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.
Biological: CYP-001
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.
Other Name: Cymerus MSCs
Inclusion Criteria:
- Male or female, 18 years of age or older
- Respiratory failure with the following signs and symptoms:
1. P/F ratio <300 mmHg
2. Onset within one week of a known insult or new or worsening respiratory symptoms.
3. Chest imaging shows bilateral opacities, which are not fully explained by
effusions, lobar/lung collapse, or nodules.
- Respiratory failure which is not fully explained by cardiac failure or fluid overload.
- Onset of respiratory failure within the past 48 hours (as defined in inclusion
criterion 2
Exclusion Criteria:
- <18 years of age
- Patient is known to be pregnant
- Known active malignancy that required treatment in the last year
- WHO Class III or IV pulmonary hypertension
- Venous thromboembolism currently receiving anti-coagulation or within the past 3
months
- Currently receiving extracorporeal life support
- Severe chronic liver disease (Child-Pugh score >12)
- "Do Not Attempt Resuscitation" order in place
- Treatment withdrawal imminent within 24 hours
- BMI > 45 kg/m2.
- Received any investigational research agent within 60 days or within five half-lives
of the last treatment (if the half-life of the investigational agent is known to be
longer than 12 days) prior to the planned administration of study treatment.
- Known positive test for human immunodeficiency virus 1 (HIV 1), HIV 2, hepatitis B
virus, Hepatitis C virus or any other infection which the opinion of the Investigator
is likely to impact on the ability of the patient to participate in the study.
- Known sensitivity to dimethylsulfoxide (DMSO) or any other component of the study
treatment.
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
Sunshine Hospital
Saint Albans, Victoria, Australia
Jolanta Airey, MD, Study Director
Cynata Therapeutics Limited