Clinical trial NCT04313647: A Tolerance Clinical Study on Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Official title: A Tolerance Clinical Study On Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
Conditions: Healthy
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.
Interventions:
description: Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
name: 1X level of MSCs-Exo
type: Biological
description: Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
name: 2X level of MSCs-Exo
type: Biological
description: Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
name: 4X level of MSCs-Exo
type: Biological
description: Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
name: 6X level of MSCs-Exo
type: Biological
description: Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)
name: 8X level of MSCs-Exo
type: Biological
Study arms:
design_group_description: Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
design_group_title: 1X level
design_group_type: Experimental
design_group_description: Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
design_group_title: 2X level
design_group_type: Experimental
design_group_description: Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
design_group_title: 4X level
design_group_type: Experimental
design_group_description: Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
design_group_title: 6X level
design_group_type: Experimental
design_group_description: Aerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)
design_group_title: 8X level
design_group_type: Experimental
Sponsor: Ruijin Hospital
Collaborators: Shanghai Cellular Biopharmaceutical Group Ltd.
Drug name mappings:
name: Allogenic Adipose MSC-Exos(Cellular Biomedicine)
lang: EN