Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells (ProTrans19+)

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ClinicalTrials.gov Identifier: NCT04869397

Recruitment Status : Recruiting

First Posted : May 3, 2021

Last Update Posted : June 15, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information

First Submitted Date ^ICMJE

April 29, 2021

First Posted Date ^ICMJE

May 3, 2021

Last Update Posted Date

June 15, 2021

Actual Study Start Date ^ICMJE

June 14, 2021

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite endpoint [ Time Frame: at 15 days after intervention ]

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

Original Primary Outcome Measures ^ICMJE

Composite endpoint: rate of use of mechanical ventilation (i.e. need for intubation) or death [ Time Frame: at 15 days after intervention ]

Change History

Current Secondary Outcome Measures ^ICMJE

Clinical status evaluation assessed by the 9-point ordinal scale [ Time Frame: day 7, 15 and 30 ]
Score 0. No clinical or virological evidence of infection. 1. No limitations of activities. 2. Ambulatory, limitation of activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, intubated and on mechanical ventilation. 7. Hospitalized, ventilation + additional organ support - pressors, RRT, ECMO, 8. Death
Survival [ Time Frame: day 7, 15 and 30 ]
Rate of patients alive at Day 7, Day 15 and Day 30
Time to clinical improvement assessed by the 9-point ordinal scale [ Time Frame: time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital ]
Score 0. No clinical or virological evidence of infection. 1. No limitations of activities. 2. Ambulatory, limitation of activities. 3. Hospitalized, not requiring supplemental oxygen. 4. Hospitalized, requiring supplemental oxygen. 5. Hospitalized, on non-invasive ventilation or high flow oxygen devices. 6. Hospitalized, intubated and on mechanical ventilation. 7. Hospitalized, ventilation + additional organ support - pressors, RRT (Renal Replacement Therapy), ECMO, 8. Death
Duration of hospitalization and ICU stay [ Time Frame: From enrolment to discharge or ICU transfer or death ]
Length of hospitalization and ICU stay in days

Original Secondary Outcome Measures ^ICMJE

Clinical status evaluation [ Time Frame: day 7, 15 and 30 ]
assessed by the 9-point ordinal scale
Survival [ Time Frame: day 7, 15 and 30 ]
Time to clinical improvement [ Time Frame: time from randomization to either an improvement of 1 point on the 9-point ordinal scale or discharge from hospital ]
assessed by the 9-point ordinal scale
Duration of hospitalization and ICU stay [ Time Frame: From enrolment to discharge or ICU transfer or death ]

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Treatment of Respiratory Complications Associated With COVID-19 Infection Using Wharton's Jelly (WJ)-Umbilical Cord (UC) Mesenchymal Stromal Cells (ProTrans®): a Randomized Phase II Controlled Clinical Trial

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)

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 a single infusion at bedside.

Placebo: Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group (NextCell Pharma).

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Covid19

Intervention ^ICMJE

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

Other Name: Protrans
Other: Placebo
Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group

Study Arms ^ICMJE

Experimental: Allogeneic Wharton's jelly-MSCs (WJ-MSC)
Intravenous administration, 1 dose, for 20 minutes

Intervention: Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC)
Placebo Comparator: Placebo
Intravenous administration, 1 dose, for 20 minutes

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

July 30, 2022

Estimated Primary Completion Date

June 30, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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 Criteria:

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Ines Colmegna	514-934-1934 ext 35639	ines.colmegna@mcgill.ca
Contact: James Martin	514-934-1934 ext 76172	james.martin@mcgill.ca

Listed Location Countries ^ICMJE

Canada

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04869397

Other Study ID Numbers ^ICMJE

2021-6954

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Sponsor ^ICMJE

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ines Colmegna

Research Institute of the McGill University Health Centre

PRS Account

McGill University Health Centre/Research Institute of the McGill University Health Centre

Verification Date

June 2021

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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