Phase 1
N=24
A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04313647 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE) — 1; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 1X level of MSCs-Exo (Biological); 2X level of MSCs-Exo (Biological); 4X level of MSCs-Exo (Biological); 6X level of MSCs-Exo (Biological); 8X level of MSCs-Exo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ruijin Hospital
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE) |
1; 0; 0; 0; 1 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT04313647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.