Mesenchymal Stromal Cell Therapy for Severe Covid-19 Infection

NCT04445454 | Recruiting Phase 1

• 1 other identifier: TJT2012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to evaluate the safety and efficacy of MSC therapy combined with best supportive care in hospitalized patients with COVID-19.

Conditions

Coronavirus Infection

Keywords

mesenchymal stromal cells

Outcome Measures

Primary Outcomes (4)

• To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

  To assess the infusional toxicity

  Day 28

• To evaluate the safety of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

  To assess the number of Adverse events of special interest : Incidence of infections (bacterial, viral, fungal, parasitic) and thrombo-embolic events.

  Day 28

• To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

  Group A (patients not under mechanical ventilation): to determine the pourcentage of patients requiring mechanical ventilation

  Day 28

• To evaluate the efficacy of intravenous infusion of MSC in patients with severe to critical COVID-19 pneumonia

  Group B (patients under mechanical ventilation): to determine the vital status (dead/alive)

  Day 28

Secondary Outcomes (10)

• To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

  Day 28

• To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

  Day 28

• To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

  Day 90

• To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

  Day 28

• To evaluate the effect of MSC administration associated with the standard of care (SOC including anti-viral therapy)

  Day 28

Other Outcomes (2)

• To investigate immune modulation

  Day 28

• To compare the cytotoxic activity of PBMCs from healthy control and COVID-19 patients (divided in responders / non-responders to MSC therapy) against MSCs in vitro

  Day 28

Study Arms (1)

MSC therapy for severe COVID-19 infection

EXPERIMENTAL

After signed informed consent, patients will receive 3 infusions of (1.5)-3.0 x106/kg BM-MSC (from the same donor) at 3-4 days interval, in addition to the standard of care for COVID-19 disease.

Biological: Mesenchymal stromal cells

Interventions

Mesenchymal stromal cells BIOLOGICAL

Bone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs.

Also known as: MSC

MSC therapy for severe COVID-19 infection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

Related Publications (1)

• Gregoire C, Layios N, Lambermont B, Lechanteur C, Briquet A, Bettonville V, Baudoux E, Thys M, Dardenne N, Misset B, Beguin Y. Bone Marrow-Derived Mesenchymal Stromal Cell Therapy in Severe COVID-19: Preliminary Results of a Phase I/II Clinical Trial. Front Immunol. 2022 Jul 4;13:932360. doi: 10.3389/fimmu.2022.932360. eCollection 2022.

  PMID: 35860245 DERIVED

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Yves Beguin, MD,PhD

  Centre Hospitalier Universitaire de Liege

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yves Beguin, MD,PhD

CONTACT

(0032)43667201; yves.beguin@chuliege.be

Audrey Janssen

CONTACT

(0032)43667470; audrey.janssen@chuliege.be

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Model Details: This study is a monocentric prospective phase I/II clinical trial, aiming at evaluating the safety and efficacy of 3 intravenous administrations of BM-MSC in 20 patients with severe to critical COVID-19 pneumonia.

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 24, 2020
• Study Start: June 12, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)