Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment of Moderate, Severe or Critical Pneumonia

StatusActive, Not Recruiting
PhasePhase 1/2
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Oct 30, 2026 → Oct 30, 2027
See other at-risk trials from M.D. Anderson Cancer Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Oct 30, 2026 to Oct 30, 2027
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 4 of 12 entries
    • Study description expanded, about 19 words
  2. Re-verified, no change to tracked fieldsv26
  3. Trial status changed: Recruiting → Active, Not Recruiting
    • Enrollment target: 70 to 65
    • Site details revised
    v25
  4. Re-verified, no change to tracked fieldsv24
  5. Primary and study completion pushed from Apr 30, 2026 to Oct 30, 2026v23
Show 21 earlier versionsHide 21 earlier versions
  1. 4 versions Re-verified since Mar 19, 2025, no change to tracked fieldsv19-v22
  2. Eligibility criteria expanded, about 48 words
    • Study description shortened, about 32 words
    • Study title expanded, about 1 word
    v18
  3. Primary and study completion dates: Apr 30, 2025 to Apr 30, 2026v17
  4. Re-verified, no change to tracked fieldsv16
  5. Primary and study completion dates: Apr 30, 2024 to Apr 30, 2025v15
  6. 3 versions Re-verified since Jun 12, 2023, no change to tracked fieldsv12-v14
  7. Primary and study completion dates: Apr 30, 2023 to Apr 30, 2024v11
  8. 4 versions Re-verified since Dec 21, 2021, no change to tracked fieldsv7-v10
  9. Primary and study completion dates: Apr 30, 2021 to Apr 30, 2023v6
  10. Phase: Phase 1 to Phase 1/2v5 Show 4 more changesShow less
    • Primary endpoints revised (4)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 9 to 12
    • Site contact updated
  11. Re-verified, no change to tracked fieldsv4
  12. Study description expanded, about 12 words
    • Site contact updated
    v3
  13. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04565665
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 COVID-19 Infection, COVID-19-Associated Acute Respiratory Distress Syndrome, Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm, Symptomatic COVID-19 Infection Laboratory-Confirmed
Related terms COVID-19, Hematologic Neoplasms
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov