Use of Stem Cells for COVID-19 TreatmentPhase 1NCT04313322
Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
A Phase 1 study testing WJ-MSCs in people with Use of Stem Cells for COVID-19 Treatment, run by Stem Cells Arabia at 1 site in Jordan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Use of Stem Cells for COVID-19 Treatment
- What is being tested?
- WJ-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteJordan
- Study dates
- 16 Mar 2020to 30 Sep 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.
Who cannot join
- 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
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- 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%.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Stem Cells Arabia
Amman, 11953
Adeeb M Alzoubi, Ph.D., +962795337575, adeebalzoubi@stemcellsarabia.net
Ahmad AlGhadi, M.Sc., +962796624217, ahmed.alghadi@stemcellsarabia.net
About this study
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.
Read the 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.
- Conditions
- Use of Stem Cells for COVID-19 Treatment
- Being tested
- WJ-MSCs
- Keywords
- Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WJ-MSCsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| WJ-MSCs | Experimental | 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. Receives: Biological: WJ-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
Measured: 3 weeks
CT Scan
Side effects measured by Chest Readiograph
Measured: 3 weeks
RT-PCR results
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Measured: 3 weeks
Secondary outcomes (1)
RT-PCR results
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start16 Mar 2020 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Use of Stem Cells for COVID-19 TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients positively diagnosed with COVID-19
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Cells Arabia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adeeb Al Zoubi, Stem Cells Arabia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313322
- Sponsor's protocol ID
- COVID-19
- Status last verified
- Mar 2020
- First submitted
- 15 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of COVID-19 Patients Using Wharton's Jelly-Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04313322
- Acronym / sponsor ID
- COVID-19
- Conditions
- Use of Stem Cells for COVID-19 Treatment
- Keywords
- Stem Cells, COVID-19, SARS CoV2, WJ MSCs, Immunomodulation,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Stem Cells ArabiaUniversity, hospital or other
- Study start
- 16 Mar 2020 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients positively diagnosed with COVID-19
| Arm | Type | Receives |
|---|---|---|
| WJ-MSCs | Experimental | Biological: WJ-MSCsWJ-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 positive according to diagnosis and clinical management of COVID-19 criteria.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WJ-MSCsWJ-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 |
Primary outcome
Clinical outcome
Time frame: 3 weeks
Improvement of clinical symptoms including duration of fever, respiratory destress, pneumonia, cough, sneezing, diarrhea.
CT Scan
Time frame: 3 weeks
Side effects measured by Chest Readiograph
RT-PCR results
Time frame: 3 weeks
Results of Real-Time Polymerase Chain Reaction of Viral RNA, Turing negative
1 secondary outcome
RT-PCR results
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing WJ-MSCs in people with Use of Stem Cells for COVID-19 Treatment, run by Stem Cells Arabia at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adeeb M AlZoubi, Ph.D. (+962795337575, adeebalzoubi@stemcellsarabia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.