Status:
TERMINATED
Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a randomized phase II placebo controlled clinical trial. Active arm: Allogeneic Wharton's jelly derived MSCs (WJ-MSCs). Both groups will receive standard of care treatment for COVID (e.g. dexa...
Detailed Description
Allogeneic Wharton's jelly-MSCs (WJ-MSC) will be provided by NextCell Pharma under the commercial name of ProTrans®. ProTrans® will be administered at a fixed dose of 100 million cells per patient in ...
Eligibility Criteria
Inclusion
- Male or female, aged 18 years-old or older
- Laboratory-confirmed SARS-CoV-2 infection determined by reverse-transcription polymerase chain reaction (RT-PCR) prior to randomization
- Hospitalized patients
- Severe COVID-19 pneumonia defined as patients who cannot saturate \> 96% on 4 L/min but are NOT on "non-invasive" ventilation nor invasive mechanical ventilation nor Extracorporeal membrane oxygenation (ECMO). Patients on high flow would be eligible if they receive treatment in a non-critical care unit only.
- Use of contraception or acceptable birth control for the duration of the study in women of childbearing potential
- Provision of written or verbal informed consent by the patient or designated substitute decision maker
Exclusion
- Inability to provide informed consent
- Patients expected to survive less than 24 hours
- Advanced directives of patient's wishes to refuse intubation.
- Patients on mechanical ventilation
- Pregnant women \[pregnancy defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin (hCG) laboratory test\]
- Breastfeeding
- Weight \> 100 kg or \< 50 kg
- Cancer not in remission or active serious illness unrelated to COVID-19.
- Any of the following laboratory results at screening: Absolute neutrophil count (ANC) ≤ 1.0 x 109/L, Platelets (PLT) \< 50 G /L, Alanine transaminase (ALT) or Aspartate transaminase (AST) \> 5N, eGFR \< 30 mL/min
- Current documented bacterial infection
- Known infection with Human immunodeficiency virus, Treponema pallidum, Hepatitis B antigen (serology consistent with previous vaccination and a history of vaccination is acceptable) or Hepatitis C
- On-going therapy against tuberculosis, or exposed to tuberculosis or have travelled in areas with high risk of tuberculosis or mycosis within the last 3 months
- Known allergies to a component of the ProTrans® product
- Pre-existing chronic respiratory diseases requiring long-term oxygen therapy or severe pulmonary hypertension (PAPS \>30 mm HG) or pulmonary fibrosis
- Pre-existing cirrhosis with basal Child and Pugh of C
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2023
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04869397
Start Date
June 14 2021
End Date
May 26 2023
Last Update
September 8 2025
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1