Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells

Study Overview
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Brief Summary
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The purpose of this study is to investigate the potential use of Wharton's Jelly Mesenchymal stem cells (WJ-MSCs) for treatment of patient diagnosed with Corona Virus SARS-CoV-2 infection, and showing symptoms of COVID-19.

Detailed Description
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COVID-19 is a condition caused by infection with Coronoa Virus (SARS-CoV-2). This virus has a high transmission rate and is spreading at very high rates. causing a worldwide pandemic. Patients diagnosed with COVID-19 and confirmed positive with the virus, will be given three IV doses of WJ-MSCs consisting of 1X10e6/kg. The three doses will be 3 days apart form each other. Patients will be followed up for a period of three weeks to assess the severity of the condition and measure the viral titers.

Official Title
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Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells

Conditions
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Use of Stem Cells for COVID-19 Treatment

Intervention / Treatment
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* Biological: WJ-MSCs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria. Exclusion Criteria: Participants in other clinical trials patients with malignant tumors pregnant and lactating women co-infection with other infectious viruses or bacteria History of several allergies Patients with history of pulmonary embolism any liver or kidney diseases HIV positive patients Considered by researchers to be not suitable to participate in this clinical trial Chronic heart failure with ejection fraction less than 30%.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Patients positively diagnosed with COVID-19
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WJ-MSCs<br>WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs. WJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously. | Biological: WJ-MSCs<br>* WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs. WJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome | Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea. | 3 weeks | 
| CT Scan | Side effects measured by Chest Readiograph | 3 weeks | 
| RT-PCR results | Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RT-PCR results | Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,