The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause
- Conditions
- Covid19Acute Respiratory Distress Syndrome
- Interventions
- Biological: CYP-001
- Registration Number
- NCT04537351
- Lead Sponsor
- Cynata Therapeutics Limited
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
-
Male or female, 18 years of age or older
-
Respiratory failure with the following signs and symptoms:
- P/F ratio <300 mmHg
- Onset within one week of a known insult or new or worsening respiratory symptoms.
- 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
- <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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CYP-001 CYP-001 The investigational medicinal product used in this study is known as CYP-001. The active agent in CYP-001 is Cymerus™ MSCs. CYP-001 is supplied as 100 million Cymerus MSCs formulated in 20 mL cryoprotectant medium. On D1 and D3, each participant randomised to receive CYP-001 will receive an IV infusion of 2 million Cymerus MSCs/kg of body weight (up to a maximum of 200 million cells per infusion).
- Primary Outcome Measures
Name Time Method Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups 7 days Assessment of respiratory dysfunction
- Secondary Outcome Measures
Name Time Method Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient) 28 days Assessment of respiratory dysfunction
Changes in P/F ratio 28 days Assessment of respiratory dysfunction
Changes in oxygenation index 28 days Assessment of respiratory dysfunction
Incidence and severity of treatment-emergent adverse events 28 days Assessment of safety
Proportional differences between groups on the Clinical Improvement Scale 28 days 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
Changes in respiratory rate 28 days Assessment of respiratory dysfunction
Changes in positive end-expiratory pressure 28 days Assessment of respiratory dysfunction
Change in C-reactive protein (CRP) levels 7 days Circulating biomarker of inflammation
Proportional differences between groups on the SF-36 28 days Quality of life assessment
Proportional differences between groups on the mini mental state examination 28 days Disability assessment
Ventilator-free days 28 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
Trial Locations
- Locations (5)
Nepean Hospital
🇦🇺Kingswood, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Footscray Hospital
🇦🇺Footscray, Victoria, Australia
St George Hospital
🇦🇺Kogarah, New South Wales, Australia
Sunshine Hospital
🇦🇺Saint Albans, Victoria, Australia