Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Exosomes in Treating Chronic Cough After COVID-19

NCT05808400 | Unknown Early Phase 1

• 1 other identifier: KY20230214-V04
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; Chronic Cough

Outcome Measures

Primary Outcomes (1)

• Cough Evaluation Test

  This score is to evaluate the relief of cough symptoms. Higher scores mean worse outcome. Minimum score is 5, maximum score is 25.

  6-14days

Secondary Outcomes (1)

• Improvement or relief time of symptoms

  6th, 15th, 28th day

Other Outcomes (1)

• Pulmonary function tests or lung CT scans

  14th day

Study Arms (2)

Exosomes treatment group

EXPERIMENTAL

Treated with umbilical cord mesenchymal stem cell-derived extracellular vesicles (EVs) preparation (Specification: 5ml, EV concentration of 1\*10\^9 particles /ml)

Biological: MSC-derived exosomes

Non-treatment group

NO INTERVENTION

No treatment

Interventions

MSC-derived exosomes BIOLOGICAL

The total volume of MSC-derived exosomes is 5ml, and exosome concentration in preparation is 1\*10\^9 particles/ml.

Exosomes treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Trial participants voluntarily participate in this study and sign an informed consent form.
• At the time of signing the informed consent form, the age of the subject should be ≥18 or ≤80 years old, with no gender restrictions.
• The subject has been diagnosed with COVID-19 (confirmed by positive nucleic acid or antigen test) and has symptoms that have lasted for more than 4 weeks.
• Negative nucleic acid or antigen test at the time of screening.
• The subject has had continuous or intermittent coughing, or loss of taste/smell for ≥4 weeks, which did not occur before the onset of COVID-19 infection.
• No prior treatment with umbilical cord mesenchymal stem cell-derived extracellular vesicles.
• The patient fully understands the purpose and requirements of this clinical study and is willing to complete all trial procedures according to the study requirements.

You may not qualify if:

• Age ≤18 or ≥80 years old.
• Acute COVID-19 patients.
• Suspected or confirmed to have severe, active bacterial, fungal, or other infections that may pose a risk when intervention measures are taken, as determined by the researcher.
• Patients with a history of diagnosed bronchial asthma, cough variant asthma, or chronic cough; patients with other pulmonary diseases such as chronic obstructive pulmonary disease, bronchiectasis, tuberculosis, lung cancer, etc.
• Any of the following during the screening period: 1) ALT or AST \> 3 times the upper limit of normal; 2) eGFR \<60 mL/min.
• Patients with a history of severe allergies.
• Patients with uncontrolled severe cardiovascular, cerebrovascular, liver, kidney, endocrine, blood system diseases, and mental illness.
• Patients with active immunosuppression, immunodeficiency, and use of immunosuppressive drugs.
• Pregnant and lactating women.
• Other factors that the researcher deems unsuitable for participation in the study based on clinical considerations.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead
• REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.: collaborator

Study Sites (1)

Huazhong University of Science and Technology Union Shenzhen Hospital

Shenzhen, Guangdong, 518052, China

RECRUITING

Related Publications (13)

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  PMID: 35058437 BACKGROUND

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MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19; Chronic Cough

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cough; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Jihui Du, PhD

  Huazhong University of Science and Technology Union Shenzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihui Du, PhD

CONTACT

8613510083963; jihuidu@email.szu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 11, 2023
• Study Start: February 15, 2023
• Primary Completion: February 15, 2024
• Study Completion: February 15, 2025
• Last Updated: April 14, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)