Human Umbilical Cord Derived Mesenchymal Stromal Cells for Treatment of Steroid-resistant and Therapy-refractory III-IV Acute Gastrointestinal Graft-versus-host Disease: An Open-label, Single-center, Self-control and Phase I/II Study
Research Square
2022
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Example: if you select the 1-year option for an article published in 2019 and a metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019. If you select the 3-year option for the same article published in 2019 and the metric category shows 90%, that means that the article or review is performing better than 90% of the other articles/reviews published in that journal in 2019, 2018 and 2017.
Citation Benchmarking is provided by Scopus and SciVal and is different from the metrics context provided by PlumX Metrics.
Article Description
Background: Acute graft-versus-host disease (aGVHD) is a life-threatening complication after allogeneic hematopoietic stem cell transplantation. First-line treatment of aGVHD is corticosteroid. Second-line therapy mainly comprises immunosuppressants. However, ∼ 25% of the patients have a steroid-resistant and therapy-refractory disease, which is associated with a very poor prognosis. An alternative therapy option for steroid-refractory and therapy-refractory aGVHD is the use of mesenchymal stromal cells (MSCs). Here, we report the results of 88 patients with grade III-IV aGVHD treated with human umbilical cord derived mesenchymal stromal cells (UC-MSC). Methods: There were 18 children and 70 adults with grade III/ IV aGVHD (82% grade IV). These patients were either resistant to steroids or refractory to 1–5 additional immunosuppressants. UC-MSCs were transfused at a median dose of 1 × 10 cells/kg with a median of 4 times (range, 1 to 16). Results: Median time between the onset of aGVHD and the first infusion of UC-MSC was 7 days (range, 3–88). The day 28 overall response rate was 51.14%, of these, 24 patients (27.27%) showed complete remission (CR), 21 (23.86%) showed partial remission (PR). The estimated survival probability at 100 days was 43.3%. And after a median follow-up of 66 months (26–122 months), the survival rate was approximately 33% (29/88). Patients developed acute gastrointestinal (GI) tract and liver GVHD showed worse overall response in day 28 than patients only with acute GI GVHD (21% vs. 58%; p= 0.037). No patient had severe side effects. Conclusions: These results suggest that UC-MSC treatment was safe and effective in children and adults, and should be considered for treating steroid-refractory aGVHD. Trial registration: ClinicalTrials: NCT01754454. Registered 21 December 2012 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01754454?cond=msc+gvhd&draw=2&rank=8
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