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IRCT20211012052743N1 IRCT 2021-11-06 Cell Gene Medicine Company Stem cell therapy for COVID-19 Clinical trial study of safety and efficacy assessment of human umbilical cord matrix mesenchymal stem cell infusion on the treatment of new coronavirus 2019 pneumonia in humans 2021-11-06 anticipated 60 Complete https://irct.ir/trial/59339 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use a randomization method to minimize the researchers' opinions 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 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 knowledge 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 patient, investigator, outcome assessor, and data analyzer does 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 similar to the main intervention so that patients, physicians, and staff who evaluating the outcomes are blind to the participant's interventions to minimize the bias in outcome measurement. 3 COVID-19 disease. Intervention 1: Intervention group: In this group, umbilical cord Wharton’s jelly mesenchymal stem cells are infused at an initial dose of 0.5-1 million/kg. This process is performed three times. 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 each time, 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: Available four months after the end of the study. To whom: Emergency medicine and infectious, pulmonology, intensive care, and other physicians. Conditions: In the case of comparison with other similar trials or treatments. Where to obtain: Avicenna Research Institute How to obtain: By referring to the central library and clinical trial center in Avicenna Research Institute can access the documents of participants, data, and results. Comments:
public Aliasghar Rezaei
Avicenna Health Technology Incubation Center, NO. 60, Golestan 4th, Amirabadi St. ,Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1984737384 +98 21 8819 2932 DR@cellgenemedicine.com Iranian academic center for education culture and research scientific Seyed Jafar Hashemian
Avicenna Health Technology Incubation Center, NO. 60, Golestan 4th, Amirabadi St. ,Velenjak, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1984737384 +98 21 8819 2932 sj-hashemian@farabi.tums.ac.ir Iranian academic center for education culture and research Iran (Islamic Republic of) Patients in the acute phase with Laboratory confirmation of SARS-COV-2 infection with RT-PCR 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 mm Hg No history of tumor or malignant disease CRP greater than normal range 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. Any active or treated Cancerous diseases. Creatinine greater than 1.7 mg/dL Co-infection of human immunodeficiency viruses, Hepatitis B, Hepatitis C and Human T-lymphotropic virus Any cardiac hemodynamic disorder Positive PPD test Positive syphilis test Treatment with cytotoxic drugs one month prior study 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 0.5-1 million/kg. This process is performed three times. 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 each time, 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: The PSI/PORT score. 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 or Chest X-Ray. Timepoint: After the second and third infusions. Method of measurement: CT scan or plain Radiography. Cell Gene Medicine Company Approved 2021-08-24 Ethics Committees of Avicenna Research Institute Avicenna Research Institute, Shahid Beheshti University, Darakeh Street Tehran Tehran Iran (Islamic Republic of)