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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Patient in Mscs group will receive MSCs implantation by intravenous injection.
Patients in comparator group will receive placebo treatment
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
RECRUITINGEffectiveness evaluation
The incidence and clinical status of progression to critical type after the third stem cell transplantation were evaluated
Time frame: Within 1 year of receiving mesenchymal stem cell transplants
Hospitalization time
The patient's hospital stay in days should be recorded.
Time frame: Time period from patient admission to discharge
oxygenation index(OI)
The oxygenation index of the patient was quantitatively measured in mmHg.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At admission, before to the stem cell transplant, and at 1 month, 6 months, and 12 months following the third MSC transplant.
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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) .
Time frame: 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).
Time frame: 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
Time frame: Within 1 year of receiving mesenchymal stem cell transplants