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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04537351
Ethics application status
Date submitted
25/08/2020
Date registered
3/09/2020
Date last updated
19/11/2020

Titles & IDs
Public title
The MEseNchymal coviD-19 Trial: a Pilot Study to Investigate Early Efficacy of MSCs in Adults With COVID-19
Scientific title
A Pilot, Open-label, Randomised Controlled Clinical Trial to Investigate Early Efficacy of CYP-001 in Adults Admitted to Intensive Care With COVID-19
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
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
Other interventions - 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.


Other interventions: 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
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups - Assessment of respiratory dysfunction
Timepoint [1] 0 0
7 days
Secondary outcome [1] 0 0
Incidence and severity of treatment-emergent adverse events - Assessment of safety
Timepoint [1] 0 0
28 days
Secondary outcome [2] 0 0
Change in C-reactive protein (CRP) levels - Circulating biomarker of inflammation
Timepoint [2] 0 0
7 days
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
28 days
Secondary outcome [4] 0 0
Changes in P/F ratio - Assessment of respiratory dysfunction
Timepoint [4] 0 0
28 days
Secondary outcome [5] 0 0
Changes in respiratory rate - Assessment of respiratory dysfunction
Timepoint [5] 0 0
28 days
Secondary outcome [6] 0 0
Changes in oxygenation index - Assessment of respiratory dysfunction
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) - Assessment of respiratory dysfunction
Timepoint [7] 0 0
28 days
Secondary outcome [8] 0 0
Changes in positive end-expiratory pressure - Assessment of respiratory dysfunction
Timepoint [8] 0 0
28 days
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
28 days
Secondary outcome [10] 0 0
Proportional differences between groups on the SF-36 - Quality of life assessment
Timepoint [10] 0 0
28 days
Secondary outcome [11] 0 0
Proportional differences between groups on the mini mental state examination - Disability assessment
Timepoint [11] 0 0
28 days

Eligibility
Key inclusion criteria
- Male or female, 18 years of age or older

- ICU admission due to strongly suspected or proven COVID 19

- P/F ratio <300 mmHg within the past 24 hours, but not sustained for more than 24 hours
at the time of enrolment.
Minimum age
18 Years
Maximum age
No limit
Gender
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/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
Footscray Hospital - Footscray
Recruitment hospital [4] 0 0
Sunshine Hospital - Saint Albans
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
3011 - Footscray
Recruitment postcode(s) [4] 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 Research Institute
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 COVID-19.
Trial website
https://clinicaltrials.gov/show/NCT04537351
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kilian Kelly, PhD
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
Cynata Project Manager
Address 0 0
Country 0 0
Phone 0 0
+ 613 9824 5254
Fax 0 0
Email 0 0
clinical@cynata.com
Contact person for scientific queries

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