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
UC-MSC
100 +/- 20x10^6 in a 50 mL vehicle solution containing human serum albumin and heparin, infused at days 0 and 3
Control
Placebo

Participants
Randomized
participants :
UC-MSC=12
Placebo=12
Characteristics of participants
N= 24
Mean age : NR
13 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=13 Critical: n=11
Number of vaccinated participants: NR
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 willing stated in the publication:
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.