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A Clinical Study on Safety and Effectiveness of Mesenchymal Stem Cell Exosomes for the Treatment of COVID-19.

NCT05787288 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2023-04-07

No results posted yet for this study

Summary

This clinical study aims to investigate the safety and efficacy of nebulized inhalation of extracellular vesicles derived from mesenchymal stem cells combined with standard therapy for COVID-19-infected individuals. The primary objective is to determine whether nebulized MSC-secreted extracellular vesicles may be a feasible approach to alleviate COVID-19-induced lung injuries and promote recovery. Participants will be allocated to receive either nebulized MSC-secreted extracellular vesicles twice a day (BID) for 5 days as the test group or nebulized saline solution twice a day for 5 days as the control group. Researchers will compare the test and control groups to evaluate the safety and efficacy of extracellular vesicles in combination with standard therapy.

Conditions

Interventions

BIOLOGICAL

Extracellular Vesicles from Mesenchymal Stem Cells

Umbilical cord mesenchymal stem cell-derived extracellular vesicle preparation; Specification: 5ml, with extracellular vesicle concentration of 1 × 109 particles/ml in the preparation;

Sponsors & Collaborators

  • REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.

    collaborator UNKNOWN

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Xiaoying Huang, Docter · First Affiliated Hospital of Wenzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2024-01-23
Completion
2025-01-23

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT05787288 on ClinicalTrials.gov