Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Stem Cells Arabia
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- CT Scan
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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%.
Arms & Interventions
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.
Intervention: WJ-MSCs (Biological)
Outcomes
Primary Outcomes
CT Scan
Time Frame: 3 weeks
Side effects measured by Chest Readiograph
Clinical outcome
Time Frame: 3 weeks
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
RT-PCR results
Time Frame: 3 weeks
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Secondary Outcomes
- RT-PCR results(8 weeks)
Investigators
Adeeb Al Zoubi
President, Chief Scientific Officer
Stem Cells Arabia