Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells

NCT04869397 | Terminated Phase 2

• 1 other identifier: 2021-6954
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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. dexamethasone)

Conditions

Covid19

Keywords

mesenchymal stromal cells; wharton's jelly; respiratory complication; biologics

Outcome Measures

Primary Outcomes (1)

• Composite endpoint

  rate of use of mechanical ventilation (i.e. need for intubation) or death

  at 15 days after intervention

Secondary Outcomes (4)

• Clinical status evaluation assessed by the 9-point ordinal scale

  day 7, 15 and 30

• Survival

  day 7, 15 and 30

• Time to clinical improvement assessed by the 9-point ordinal scale

  time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital

• Duration of hospitalization and ICU stay

  From enrolment to discharge or ICU transfer or death

Study Arms (2)

Allogeneic Wharton's jelly-MSCs (WJ-MSC)

EXPERIMENTAL

Intravenous administration, 1 dose, for 20 minutes

Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC)

Placebo

PLACEBO COMPARATOR

Intravenous administration, 1 dose, for 20 minutes

Other: Placebo

Interventions

Allogeneic Wharton's jelly-MSCs (WJ-MSC) BIOLOGICAL

The product is provided cryopreserved by NextCell Pharma. The cells are frozen in cryobags at a concentration of 2 × 107 cells/ml in 5% Human Serum Albumin (HSA) and 10% dimethylsulfoxide (DMSO). One cryobag contains one dose. The bags are frozen in a controlled rate freezer and directly transferred to -190 ºC for storage until the time of infusion. Cryobags are thawed at bedside and diluted in 100 ml of saline prior to administration. Cells will be delivered at a rate of 5 million cells per minute over a total of 20 minutes.

Also known as: Protrans

Allogeneic Wharton's jelly-MSCs (WJ-MSC)

Placebo OTHER

Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Ines Colmegna

  Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 3, 2021
• Study Start: June 14, 2021
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

CA (1)