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      Evaluation of the safety and efficacy of using human menstrual blood‐derived mesenchymal stromal cells in treating severe and critically ill COVID‐19 patients: An exploratory clinical trial

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          Abstract

          The coronavirus disease 2019 (COVID‐19), caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) was identified in December 2019 and has subsequently spread worldwide. Currently, there is no effective method to cure COVID‐19. Mesenchymal stromal cells (MSCs) may be able to effectively treat COVID‐19, especially for severe and critical patients. Menstrual blood‐derived MSCs have recently received much attention due to their superior proliferation ability and their lack of ethical problems. Forty‐four patients were enrolled from January to April 2020 in a multicenter, open‐label, nonrandomized, parallel‐controlled exploratory trial. Twenty‐six patients received allogeneic, menstrual blood‐derived MSC therapy, and concomitant medications (experimental group), and 18 patients received only concomitant medications (control group). The experimental group was treated with three infusions totaling 9 × 10 7 MSCs, one infusion every other day. Primary and secondary endpoints related to safety and efficacy were assessed at various time points during the 1‐month period following MSC infusion. Safety was measured using the frequency of treatment‐related adverse events (AEs). Patients in the MSC group showed significantly lower mortality (7.69% died in the experimental group vs 33.33% in the control group; P = .048). There was a significant improvement in dyspnea while undergoing MSC infusion on days 1, 3, and 5. Additionally, SpO 2 was significantly improved following MSC infusion, and chest imaging results were improved in the experimental group in the first month after MSC infusion. The incidence of most AEs did not differ between the groups. MSC‐based therapy may serve as a promising alternative method for treating severe and critical COVID‐19.

          Abstract

          Menstrual blood‐derived MSC transplantation significantly lowers the mortality of severe and critical SARS‐CoV‐2‐induced COVID‐19.

          This prospective and systematic report assessed the ability of menstrual blood‐derived MSCs to treat both severe and critically ill COVID‐19 patients.

          MSC‐based therapy may serve in future clinical applications as an alternative way for the treatment of COVID‐19

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          Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China

          Chaolin Huang, Yeming Wang, Xingwang Li … (2020)
          Summary Background A recent cluster of pneumonia cases in Wuhan, China, was caused by a novel betacoronavirus, the 2019 novel coronavirus (2019-nCoV). We report the epidemiological, clinical, laboratory, and radiological characteristics and treatment and clinical outcomes of these patients. Methods All patients with suspected 2019-nCoV were admitted to a designated hospital in Wuhan. We prospectively collected and analysed data on patients with laboratory-confirmed 2019-nCoV infection by real-time RT-PCR and next-generation sequencing. Data were obtained with standardised data collection forms shared by WHO and the International Severe Acute Respiratory and Emerging Infection Consortium from electronic medical records. Researchers also directly communicated with patients or their families to ascertain epidemiological and symptom data. Outcomes were also compared between patients who had been admitted to the intensive care unit (ICU) and those who had not. Findings By Jan 2, 2020, 41 admitted hospital patients had been identified as having laboratory-confirmed 2019-nCoV infection. Most of the infected patients were men (30 [73%] of 41); less than half had underlying diseases (13 [32%]), including diabetes (eight [20%]), hypertension (six [15%]), and cardiovascular disease (six [15%]). Median age was 49·0 years (IQR 41·0–58·0). 27 (66%) of 41 patients had been exposed to Huanan seafood market. One family cluster was found. Common symptoms at onset of illness were fever (40 [98%] of 41 patients), cough (31 [76%]), and myalgia or fatigue (18 [44%]); less common symptoms were sputum production (11 [28%] of 39), headache (three [8%] of 38), haemoptysis (two [5%] of 39), and diarrhoea (one [3%] of 38). Dyspnoea developed in 22 (55%) of 40 patients (median time from illness onset to dyspnoea 8·0 days [IQR 5·0–13·0]). 26 (63%) of 41 patients had lymphopenia. All 41 patients had pneumonia with abnormal findings on chest CT. Complications included acute respiratory distress syndrome (12 [29%]), RNAaemia (six [15%]), acute cardiac injury (five [12%]) and secondary infection (four [10%]). 13 (32%) patients were admitted to an ICU and six (15%) died. Compared with non-ICU patients, ICU patients had higher plasma levels of IL2, IL7, IL10, GSCF, IP10, MCP1, MIP1A, and TNFα. Interpretation The 2019-nCoV infection caused clusters of severe respiratory illness similar to severe acute respiratory syndrome coronavirus and was associated with ICU admission and high mortality. Major gaps in our knowledge of the origin, epidemiology, duration of human transmission, and clinical spectrum of disease need fulfilment by future studies. Funding Ministry of Science and Technology, Chinese Academy of Medical Sciences, National Natural Science Foundation of China, and Beijing Municipal Science and Technology Commission.
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            Clinical Characteristics of Coronavirus Disease 2019 in China

