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

NCT04366271 | Withdrawn Phase 2

• 2 other identifiers: MESCEL-COVID192020-001450-22
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 6

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.

Conditions

COVID

Keywords

COVID-19; mesenchymal cells from umbilical cord

Outcome Measures

Primary Outcomes (1)

• 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

  28 days

Secondary Outcomes (10)

• Mortality due to lung involvement due to SARS-CoV-2 virus infection at 14 days of treatment

  14 days

• Mortality from any cause at 28 days

  28 days

• Days without mechanical respirator and without vasopressor treatment for 28 days

  28 days

• Patients alive without mechanical ventilation and without vasopressors on day 28

  28 days

• Patients alive and without mechanical ventilation on day 14

  14 days

Study Arms (2)

Mesenchymal cells

EXPERIMENTAL

Undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue

Biological: Mesenchymal cells

Standard of care

ACTIVE COMPARATOR

Standard of care

Drug: Standard of care

Interventions

Mesenchymal cells BIOLOGICAL

1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue

Mesenchymal cells

Standard of care DRUG

Best treatment option for COVID-19 according to investigator criteria

Standard of care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Infantil Universitario Niño Jesús, Madrid, Spain: lead
• Apices Soluciones S.L.: collaborator

Study Sites (6)

Hospital Universitario de Getafe

Getafe, Madrid, 28320, Spain

Location

Hospital Universitario de Cruces

Barakaldo, 48903, Spain

Location

Hospital Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Infantil Universitario Niño Jesus

Madrid, 28009, Spain

Location

Hospital Ramón Y Cajal

Madrid, 28034, Spain

Location

Complejo Universitario La Paz

Madrid, 28046, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Luis Madero, MD

  Hospital Infantil Universitario Niño Jesús, Oncohematology Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 28, 2020
• Study Start: May 7, 2020
• Primary Completion: July 31, 2020
• Study Completion: May 31, 2021
• Last Updated: August 27, 2021

Record last verified: 2021-08

Locations

ES (6)