2020年阿布扎比自体非造血富集干细胞雾化吸入治疗新冠患者的安全性与有效性：一项随机临床试验

Safety and efficacy of autologous non-hematopoietic enriched stem cell nebulization in COVID-19 patients: a randomized clinical trial, Abu Dhabi 2020.

作者信息

Ventura-Carmenate Yendry, Alkaabi Fatima Mohammed, Castillo-Aleman Yandy Marx, Villegas-Valverde Carlos Agustin, Ahmed Yasmine Maher, Sanna Pierdanilo, Almarzooqi Ayesha Abdulla, Abdelrazik Abeer, Torres-Zambrano Gina Marcela, Wade-Mateo Maura, Quesada-Saliba David, Abdel Hadi Loubna, Bencomo-Hernandez Antonio Alfonso, Rivero-Jimenez Rene Antonio

机构信息

Abu Dhabi Stem Cells Center, Al Misahah Street, Villa No. 25, Rowdhat, Zone-1, POB 4600, Abu Dhabi City, United Arab Emirates.

Sheikh Khalifa Medical City Hospital, POB 51900, Abu Dhabi City, United Arab Emirates.

出版信息

Transl Med Commun. 2021;6(1):25. doi: 10.1186/s41231-021-00101-5. Epub 2021 Nov 3.

BACKGROUND

The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed.

METHOD

An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the "SENTAD-COVID Study" was conducted by the under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first.

RESULTS

The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group ( = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56-1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56-0.88).

CONCLUSIONS

Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients.

TRIAL REGISTRATION

ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.

背景

新型严重急性呼吸综合征冠状病毒2（SARS-CoV-2）引发了2019冠状病毒病（COVID-19）大流行。目前，由于全球疫苗接种率不足，迫切需要找到治疗方案以减轻该病毒的影响。

方法

一项名为“SENTAD-COVID研究”的适应性、多中心、开放标签随机对照I/II期临床试验，于2020年4月4日至7月31日在阿联酋机构审查委员会（IRB）的COVID-19研究委员会的特殊条件批准下进行，使用通过压缩机（喷射）雾化给药的自体外周血非造血富集干细胞鸡尾酒（PB-NHESC-C）作为标准护理疗法的补充。主要终点包括安全性和有效性评估、不良事件、28天内的死亡率以及通过七分类有序量表降低2分或出院（以先发生者为准）来衡量的临床改善时间。

结果

该研究共纳入139例随机分组的COVID-19患者，实验组69例，对照组（标准护理）70例。鸡尾酒治疗组的总生存率为94.20%，而对照组为90.27%。接受PB-NHESC-C治疗的50例（72.46%）患者和对照组的51例（72.85%）患者报告了不良事件（P = 0.9590），这些不良事件在COVID-19中较为常见。干预的前9天后，鸡尾酒治疗组67.3%的患者康复出院，而对照组为53.1%（相对危险度RR = 0.84；95%置信区间CI，0.56 - 1.28）。与对照组（17.0%）相比，鸡尾酒治疗组患者（42.0%）更频繁地出现病情改善，即严重程度量表至少降低2分（RR = 0.69；95% CI，0.56 - 0.88）。