S44 Repair of acute respiratory distress syndrome in COVID-19 by stromal cells (REALIST-COVID trial): 1 year follow up for safety and pulmonary dysfunction

‘The fast and the furious’ – Clinical studies in COVID-19 Pub Date : 2022-11-01 DOI:10.1136/thorax-2022-btsabstracts.50

HJ Gardiner, Ea Gorman, A. Rostron, M. Shankar-Hari, J. Bannard-Smith, A. Bentley, D. Brealey, C. Campbell, G. Curley, M. Clarke, Ahilanandan Dushianthan, P. Hopkins, C. Jackson, K. Kefela, J. Laffey, C. McDowell, M. McFarland, J. McFerran, P. McGuigan, G. Perkins, J. Silversides, J. Smythe, J. Thompson, WS Tunnicliffe, Idm Welters, B. Williams, D. McAuley, C. O’Kane

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Abstract

S44 Table 1Summary of significant medical events, thoracic computed tomography (CT) and pulmonary function tests (PFTs) in ORBCEL-C and placebo groups at 1 year follow upORBCEL-C Placebo Number of patients followed up 20 21 Significant medical events Number of patients with SMEs 6/20 9/21 Total SME events 7 11 Classification Respiratory,thoracic and mediastinal disorders 4 6 Neoplasm - benign, malignant, unspecified 1 0 Infections and infestations 1 1 Cardiac disorders 1 0 Metabolism and nutrition disorders 0 1 Injury, poisoning and procedural complications 0 1 Renal and urinary disorders 0 1 Gastrointestinal disorders 0 1 Thoracic CT Number of CTs available 5 8 Time to CT (Median, IQR) 181 (157–198) 203 (95–233) Evidence of ILD on CT 4 6 PFTs Number of PFTs available 10 8 Time to PFTs (Median, IQR) 184.5 (117.5–292.75) 203.5 (118.25–242.5) FEV1 (Mean, SD) 84.9 (13.6) 80.5 (13.3) FEV1 <80% predicted (n,%) 4/10 (44%) 4/8 (50%) FVC (Mean, SD) 78.4 (13.2) 79.3 (16.5) FVC <80% predicted (n,%) 5/10 (55%) 5/8 (62.5%) FEV1/FVC ratio (Mean, SD, n) 0.88 (0.12) N=8 0.76 (0.05) N=5 FEV1/FVC <0.7 (n,%) 0 (0%) 0 (0%) TLCO (Mean, SD, n) 78.9 (14.8) N=9 61.9 (13.4) N=7 TLCO <80% (n,%) 6/9 (66.7%) 7/7 (100%) ConclusionsOne year follow up supports the safety of ORBCEL-C MSCs in patients with moderate to severe ARDS due to COVID-19. A similar incidence of pulmonary dysfunction is reported in both groups at long term follow up.Please refer to page A?? for declarations of interest related to this .

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基质细胞修复COVID-19急性呼吸窘迫综合征(REALIST-COVID试验):1年的安全性和肺功能障碍随访

表1 ORBCEL-C组和安慰剂组随访1年的重大医疗事件、胸部计算机断层扫描(CT)和肺功能检查(PFTs)汇总upORBCEL-C安慰剂组随访患者人数2021重大医疗事件SME患者人数6/20 9/21 SME事件总数711分类呼吸、胸部和纵隔疾病46肿瘤-良性、恶性、不明1 0感染和感染1 1心脏疾病代谢和营养障碍0 1损伤、中毒和程序性并发症0 1 0 1胃肠道功能紊乱0 1肾和泌尿疾病胸CT数的CTs 5 8次CT(中位数,IQR) 181(157 - 198) 203(95 - 233)的证据ILD CT 4 6可用的击球击球数10 8时间击球(中位数,差)184.5 (117.5 - -292.75)203.5 (118.25 - -242.5)FEV1(意思是,SD) 84.9 (13.6) 80.5 (13.3) FEV1 < 80% (n, %) 4/10(44%)的4/8 (50%)FVC(意思是,SD) 78.4 (79.3 - 13.2) (16.5) FVC < 80%预测(n, %) 5/10(55%)的5/8 (62.5%)FEV1 / FVC的比率(意思是,SD, n) 0.88 (0.12) (0.05) 0.76 n = 8 n = 5 FEV1 / FVC的< 0.7 (n, %) 0 (0%) 0 (0%) TLCO(意思是,SD, n) 78.9 (14.8) (13.4) 61.9 n = 9 n = 7 TLCO < 80% (n, %) 6/9(66.7%)的7/7 (100%)ConclusionsOne年跟进支持的安全ORBCEL-C msc中度到重度的患者由于COVID-19 ARDS。在长期随访中，两组肺功能障碍发生率相似。请参考A页??与此相关的利益声明。

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‘The fast and the furious’ – Clinical studies in COVID-19

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