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NCT04565665 · ClinicalTrials.gov registry record · Phase 1
Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia
A Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT04565665: Recruiting Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, sponsored by M.D. Anderson Cancer Center.
NCT04565665 is a Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 70 participants, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04565665, a Phase 1 study of Malignant Solid Neoplasm and Hematopoietic and Lymphoid Cell Neoplasm, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Serious adverse events with be comprised of grade 3 or 4 graft versus host disease or death and will be estimated and reported overall and by group, along with 95% confidence intervals.
Conditions Studied
Interventions
- OTHER Best Practice
- BIOLOGICAL Mesenchymal Stem Cell
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 1 |
What NCT04565665 shows while recruiting
NCT04565665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 1,140-participant average among 176 other Malignant Solid Neoplasm trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Malignant Solid Neoplasm appearing as the primary indexed condition, and to 2 interventions - of which Best Practice is the first listed.
NCT04565665 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04565665 about?
NCT04565665 is a clinical study titled "Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia". 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 phas...
What is the current status of trial NCT04565665?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2020-07-29. Estimated completion is 2026-04-30.
What conditions does trial NCT04565665 study?
This clinical trial studies the following conditions: Malignant Solid Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm, COVID-19 Infection, Symptomatic COVID-19 Infection Laboratory-Confirmed, COVID-19-Associated Acute Respiratory Distress Syndrome.
What interventions are being tested in trial NCT04565665?
The interventions under investigation include: Best Practice (OTHER), Mesenchymal Stem Cell (BIOLOGICAL).
Who is sponsoring clinical trial NCT04565665?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04565665 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malignant Solid Neoplasm
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04565665's enrollment target sits among peer trials
70 110th of 176 higher than 65 of 176 other Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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