None listed
Conditions
Brief summary
The purpose of this study is to assess the early efficacy of mesenchymal stem cells (Cynata Therapeutics Limited, CYP-001) in adults admitted to intensive care with Respiratory Distress due to COVID-19 or another underlying condition.
Interventions
Treatment: Other- Mesenchymoangioblast-derived mesenchymal stem cells (CYP-001)
Intervention group: Mesenchymoangioblast-derived mesenchymal stem cells (CYP-001) at a dose of 2 million cells/kg (up to a maximum of 200 million cells) by IV infusion on two occasions (Day 1 and Day 3) PLUS standard of care in ICU
Control group: standard of care in ICU
The active agent in CYP-001 is allogeneic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs), which are produced using the pro
Treatment: Other- Mesenchymoangioblast-derived mesenchymal stem cells (CYP-001) Intervention group: Mesenchymoangioblast-derived mesenchymal stem cells (CYP-001) at a dose of 2 million cells/kg (up to a maximum of 200 million cells) by IV infusion on two occasions (Day 1 and Day 3) PLUS standard of care in ICU Control group: standard of care in ICU The active agent in CYP-001 is allogeneic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs), which are produced using the proprietary Cymerus™ platform technology. Cymerus™ refers to the process of generating cell-based products from intermediate cells, MCAs, which in turn are derived from induced pluripotent stem cells or iPSCs. The iPSCs used in the Cymerus™ process were derived from blood donated by a fully-consented healthy adult donor, and were reprogrammed using a transgene-free, viral-free and feeder-free technique. The PI or authorised designee will ensure that the study treatment at site is safely handled and administered in compliance with requirements. The infusion of the treatment itself will last no longer than 40 minutes, at a rate of 1mL/min, administered via ICU staff.
Sponsors
Cynata Therapeutics Limited
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
1. Male or female, 18 years of age or older 2. Respiratory failure with the following signs and symptoms: P/F ratio <300 mmHg Onset within one week of insult or new or worsening respiratory symptoms. Chest imaging shows bilateral opacities, which are not fully explained by effusions, lobar/lung collapse, or nodules. 3. Respiratory failure which is not fully explained by cardiac failure or fluid overload. 4. Onset of respiratory failure (as defined in inclusion criterion 2) within the past 48 hours.
Exclusion criteria
1. <18 years of age 2. Patient is known to be pregnant 3. Known active malignancy that required treatment in the last year 4. WHO (2019) Class III, IV or V pulmonary hypertension 5. Venous thromboembolism currently receiving anti-coagulation or within the past 3 months 6. Currently receiving extracorporeal life support 7. Severe chronic liver disease (Child-Pugh score >12) 8. “Do Not Attempt Resuscitation” order in place 9. Treatment withdrawal imminent within 24 hours 10. BMI > 45 kg/m2. 11. 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. 12. 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. 13. Known sensitivity to DMSO or any other component of the study treatments.
Outcome results
None listed