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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04313322
Recruitment Status : Recruiting
First Posted : March 18, 2020
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Adeeb Al Zoubi, Stem Cells Arabia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Use of Stem Cells for COVID-19 Treatment Biological: WJ-MSCs Phase 1

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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical outcome [ Time Frame: 3 weeks ]
    Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.

  2. CT Scan [ Time Frame: 3 weeks ]
    Side effects measured by Chest Readiograph

  3. RT-PCR results [ Time Frame: 3 weeks ]
    Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative


Secondary Outcome Measures :
  1. RT-PCR results [ Time Frame: 8 weeks ]
    Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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%.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Adeeb M AlZoubi, Ph.D. +962795337575 adeebalzoubi@stemcellsarabia.net
Contact: Ahmad Y AlGhadi, M.Sc. +962796624217 ahmed.alghadi@stemcellsarabia.net

Locations
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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.         
Sponsors and Collaborators
Stem Cells Arabia
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adeeb Al Zoubi, Stem Cells Arabia:
Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
Additional relevant MeSH terms:
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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