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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04313322
Enrollment
5
Registered
2020-03-18
Start date
2020-03-16
Completion date
2020-09-30
Last updated
2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Use of Stem Cells for COVID-19 Treatment

Keywords

Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,

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.

Interventions

BIOLOGICALWJ-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.

Sponsors

Stem Cells Arabia
Lead SponsorOTHER

Study design

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.

Intervention model description

Patients positively diagnosed with COVID-19

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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%.

Design outcomes

Primary

MeasureTime frameDescription
Clinical outcome3 weeksImprovement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
CT Scan3 weeksSide effects measured by Chest Readiograph
RT-PCR results3 weeksResults of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative

Secondary

MeasureTime frameDescription
RT-PCR results8 weeksResults of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative

Countries

Jordan

Contacts

Primary ContactAdeeb M AlZoubi, Ph.D.
adeebalzoubi@stemcellsarabia.net+962795337575
Backup ContactAhmad Y AlGhadi, M.Sc.
ahmed.alghadi@stemcellsarabia.net+962796624217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026