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

NCT05787288 | Unknown Early Phase 1

• 1 other identifier: KY2022-205
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia

Keywords

COVID-19, Exosomes, Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (3)

• Symptom remission time after atomizing medication;

  Symptom remission time after atomizing medication;

  3 months

• Improvement of serum inflammatory markers;

  Improvement of serum inflammatory markers;

  3 months

• If there is baseline CT, CT review and comparison;

  If there is baseline CT, CT review and comparison;

  3 months

Secondary Outcomes (2)

• Length of be hospitalized;

  3 months

• Recovery time (nucleic acid turned negative)

  3 months

Study Arms (2)

Test Group

EXPERIMENTAL

Nebulized Mesenchymal Stem Cell Exosomes-derived extracellular vesicles twice a day (BID) for 5 days

Biological: Extracellular Vesicles from Mesenchymal Stem Cells

Control Group

SHAM COMPARATOR

Nebulized saline solution twice a day (BID) for 5 days

Biological: Extracellular Vesicles from Mesenchymal Stem Cells

Interventions

Extracellular Vesicles from Mesenchymal Stem Cells BIOLOGICAL

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

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) Voluntary participation of the patient and signing of the informed consent form; (b) The age of the patient at the time of signing the informed consent form should be ≥18 years old and ≤75 years old, regardless of gender; (c) The patient meets the criteria for moderate and severe patients with COVID-19 infection in China's "Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 10)", as follows:
• Moderate: continued fever \>3 days and/or cough, dyspnea, or other symptoms, but respiratory rate (RR) \<30 breaths/min, and oxygen saturation (SpO2) \>93% at rest when inhaling air. Characteristic imaging manifestations of COVID-19 pneumonia can be observed (imaging is optional and can be included or excluded).
• Severe: Any one of the following in adults cannot be explained by causes other than COVID-19 infection:
• dyspnea with RR ≥30 breaths/min.
• SpO2≤93% at rest when inhaling air.
• Ratio of partial pressure of arterial oxygen to fraction of inspired oxygen (PaO2/FiO2) ≤300 mmHg.
• Disease progression with significant increase in pulmonary lesions within 24-48 hours.
• Critical: Any one of the following conditions:
• respiratory failure requiring mechanical ventilation.
• shock.
• other organ dysfunction requiring ICU monitoring and treatment. (d) Positive nucleic acid or antigen test; (e) No prior treatment with umbilical cord mesenchymal stem cell-derived exosomes; (f) The patient has a full understanding of the purpose and requirements of this trial and is willing to complete all trial procedures according to the trial requirements.

You may not qualify if:

• (a) Female patients of childbearing age who are pregnant, lactating, or planning to conceive within the past year; (b) Severe heart, brain, kidney, hematopoietic system diseases, or other serious illnesses; (c) Neuro-muscular diseases causing impaired natural ventilation, including but not limited to spinal cord injury above the level of C5, amyotrophic lateral sclerosis, Guillain-Barre syndrome, and myasthenia gravis; (d) Currently undergoing hemodialysis or peritoneal dialysis; (e) Acute myocardial infarction within 30 days prior to screening; (f) Patients with lung or bone marrow transplantation; (g) History of epilepsy requiring continuous anticonvulsant treatment, or received anticonvulsant treatment within the past 3 years; (h) Active immunosuppression, defined as receiving immunosuppressive drugs or having medical conditions related to immunodeficiency. This includes:
• HIV (AIDS or CD4\<200 cells/mm3).
• chemotherapy within 4 weeks before randomization.
• long-term immunosuppressive therapy, including maintenance prednisone therapy (\>40mg/day or equivalent for \>1 month).
• absolute neutrophil count \<500/mm3. Exceptions are patients who have received short-term systemic (intravenous or oral) steroid treatment for \<1 week or topical steroid treatment for skin disorders; (i) Patients with severe allergic reactions or contraindications to the treatment regimen in this study; (j) Patients with doubts about the treatment plan or obvious mental and psychological disorders; (k) Patients whom the investigator considers unsuitable for participation in this trial (such as factors that may reduce compliance with follow-up or refusal to accept relevant supportive treatment by the patient).

Sponsors & Collaborators

• First Affiliated Hospital of Wenzhou Medical University: lead
• REGEN-αGEEK (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD.: collaborator

Study Sites (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

Related Publications (22)

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MeSH Terms

Conditions

COVID-19

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

Study Officials

• Xiaoying Huang, Docter

  First Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Yao, Master

CONTACT

0577-55579271; zdyaodan@163.com

Xiaoying Huang, Docter

CONTACT

0577-55579272; zjwzhxy@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of First Affiliated Hospital of Wenzhou Medical University

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: March 28, 2023
• Study Start: January 23, 2023
• Primary Completion: January 23, 2024
• Study Completion: January 23, 2025
• Last Updated: April 7, 2023

Record last verified: 2023-04

Locations

CN (1)