Ignite Creation Date:
2024-05-06 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 2:18 PM
Study NCT ID:
NCT05127122
Status:
WITHDRAWN
Last Update Posted:
2024-02-12
First Post:
2021-11-09
Brief Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS
Sponsor:
Direct Biologics LLC
Organization:
Direct Biologics LLC
Study Overview
Official Title:
Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Acute Respiratory Distress Syndrome A Phase III Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in development plan
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXIT-ARDS
Brief Summary:
To evaluate the safety and efficacy of intravenousIV administration of bone marrow mesenchymal stem cell derived extracellular vesiclesEV ExoFlo as treatment for Acute Respiratory Distress Syndrome
Detailed Description:
To evaluate the safety and efficacy of intravenousIV administration of bone marrow mesenchymal stem cell-derived extracellular vesicles EV ExoFlo as treatment for Acute Respiratory Distress Syndrome ExoFlo is also referred to as Investigational Product IP throughout the protocol The duration of the study is 60 days and the endpoints are as follows
Primary Endpoint
1 The incidence of serious adverse events
2 All-Cause Mortality at 28 days
Secondary Endpoints
1 Ventilator-free days at 28days
2 Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen PaO2FiO2 ratio from pre-infusion baselineDay 0to Day 7
The study population will consist of 81 inpatient adult patients between 18 and 85 years of age with moderate to severe ARDS as defined by modified Berlins criteria Patients will be randomized via Interactive Response Technology to one of the following 3 treatment arms
1 PLACEBO Normal saline 100 mL
2 EXPERIMENTAL IP 10 mL mixed with Normal Saline 90 mL
3 EXPERIMENTAL IP 15 mL mixed with Normal Saline 85 mL
Primary Endpoint
1 The incidence of serious adverse events
2 All-Cause Mortality at 28 days
Secondary Endpoints
1 Ventilator-free days at 28days
2 Improvement in partial pressure of arterial oxygen to fraction of inspired oxygen PaO2FiO2 ratio from pre-infusion baselineDay 0to Day 7
The study population will consist of 81 inpatient adult patients between 18 and 85 years of age with moderate to severe ARDS as defined by modified Berlins criteria Patients will be randomized via Interactive Response Technology to one of the following 3 treatment arms
1 PLACEBO Normal saline 100 mL
2 EXPERIMENTAL IP 10 mL mixed with Normal Saline 90 mL
3 EXPERIMENTAL IP 15 mL mixed with Normal Saline 85 mL
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?:
None
Is an FDA AA801 Violation?:
None