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

Phase 1

• Conditions: Use of Stem Cells for COVID-19 Treatment
• Interventions: Biological: WJ-MSCs

• Registration Number: NCT04313322
• Lead Sponsor: Stem Cells Arabia

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-15
• Last Update Submitted: 2020-03-15
• Study Start: 2020-03-16
• Study First Posted: 2020-03-18
• Last Update Posted: 2020-03-18
• Primary Completion: 2020-06-30
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
WJ-MSCs	WJ-MSCs	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
RT-PCR results	8 weeks	Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative

Trial Locations

Locations (1)

Stem Cells Arabia; 🇯🇴 Amman, Jordan