Stem cell shot for COVID-19 fizzles in small trial
NCT ID NCT04869397
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 Hide 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
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