Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
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ClinicalTrials.gov Identifier: NCT04313322 |
Recruitment Status : Unknown
Verified March 2020 by Adeeb Al Zoubi, Stem Cells Arabia.
Recruitment status was: Recruiting
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Use of Stem Cells for COVID-19 Treatment | Biological: WJ-MSCs | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 5 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Patients positively diagnosed with COVID-19 |
Masking: | None (Open Label) |
Masking Description: | None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome. |
Primary Purpose: | Treatment |
Official Title: | Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells |
Estimated Study Start Date : | March 16, 2020 |
Estimated Primary Completion Date : | June 30, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: 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. |
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. |
- Clinical outcome [ Time Frame: 3 weeks ]Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
- CT Scan [ Time Frame: 3 weeks ]Side effects measured by Chest Readiograph
- RT-PCR results [ Time Frame: 3 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
- RT-PCR results [ Time Frame: 8 weeks ]Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | 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%.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04313322
Contact: Adeeb M AlZoubi, Ph.D. | +962795337575 | adeebalzoubi@stemcellsarabia.net | |
Contact: Ahmad Y AlGhadi, M.Sc. | +962796624217 | ahmed.alghadi@stemcellsarabia.net |
Jordan | |
Stem Cells Arabia | Recruiting |
Amman, Jordan, 11953 | |
Contact: Adeeb M Alzoubi, Ph.D. +962795337575 adeebalzoubi@stemcellsarabia.net | |
Contact: Ahmad AlGhadi, M.Sc. +962796624217 ahmed.alghadi@stemcellsarabia.net | |
Sub-Investigator: Ahmad Y AlGhadi, M.Sc. | |
Sub-Investigator: Sumaya H Aldajah, M.Sc. | |
Sub-Investigator: Marwa E Tapponi, Pharm.D. | |
Sub-Investigator: Sameh N AlBakheet, B.Sc. | |
Sub-Investigator: Mahasen Zalloum, B.Sc. |
Responsible Party: | Adeeb Al Zoubi, President, Chief Scientific Officer, Stem Cells Arabia |
ClinicalTrials.gov Identifier: | NCT04313322 |
Other Study ID Numbers: |
COVID-19 |
First Posted: | March 18, 2020 Key Record Dates |
Last Update Posted: | March 18, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation, |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |