The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause

Covid19 Clinical Trial

— MEND  

Official title:

A Pilot, Open-label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care With Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04537351
• Other study ID #: CYP-COVID-19-01
• Status: Completed
• Phase: Phase 1
• Start date: August 24, 2020
• Est. completion date: May 18, 2022

Study information

• Verified date: August 2023
• Source: Cynata Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 18, 2022
• Est. primary completion date: April 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• COVID-19
• Covid19
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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.

Locations

Country	Name	City	State
Australia	Footscray Hospital	Footscray	Victoria
Australia	Nepean Hospital	Kingswood	New South Wales
Australia	St George Hospital	Kogarah	New South Wales
Australia	Sunshine Hospital	Saint Albans	Victoria
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cynata Therapeutics Limited	Cerebral Palsy Alliance

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups	Assessment of respiratory dysfunction	7 days
Secondary	Incidence and severity of treatment-emergent adverse events	Assessment of safety	28 days
Secondary	Change in C-reactive protein (CRP) levels	Circulating biomarker of inflammation	7 days
Secondary	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	28 days
Secondary	Changes in P/F ratio	Assessment of respiratory dysfunction	28 days
Secondary	Changes in respiratory rate	Assessment of respiratory dysfunction	28 days
Secondary	Changes in oxygenation index	Assessment of respiratory dysfunction	28 days
Secondary	Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)	Assessment of respiratory dysfunction	28 days
Secondary	Changes in positive end-expiratory pressure	Assessment of respiratory dysfunction	28 days
Secondary	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	28 days
Secondary	Proportional differences between groups on the SF-36	Quality of life assessment	28 days
Secondary	Proportional differences between groups on the mini mental state examination	Disability assessment	28 days