Trial NCT04355728
Publication Lanzoni G, Stem Cells Transl Me, 2021 (published paper)
Dates: 2020-04-25 to 2020-07-21
Funding: Mixed (Ugo Colombo;
Simkins Family Foundation; Fondazione Silvio
Tronchetti Provera; Barilla Group & Family; Diabetes Research Institute Foundation;
The Cure Alliance; NABTU; NCATS)
Conflict of interest: No
| Methods | |
| RCT Blinding: | |
| Location :
Single center / USA Follow-up duration (days): 60 | |
| Inclusion criteria | 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 < 300 mmHg Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan |
| Exclusion criteria | PaO2/FiO2 ≥ 300 at the time of enrollment
A previous MSC infusion not related to this trial History of Pulmonary Hypertension (WHO Class III/IV) History of left atrial hypertension or decompensated left heart failure Pregnant or lactating patient Unstable arrhythmia Patients with previous lung transplant Patients currently receiving chronic dialysis Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO) Presence of any active malignancy (except non-melanoma skin cancer) Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50% Moderate to severe liver disease (AST and ALT >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 |
| Interventions | |
| Treatment
Umbilical cord mesenchymal stem cell infusion 100 +/- 20x10^6 in a 50 mL vehicle solution containing human serum albumin and heparin, infused at days 0 and 3 |
|
| Control
Placebo Duration : 4 days | |
| Participants | |
| Randomized 24 participants (n1=12 / n2= 12) | |
| Characteristics of participants N=24 Mean age : 59.2 13 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=13 Critical: n=11 | |
| Primary outcome | |
| In the register Incidence of pre-specified infusion associated adverse events [ Time Frame: Day 5 ] Incidence of Severe Adverse Events [ Time Frame: 90 days ] | |
| In the report Safety, as defined by the occurrence of pre-specified infusion associated AEs, occurring within 6 hours from each infusion; Cardiac arrest or death within 24 h post infusion; Incidence of AEs | |
| Documents available |
Protocol Yes. In English Statistical plan NR Data-sharing stated Yes |
| Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review |
Some concerns |
| General comment |
In addition to the published article, the pre-print article, the trial registry and supplementary appendix as well as responses from contact with authors were used in data extraction and assessment of risk of bias. The study protocol was referenced in the paper but no date was provided to determine its prospective or retrospective nature and aid in the risk of bias assessment for the domain 'Selection of Reported Result'.
There were no substantive differences between the pre-print article and the trial registry in population, procedures and interventions. There were some differences between the pre-print article and trial registry in secondary laboratory outcomes. On February 12th, 2021, we received additional information from authors on this study. This study was updated with data from contact with authors on March 30th, 2021. |