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OpenTrials
Completed

NCT Number: NCT04313647

A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers

Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. These vesicles have a content that includes cytokines and growth factors, signaling lipids, mRNAs, and regulatory miRNAs. Exosomes are involved in cell-to-cell communication, cell signaling, and altering cell or tissue metabolism at short or long distances in the body, and can influence tissue responses to injury, infection, and disease.

Experimental studies have demonstrated that mesenchymal stem cells (MSCs) or their exosomes (MSCs-Exo) significantly reduced lung inflammation and pathological impairment resulting from different types of lung injury. In addition, macrophage phagocytosis, bacterial killing and outcome were improved. It is highly likely that MSCs-Exo have the similar therapeutic effect on inoculation pneumonia as MSCs themselves.

This clinical study will be performed to evaluate the safety and tolerance of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in healthy volunteers.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

About this study

Experimental studies have demonstrated that mesenchymal stem cells (MSCs) or their exosomes (MSCs-Exo) significantly reduced lung inflammation and pathological impairment resulting from different types of lung injury. In addition, macrophage phagocytosis, bacterial killing and outcome were improved. It is highly likely that MSCs-Exo have the similar therapeutic effect on inoculation pneumonia as MSCs themselves.

Although human bone marrow MSCs have been safely administered in patients with ARDS and septic shock (phase I/II trials), it seems safer to deliver MSCs-Exo rather than live MSCs. The intravenous administration of MSCs may result in aggregating or clumping in the injured microcirculation and carries the risk of mutagenicity and oncogenicity, which do not exist by treating with nebulized MSCs-Exo. Another advantage of MSCs-Exo over MSCs is the possibility of storing them for several weeks/months allowing their safe transportation and delayed therapeutic use.

The purpose of this study, therefore, is to explore the safety and efficiency as well as provide a clinical dose reference for the subsequent trails of aerosol inhalation of MSCs-Exo in the treatment of severe lung diseases (including severe lung infection, acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD), etc.)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers.
  • Age: 19-45, males and females.
  • The weight is within ± 10% of the standard weight [standard weight (kg) = 0.7 × (height cm-80)].
  • Examination indices of heart, liver, kidney and blood are all within the normal range.
  • According to Good Clinical Practice (GCP), volunteers who understand and voluntarily sign the consent form before this study.

Exclusion criteria

  • Women in pregnancy or lactation.
  • Primary diseases of important organs.
  • Mentally or physically disabled patients.
  • Suspected or definite history of alcohol and drug abuse.
  • According to the investigator's judgment, there is a low possibility of enrollment (such as frailty, etc.).
  • Volunteers who are allergic to the components of this medicine, or have a history of allergies to two or more drugs or food.
  • Volunteers who have diseases (such as insomnia) and are using other preventive and therapeutic drugs before this study.

Treatment and study plan

1X level of MSCs-Exo

Biological

Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)

2X level of MSCs-Exo

Biological

Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)

4X level of MSCs-Exo

Biological

Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)

6X level of MSCs-Exo

Biological

Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)

8X level of MSCs-Exo

Biological

Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)

Primary outcomes

  1. Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE)

    Time frame: from Day 0 to Day 7

    Safety evaluation within 7 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)

Other outcomes

  1. Alanine Aminotransferase (ALT) (IU/L)

    Time frame: day 0 and day 7

    one of the indexes about liver function

  2. Creatinine (Cr) (μmol/L)

    Time frame: day 0 and day 7

    One of the indexes about kidney function

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai AbelZeta Ltd.

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 18, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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