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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD relating to efficacy of MSCs in COVID-19 may be shared, subject to permission from Sponsor and ethics approval if required. All de-identified data collected during this study may be shared confidentially to contribute to meta-analysis of mesenchymal stem cell treatments for COVID-19. Request for IPD from this trial for other purposes will be considered by the Sponsor.
When will data be available (start and end dates)?
Data requests will be considered after the completion of the study. There is no specified end date.
Available to whom?
All reasonable requests for raw and analysed data that are not included in primary publications from this study may be available upon request and discretion from the Sponsor from the beginning to the trial. Data may be made available to active collaborators in the COVID-19 Stem Cell Treatment (CSCT) Group, subject to permission from the Sponsor and ethics approval if required. All other reasonable requests for raw and analysed data will be considered by the Sponsor. Data may be obtained upon permission from the Sponsor.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04537351