Department of Haematology and GMP Cellular Therapy Unit, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain.
Instituto de Investigación Sanitaria Puerta de Hierro Segovia Arana, Madrid, Spain.
Bone Marrow Transplant. 2024 Jun;59(6):777-784. doi: 10.1038/s41409-024-02230-5. Epub 2024 Feb 26.
Mesenchymal stromal cells (MSC) have immunomodulatory and tissue-regenerative properties and have shown promising results in acute respiratory distress syndrome (ARDS) of multiple causes, including COVID-19. We conducted a randomised (1:1), placebo-controlled, double-blind clinical trial to assess the efficacy and safety of one bone marrow-derived MSC infusion in twenty patients with moderate to severe ARDS caused by COVID-19. The primary endpoint (increase in PaO2/FiO2 ratio from baseline to day 7, MSC 83.3 versus placebo 57.6) was not statistically significant, although a clinical improvement at day 7 in the WHO scale was observed in MSC patients (5, 50% vs 0, 0%, p = 0.033). Median time to discontinuation of supplemental oxygen was also shorter in the experimental arm (14 versus 23 days, p = 0.007), resulting in a shorter hospital stay (17.5 versus 28 days, p = 0.042). No significant differences were observed for other efficacy or safety secondary endpoints. No infusion or treatment-related serious adverse events occurred during the one-year follow-up. This study did not meet the primary endpoint of PaO2/FiO2 increase by day 7, although it suggests that MSC are safe in COVID-19 ARDS and may accelerate patients' clinical recovery and hospital discharge. Larger studies are warranted to elucidate their role in ARDS and other inflammatory lung disorders.Trial Registration: EudraCT Number: 2020-002193-27, registered on July 14th, 2020, https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002193-27/ES . NCT number: NCT04615429, registered on November 4th, 2020, https://clinicaltrials.gov/ct2/show/NCT04615429 .
间充质基质细胞（MSC）具有免疫调节和组织再生特性，并在多种原因引起的急性呼吸窘迫综合征（ARDS）中显示出良好的效果，包括 COVID-19。我们进行了一项随机（1:1）、安慰剂对照、双盲临床试验，以评估一次骨髓来源 MSC 输注在 20 例由 COVID-19 引起的中重度 ARDS 患者中的疗效和安全性。主要终点（从基线到第 7 天 PaO2/FiO2 比值的增加，MSC 为 83.3，安慰剂为 57.6）没有统计学意义，尽管在第 7 天，MSC 患者的 WHO 量表上观察到临床改善（5，50%比 0，0%，p=0.033）。实验组中停止补充氧气的中位时间也更短（14 天比 23 天，p=0.007），导致住院时间更短（17.5 天比 28 天，p=0.042）。其他疗效或安全性次要终点无显著差异。在为期一年的随访期间，未观察到与输注或治疗相关的严重不良事件。这项研究没有达到第 7 天 PaO2/FiO2 增加的主要终点，但它表明 MSC 在 COVID-19 ARDS 中是安全的，可能加速患者的临床康复和出院。需要更大规模的研究来阐明它们在 ARDS 和其他炎症性肺部疾病中的作用。试验注册：EudraCT 编号：2020-002193-27，于 2020 年 7 月 14 日注册，https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-002193-27/ES。NCT 编号：NCT04615429，于 2020 年 11 月 4 日注册，https://clinicaltrials.gov/ct2/show/NCT04615429。
