A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Intervention: 1X level of MSCs-Exo; 2X level of MSCs-Exo; 4X level of MSCs-Exo; 6X level of MSCs-Exo; 8X level of MSCs-Exo
Intervention description: Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml); Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml); Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml); Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml); Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: MSCs-exosomes
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: mesenchymal stem cells; exosomes; mesh nebulizer

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy volunteers.

          2. Age: 19-45, males and females.

          3. The weight is within ± 10% of the standard weight [standard weight (kg) = 0.7 ×
             (height cm-80)].

          4. Examination indices of heart, liver, kidney and blood are all within the normal range.

          5. According to Good Clinical Practice (GCP), volunteers who understand and voluntarily
             sign the consent form before this study.

        Exclusion Criteria:

          1. Women in pregnancy or lactation.

          2. Primary diseases of important organs.

          3. Mentally or physically disabled patients.

          4. Suspected or definite history of alcohol and drug abuse.

          5. According to the investigator's judgment, there is a low possibility of enrollment
             (such as frailty, etc.).

          6. Volunteers who are allergic to the components of this medicine, or have a history of
             allergies to two or more drugs or food.

          7. Volunteers who have diseases (such as insomnia) and are using other preventive and
             therapeutic drugs before this study.