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

NCT ID: NCT04313322

Last Updated: 2020-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2020-09-30

Brief Summary

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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

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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.

Conditions

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Use of Stem Cells for COVID-19 Treatment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Patients positively diagnosed with COVID-19
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

None. This is a direct study for the potential effects of WJ-MSCs on COVID-19 outcome.

Study Groups

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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.

Group Type EXPERIMENTAL

WJ-MSCs

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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%.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Stem Cells Arabia

OTHER

Sponsor Role lead

Responsible Party

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Adeeb Al Zoubi

President, Chief Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stem Cells Arabia

Amman, , Jordan

Site Status RECRUITING

Countries

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Jordan

Central Contacts

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Adeeb M AlZoubi, Ph.D.

Role: CONTACT

+962795337575

Ahmad Y AlGhadi, M.Sc.

Role: CONTACT

+962796624217

Facility Contacts

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Adeeb M Alzoubi, Ph.D.

Role: primary

+962795337575

Ahmad AlGhadi, M.Sc.

Role: backup

+962796624217

Other Identifiers

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COVID-19

Identifier Type: -

Identifier Source: org_study_id

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