RT Journal Article
SR Electronic
T1 Late Breaking Abstract - High cumulative dose of allogeneic mesenchymal stem cells in patients with progressive idiopathic pulmonary fibrosis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP PA1297
DO 10.1183/13993003.congress-2019.PA1297
VO 54
IS suppl 63
A1 Averyanov, Alexander
A1 Sotnikova, Anna
A1 Koroleva, Irina
A1 Konoplyannikov, Mikhail
A1 Danilevskaya, Olesya
A1 Lesnyak, Victor
A1 Baklaushev, Vladimir
YR 2019
UL http://erj.ersjournals.com/content/54/suppl_63/PA1297.abstract
AB Rationale: Three published Phase 1 studies demonstrated safety and mild beneficial effects of mesenchymal stem cells (MSCs) with the maximum dose 200 million cells in patients with idiopathic pulmonary fibrosis (IPF).Aim: The aim of this 52-week open-labeled, randomized, placebo-controlled Phase 1-2A study was to evaluate safety, tolerability and efficacy of high cumulative dose of MSCs in severe to moderate IPF patients with rapid lung function decline.Methods: 20 patients with FVC> 40% and DLCO> 20% declined > 10% over the previous 12 months were randomized into 2 groups: one group received 2 intravenous doses of allogeneic bone marrow-derived MSCs (2 x 108 cells in each dose) every 3 months, and the second group received a placebo. A total amount of 1.6 x 109 MSCs had been administered to each patient by the end of study.Results: Of the 20 initially recruited patients, 16 completed the study. 4 patients (two from each group) died from respiratory failure progression. Adverse events (AE) were more frequently observed in the group received MSCs (n=26) compared with placebo (n=16). Among AE transient fever and chills were registered more often in MSCs group, predominantly in the first day after infusion. The FVC decline for 12 months in the MSCs therapy group was 4.3%, and 13.2% in the placebo group. Mean 6MWD increased from 294 to 346 meters in MSCs treated patients but decreased by 21 meter in placebo group.Conclusion: Intravenous therapy by high cumulative dose of allogeneic MSCs (1.6 x 109) in patients with progressive IPF course is associated with more frequent non-severe AE and decelerated decline of pulmonary function compared with placebo.FootnotesCite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA1297.This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).