HealthyPhase 1NCT04313647

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

A Phase 1 study testing 1X level of MSCs-Exo, 2X level of MSCs-Exo and 4X level of MSCs-Exo in people with Healthy, run by Ruijin Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: 1X level of MSCs-Exo, 2X level of MSCs-Exo and 4X level of MSCs-Exo
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 12 Mar 2020to 31 Jul 2020
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: 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.

Read the detailed description

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.)

Conditions: Healthy
Being tested: 1X level of MSCs-Exo, 2X level of MSCs-Exo, 4X level of MSCs-Exo, 6X level of MSCs-Exo, 8X level of MSCs-Exo
Keywords: mesenchymal stem cells, exosomes, mesh nebulizer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1X level of MSCs-ExoBiological
Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
2X level of MSCs-ExoBiological
Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
4X level of MSCs-ExoBiological
Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
6X level of MSCs-ExoBiological
Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
8X level of MSCs-ExoBiological
Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)

Study groups in NCT04313647
Study group	Role	What they receive
1X level	Experimental	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) Receives: Biological: 1X level of MSCs-Exo
2X level	Experimental	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) Receives: Biological: 2X level of MSCs-Exo
4X level	Experimental	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) Receives: Biological: 4X level of MSCs-Exo
6X level	Experimental	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) Receives: Biological: 6X level of MSCs-Exo
8X level	Experimental	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) Receives: Biological: 8X level of MSCs-Exo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Mar 202031 Jul 2020

First posted18 Mar 2020
Study start12 Mar 2020
Primary completion30 Apr 2020
Study completion31 Jul 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Ruijin HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: MSCs-exosomes
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04313647
Sponsor's protocol ID: MEXVT
Status last verified: May 2021
First submitted: 17 Mar 2020
Last updated: 4 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan to make individual participant data available to other researchers.

Publications

Shi MM, Yang QY, Monsel A, Yan JY, Dai CX, Zhao JY, Shi GC, Zhou M, Zhu XM, Li SK, Li P, Wang J, Li M, Lei JG, Xu D, Zhu YG, Qu JM. Preclinical efficacy and clinical safety of clinical-grade nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles. J Extracell Vesicles. 2021 Aug;10(10):e12134. doi: 10.1002/jev2.12134. Epub 2021 Aug 14.
PubMed 34429860

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Tolerance Clinical Study On Aerosol Inhalation of Mesenchymal Stem Cells Exosomes In Healthy Volunteers
ClinicalTrials.gov ID: NCT04313647
Acronym / sponsor ID: MEXVT
Conditions: Healthy
Keywords: mesenchymal stem cells, exosomes, mesh nebulizer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Ruijin HospitalUniversity, hospital or other
Collaborators: Shanghai AbelZeta Ltd.
Study start: 12 Mar 2020 (actual)
Primary completion: 30 Apr 2020 (actual)
Study completion: 31 Jul 2020 (actual)
First posted: 18 Mar 2020 (actual)
Results: Posted 4 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5
Model description: MSCs-exosomes

Arm	Type	Receives
1X level	Experimental	Biological: 1X level of MSCs-ExoAerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
2X level	Experimental	Biological: 2X level of MSCs-ExoAerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
4X level	Experimental	Biological: 4X level of MSCs-ExoAerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
6X level	Experimental	Biological: 6X level of MSCs-ExoAerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
8X level	Experimental	Biological: 8X level of MSCs-ExoAerosol inhalation of MSCs-derived exosomes treatment participants will receive once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1X level of MSCs-ExoOnce aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)	Biological	1X level
2X level of MSCs-ExoOnce aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)	Biological	2X level
4X level of MSCs-ExoOnce aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)	Biological	4X level
6X level of MSCs-ExoOnce aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)	Biological	6X level
8X level of MSCs-ExoOnce aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)	Biological	8X level

Primary outcome

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)

Results and safety

Results posted to the registry on 4 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1X Level	3	3
2X Level	3	3
4X Level	6	6
6X Level	6	6
8X Level	6	6

Primary outcome: Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE)

Time frame: from Day 0 to Day 7. Count of participants. Unit: Participants

Measure	1X Level n = 3	2X Level n = 3	4X Level n = 6	6X Level n = 6	8X Level n = 6
Value	1	0	0	0	1

Adverse events

Time frame: 7days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1X Level	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
2X Level	0 of 3 (0%)	0 of 3 (0%)	0 of 3
4X Level	0 of 6 (0%)	0 of 6 (0%)	0 of 6
6X Level	0 of 6 (0%)	0 of 6 (0%)	0 of 6
8X Level	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34429860Shi MM, Yang QY, Monsel A, Yan JY, Dai CX, Zhao JY, Shi GC, Zhou M, Zhu XM, Li SK, Li P, Wang J, Li M, Lei JG, Xu D, Zhu YG, Qu JM. Preclinical efficacy and clinical safety of clinical-grade nebulized allogenic adipose mesenchymal stromal cells-derived extracellular vesicles. J Extracell Vesicles. 2021 Aug;10(10):e12134. doi: 10.1002/jev2.12134. Epub 2021 Aug 14.
Individual participant dataSharing planned: No. No plan to make individual participant data available to other researchers.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jieming Qu, MD,PhD principal investigator

Ruijin Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 1X level of MSCs-Exo, 2X level of MSCs-Exo and 4X level of MSCs-Exo in people with Healthy, run by Ruijin Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Reaction (AE) and Severe Adverse Reaction (SAE) (time frame: from Day 0 to Day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04313647, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.