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

Use of Stem Cells for COVID-19 Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04313322
• Other study ID #: COVID-19
• Status: Recruiting
• Phase: Phase 1
• Start date: March 16, 2020
• Est. completion date: September 30, 2020

Study information

• Verified date: March 2020
• Source: Stem Cells Arabia
• Contact: Adeeb M AlZoubi, Ph.D.
• Phone: +962795337575
• Email: adeebalzoubi[@]stemcellsarabia.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Use of Stem Cells for COVID-19 Treatment

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
Jordan	Stem Cells Arabia	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Stem Cells Arabia

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome	Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.	3 weeks
Primary	CT Scan	Side effects measured by Chest Readiograph	3 weeks
Primary	RT-PCR results	Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative	3 weeks
Secondary	RT-PCR results	Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative	8 weeks