None listed
Conditions
Brief summary
Umbilical Cord Blood derived cells have the potential for use in the treatment of acute COVID-19 associated pneumonia which can lead to Acute Respiratory Distress Syndrome (ARDS). The capacity to obtain expanded, off the shelf, cord blood units, containing highly potent anti-inflammatory and immune-modulatory cells, will provide a therapeutic option for patients displaying a compromised respiratory system following COVID-19 infection, before the disease progresses to ARDS and death.
Interventions
5 million/ kg expanded umbilical cord blood cells (max -500 million cells) given intravenously over an hour by hospital staff under observation by research team. Single administration sourced from off the shelf UCB units. This is in addition to standard supportive management as per hospital protocol.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Hospitalised patients with confirmed SARS-CoV2 infection (based on appropriate nucleic acid or other testing), and 1) Expected to remain an in-patient for at least 48 hours with 2) Features consistent with viral pneumonia on Chest CT or X-Ray (in the opinion of the investigator) and 3) Are unable to maintain a peripheral oxygen saturation of 95% or greater in room air
Exclusion criteria
1) Patients with known allergies to stem cell preparations 2) Patients with known significant lung disease before COVID-19 presentation 3) Receiving invasive/ mechanical ventilatory support 4) Patients with underlying disease, comorbidities or clinical status that in the opinion of the investigator suggests death is imminent and/or likely to occur the next 48 hours 5) Currently on other investigational stem cell therapies 6) Known pregnancy 7) Patient unable to provide consent 8) The treating team deems that enrolment in the study is not in the best interests of the patient.
Outcome results
None listed