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Stem cell shot for COVID-19 fizzles in small trial

NCT ID NCT04869397

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested whether a single infusion of stem cells from umbilical cord tissue (ProTrans®) could help hospitalized adults with severe COVID-19 avoid ventilators or death. The trial was stopped early after enrolling only 19 people, so we cannot draw firm conclusions. Both the stem cell group and the placebo group received standard COVID care, including dexamethasone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
umbilical cord stem cells (ProTrans®)
What this could lead to
If successful, this could point toward a cell-based treatment to reduce the need for ventilators and lower death risk in severe COVID-19.
What could go wrong
The trial was terminated early with only 19 participants, so results are very limited. It is unclear if the stem cells provide any real benefit over standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Jun 2021

Finished

May 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.