Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537351
Status:
COMPLETED
Last Update Posted:
2023-09-01
First Post:
2020-08-25
Brief Title:
The MEseNchymal coviD-19 Trial MSCs in Adults With Respiratory Failure Due to COVID-19 or Another Underlying Cause
Sponsor:
Cynata Therapeutics Limited
Organization:
Cynata Therapeutics Limited
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MEND
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 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 MSCskg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None