MedTrace Logo

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

NCT04313647 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2021-08-04

Study results available
· View outcomes & findings →

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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

1X level of MSCs-Exo

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

BIOLOGICAL

2X level of MSCs-Exo

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

BIOLOGICAL

4X level of MSCs-Exo

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

BIOLOGICAL

6X level of MSCs-Exo

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

BIOLOGICAL

8X level of MSCs-Exo

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

Sponsors & Collaborators

  • Shanghai AbelZeta Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

Principal Investigators

  • Jieming Qu, MD,PhD · Ruijin Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2020-04-30
Completion
2020-07-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04313647 on ClinicalTrials.gov