Clinical trial NCT04537351: The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Covid19
Acute Respiratory Distress Syndrome
Keywords: Mesenchymal stem cells
MSC
Induced pluripotent stem cells
iPSC
Cellular therapy
Lead sponsor: Cynata Therapeutics Limited
Sponsor class: INDUSTRY
Collaborators: name: Cerebral Palsy Alliance
First posted: 2020-09-03
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
timeFrame: 7 days
Secondary outcomes:
measure: Incidence and severity of treatment-emergent adverse events
timeFrame: 28 days
measure: Change in C-reactive protein (CRP) levels
timeFrame: 7 days
measure: Proportional differences between groups on the Clinical Improvement Scale
timeFrame: 28 days
measure: Changes in P/F ratio
timeFrame: 28 days
measure: Changes in respiratory rate
timeFrame: 28 days
measure: Changes in oxygenation index
timeFrame: 28 days
measure: Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)
timeFrame: 28 days
measure: Changes in positive end-expiratory pressure
timeFrame: 28 days
measure: Ventilator-free days
timeFrame: 28 days
measure: Proportional differences between groups on the SF-36
timeFrame: 28 days
measure: Proportional differences between groups on the mini mental state examination
timeFrame: 28 days
Other outcomes:
Locations:
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Saint Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
Study officials:
affiliation: Cynata Therapeutics Limited
name: Jolanta Airey, MD
role: STUDY_DIRECTOR
References: