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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04537351




Registration number
NCT04537351
Ethics application status
Date submitted
25/08/2020
Date registered
3/09/2020
Date last updated
1/09/2023

Titles & IDs
Public title
The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause
Scientific 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
Secondary ID [1] 0 0
CYP-COVID-19-01
Universal Trial Number (UTN)
Trial acronym
MEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Acute Respiratory Distress Syndrome 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CYP-001

Experimental: 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).

No intervention: Standard of care - Control participants will be randomised to received standard of care treatment.


Treatment: Other: 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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Change in C-reactive protein (CRP) levels
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
Proportional differences between groups on the Clinical Improvement Scale
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Changes in P/F ratio
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Changes in respiratory rate
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Changes in oxygenation index
Timepoint [6] 0 0
28 days
Secondary outcome [7] 0 0
Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)
Timepoint [7] 0 0
28 days
Secondary outcome [8] 0 0
Changes in positive end-expiratory pressure
Timepoint [8] 0 0
28 days
Secondary outcome [9] 0 0
Ventilator-free days
Timepoint [9] 0 0
28 days
Secondary outcome [10] 0 0
Proportional differences between groups on the SF-36
Timepoint [10] 0 0
28 days
Secondary outcome [11] 0 0
Proportional differences between groups on the mini mental state examination
Timepoint [11] 0 0
28 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
18/05/2022
Sample size
Target
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
St George Hospital - Kogarah
Recruitment hospital [3] 0 0
Westmead Hospital - Westmead
Recruitment hospital [4] 0 0
Footscray Hospital - Footscray
Recruitment hospital [5] 0 0
Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
3011 - Footscray
Recruitment postcode(s) [5] 0 0
3021 - Saint Albans

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Cynata Therapeutics Limited
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cerebral Palsy Alliance
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT04537351
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jolanta Airey, MD
Address 0 0
Cynata Therapeutics Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04537351