COVIDPhase 2MESCEL-COVID19NCT04366271
Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19
A Phase 2 study testing Mesenchymal cells in people with COVID, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 6 sites in Spain.
Trial summary
The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COVID
- What is being tested?
- Mesenchymal cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesSpain
- Study dates
- 7 May 2020to 31 May 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 40 and 80 years
- Body weight between 50 kg and 100 kg
- PCR diagnosis of SARS-CoV-2 virus infection
- Clinical diagnosis of severe lung involvement associated with SARSCoV- 2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet at least one of the following criteria:
- Respiratory distress with ≥ 30 breaths per minute; or
- Oxygen saturation ≤ 93% at baseline; or
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- Partial arterial oxygen pressure (PaO2) / Fraction of inspiration of O2 (FiO2) ≤300mmHg. (PaO2 / FiO2 is accepted based on SatO2). Patients who do not require respiratory support, or who require noninvasive respiratory support (conventional, high-flow oxygen therapy, or non-invasive mechanical ventilation) are considered eligible.
- Patients who are already receiving the standard medical treatment available for severe lung involvement associated with SARS-CoV-2 virus infection or any of the standard treatments are contraindicated in the patient and cannot be used and it is necessary to consider other alternatives.
- Women who are surgically sterile or postmenopausal or women of childbearing potential with negative urine or serum pregnancy test or men willing to use condoms for the entire duration of the study or for three months after the last dose of the investigational drug, whichever is later, or have a partner who is using a contraceptive method with high efficacy, such as described above.
- Signed informed consent.
Who cannot join
- Clinical diagnosis of critically serious lung involvement associated with SARS-CoV-2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet any of the following criteria:
- Respiratory failure requiring invasive mechanical ventilation; or
- Shock; or
- Combination with failure of another organ; need for ICU admission for monitoring / treatment.
- Patients who are expected to develop rapidly fatal disease within 72 hours of enrollment.
- Inability to maintain a mean arterial pressure > 50 mmHg before selection despite the presence of vasopressors and intravenous fluids.
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- Patients requiring treatment with vasopressors (dopamine > 5 mg / kg / min or any dose of epinephrine, norepinephrine, phenylephrine, or vasopressin) for at least 2 hours to maintain systolic blood pressure (SBP) > 90 mmHg (or mean blood pressure [MBP] > 70 mmHg) after adequate fluid administration.
- Patients who are not expected to live more than 3 months due to other medical illnesses, such as neoplasia or other terminal illnesses.
- Patients with primary or metastatic lung cancer or with chemotherapy scheduled for the next 90 days.
- Patients with a known primary immunodeficiency disorder or with acquired immunodeficiency syndrome (HIV infection) with a CD4 count <200 cells / mm3 or who do not have an undetectable viral load (<200 copies).
- Patients receiving immunosuppressive therapy (including chronic treatment with any alpha antitumor necrosis factor [TNFa]) or corticosteroid therapy.
- Granulocytopenia, not due to sepsis, evidenced by an absolute neutrophil count <500 per μL.
- Hematologic or lympho-reticular malignancies, unless in remission.
- Patients who have received a stem cell, organ, or bone marrow transplant in the last 6 months.
- Patients in current treatment with a biological product (eg, antibodies, cell therapy) or with plasmapheresis in the last 8 weeks.
- Patients who are currently receiving or have received another investigational drug in the 90 days prior to study initiation (or 5 halflives of the investigational compound, whichever is longer).
- Known allergies or hypersensitivity to antibiotics and/or any component of the investigational product.
- Patients with known severe liver function impairment.
- Patients with known severe kidney function impairment.
- Patients admitted in the previous 15 days for causes other than SARS-CoV-2 virus infection.
- Diseases other than SARS-CoV-2 virus infection leading to New York Heart Association class IV status.
- Terminal neuromuscular disorders that alter the gradual withdrawal of the ventilator (eg, amyotrophic lateral sclerosis).
- Patients with complete tetraplegia (traumatic or otherwise).
- Dementia-Alzheimer and another situation in which is considered patient can not understand what is explaining, can not read or does not understand the language.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Spain6 sites
Hospital Universitario de Cruces
Barakaldo, 48903
Hospital Universitario de Getafe
Getafe, Madrid, 28320
Hospital Universitario de La Princesa
Madrid, 28006
Hospital Infantil Universitario Niño Jesus
Madrid, 28009
Hospital Ramón Y Cajal
Madrid, 28034
Complejo Universitario La Paz
Madrid, 28046
About this study
Official title: Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19
The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus.
In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
- Conditions
- COVID
- Being tested
- Mesenchymal cells, Standard of care
- Keywords
- COVID-19, mesenchymal cells from 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.
