Back to resultsTreatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Primary Purpose
Use of Stem Cells for COVID-19 Treatment
Status
Unknown status
Phase
Phase 1
Locations
Jordan
Study Type
Interventional
Intervention
WJ-MSCs
Sponsored by
About this trial
This is an interventional treatment trial for Use of Stem Cells for COVID-19 Treatment focused on measuring Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
Eligibility 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%.
Sites / Locations
- Stem Cells ArabiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WJ-MSCs
Arm Description
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.
Outcomes
Primary Outcome Measures
Clinical outcome
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
CT Scan
Side effects measured by Chest Readiograph
RT-PCR results
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Secondary Outcome Measures
RT-PCR results
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04313322
Brief Title
Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Official Title
Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 16, 2020 (Anticipated)
Primary Completion Date
June 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stem Cells Arabia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Use of Stem Cells for COVID-19 Treatment
Keywords
Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
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.
Allocation
N/A
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
WJ-MSCs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
WJ-MSCs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical outcome
Description
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
Time Frame
3 weeks
Title
CT Scan
Description
Side effects measured by Chest Readiograph
Time Frame
3 weeks
Title
RT-PCR results
Description
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
RT-PCR results
Description
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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%.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adeeb M AlZoubi, Ph.D.
Phone
+962795337575
Email
adeebalzoubi@stemcellsarabia.net
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Y AlGhadi, M.Sc.
Phone
+962796624217
Email
ahmed.alghadi@stemcellsarabia.net
Facility Information:
Facility Name
Stem Cells Arabia
City
Amman
ZIP/Postal Code
11953
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adeeb M Alzoubi, Ph.D.
Phone
+962795337575
Email
adeebalzoubi@stemcellsarabia.net
First Name & Middle Initial & Last Name & Degree
Ahmad AlGhadi, M.Sc.
Phone
+962796624217
Email
ahmed.alghadi@stemcellsarabia.net
First Name & Middle Initial & Last Name & Degree
Ahmad Y AlGhadi, M.Sc.
First Name & Middle Initial & Last Name & Degree
Sumaya H Aldajah, M.Sc.
First Name & Middle Initial & Last Name & Degree
Marwa E Tapponi, Pharm.D.
First Name & Middle Initial & Last Name & Degree
Sameh N AlBakheet, B.Sc.
First Name & Middle Initial & Last Name & Degree
Mahasen Zalloum, B.Sc.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
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