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This study is to evaluate the safety and efficacy of umbilical cord mesenchymal stem cells Therapy for COVID-19.
Since 2019, novel coronavirus Disease 2019 (COVID-19) has spread and prevailed all over the world. COVID-19 has a wide range of clinical manifestations of respiratory and non-respiratory symptoms, including mild or severe influenza-like syndrome, respiratory distress or respiratory failure, and may end in multiple organ failure. Mesenchymal stem cells (MSCS) are considered as ideal seed cells for the treatment of various diseases due to their unique immune regulation, self-renewal and multiple differentiation potentials. The safety of MSC transplantation in the treatment of COVID-19 patients has been proved by a number of clinical studies, and has shown good clinical efficacy in shortening the course of the disease, alleviating lung damage, and reducing the level of inflammatory factors. However, previous clinical studies mainly focused on the efficacy of MSC transplantation in critically ill patients of COVID-19, ignoring the important role of cell transplantation in delaying or preventing COVID-19 's progress and preventing reinfection.COVID-19 has spread throughout the country and even the world, and the increase in severe and critical cases has caused a great impact on national medical and health resources. Stem cell transplantation offers new treatment ideas for COVID-19 patients. Since the role of cell transplantation in delaying or preventing the progression of light and medium novel coronavirus infection and preventing reinfection has not been clearly reported, this study intends to use MSC transplantation to evaluate the role of stem cells in the occurrence and development of novel coronavirus infection, so as to provide an important reference for the prevention and treatment of COVID-19 by MSC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs group | Experimental | Patient in Mscs group will receive MSCs implantation by intravenous injection Within 10-15 days of infection |
|
| comparator | Placebo Comparator | Patients in comparator group will receive placebo treatment Within 10-15 days of infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical cord mesenchymal stem cells implantation | Biological | Patient in Mscs group will receive MSCs implantation by intravenous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness evaluation | The incidence and clinical status of progression to critical type after the third stem cell transplantation were evaluated | Within 1 year of receiving mesenchymal stem cell transplants |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization time | The patient's hospital stay in days should be recorded. | Time period from patient admission to discharge |
| oxygenation index（OI） | The oxygenation index of the patient was quantitatively measured in mmHg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianyun Wang, Doctor | Contact | 031187156290 | wangxianyun_mbb@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xifeng Jiang, Doctor | The First Hospital of Hebei Medical University | Study Chair |
| Gang Liu, Master | The First Hospital of Hebei Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31978293 | Result | Munster VJ, Koopmans M, van Doremalen N, van Riel D, de Wit E. A Novel Coronavirus Emerging in China - Key Questions for Impact Assessment. N Engl J Med. 2020 Feb 20;382(8):692-694. doi: 10.1056/NEJMp2000929. Epub 2020 Jan 24. No abstract available. | |
| 29859173 | Result | Galipeau J, Sensebe L. Mesenchymal Stromal Cells: Clinical Challenges and Therapeutic Opportunities. Cell Stem Cell. 2018 Jun 1;22(6):824-833. doi: 10.1016/j.stem.2018.05.004. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Comparator | Other | Patients in comparator group will receive placebo treatment |
|
| At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant. |
| Oxygen saturation（SaO2） | The blood oxygen saturation of patients was monitored by oximeter. | At the time of our patient's hospitalization and 7 days after receiving the third MSC transplant. |
