Covid19Phase 1MENDNCT04537351
The MEseNchymal coviD-19 Trial: MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause
A Phase 1 study testing CYP-001 in people with Covid19 and Acute Respiratory Distress Syndrome, run by Cynata Therapeutics Limited at 5 sites in Australia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Acute Respiratory Distress Syndrome
- What is being tested?
- CYP-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 5 sitesAustralia
- Study dates
- 24 Aug 2020to 18 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, 18 years of age or older
- Respiratory failure with the following signs and symptoms:
- P/F ratio <300 mmHg
- Onset within one week of a known insult or new or worsening respiratory symptoms.
- 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
Who cannot join
- <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
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Footscray Hospital
Footscray, Victoria, 3011
Nepean Hospital
Kingswood, New South Wales, 2747
St George Hospital
Kogarah, New South Wales, 2217
Sunshine Hospital
Saint Albans, Victoria, 3021
Westmead Hospital
Westmead, New South Wales, 2145
About this study
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
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
Read the 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.
- Conditions
- Covid19, Acute Respiratory Distress Syndrome
- Being tested
- CYP-001
- Keywords
- Mesenchymal stem cells, MSC, Induced pluripotent stem cells, iPSC, Cellular therapy
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYP-001Biological
Also called Cymerus MSCs
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.
| Study group | Role | What they receive |
|---|---|---|
| CYP-001 | Experimental | 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). Receives: Biological: CYP-001 |
| Standard of care | No intervention | Control participants will be randomised to received standard of care treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
Assessment of respiratory dysfunction
Measured: 7 days
Secondary outcomes (11)
Incidence and severity of treatment-emergent adverse events
Assessment of safety
Measured: 28 days
Change in C-reactive protein (CRP) levels
Circulating biomarker of inflammation
Measured: 7 days
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
Measured: 28 days
Changes in P/F ratio
Assessment of respiratory dysfunction
Measured: 28 days
Changes in respiratory rate
Assessment of respiratory dysfunction
Measured: 28 days
Changes in oxygenation index
Assessment of respiratory dysfunction
Measured: 28 days
Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)
Assessment of respiratory dysfunction
Measured: 28 days
Changes in positive end-expiratory pressure
Assessment of respiratory dysfunction
Measured: 28 days
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
Measured: 28 days
Proportional differences between groups on the SF-36
Quality of life assessment
Measured: 28 days
Proportional differences between groups on the mini mental state examination
Disability assessment
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start24 Aug 2020
- Primary completion27 Apr 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynata Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cerebral Palsy Alliance
- Responsible party
- Sponsor
- Investigators
- Jolanta Airey, MD, Study director, Cynata Therapeutics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537351
- Sponsor's protocol ID
- CYP-COVID-19-01
- Acronym
- MEND
- Status last verified
- Aug 2023
- First submitted
- 25 Aug 2020
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04537351
- Acronym / sponsor ID
- MEND / CYP-COVID-19-01
- Conditions
- Covid19, Acute Respiratory Distress Syndrome
- Keywords
- Mesenchymal stem cells, MSC, Induced pluripotent stem cells, iPSC, Cellular therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Cynata Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Cerebral Palsy Alliance
- Study start
- 24 Aug 2020 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 3 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CYP-001 | Experimental | Biological: CYP-001The 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). |
| Standard of care | No intervention | –Control participants will be randomised to received standard of care treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, 18 years of age or older
- Respiratory failure with the following signs and symptoms:
- 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
Key exclusion criteria (13 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYP-001Also: Cymerus MSCsThe 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. | Biological | CYP-001 |
Primary outcome
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups
Time frame: 7 days
Assessment of respiratory dysfunction
11 secondary outcomes
Incidence and severity of treatment-emergent adverse events
Time frame: 28 days
Change in C-reactive protein (CRP) levels
Time frame: 7 days
Proportional differences between groups on the Clinical Improvement Scale
Time frame: 28 days
Changes in P/F ratio
Time frame: 28 days
Changes in respiratory rate
Time frame: 28 days
Changes in oxygenation index
Time frame: 28 days
Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient)
Time frame: 28 days
Changes in positive end-expiratory pressure
Time frame: 28 days
Ventilator-free days
Time frame: 28 days
Proportional differences between groups on the SF-36
Time frame: 28 days
Proportional differences between groups on the mini mental state examination
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jolanta Airey, MD study director
Cynata Therapeutics Limited
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CYP-001 in people with Covid19 and Acute Respiratory Distress Syndrome, run by Cynata Therapeutics Limited at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.