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

The purpose of this study is to evaluate the safety, efficacy, and dose determination of human umbilical cord matrix-derived mesenchymal stem cell injection in the treatment of new COVID-19 pneumonia in humans. The main aim is to decrease mortality.

This study is a parallel randomized controlled clinical trial study design. The sample size of the study is 60 COVID-19 patients that are assigned to intervention and control groups using a simple randomization method.

This study is performed to decrease the mortality and other complications of patients with COVID-19 and normalize blood Parameters and chest CT scan at the hospital. Included and admitted patients in infectious and intensive care units, are followed up for up to 28 days for the intended outcome after receiving the intervention.

Patients with an acute form of COVID-19 infection who are confirmed by RT-PCR and HRCT are included. Any confirmed pregnancy, ARDS with other reasons, active cancerous disease, hematological disorders, heart failure, viral disease, acquired or inherited immune deficiency, and mental illness are excluded.

Patients in the intervention group are injected with an initial dose of 0.5 -1 million/ kg of MSC. This process is repeated 3- 4 times. This intervention is supplemented with other treatments. The control group is received standard viral treatment along with placebo (normal saline) instead of the intervention.

Death, FIO2, Interleukin profile, Pneumonia severity index, Oxygen Saturation index, Procalcitonin, C reactive protein, Lymphocyte count, CD3 +, CD4 +, and CD8 + T cells count, improved pneumonia using CT scan.

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.

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.

Findings of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Available four months after the end of the study.

Emergency medicine and infectious, pulmonology, intensive care, and other physicians.

In the case of comparison with other similar trials or treatments.

Avicenna Research Institute

By referring to the central library and clinical trial center in Avicenna Research Institute can access the documents of participants, data, and results.