Mesenchymal cellsBiological
1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
Standard of careDrug
Best treatment option for COVID-19 according to investigator criteria
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal cells | Experimental | Undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue Receives: Biological: Mesenchymal cells |
| Standard of care | Active comparator | Standard of care Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Measured: 28 days
Secondary outcomes (10)
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Measured: 14 days
Mortality from any cause at 28 days
Percentage of patients death due to any cause at 28 days of treatment
Measured: 28 days
Days without mechanical respirator and without vasopressor treatment for 28 days
Number of days without mechanical respirator and without vasopressor treatment for 28 days
Measured: 28 days
Patients alive without mechanical ventilation and without vasopressors on day 28
Percentage of patients alive without mechanical ventilation and without vasopressors on day 28
Measured: 28 days
Patients alive and without mechanical ventilation on day 14
Percentage of patients alive and without mechanical ventilation on day 14
Measured: 14 days
Patients alive and without mechanical ventilation on day 28
Percentage of patients alive and without mechanical ventilation on day 28
Measured: 28 days
Patients alive and without vasopressors on day 28
Percentage of patients alive and without vasopressors on day 28
Measured: 28 days
Days without vasopressors for 28 days
Number of days without vasopressors for 28 days
Measured: 28 days
Patients cured at 15 days
Percentage of patients cured at 15 days
Measured: 15 days
Incidence of Treatment-Emergent Adverse Events
Percentage of patients with each adverse event
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start7 May 2020
- Primary completion31 Jul 2020
- Study completion31 May 2021
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Sponsor type
- University, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Principal investigator, Mrs. Laura Aranzasti, Hospital Infantil Universitario Niño Jesús, Madrid, Spain
- Investigators
- Luis Madero, MD, Study chair, Hospital Infantil Universitario Niño Jesús, Oncohematology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366271
- Sponsor's protocol ID
- MESCEL-COVID19
- Other IDs
- 2020-001450-22
- Acronym
- MESCEL-COVID19
- Status last verified
- Aug 2021
- First submitted
- 23 Apr 2020
- Last updated
- 27 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19
- ClinicalTrials.gov ID
- NCT04366271
- Acronym / sponsor ID
- MESCEL-COVID19 / MESCEL-COVID19
- Conditions
- COVID
- Keywords
- COVID-19, mesenchymal cells from umbilical cord
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Infantil Universitario Niño Jesús, Madrid, SpainUniversity, hospital or other
- Collaborators
- Apices Soluciones S.L.
- Study start
- 7 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 28 Apr 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 SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus.
In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal cells | Experimental | Biological: Mesenchymal cellsUndifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue |
| Standard of care | Active comparator | Drug: Standard of careStandard of care |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients aged between 40 and 80 years
- Body weight between 50 kg and 100 kg
- PCR diagnosis of SARS-CoV-2 virus infection
- Clinical diagnosis of severe lung involvement associated with SARSCoV- 2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet at least one of the following criteria:
- Patients who are already receiving the standard medical treatment available for severe lung involvement associated with SARS-CoV-2 virus infection or any of the standard treatments are contraindicated in the patient and cannot be used and it is necessary to consider other alternatives.
Key exclusion criteria (24 listed)
- Clinical diagnosis of critically serious lung involvement associated with SARS-CoV-2 virus infection according to the criteria of the National Health Commission of China, that is, patients who meet any of the following criteria:
- Patients who are expected to develop rapidly fatal disease within 72 hours of enrollment.
- Inability to maintain a mean arterial pressure > 50 mmHg before selection despite the presence of vasopressors and intravenous fluids.
- Patients requiring treatment with vasopressors (dopamine > 5 mg / kg / min or any dose of epinephrine, norepinephrine, phenylephrine, or vasopressin) for at least 2 hours to maintain systolic blood pressure (SBP) > 90 mmHg (or mean blood pressure [MBP] > 70 mmHg) after adequate fluid administration.
- Patients who are not expected to live more than 3 months due to other medical illnesses, such as neoplasia or other terminal illnesses.
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 |
|---|---|---|
| Mesenchymal cells1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue | Biological | Mesenchymal cells |
| Standard of careBest treatment option for COVID-19 according to investigator criteria | Drug | Standard of care |
Primary outcome
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Time frame: 28 days
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
10 secondary outcomes
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Time frame: 14 days
Mortality from any cause at 28 days
Time frame: 28 days
Days without mechanical respirator and without vasopressor treatment for 28 days
Time frame: 28 days
Patients alive without mechanical ventilation and without vasopressors on day 28
Time frame: 28 days
Patients alive and without mechanical ventilation on day 14
Time frame: 14 days
Patients alive and without mechanical ventilation on day 28
Time frame: 28 days
Patients alive and without vasopressors on day 28
Time frame: 28 days
Days without vasopressors for 28 days
Time frame: 28 days
Patients cured at 15 days
Time frame: 15 days
Incidence of Treatment-Emergent Adverse Events
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2021.
- Individual participant dataSharing planned: Undecided
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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.
Luis Madero, MD study chair
Hospital Infantil Universitario Niño Jesús, Oncohematology Department
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesenchymal cells in people with COVID, run by Hospital Infantil Universitario Niño Jesús, Madrid, Spain at 6 sites in Spain.
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 10 inclusion and 24 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: withdrawn, as of the sponsor's last update on 27 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment (time frame: 28 days). 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 27 Aug 2021.