| Chest CT | A computed tomography (CT) scan of the patient's chest was performed to evaluate the level of inflammation, the scope of the involvement, and the degree of fibrosis in the heart and lungs. | At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant. |
| Pulmonary function evaluation | Lung ventilation experiments were used to measure the lung volume (in ml) and airway patency (in ml) of patients in order to assess their lung function. | At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant. |
| Blood biochemical examination | The progression of the lesion was determined by blood chemistry tests on a patient's blood sample, which mostly included liver function: Alanine aminotransferase (U/L)，Glutamic oxaloacetic transaminase (U/L), renal function:blood urea nitrogen (mmol/L) and serum creatinine (umol/L), cardiac function: creatine kinase isoenzymes(U/L) and Troponin(ng/ml), and inflammatory factors: C- reactive protein (mg/dl) and Interleukin- 6(Pg/ml) . | At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant. |
| Echocardiographic examination of heart function | Echocardiography was used to evaluate the patient's myocardial contractility, primarily focusing on left ventricular ejection fraction (LVEF). | At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant. |
| Safety assessment | infusion and allergic reactions, life-threatening adverse events | Within 1 year of receiving mesenchymal stem cell transplants |
| Wuzhuang Sun, Master |
| The First Hospital of Hebei Medical University |
| Study Director |
| Baoyong Yan, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Mingqi Zheng, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Ding Yu, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Le Wang, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Yajie Wang, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Quanhai Li, Master | The First Hospital of Hebei Medical University | Principal Investigator |
| Xianyun Wang, Doctor | The First Hospital of Hebei Medical University | Principal Investigator |
| Jiawei Yang, Postgraduate | The First Hospital of Hebei Medical University | Principal Investigator |
| Tianshuo Li, Postgraduate | The First Hospital of Hebei Medical University | Principal Investigator |
| 33514427 | Result | Hashemian SR, Aliannejad R, Zarrabi M, Soleimani M, Vosough M, Hosseini SE, Hossieni H, Keshel SH, Naderpour Z, Hajizadeh-Saffar E, Shajareh E, Jamaati H, Soufi-Zomorrod M, Khavandgar N, Alemi H, Karimi A, Pak N, Rouzbahani NH, Nouri M, Sorouri M, Kashani L, Madani H, Aghdami N, Vasei M, Baharvand H. Mesenchymal stem cells derived from perinatal tissues for treatment of critically ill COVID-19-induced ARDS patients: a case series. Stem Cell Res Ther. 2021 Jan 29;12(1):91. doi: 10.1186/s13287-021-02165-4. |
| 34750382 | Result | Zanirati G, Provenzi L, Libermann LL, Bizotto SC, Ghilardi IM, Marinowic DR, Shetty AK, Da Costa JC. Stem cell-based therapy for COVID-19 and ARDS: a systematic review. NPJ Regen Med. 2021 Nov 8;6(1):73. doi: 10.1038/s41536-021-00181-9. |
| 31986257 | Result | Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available. |
| 32085846 | Result | Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available. |
| 25329189 | Result | Wang Y, Chen X, Cao W, Shi Y. Plasticity of mesenchymal stem cells in immunomodulation: pathological and therapeutic implications. Nat Immunol. 2014 Nov;15(11):1009-16. doi: 10.1038/ni.3002. |
| 32257537 | Result | Leng Z, Zhu R, Hou W, Feng Y, Yang Y, Han Q, Shan G, Meng F, Du D, Wang S, Fan J, Wang W, Deng L, Shi H, Li H, Hu Z, Zhang F, Gao J, Liu H, Li X, Zhao Y, Yin K, He X, Gao Z, Wang Y, Yang B, Jin R, Stambler I, Lim LW, Su H, Moskalev A, Cano A, Chakrabarti S, Min KJ, Ellison-Hughes G, Caruso C, Jin K, Zhao RC. Transplantation of ACE2- Mesenchymal Stem Cells Improves the Outcome of Patients with COVID-19 Pneumonia. Aging Dis. 2020 Mar 9;11(2):216-228. doi: 10.14336/AD.2020.0228. eCollection 2020 Apr. |
| 32811531 | Result | Shu L, Niu C, Li R, Huang T, Wang Y, Huang M, Ji N, Zheng Y, Chen X, Shi L, Wu M, Deng K, Wei J, Wang X, Cao Y, Yan J, Feng G. Treatment of severe COVID-19 with human umbilical cord mesenchymal stem cells. Stem Cell Res Ther. 2020 Aug 18;11(1):361. doi: 10.1186/s13287-020-01875-5. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |