Phase 2
N=28
Mesenchymal Stromal Cells for the Treatment of SARS-CoV-2 Induced Acute Respiratory Failure (COVID-19 Disease)
Sars-CoV2 · Acute Respiratory Distress Syndrome · COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04345601 ↗Enrolled (actual)
28
Serious AEs
10.7%
Results posted
Apr 2024
Primary outcome: Primary: Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) — 0; 0 proportion of participant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mesenchymal Stromal Cells (Biological); Supportive Care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor College of Medicine
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants With Treatment-related Serious Adverse Events (tSAEs) |
0; 0 | — |
| PRIMARY Number of Participants With Improvement by at Least Two Categories on a Six Category Ordinal Scale at Day 14 |
2; 2; 5; 4; 8; 7 | — |
| SECONDARY Clinical Status Determined by 6-point Ordinal Scale at Day 28 |
3; 4; 7; 0; 0; 0 | — |
| SECONDARY Severity of Acute Respiratory Distress Syndrome (ARDS) at Day 14 |
1; 3; 4; 2; 1; 2 | — |
| SECONDARY Number of Oxygenation Free Days at Day 28 |
6; 0; 7 | — |
| SECONDARY Number of Participants With Progression to Mechanical Ventilation or ECMO |
1; 6; 3; 4; 2; 5 | — |
| SECONDARY Duration of Mechanical Ventilation and/or ECMO |
0; 11; 1 | — |
| SECONDARY Duration of ICU Stay |
16; 19; 13 | — |
| SECONDARY Duration of Hospital Stay |
24; 24; 17 | — |
| SECONDARY Overall Survival |
1; 0.70; 0.825 | — |
| SECONDARY All-cause Mortality |
0; 3; 2 | — |
Summary
***At this time, we are only enrolling at Houston Methodist Hospital (HMH)/Baylor College of Medicine (BCM) and are not shipping cells outside of BCM/HMH.***
This is a study for patients who have respiratory infection caused by SARS-CoV-2 that have not gotten better. Because there is no standard treatment for this infection, patients are being asked to volunteer for a gene transfer research study using mesenchymal stem cells (MSCs).
Stem cells are cells that do not yet have a specific function in the body. Mesenchymal stem cells (MSCs) are a type of stem cell that can be grown from bone marrow (the spongy tissue inside of bones). Stem cells can develop into other types of more mature (specific) cells, such as blood and muscle cells.
The purpose of this study is to see if MSCs versus controls can help to treat respiratory infections caused by SARS-CoV-2.
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Confirmed SARS-CoV2 infection real-time reverse transcription polymerase chain reaction (RT-PCR) assay
- Moderate OR severe ARDS, based on the degree of impairment of oxygenation as defined by the ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2):
- Moderate ARDS: PaO2/FiO2 100-200 mmHg OR
- Severe ARDS: PaO2/FiO2 ≤100 mmHg
- If on invasive or noninvasive (BiPAP) mechanical ventilator, PEEP ≥5 cm H2O
- Bilateral opacities present on chest radiograph or computed tomographic (CT) scan, that are not fully explained by pleural effusions, lung collapse, or lung nodules.
Exclusion Criteria
- Currently receiving extracorporeal membrane oxygenation (ECMO)
- Severe chronic respiratory disease requiring use of home oxygen
- Pregnant or lactating
- Known hypersensitivity to dimethyl sulfoxide (DMSO)
- Unstable hemodynamics as deemed by the treating physician/investigator including but not limited to unstable, ventricular tachycardia or new cardiac arrythmia requiring cardioversion.
- Uncontrolled bacterial or fungal co-infection
- Any end-stage organ disease or condition, which in the opinion of the Investigator, makes the patient an unsuitable candidate for treatment
- Inability to obtain informed consent (from patient or legally appropriate proxy)
- Presence of any contraindication to receiving prophylactic low dose unfractionated or low molecular weight heparin.
- Respiratory failure not fully explained by cardiac failure or fluid overload.
Data sourced from ClinicalTrials.gov (NCT04345601). 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.