None listed
Conditions
Brief summary
Already, there are five clinical trials registered at Monash Health to assess the safety and efficacy of allogeneic amniotic epithelial cells for (i) bronchopulmonary dysplasia; (ii) acute ischaemic stroke; (iii) compensated liver cirrhosis; and (iv) Crohn’s related perianal fistulas. To date, 27 individuals (17 neonates, 10 adults) have received allogeneic amniotic epithelial cells intravenously. No serious adverse events associated with cell administration or tumorigenesis have been reported. Preclinical biodistribution studies indicate that the AECs do not engraft and are not detected in any tissues after 5 days. Intravenous infusions of up to 8 million cells per kilogram have been well tolerated in extremely premature babies. Based on our extensive preclinical and clinical expertise with AEC, we propose a Phase 1b/2a trial to assess the safety and efficacy of allogeneic AECs for the treatment of COVID-19 related respiratory illness and multi-organ complications.
Interventions
8 million amniotic epithelial cells (hAECs) per kg bodyweight in saline containing 2% human serum albumin will be delivered intravenously over the course of an hour by a nurse under the supervision of an ICU consultant.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients included in this study must satisfy ALL of the following criteria: • Proven or highly suspected COVID-19 through a polymerase chain reaction (PCR) test of a nasal swab; or a negative PCR test with typical radiological finding or CT scan in the absence of alternate diagnoses; or patients with respiratory failure of infective origin admitted to ICU during the COVID-19 pandemic • Receiving supplemental oxygen, due to respiratory failure, with PaO2/FiO2 ratio less than or equal to 200 (moderate to severe) or an SaO2 < 92% while receiving more than or equal to 4 litres of O2 via face mask.
Exclusion criteria
Patients will be excluded if they have ANY of the following: • Less than 18 years old • Have been intubated for more than 48 hours, • Documented significant chronic obstructive airway disease • Death is imminent and inevitable within 24 hours, • Limitation of therapy includes no invasive mechanical ventilation, • Severe global left ventricular dysfunction with an ejection fraction of <25%, • Receiving extracorporeal support or is highly likely within the next 12 hours, • Acute fulminant hepatitis
Outcome results
None listed