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

July 13, 2021 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Although human bone marrow MSCs have been safely administered in patients with ARDS and septic shock (phase I/II trials), it seems safer to deliver MSCs-Exo rather than live MSCs. The intravenous administration of MSCs may result in aggregating or clumping in the injured microcirculation and carries the risk of mutagenicity and oncogenicity, which do not exist by treating with nebulized MSCs-Exo. Another advantage of MSCs-Exo over MSCs is the possibility of storing them for several weeks/months allowing their safe transportation and delayed therapeutic use.

The purpose of this study, therefore, is to explore the safety and efficiency as well as provide a clinical dose reference for the subsequent trails of aerosol inhalation of MSCs-Exo in the treatment of severe lung diseases (including severe lung infection, acute respiratory distress syndrome (ARDS) and chronic obstructive pulmonary disease (COPD), etc.)

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1X level
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)
Biological: 1X level of MSCs-Exo
Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
Experimental: 2X level
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)
Biological: 2X level of MSCs-Exo
Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
Experimental: 4X level
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)
Biological: 4X level of MSCs-Exo
Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
Experimental: 6X level
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)
Biological: 6X level of MSCs-Exo
Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
Experimental: 8X level
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)
Biological: 8X level of MSCs-Exo
Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE)
Time Frame: from Day 0 to Day 7
Safety evaluation within 7 days after first treatment, including frequency of adverse reaction (AE) and severe adverse reaction (SAE)
from Day 0 to Day 7

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine Aminotransferase (ALT) (IU/L)
Time Frame: day 0 and day 7
one of the indexes about liver function
day 0 and day 7
Creatinine (Cr) (μmol/L)
Time Frame: day 0 and day 7
One of the indexes about kidney function
day 0 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Cellular Biomedicine Group Ltd.

Investigators

  • Principal Investigator: Jieming Qu, MD,PhD, Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Actual)

April 30, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

March 17, 2020

First Submitted That Met QC Criteria

March 17, 2020

First Posted (Actual)

March 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEXVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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