Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

Launched by UNIVERSITY OF LIEGE · Jun 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Mesenchymal Stromal Cell (MSC) therapy for patients with severe COVID-19 infection. The goal is to see if this therapy, combined with the best supportive care, is safe and effective for hospitalized patients suffering from severe pneumonia caused by the virus. The trial is currently recruiting participants who are 18 to 70 years old and have been diagnosed with COVID-19 pneumonia, requiring oxygen support.

To join the study, potential participants must have a confirmed diagnosis of COVID-19 and show specific signs of severe illness, such as low oxygen levels. They cannot have certain conditions, like being pregnant or having other serious infections. If eligible, participants will receive MSC therapy and will be closely monitored for their safety and health outcomes. It's important to note that written consent is needed to participate, which can be provided by the patient or a legal representative if the patient is unable to do so. This trial aims to find new ways to help those seriously affected by COVID-19, and your involvement could contribute to important research in this area.

Gender

ALL

Eligibility criteria

• • COVID-19 patients Inclusion criteria
• • Male or female patients aged at least 18 years and up to 70 years
• * Diagnosed with microbiologically or radiologically confirmed COVID-19 pneumonia as defined by:
• • Extensive interstitial pneumonia on CT scan, consistent with viral pneumonia, within 10 days prior to randomization
• • And either positive result of COVID-19 PCR test within 14 days prior to inclusion or positive result of SARS-CoV2 PCR or serology within 14 days after inclusion.
• * Requiring oxygen administration (SpO2 ≤ 93% on room air):
• • Group A: in standard or intensive care unit requiring supplemental oxygen
• * Group B: in intensive care unit under mechanical ventilation administered through a tracheal tube, either:
• • for less than or equal to 7 days
• • for 7 to 14 days, with persisting high inflammation (ferritin \> 2,000 µg/L; ferritin \> 1,000 µg/L and rising; lymphocytes \< 800 with CRP \> 70 mg/L and rising or ferritin \> 700 µg/L and rising or LDH \> 300 UI/L or D-Dimers \> 1000 ng/ml), not explained by superinfection. Rising = compared to previous 24H.
• • Written consent of the patient, or - if impossible (clinical condition precluding capacity to consent) - of his/her legal representative, or - if impossible - of an impartial witness such as a physician from a non-participating department or member of the Ethics Committee. Any consent obtained this way shall be documented and confirmed by way of normal consent procedures at the earliest opportunity when the patient has recovered
• • Exclusion criteria
• • Ongoing pregnancy. Women of childbearing potential (WOCBP, defined as a premenopausal female capable of becoming pregnant) should use an appropriate method of contraception (oral, injectable, or mechanical contraception; women whose partners have been vasectomized or have received or are utilizing mechanical contraceptive devices).
• • Extracorporeal membrane oxygenation
• • Limitations to intensity of care
• • Life expectancy \< 24 hours
• • Known allergy to IMP component
• • Active secondary infection
• • Any malignancy (except non-melanoma skin carcinoma) within 2 years before inclusion
• • Pre-existing thrombo-embolic pathology
• • Signs of an active drug or alcohol dependence, serious current illness, mental illness or any factors which, in the opinion of the Investigator, may interfere with subject's ability to understand and comply with study requirements
• • Patients with any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the patient's safe participation in and completion of the study.
• • Participation in another clinical trial(use of anti-viral/supportive drugs for COVID-19 infection on a compassionate use basis is not an exclusion criterion).
• • MSC donors Inclusion criteria
• • Unrelated to the patient
• • Male or female
• • Age \> 18 yrs
• • No HLA matching required
• • Fulfills generally accepted criteria for allogeneic HSC donation
• • Informed consent given by donor
• • Exclusion criteria
• • Any condition not fulfilling inclusion criteria
• • Known allergy to lidocaine
• • Any risk factor for transmissible infectious diseases, in particular HIV