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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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Nepean Hospital
Kingswood, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Footscray Hospital
Footscray, Victoria, Australia
Sunshine Hospital
Saint Albans, Victoria, Australia
Start Date
August 24, 2020
Primary Completion Date
April 27, 2022
Completion Date
May 18, 2022
Last Updated
September 1, 2023
14
ACTUAL participants
CYP-001
BIOLOGICAL
Lead Sponsor
Cynata Therapeutics Limited
Collaborators
NCT07450846
NCT07414056
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06701669