Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19
NCT05808400 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-04-14
Summary
This clinical trial aims to evaluate the safety and effectiveness of umbilical cord mesenchymal stem cell (UCMSC)-derived extracellular vesicle nebulization inhalation therapy for the treatment of chronic cough after COVID-19 infection. The main objective is to assess whether UCMSC-derived exosome nebulization inhalation therapy alleviates chronic cough after COVID-19.
Participants will be asked to complete a questionnaire to help researchers evaluate their cough severity and to record their scores before nebulization inhalation of UCMSC-derived exosomes. Participants will receive either continuous nebulized inhalation of UCMSC-derived exosomes for 5 days, twice daily, or no treatment. Researchers will compare the experimental and control groups to evaluate the safety and efficacy of UCMSC-derived exosomes for the treatment of chronic cough after COVID-19 infection.
Conditions
- Long COVID-19 Syndrome
Interventions
- BIOLOGICAL
-
MSC-derived exosomes
The total volume of MSC-derived exosomes is 5ml, and exosome concentration in preparation is 1\*10\^9 particles/ml.
Sponsors & Collaborators
-
REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.
collaborator UNKNOWN -
Huazhong University of Science and Technology
lead OTHER
Principal Investigators
-
Jihui Du, PhD · Huazhong University of Science and Technology Union Shenzhen Hospital
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-02-15
- Primary Completion
- 2024-02-15
- Completion
- 2025-02-15
Countries
- China
Study Locations
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