COVID-19Phase 2CELMANCT04429763
Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19 Pneumonia
A Phase 2 study testing Umbilical cord derived mesenchymal stem cells in people with COVID-19, run by Trustem.
Trial summary
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Umbilical cord derived mesenchymal stem cells
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2020to Nov 2020
- Phase
- Phase 2
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Severe COVID-19.
- Infection confirmed by PCR test.
- Hospitalized in general room (respiratory isolation area).
Who cannot join
- Shock or multiorgan disfunction that require continous vital signs monitorization
- Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
- Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
- Pregnant women or breast feeding.
- Advanced hearth failure.
- VIH/AIDS.
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- Bacterial or fungical uncontroled infection.
- Permanente use of immunosupresants or have had received an organ trasnplanted in the past six months.
- Imposibility to sign the informent consent format.
- Patients involved in another clinical trial with drugs or interventions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
The disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.
There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.
It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
Read the detailed description
Objetive:
Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients.
Metodology:
Fase II, controled clinical trial, double blinded, compared with placebo, with paralel groups, and one to one asignation. It will be included patients between 18 and 79 years old, hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis. It will be excluded those who have indication for management in Intensive Care Unit, have any condition that seriusly affect their survival, pregnant whomen or breast feeding, those who have an advanced hearth failure, HIV infected, those who have a bacterial or fungal uncontroled infection, those who require permanent immunosupresive therapy or have had an organ trasplant, those who have no possibility to sign the informed consent format or are involved in another clinical trial with drugs or interventions.
It will vinculate 30 patients randomly assigned, by centralized electronic assignation sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human umbilical cord or to placebo group.
The primary result it will be a composed point of time to the occurrence of the clinical detriment or the death (the first that occurs) and the secondary result will be the components of each primary point, the clinical recovery, the time to the time to the discharge from the hospital, and the clinical follow-up, including respiratory function, and markers of inflammation, haematological and kidney, in addition of the safety markers.
It will be done a comparison of the incidence rates, by ratio of incidence rates and their respective confidence interval. It will be construct Kaplan-Meier curves that will compared by the statics of logaritmic rank (log-rank test).
It will be developed a multivariate analysis, with the Cox proportional risks methodology, estimating the Hazard Ratio epidemiologic.
- Conditions
- COVID-19
- Being tested
- Umbilical cord derived mesenchymal stem cells, Placebo
- Keywords
- Mesenchymal Stem Cells, Umbilical Cord
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord derived mesenchymal stem cellsBiological
One dosis of 1*10^6 cells/Kg
PlaceboBiological
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Usual tratment for COVID-19 plus MSC Receives: Biological: Umbilical cord derived mesenchymal stem cells |
| Control | Placebo comparator | Usual treatment for COVID-19 Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical deterioration or death
Change in two or more degrees in the NEWS scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1\*10\^6 cells/Kg or placebo
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trustem
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose, Hospital Infantil Universitario de San Jose
- Responsible party
- Sponsor
- Investigators
- Guillermo Sánchez-Vanegas, MD, PhD, Study chair, Fundación Universitaria de Ciencias de la SaludCarlos Escobar-Soto, MD, PhD, Study director, Trustem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429763
- Sponsor's protocol ID
- 202001
- Acronym
- CELMA
- Status last verified
- Jun 2020
- First submitted
- 10 Jun 2020
- Last updated
- 12 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Mesenchymal Stem Cells in the Management of Severe COVID-19
- ClinicalTrials.gov ID
- NCT04429763
- Acronym / sponsor ID
- CELMA / 202001
- Conditions
- COVID-19
- Keywords
- Mesenchymal Stem Cells, Umbilical Cord
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- TrustemIndustry (pharma, biotech, devices)
- Collaborators
- Fundación Universitaria de Ciencias de la Salud, Hospital de San Jose, Hospital Infantil Universitario de San Jose
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 12 Jun 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 disease caused by the new coronavirus, SARS-CoV-2, called COVID-19, it has considered a worldwide pandemia by the WHO. Suddently, it produces a lot of patients severe ill, in a little geographic area, that could surpase the resourses of the any health system in the world.
