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IRCT20200421047150N1 IRCT 2020-05-14 DEY Company Stem cell treatment for COVID-19 Assessment of safety, efficacy and effective dose determination of human umbilical cord Wharton’s jelly mesenchymal stem cell transplantation on treatment of COVID-19 (coronavirus) pneumonia and complications in humans 2020-05-12 anticipated 90 Complete https://irct.ir/trial/47964 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use a randomization method to minimize the researchers' opinion to select participation in study groups to control bias. After selection, participants are assigned to the groups using a simple randomization method for received intervention and placebo in each participant. The randomization process is performed using Random Allocation software, and since this study consists of two groups, the allocation outputs of the participants are identified by A and B so the assign of each patient in each group is unpredictable to other members of the research team. We do not notify the team manager after selecting each patient and they send out each patient's intervention type based on the software output, without the known of other team members. Only the clinical care is aware of any patient's intervention in cases where the patient's condition is inappropriate, Blinding description: After selecting each patient to the study, the patients are selected based on the randomization output is taken from the randomization software and matching it with the patient number of the intervention in such a way that each the patients, investigators and outcome assessor do not determine the type of intervention the patients receive. Blinding in this study is triple blind. To maintain the blindness of the study the injection shape and color of the placebo are be similar to the main intervention so that patients and physicians evaluating the outcomes are blind of the participant's interventions to minimize the bias in outcome measurement. 2-3 COVID-19. Intervention 1: Intervention group: In this group, umbilical cord Wharton’s jelly mesenchymal stem cells are infused at an initial dose of 0.5-2 milion/ kg. This process is performed on the first, third and sixth days. This intervention is done along with other standard treatments for this type of patients, varying in severity of COVID-19 Infectious, and in accordance with national and international guidelines. Intervention 2: Control group: This group, like the intervention group, will receive all standard medication according to national and international guidelines, depending on the severity of COVID-19. But on the first, third and sixth day, placebo (normal saline) is infused. Yes - There is a plan to make this available What will be shared: Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables. When: Availability four months after the end of study To whom: Emergency medicine and infectious, pulmonology, intensive care, and other specialists Conditions: In the case of comparison with other similar trials or treatment Where to obtain: Shahid Beheshti University of Medical Sciences How to obtain: By referring to the central library and clinical trial center in Iran University of Medical Sciences can access to the documents of participants, data and results Comments:
public Mohamad Fathi
Shahid Modarres Hospital, Saadat Abad St.,Yadegare Imam Highway
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2351 5366 fathi_mansor@yahoo.com Shahid Beheshti University of Medical Sciences scientific Mehran Lak
Shahid Modarres Hospital, Saadat Abad St.,Yadegare Imam Highway
Tehran Iran (Islamic Republic of) 1998734383 +98 21 2351 5366 Lakmehran@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients in acute phase with Laboratory confirmation of SARS-COV-2 infection, Pneumonia confirmed by chest x-ray or Computed tomography Scan, Respiratory rate> 30 times / minute, Oxygen Saturation less than 93% , Arterial oxygen partial pressure (Pao2) /oxygen inhalation(Fio2) less than 300 mmHg No history of tumor or malignant disease 18 years 85 years Both Pregnant patient with a positive pregnancy test or during lactation or who is planning to become pregnant during the study, The definitive history of acquired or inherited immune deficiency diseases, The definitive psychotic illness, A history of serious mental illness or a history of suicide. Creatinine greater than 1.7 mg/dL. Any active or treated Cancerous diseases. Hepatic enzymes three times normal or white blood cell count lower than 3000 per microliter and hemoglobin less than 10 g/dl. Any cardiac hemodynamic disorder. Co-infection of human immunodeficiency viruses, Hepatitis B, Hepatitis C and Human T-lymphotropic virus U07.01 COVID-19 disease Treatment - Drugs Placebo Intervention group: In this group, umbilical cord Wharton’s jelly mesenchymal stem cells are infused at an initial dose of 0.5-2 milion/ kg. This process is performed on the first, third and sixth days. This intervention is done along with other standard treatments for this type of patients, varying in severity of COVID-19 Infectious, and in accordance with national and international guidelines. Control group: This group, like the intervention group, will receive all standard medication according to national and international guidelines, depending on the severity of COVID-19. But on the first, third and sixth day, placebo (normal saline) is infused. Death. Timepoint: Up to 28 days after starting the study. Method of measurement: Patient observation and evaluation of vital signs. Evaluation of Pneumonia Severity Index. Timepoint: Up to 28 days. Method of measurement: PSI. Evaluation of oxygen supply index. Timepoint: Discharge from ICU. Method of measurement: Pulse Oximeter. C- Reactive protein. Timepoint: 28 days or until the marker is normalized. Method of measurement: Blood sample. Procalcitonin. Timepoint: Until the marker is normalized. Method of measurement: Blood sample. Lymphocyte count. Timepoint: Until the marker is normalized. Method of measurement: CBC. Counting of CD3 +, CD4 + and CD8 + T cells. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. + CD4 + / CD8 ratio. Timepoint: Before the first injection and after the third injection. Method of measurement: Flow cytometry. Improve pneumonia evaluated by CT scan. Timepoint: After the second and third infusions. Method of measurement: CT scan. DEY Company Approved 2020-04-06 Ethics Committee in Biomedical Research of Shahid Beheshti University of Medical Science 7th Floor,, Arabi Ave, Velenjak tehran Tehran Iran (Islamic Republic of)