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Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19 (MESCEL-COVID19)

Primary Purpose

COVID

Status
Withdrawn
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Mesenchymal cells
Standard of care
Sponsored by
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID focused on measuring COVID-19, mesenchymal cells from umbilical cord

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients aged between 40 and 80 years
  2. Body weight between 50 kg and 100 kg
  3. PCR diagnosis of SARS-CoV-2 virus infection
  4. 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:

    1. Respiratory distress with ≥ 30 breaths per minute; or
    2. Oxygen saturation ≤ 93% at baseline; or
    3. 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.
  5. 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.
  6. 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.
  7. Signed informed consent.

Exclusion Criteria:

  1. 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:

    1. Respiratory failure requiring invasive mechanical ventilation; or
    2. Shock; or
    3. Combination with failure of another organ; need for ICU admission for monitoring / treatment.
  2. Patients who are expected to develop rapidly fatal disease within 72 hours of enrollment.
  3. Inability to maintain a mean arterial pressure > 50 mmHg before selection despite the presence of vasopressors and intravenous fluids.
  4. 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.
  5. Patients who are not expected to live more than 3 months due to other medical illnesses, such as neoplasia or other terminal illnesses.
  6. Patients with primary or metastatic lung cancer or with chemotherapy scheduled for the next 90 days.
  7. 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).
  8. Patients receiving immunosuppressive therapy (including chronic treatment with any alpha antitumor necrosis factor [TNFa]) or corticosteroid therapy.
  9. Granulocytopenia, not due to sepsis, evidenced by an absolute neutrophil count <500 per μL.
  10. Hematologic or lympho-reticular malignancies, unless in remission.
  11. Patients who have received a stem cell, organ, or bone marrow transplant in the last 6 months.
  12. Patients in current treatment with a biological product (eg, antibodies, cell therapy) or with plasmapheresis in the last 8 weeks.
  13. 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).
  14. Known allergies or hypersensitivity to antibiotics and/or any component of the investigational product.
  15. Patients with known severe liver function impairment.
  16. Patients with known severe kidney function impairment.
  17. Patients admitted in the previous 15 days for causes other than SARS-CoV-2 virus infection.
  18. Diseases other than SARS-CoV-2 virus infection leading to New York Heart Association class IV status.
  19. Terminal neuromuscular disorders that alter the gradual withdrawal of the ventilator (eg, amyotrophic lateral sclerosis).
  20. Patients with complete tetraplegia (traumatic or otherwise).
  21. 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.

Sites / Locations

  • Hospital Universitario de Getafe
  • Hospital Universitario de Cruces
  • Hospital Universitario de La Princesa
  • Hospital Infantil Universitario Niño Jesus
  • Hospital Ramón Y Cajal
  • Complejo Universitario La Paz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesenchymal cells

Standard of care

Arm Description

Undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue

Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Mortality from any cause at 28 days
Percentage of patients death due to any cause at 28 days of treatment
Days without mechanical respirator and without vasopressor treatment for 28 days
Number of days without mechanical respirator and without vasopressor treatment for 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
Patients alive and without mechanical ventilation on day 14
Percentage of patients alive and without mechanical ventilation on day 14
Patients alive and without mechanical ventilation on day 28
Percentage of patients alive and without mechanical ventilation on day 28
Patients alive and without vasopressors on day 28
Percentage of patients alive and without vasopressors on day 28
Days without vasopressors for 28 days
Number of days without vasopressors for 28 days
Patients cured at 15 days
Percentage of patients cured at 15 days
Incidence of Treatment-Emergent Adverse Events
Percentage of patients with each adverse event

Full Information

First Posted
April 23, 2020
Last Updated
August 24, 2021
Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators
Apices Soluciones S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT04366271
Brief Title
Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19
Acronym
MESCEL-COVID19
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
May 7, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborators
Apices Soluciones S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID
Keywords
COVID-19, mesenchymal cells from umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal cells
Arm Type
Experimental
Arm Description
Undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Standard of care
Intervention Type
Biological
Intervention Name(s)
Mesenchymal cells
Intervention Description
1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
Intervention Type
Drug
Intervention Name(s)
Standard of care
Intervention Description
Best treatment option for COVID-19 according to investigator criteria
Primary Outcome Measure Information:
Title
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Description
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Description
Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment
Time Frame
14 days
Title
Mortality from any cause at 28 days
Description
Percentage of patients death due to any cause at 28 days of treatment
Time Frame
28 days
Title
Days without mechanical respirator and without vasopressor treatment for 28 days
Description
Number of days without mechanical respirator and without vasopressor treatment for 28 days
Time Frame
28 days
Title
Patients alive without mechanical ventilation and without vasopressors on day 28
Description
Percentage of patients alive without mechanical ventilation and without vasopressors on day 28
Time Frame
28 days
Title
Patients alive and without mechanical ventilation on day 14
Description
Percentage of patients alive and without mechanical ventilation on day 14
Time Frame
14 days
Title
Patients alive and without mechanical ventilation on day 28
Description
Percentage of patients alive and without mechanical ventilation on day 28
Time Frame
28 days
Title
Patients alive and without vasopressors on day 28
Description
Percentage of patients alive and without vasopressors on day 28
Time Frame
28 days
Title
Days without vasopressors for 28 days
Description
Number of days without vasopressors for 28 days
Time Frame
28 days
Title
Patients cured at 15 days
Description
Percentage of patients cured at 15 days
Time Frame
15 days
Title
Incidence of Treatment-Emergent Adverse Events
Description
Percentage of patients with each adverse event
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Madero, MD
Organizational Affiliation
Hospital Infantil Universitario Niño Jesús, Oncohematology Department
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario de Getafe
City
Getafe
State/Province
Madrid
ZIP/Postal Code
28320
Country
Spain
Facility Name
Hospital Universitario de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Infantil Universitario Niño Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Ramón Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Complejo Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19

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