Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The MEseNchymal coviD-19 Trial: a Pilot Study to Investigate Early Efficacy of MSCs in Adults With COVID-19 (MEND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04537351
Recruitment Status : Recruiting
First Posted : September 3, 2020
Last Update Posted : November 19, 2020
Sponsor:
Collaborator:
Cerebral Palsy Alliance Research Institute
Information provided by (Responsible Party):
Cynata Therapeutics Limited

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.

Condition or disease Intervention/treatment Phase
Covid19 Acute Respiratory Distress Syndrome Biological: CYP-001 Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 24, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021


Arm Intervention/treatment
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).
Biological: 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.
Other Name: Cymerus MSCs

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



Primary Outcome Measures :
  1. Trend in trajectory of PaO2/FiO2 ratio (P/F ratio) between groups [ Time Frame: 7 days ]
    Assessment of respiratory dysfunction


Secondary Outcome Measures :
  1. Incidence and severity of treatment-emergent adverse events [ Time Frame: 28 days ]
    Assessment of safety

  2. Change in C-reactive protein (CRP) levels [ Time Frame: 7 days ]
    Circulating biomarker of inflammation

  3. Proportional differences between groups on the Clinical Improvement Scale [ Time Frame: 28 days ]
    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

  4. Changes in P/F ratio [ Time Frame: 28 days ]
    Assessment of respiratory dysfunction

  5. Changes in respiratory rate [ Time Frame: 28 days ]
    Assessment of respiratory dysfunction

  6. Changes in oxygenation index [ Time Frame: 28 days ]
    Assessment of respiratory dysfunction

  7. Changes in respiratory compliance (the change in lung volume per unit change in transmural pressure gradient) [ Time Frame: 28 days ]
    Assessment of respiratory dysfunction

  8. Changes in positive end-expiratory pressure [ Time Frame: 28 days ]
    Assessment of respiratory dysfunction

  9. Ventilator-free days [ Time Frame: 28 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

  10. Proportional differences between groups on the SF-36 [ Time Frame: 28 days ]
    Quality of life assessment

  11. Proportional differences between groups on the mini mental state examination [ Time Frame: 28 days ]
    Disability assessment



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04537351


Contacts
Layout table for location contacts
Contact: Cynata Project Manager + 613 9824 5254 clinical@cynata.com

Locations
Layout table for location information
Australia, New South Wales
Nepean Hospital Recruiting
Kingswood, New South Wales, Australia, 2747
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Footscray Hospital Not yet recruiting
Footscray, Victoria, Australia, 3011
Sunshine Hospital Not yet recruiting
Saint Albans, Victoria, Australia, 3021
Sponsors and Collaborators
Cynata Therapeutics Limited
Cerebral Palsy Alliance Research Institute
Investigators
Layout table for investigator information
Study Director: Kilian Kelly, PhD Cynata Therapeutics Limited
Layout table for additonal information
Responsible Party: Cynata Therapeutics Limited
ClinicalTrials.gov Identifier: NCT04537351    
Other Study ID Numbers: CYP-COVID-19-01
First Posted: September 3, 2020    Key Record Dates
Last Update Posted: November 19, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Data requests will be considered after the completion of the study. There is no specified end date.
Access Criteria: 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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Cynata Therapeutics Limited:
Mesenchymal stem cells
MSC
Induced pluripotent stem cells
iPSC
Cellular therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury