clinical trials for various inflammatory conditions. Due to an increase in published randomized controlled trials (RCTs) from 2012–2019, we performed an updated systematic review to further characterize the MSC safety profile. Methods: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Web of Science (to May 2018) were searched. RCTs that compared intravascular delivery of MSCs to controls in adult populations were included. Pre-specified adverse events were grouped according to: (1) immediate, (2) infection, (3) thrombotic/embolic, and (4) longer-term events (mortality, malignancy). Adverse events were pooled and meta-analyzed by fitting inverse-variance binary random effects models. Primary and secondary clinical efficacy endpoints were summarized descriptively. Findings: 7473 citations were reviewed and 55 studies met inclusion criteria (n = 2696 patients). MSCs as compared to controls were associated with an increased risk of fever (Relative Risk (RR) = 2·48, 95% Confidence Interval (CI) = 1·27–4·86; I2 = 0%), but not non-fever acute infusional toxicity, infection, thrombotic/embolic events, death, or malignancy (RR = 1·16, 0·99, 1·14, 0·78, 0·93; 95% CI = 0·70–1·91, 0·81–1·21, 0·67–1·95, 0·65–0·94, 0·60–1·45; I2 = 0%, 0%, 0%, 0%, 0%). No included trials were ended prematurely due to safety concerns. Interpretations: MSC therapy continues to exhibit a favourable safety profile. Future trials should continue to strengthen study rigor, reporting of MSC characterization, and adverse events. Funding: Stem Cell Network, Ontario Institute for Regenerative Medicine and Ontario Research Fund Keywords: Mesenchymal stem cells, Safety, Adverse events, Systematic review |
| اللغة: | English |
| تدمد: | 2589-5370 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::d8b380cb573d443cfa0deb9892883029Test http://www.sciencedirect.com/science/article/pii/S2589537019302585Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....d8b380cb573d443cfa0deb9892883029 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 25895370 |
|---|