            Wei-jie Guan, Zheng-yi Ni, Yu Hu … (2020)
            Abstract Background Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients. Methods We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in mainland China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death. Results The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission. Conclusions During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.)
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              Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study

              Nanshan Chen, Min Zhou, Xuan Dong … (2022)
              Summary Background In December, 2019, a pneumonia associated with the 2019 novel coronavirus (2019-nCoV) emerged in Wuhan, China. We aimed to further clarify the epidemiological and clinical characteristics of 2019-nCoV pneumonia. Methods In this retrospective, single-centre study, we included all confirmed cases of 2019-nCoV in Wuhan Jinyintan Hospital from Jan 1 to Jan 20, 2020. Cases were confirmed by real-time RT-PCR and were analysed for epidemiological, demographic, clinical, and radiological features and laboratory data. Outcomes were followed up until Jan 25, 2020. Findings Of the 99 patients with 2019-nCoV pneumonia, 49 (49%) had a history of exposure to the Huanan seafood market. The average age of the patients was 55·5 years (SD 13·1), including 67 men and 32 women. 2019-nCoV was detected in all patients by real-time RT-PCR. 50 (51%) patients had chronic diseases. Patients had clinical manifestations of fever (82 [83%] patients), cough (81 [82%] patients), shortness of breath (31 [31%] patients), muscle ache (11 [11%] patients), confusion (nine [9%] patients), headache (eight [8%] patients), sore throat (five [5%] patients), rhinorrhoea (four [4%] patients), chest pain (two [2%] patients), diarrhoea (two [2%] patients), and nausea and vomiting (one [1%] patient). According to imaging examination, 74 (75%) patients showed bilateral pneumonia, 14 (14%) patients showed multiple mottling and ground-glass opacity, and one (1%) patient had pneumothorax. 17 (17%) patients developed acute respiratory distress syndrome and, among them, 11 (11%) patients worsened in a short period of time and died of multiple organ failure. Interpretation The 2019-nCoV infection was of clustering onset, is more likely to affect older males with comorbidities, and can result in severe and even fatal respiratory diseases such as acute respiratory distress syndrome. In general, characteristics of patients who died were in line with the MuLBSTA score, an early warning model for predicting mortality in viral pneumonia. Further investigation is needed to explore the applicability of the MuLBSTA score in predicting the risk of mortality in 2019-nCoV infection. Funding National Key R&D Program of China.
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                Author and article information

