Covid19Phase 2ProTrans19+NCT04869397
Treatment of Respiratory Complications Associated With COVID-19 Using Umbilical Cord Mesenchymal Stromal Cells
A Phase 2 study testing Allogeneic Wharton's jelly-MSCs (WJ-MSC) in people with Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Allogeneic Wharton's jelly-MSCs (WJ-MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jun 2021to 26 May 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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)
Read the 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).
- Conditions
- Covid19
- Being tested
- Allogeneic Wharton's jelly-MSCs (WJ-MSC), Placebo
- Keywords
- mesenchymal stromal cells, wharton's jelly, respiratory complication, biologics
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Wharton's jelly-MSCs (WJ-MSC)Biological
Also called Protrans
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.
PlaceboOther
Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic Wharton's jelly-MSCs (WJ-MSC) | Experimental | Intravenous administration, 1 dose, for 20 minutes Receives: Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC) |
| Placebo | Placebo comparator | Intravenous administration, 1 dose, for 20 minutes Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint
rate of use of mechanical ventilation (i.e. need for intubation) or death
Measured: at 15 days after intervention
Secondary outcomes (4)
Clinical status evaluation assessed by the 9-point ordinal scale
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
Measured: day 7, 15 and 30
Survival
Rate of patients alive at Day 7, Day 15 and Day 30
Measured: day 7, 15 and 30
Time to clinical improvement assessed by the 9-point ordinal scale
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
Measured: 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
Length of hospitalization and ICU stay in days
Measured: From enrolment to discharge or ICU transfer or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start14 Jun 2021
- Primary completion26 May 2023
- Study completion26 May 2023
Why it stopped: DSMB advised discontinuing the study prematurely because recruitment goals were not achieved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Colmegna, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ines Colmegna, Principal investigator, Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869397
- Sponsor's protocol ID
- 2021-6954
- Acronym
- ProTrans19+
- Status last verified
- Aug 2025
- First submitted
- 29 Apr 2021
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04869397
- Acronym / sponsor ID
- ProTrans19+ / 2021-6954
- Conditions
- Covid19
- Keywords
- mesenchymal stromal cells, wharton's jelly, respiratory complication, biologics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: DSMB advised discontinuing the study prematurely because recruitment goals were not achieved.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- 26 May 2023 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Allogeneic Wharton's jelly-MSCs (WJ-MSC) | Experimental | Biological: Allogeneic Wharton's jelly-MSCs (WJ-MSC)Intravenous administration, 1 dose, for 20 minutes |
| Placebo | Placebo comparator | Other: PlaceboIntravenous administration, 1 dose, for 20 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic Wharton's jelly-MSCs (WJ-MSC)Also: ProtransThe 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. | Biological | Allogeneic Wharton's jelly-MSCs (WJ-MSC) |
| PlaceboSodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group | Other | Placebo |
Primary outcome
Composite endpoint
Time frame: at 15 days after intervention
rate of use of mechanical ventilation (i.e. need for intubation) or death
4 secondary outcomes
Clinical status evaluation assessed by the 9-point ordinal scale
Time frame: day 7, 15 and 30
Survival
Time frame: day 7, 15 and 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
Duration of hospitalization and ICU stay
Time frame: From enrolment to discharge or ICU transfer or death
Results and safety
The study was stopped early (reason given: DSMB advised discontinuing the study prematurely because recruitment goals were not achieved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ines Colmegna principal investigator
Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Wharton's jelly-MSCs (WJ-MSC) in people with Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: DSMB advised discontinuing the study prematurely because recruitment goals were not achieved.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (time frame: at 15 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.