Status:
COMPLETED
A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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...
Detailed Description
Experimental studies have demonstrated that mesenchymal stem cells (MSCs) or their exosomes (MSCs-Exo) significantly reduced lung inflammation and pathological impairment resulting from different type...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04313647
Start Date
March 12 2020
End Date
July 31 2020
Last Update
August 4 2021
Active Locations (1)
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1
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025