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

March 15, 2020 updated by: Adeeb Al Zoubi, Stem Cells Arabia
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11953
        • Recruiting
        • Stem Cells Arabia
        • Contact:
        • Contact:
        • 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.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RT-PCR results
Time Frame: 8 weeks
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stem Cells Arabia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 16, 2020

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

September 30, 2020

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

March 15, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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