There is no documentation of an effective alternative for the treatment of the severe ill patients, that can reduce the mortality or the adverse events suffered by these people.
It is has suggested the usefulness of the Mesenchymal Stem cells (MSC) for the management of these patients, thanks to their direct and indirect antiviral capacity, and its potency as immunomodulator, that could ameliorate the lung disease and the severity of COVID-19.
Detailed description
Objetive:
Evaluate the effect of MSC derived from human umbilical cord compared with placebo, over the clinical progresion and mortality of hospitalized COVID-19 patients.
Metodology:
Fase II, controled clinical trial, double blinded, compared with placebo, with paralel groups, and one to one asignation. It will be included patients between 18 and 79 years old, hositalized in general room (respiratory isolation area) with confirmed COVID-19 diagnosis. It will be excluded those who have indication for management in Intensive Care Unit, have any condition that seriusly affect their survival, pregnant whomen or breast feeding, those who have an advanced hearth failure, HIV infected, those who have a bacterial or fungal uncontroled infection, those who require permanent immunosupresive therapy or have had an organ trasplant, those who have no possibility to sign the informed consent format or are involved in another clinical trial with drugs or interventions.
It will vinculate 30 patients randomly assigned, by centralized electronic assignation sequence, for the experimental group who will received 1*10^6 cells/Kg extracted from human umbilical cord or to placebo group.
The primary result it will be a composed point of time to the occurrence of the clinical detriment or the death (the first that occurs) and the secondary result will be the components of each primary point, the clinical recovery, the time to the time to the discharge from the hospital, and the clinical follow-up, including respiratory function, and markers of inflammation, haematological and kidney, in addition of the safety markers.
It will be done a comparison of the incidence rates, by ratio of incidence rates and their respective confidence interval. It will be construct Kaplan-Meier curves that will compared by the statics of logaritmic rank (log-rank test).
It will be developed a multivariate analysis, with the Cox proportional risks methodology, estimating the Hazard Ratio epidemiologic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- It will be included 30 patients, randomly assigned by centralized electronic sequence of assignation, for the application of a single dosis of 1*10^6 cells/Kg or placebo
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Umbilical cord derived mesenchymal stem cellsUsual tratment for COVID-19 plus MSC |
| Control | Placebo comparator | Biological: PlaceboUsual treatment for COVID-19 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Severe COVID-19.
- Infection confirmed by PCR test.
- Hospitalized in general room (respiratory isolation area).
Key exclusion criteria (10 listed)
- Shock or multiorgan disfunction that require continous vital signs monitorization
- Punctuation equal or more than 7 in the National Early Warning Score (NEWS) - 2 scale.
- Condition that seriously affects the patient survival expectancies, including any active cancer, hemorragia, any blood disease or severe malnutrition.
- Pregnant women or breast feeding.
- Advanced hearth failure.
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 |
|---|---|---|
| Umbilical cord derived mesenchymal stem cellsOne dosis of 1*10^6 cells/Kg | Biological | Experimental |
| PlaceboPlacebo | Biological | Control |
Primary outcome
Clinical deterioration or death
Time frame: 4 weeks
Change in two or more degrees in the NEWS scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2020.
- Individual participant dataSharing planned: No
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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.
Guillermo Sánchez-Vanegas, MD, PhD study chair
Fundación Universitaria de Ciencias de la Salud
Carlos Escobar-Soto, MD, PhD study director
Trustem
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Umbilical cord derived mesenchymal stem cells in people with COVID-19, run by Trustem.
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 3 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 12 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jhon Jaime Sprockel Díaz, MD, Esp (+573538000, jjsprockel@fucsalud.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical deterioration or death (time frame: 4 weeks). 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 12 Jun 2020.