Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
1 other identifier
interventional
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2020
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 15, 2020
CompletedStudy Start
First participant enrolled
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedMarch 18, 2020
March 1, 2020
4 months
March 15, 2020
March 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Clinical outcome
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
3 weeks
CT Scan
Side effects measured by Chest Readiograph
3 weeks
RT-PCR results
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
3 weeks
Secondary Outcomes (1)
RT-PCR results
8 weeks
Study Arms (1)
WJ-MSCs
EXPERIMENTALWJ-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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stem Cells Arabia
Amman, 11953, Jordan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- President, Chief Scientific Officer
Study Record Dates
First Submitted
March 15, 2020
First Posted
March 18, 2020
Study Start
March 16, 2020
Primary Completion
June 30, 2020
Study Completion
September 30, 2020
Last Updated
March 18, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share