CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 8 enrolled
Drug / intervention
Mesenchymal stromal cells +1 morebiological
Likely dose
Mesenchymal stromal cells 60 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04466098
NCT04466098Phase 2Completed
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Multi-center, Randomized, Placebo Controlled, Interventional Phase 2A Clinical Trial Evaluating the Safety and Potential Efficacy of Multiple Dosing of Mesenchymal Stromal Cells in Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-Cov-2)

Masonic Cancer Center, University of Minnesota·interventional·Posted Jul 10, 2020·Updated Jan 29, 2025

In Brief

A Phase 2 clinical trial evaluating Mesenchymal stromal cells and Placebo for Acute Respiratory Distress Syndrome and 2 related conditions. Completed, enrolled 8 participants across 2 sites.

Detailed Summary

This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Respiratory Distress Syndrome, ARDS (Moderate or Severe), COVID-19 Pneumonia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartJul 30, 2020
Primary CompletionFeb 25, 2022
Study CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.0 years ago

Interventions

Mesenchymal stromal cellsbiological

Thawed product containing MSC(300x10\^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin \[total volume 60 mL\]

Placeboother

Dextran 40 + 5% human serum albumin \[total volume 60 mL\]