MedTrace Logo

Safety and Effectiveness of Placental Derived Exosomes and Umbilical Cord Mesenchymal Stem Cells in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS) Associated With the Novel Corona Virus Infection (COVID-19)

NCT05387278 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-19

No results posted yet for this study

Summary

Recent advances have been made in prevention of the viral infection via vaccines but there is still need for effective treatment options for patients. Novel therapies need to be developed to further improve clinical outcomes. The biggest medical challenge in the response to COVID-19 is ARDS requiring hospitalization in an intensive care setting and ventilator dependence. Intravenously administered umbilical cord derived exosomes and stem cells have been reported in literature to alleviate pulmonary distress in such patients.

The purpose of this study is to explore the safety and benefits of intravenous administration of WJPure and EVPure in the treatment of COVID-19 patients with moderate to severe ARDS. .

Conditions

  • COVID-19 Acute Respiratory Distress Syndrome
  • Respiratory Distress Syndrome

Interventions

DRUG

EV-Pure™ and WJ-Pure™

The treatment consists of administration of WJ-Pure™ and EV-Pure™ plus standard care

DRUG

Placebo

Cryopreservation media plus standard care

Sponsors & Collaborators

  • Vitti Labs, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2025-10-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05387278 on ClinicalTrials.gov