Phase 2
Completed N=24
Use of UC-MSCs for COVID-19 Patients
Corona Virus Infection · Acute Respiratory Distress Syndrome · ARDS, Human · COVID
Source: ClinicalTrials.gov NCT04355728 ↗
Enrolled (actual)
24
Serious AEs
54.2%
Results posted
Dec 2021
Primary outcomePrimary: Number of Participants With Pre-Specified Infusion Associated Adverse Events — 1; 1; 1; 1 Participants
Summary
The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Pre-Specified Infusion Associated Adverse Events |
1; 1; 1; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Serious Adverse Events by 31 Days After First Infusion |
2; 8 | .04 sig |
| PRIMARY Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90 |
41.67; 66.67 | — |
| PRIMARY Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) |
40; 37; 6; 16 | — |
| PRIMARY Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity |
15; 13; 22; 21; 9; 19 | — |
| PRIMARY Subjects With Adverse Events and Serious Adverse Events by Severity |
7; 5; 7; 8; 5; 7 | — |
| PRIMARY Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment |
42; 45; 3; 7; 1; 1 | — |
| PRIMARY Subjects With Adverse Events by Relatedness to Treatment |
8; 10; 1; 4; 1; 1 | — |
| SECONDARY Survival at 31 Days Post First Infusion |
10; 5 | — |
| SECONDARY Survival at 60 Days Post First Infusion |
9; 5 | — |
| SECONDARY Time to Recovery |
23; NA; 15; NA; 8; 12 | 0.0307 sig |
| SECONDARY Ventilator-Free Days Throughout 28 Days Post Second Infusion |
28; 0 | .0563 |
| SECONDARY Ventilator-Free Days Throughout 90 Days |
90; 0 | .0563 |
| SECONDARY Respiratory Rate and Oxygenation Index (ROX Index) |
9.57; 7.44 | — |
| SECONDARY Oxygenation Index (OI) |
9.62; 12.74 | — |
| SECONDARY Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat) |
9.73; 11.67; 28.67; 24 | — |
| SECONDARY Sequential Organ Failure Assessment (SOFA) Scores |
6.56; 6.82 | — |
| SECONDARY Smell Identification Test (SIT) Scores |
— | — |
| SECONDARY White Blood Cell Count (WBC) |
13.43; 15.53 | — |
| SECONDARY Platelets Count |
342; 397.89 | — |
| SECONDARY Hemogoblin |
11.93; 11.94 | — |
| SECONDARY Hematocrit |
37.98; 36.73 | — |
| SECONDARY Neutrophils |
9.74; 13.4 | — |
| SECONDARY Lymphocytes |
1.38; 0.8 | — |
| SECONDARY Glomerular Filtration Rate |
60.59; 68.67 | — |
| SECONDARY Total Protein |
5.88; 5.8 | — |
| SECONDARY Sodium |
141.22; 141 | — |
| SECONDARY Potassium |
4.25; 4.37 | — |
| SECONDARY Creatinine |
1.21; 1.24 | — |
| SECONDARY Glucose |
153.11; 183.89 | — |
| SECONDARY Albumin |
2.96; 2.73 | — |
| SECONDARY Alkaline Phosphatase |
136.2; 202.5 | — |
| SECONDARY Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT) |
64.4; 65.67 | — |
| SECONDARY Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT) |
55.8; 47 | — |
| SECONDARY Total Bilirubin |
0.88; 0.77 | — |
| SECONDARY Blood Urea Nitrogen (BUN) |
48; 47.67 | — |
| SECONDARY Calcium |
8.5; 8.27 | — |
| SECONDARY Chloride |
101.56; 102.44 | — |
| SECONDARY Carbon Dioxide (CO2) |
28.44; 26.44 | — |
| SECONDARY C-Reactive Protein Levels |
101.01; 112.55 | — |
| SECONDARY Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio |
33.6; 34.64 | — |
| SECONDARY D-dimer Levels |
6.2; 4.69 | — |
| SECONDARY 25-Hydroxy Vitamin D Levels |
23.21; 27.58 | — |
| SECONDARY Tumor Necrosis Factor-alpha (TNFα) |
349; 451 | 0.0356 sig |
| SECONDARY Tumor Necrosis Factor-beta (TNFβ) |
829; 1540 | 0.0215 sig |
| SECONDARY Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2) |
26609.09; 23111.11 | 0.0210 sig |
| SECONDARY Viral Load by SARS-CoV-2 RT-PCR |
0; 0 | — |
| SECONDARY Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion |
10; 11; 2; 0; 4; 6 | 0.48 |
| SECONDARY Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion |
9; 9; 1; 2; 5; 5 | 1.00 |
| SECONDARY Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion |
5; 3; 0; 1; 4; 2 | 0.44 |
| SECONDARY Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG |
2; 2; 1; 0; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:
- Patient currently hospitalized
- Aged ≥ 18 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
- PaO2/FiO2 ratio 5 X ULN)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
- Baseline QT prolongation
- Moribund patient not expected to survive > 24 hours
Data sourced from ClinicalTrials.gov (NCT04355728). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.