This is a pilot, multi-centre, open-label randomised controlled study to assess the early efficacy of intravenous (IV) administration of CYP-001 in adults admitted to an intensive care unit (ICU) with respiratory failure
After enrolment upon meeting eligibility criteria (D0), participants baseline data will be collected and participants will be randomised to receive either standard of care treatment only, or standard of care plus CYP-001. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus mesenchymal stem cells (MSCs)/kg of body weight (up to a maximum of 200 million cells). Participants will have further data collection throughout their ICU and hospital stay and follow up to 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
The active agent in CYP-001 is Cymerus mesenchymal stem cells (MSCs), which are derived through a proprietary induced pluripotent stem cell (iPSC) and mesenchymoangioblast (MCA)-derived production process.
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Footscray Hospital
Footscray, Victoria, Australia
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
Assessment of respiratory dysfunction
Time frame: 7 days
Incidence and severity of treatment-emergent adverse events
Assessment of safety
Time frame: 28 days
Change in C-reactive protein (CRP) levels
Circulating biomarker of inflammation
Time frame: 7 days
Proportional differences between groups on the Clinical Improvement Scale
Not hospitalised, with resumption of normal activities = 1; Not hospitalised, but unable to resume normal activities = 2; Hospitalised, not requiring supplemental oxygen = 3; Hospitalised, requiring supplemental oxygen = 4; Hospitalised, requiring humidified nasal high-flow oxygen therapy, non-invasive mechanical ventilation, or both = 5; Hospitalised, requiring invasive mechanical ventilation, extracorporeal membrane oxygenation or both = 6; Death = 7
Time frame: 28 days
Changes in P/F ratio
Assessment of respiratory dysfunction
Time frame: 28 days
Changes in respiratory rate
Assessment of respiratory dysfunction
Time frame: 28 days
Changes in oxygenation index
Assessment of respiratory dysfunction
Time frame: 28 days
Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)
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Sunshine Hospital
Saint Albans, Victoria, Australia
Assessment of respiratory dysfunction
Time frame: 28 days
Changes in positive end-expiratory pressure
Assessment of respiratory dysfunction
Time frame: 28 days
Ventilator-free days
Number of days from the time of initiating unassisted breathing to D28, assuming survival for at least 48 hours after initiating unassisted breathing and continued unassisted breathing to D28
Time frame: 28 days
Proportional differences between groups on the SF-36
Quality of life assessment
Time frame: 28 days
Proportional differences between groups on the mini mental state examination
Disability assessment
Time frame: 28 days