NCT05127122

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for ARDS

Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Acute Respiratory Distress Syndrome: A Phase I/II Clinical Trial

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Direct Biologics, LLC · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of intravenous(IV) administration of bone marrow mesenchymal stem cell derived extracellular vesicles(EV), ExoFlo, as treatment for Acute Respiratory Distress Syndrome.

Detailed description

To evaluate the safety and efficacy of intravenous(IV) 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 (PaO2/FiO2) ratio from pre-infusion baseline(Day 0)to 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 Berlin's 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

Conditions

• ARDS, Human

Interventions

Type	Name	Description
DRUG	Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles	Injectable
OTHER	Saline	Placebo Saline

Timeline

• Start date: 2024-12-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2021-11-19
• Last updated: 2024-07-29

Regulatory

• FDA-regulated drug study