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Hematopoietic and Lymphoid Cell Neoplasm / COVID 19 Associated Acute Respiratory Distress Syndrome / Mesenchymal Stem Cell · Phase 1/2 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a clinical trial registry entry for a planned Phase 1/2 study of cord blood-derived mesenchymal stem cells in COVID-19-associated ARDS. No results are posted. The record describes the study design and primary outcome measures but provides no efficacy or safety data.
Phase 1/2, Interventional, Randomized, Parallel, Open label, Treatment purpose. COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic CO…; age from 18 Years. Intervention: Phase II Arm I (mesenchymal stem cells); Pilot study (mesenchymal stem cells). Compared with: Phase II Arm II (standard of care) — Active Comparator. n = 65. 1 site: United States.
This is a clinical trial registry entry for a planned Phase 1/2 study of cord blood-derived mesenchymal stem cells in COVID-19-associated ARDS. No results are posted. The record describes the study design and primary outcome measures but provides no efficacy or safety data.
No data on efficacy endpoints (mortality, respiratory function, hospital discharge) are available.
No clinical impact can be assessed from this registry record as no results have been posted. Clinicians should await publication of Phase 1 safety data and Phase 2 comparative efficacy data before considering clinical application.
This is a Phase 1/2 trial registration with no posted results; the study is active but not yet recruiting and outcome data are not available.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed from this registry record as no results have been posted. Clinicians should await publication of Phase 1 safety data and Phase 2 comparative efficacy data before considering clinical application.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT04565665). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 65 participants (ESTIMATED). Conditions: COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed. Interventions: OTHER: Best Practice; BIOLOGICAL: Mesenchymal Stem Cell. Primary outcome measures: Incidence of composite serious adverse events (Phase I) , Within 30 days of the first mesenchymal stem cell (MSC) infusion; Patients alive without grade 3, 4 infusional toxicity (Phase II) , At day 30 post MSC infusion; Patients alive with grade 3 or 4 infusional toxicity (Phase II) , At day 30 post MSC infusion; Patients not alive (Phase II) , At day 30 post MSC infusion. Brief summary: This is a phase I trial followed by a phase II randomized trial. The purpose of phase I study is the feasibility of treating patients with acute respiratory distress syndrome (ARDS) related to COVID-19 infection (COVID-19) with cord blood-derived mesenchymal stem cells (MSC). The purpose of the phase II trial is to compare the effect of MSC with standard of care in these patients. MSCs are a type of stem cells that can be taken from umbilical cord blood and grown into many different cell types that can be used to treat cancer and other diseases. The MSCs being used for infusion in this trial are collected from healthy, unrelated donors and are stored and grown in a laboratory. Giving MSC infusions may help control the symptoms of COVID-19 related ARDS.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.