                Contributors
                Yingan Jiang: jiangya_cn@aliyun.com
                Lingling Tang: lltang72@126.com
                Charlie Xiang:
                ORCID: https://orcid.org/0000-0002-9193-3900
                cxiang@zju.edu.cn
                Lanjuan Li: ljli@zju.edu.cn
                Journal
                Journal ID (nlm-ta): Clin Transl Med
                Journal ID (iso-abbrev): Clin Transl Med
                Journal ID (doi): 10.1002/(ISSN)2001-1326
                Journal ID (publisher-id): CTM2
                Title: Clinical and Translational Medicine
                Publisher: John Wiley and Sons Inc. (Hoboken )
                ISSN (Electronic): 2001-1326
                Publication date (Electronic): 27 January 2021
                Publication date Collection: February 2021
                Volume: 11
                Issue: 2 ( doiID: 10.1002/ctm2.v11.2 )
                Electronic Location Identifier: e297
                Affiliations
                [ 1 ] State Key Laboratory for Diagnosis and Treatment of Infectious Diseases National Clinical Research Center for Infectious Diseases Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
                [ 2 ] Department of Infectious Diseases Renmin Hospital of Wuhan University Wuhan Hebei P.R. China
                [ 3 ] Innovative Precision Medicine (IPM) Group Hangzhou Zhejiang P. R. China
                [ 4 ] Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College Hangzhou Zhejiang P. R. China
                [ 5 ] Department of Respiratory Disease Thoracic Disease Centre The First Affiliated Hospital College of Medicine Zhejiang University Hangzhou Zhejiang P. R. China
                Author notes
                [*] [* ] Correspondence

                Prof. Yingan Jiang, Department of Infectious Diseases, Renmin Hospital of Wuhan University, Wuhan, Hebei, P. R. China.

                Email: jiangya_cn@ 123456aliyun.com (Y.J.)

                Prof. Lingling Tang, Shulan (Hangzhou) Hospital, Zhejiang Shuren University Shulan International Medical College, Hangzhou, Zhejiang, P. R. China.

                Email: lltang72@ 123456126.com (L.T.)

                Profs. Lanjuan Li and Charlie Xiang, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases；National Clinical Research Center for Infectious Diseases；Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases，the First Affiliated Hospital，College of Medicine, Zhejiang University, Hangzhou, Zhejiang, P. R. China.

                ljli@ 123456zju.edu.cn (L.L); cxiang@ 123456zju.edu.cn (C.X.)

                [#]

                Xiaowei Xu, Wanli Jiang, Lijun Chen, and Zhenyu Xu contributed equally to this manuscript.

                Author information
                https://orcid.org/0000-0001-9374-6466
                https://orcid.org/0000-0003-1007-3951
                https://orcid.org/0000-0002-9193-3900
                Article
                Publisher ID: CTM2297
                DOI: 10.1002/ctm2.297
                PMC ID: 7839959
                PubMed ID: 33634996
                SO-VID: accb5cb5-4fc6-42dd-aa90-4b02fb475e2b
                Copyright © © 2021 The Authors. Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics
                License:

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 17 August 2020
                Date revision received : 07 January 2021
                Date accepted : 11 January 2021
                Page count
                Figures: 4, Tables: 8, Pages: 22, Words: 13190
                Funding
                Funded by: the Zhejiang Key Research and Development Program
                Award ID: 2020C03125
                Award ID: 2020C04016
                Funded by: National Natural Science Foundation of China , open-funder-registry 10.13039/501100001809;
                Award ID: 81900563
                Award ID: 81802278
                Funded by: National Science & Technology Major Project “Key New Drug Creation and Manufacturing Program”
                Award ID: 2018ZX09201002‐005
                Funded by: National Key R&D Program of China
                Award ID: 2017YFA0105701
                Funded by: the Independent Task of State Key Laboratory for Diagnosis and Treatment of Infectious Diseases
                Funded by: the National Science and Technology Major Project
                Award ID: 2017ZX10204401
                Categories
                Subject: Research Article
                Subject: Research Articles
                Custom metadata
                source-schema-version-number 2.0
                cover-date February 2021
                details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_JATSPMC version:5.9.7 mode:remove_FC converted:27.01.2021

                ScienceOpen disciplines: Medicine
                Keywords: coronavirus disease 2019 (covid‐19),mesenchymal stromal cells,safety and efficacy,severe and critical patients
                Data availability:
                ScienceOpen disciplines: Medicine
                Keywords: coronavirus disease 2019 (covid‐19), mesenchymal stromal cells, safety and efficacy, severe and critical patients

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