ArticleEClinicalMedicine2021
Repair of acute respiratory distress syndrome by stromal cell administration (REALIST) trial: A phase 1 trial.
Article in EClinicalMedicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.
- Efficacy and safety of mesenchymal stem/stromal cells and their derived extracellular vesicles for acute respiratory distress syndrome: a systematic review and meta-analysis.Stem cell research & therapy · 2025Pooled it
- High-flow nasal oxygen versus conventional oxygen therapy and noninvasive ventilation in COVID-19 respiratory failure: a systematic review and network meta-analysis of randomised controlled trials.British journal of anaesthesia · 2024Pooled it
- Systematic review and meta-analysis of cell therapy for COVID-19: global clinical trial landscape, published safety/efficacy outcomes, cell product manufacturing and clinical delivery.Frontiers in immunology · 2023Pooled it
- Safety, efficacy and biomarkers analysis of mesenchymal stromal cells therapy in ARDS: a systematic review and meta-analysis based on phase I and II RCTs.Stem cell research & therapy · 2022Pooled it
- Repeated Infusions of Bone-Marrow-Derived Mesenchymal Stem Cells over 8 Weeks for Steroid-Refractory Chronic Graft-versus-Host Disease: A Prospective, Phase I/II Clinical Study.International journal of molecular sciences · 2024Trial
- Ferroptosis-Senescence Crosstalk in Sepsis-Associated Acute Lung Injury: Mechanisms and Therapeutic Opportunities.Biomedicines · 2026Review
- Mesenchymal Stromal Cell-Based Therapies in Sepsis-Induced Acute Lung and Kidney Injury: Current Advances and Perspectives.International journal of molecular sciences · 2026Review
- Don't Cut the Cord: Why Umbilical Cord Blood Still Deserves a Place in Transplantation.International journal of immunogenetics · 2026Review
- The PPARβ/Delta-Induced Mesenchymal Stromal Cell Secretome Has Cytoprotective Effects via ANGPTL4 in a Pre-Clinical Model of Acute Lung Inflammation.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026Article
- Dimethyl sulfoxide in cryopreserved mesenchymal stromal cell therapy products: is there a safety risk to patients?Journal of translational medicine · 2025Review
- Advances in acute respiratory distress syndrome: focusing on heterogeneity, pathophysiology, and therapeutic strategies.Signal transduction and targeted therapy · 2025Review
- The ARDS microenvironment enhances MSC-induced repair via VEGF in experimental acute lung inflammation.Molecular therapy : the journal of the American Society of Gene Therapy · 2024Article
- Unveiling heterogeneity in MSCs: exploring marker-based strategies for defining MSC subpopulations.Journal of translational medicine · 2024Review
- Multipotent mesenchymal stromal/stem cell-based therapies for acute respiratory distress syndrome: current progress, challenges, and future frontiers.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2024Review
- 11β hydroxysteroid dehydrogenase type 1 transgenic mesenchymal stem cells attenuate inflammation in models of sepsis.Frontiers in bioengineering and biotechnology · 2024Article
- Article
- Acute Respiratory Distress Syndrome; A Review of Recent Updates and a Glance into the Future.Diagnostics (Basel, Switzerland) · 2023Review
- PGE2 Produced by Exogenous MSCs Promotes Immunoregulation in ARDS Induced by Highly Pathogenic Influenza A through Activation of the Wnt-β-Catenin Signaling Pathway.International journal of molecular sciences · 2023Review
- Key Role of Mesenchymal Stromal Cell Interaction with Macrophages in Promoting Repair of Lung Injury.International journal of molecular sciences · 2023Review
- Understanding the Role of Mesenchymal Stromal Cells in Treating COVID-19 Acute Respiratory Distress Syndrome.American journal of respiratory and critical care medicine · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 8 institutions in 2 countries.
Funding
Abstract
backgroundMesenchymal stromal cells (MSCs) may be of benefit in acute respiratory distress syndrome (ARDS) due to immunomodulatory, reparative, and antimicrobial actions. ORBCEL-C is a population of CD362 enriched umbilical cord-derived MSCs. The REALIST phase 1 trial investigated the safety and feasibility of ORBCEL-C in patients with moderate to severe ARDS.
methodsREALIST phase 1 was an open label, dose escalation trial in which cohorts of mechanically ventilated patients with moderate to severe ARDS received increasing doses (100, 200 or 400 × 10
findingsNine patients were recruited between the 7th January 2019 and 14th January 2020. Study drug administration was well tolerated and no dose limiting toxicity was reported in any of the three cohorts. Eight adverse events were reported for four patients. Pyrexia within 24 h of study drug administration was reported in two patients as pre-specified adverse events. A further two adverse events (non-sustained ventricular tachycardia and deranged liver enzymes), were reported as adverse reactions. Four serious adverse events were reported (colonic perforation, gastric perforation, bradycardia and myocarditis) but none were deemed related to administration of ORBCEL-C. At day 28 no patients had died in cohort one (100 × 10
interpretationA single intravenous infusion of ORBCEL-C was well tolerated in patients with moderate to severe ARDS. No dose limiting toxicity was reported up to 400 × 10
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.