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AzTrials

Acute Respiratory Distress SyndromePhase 1/2NCT04602104

A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS

A Phase 1/2 study testing low dose hMSC-Exos, medium dose hMSC-Exos and high dose hMSC-Exos in people with Acute Respiratory Distress Syndrome, 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

To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS) Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
low dose hMSC-Exos, medium dose hMSC-Exos and high dose hMSC-Exos
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteChina
Study dates
30 Nov 2020to 11 Jan 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subjects themselves or their family members voluntarily participate in this study and sign the informed consent form;
  • 18-70 years old, male or female;
  • Definitely diagnosed as acute respiratory distress syndrome (ARDS) (according to the Berlin definition and diagnostic criteria of ARDS);
  • Course of disease <96 hours after diagnosis;
  • Chest X-ray showed bilateral infiltration with pulmonary edema; no clinical manifestations of left ventricular hypertension, or pulmonary artery wedge pressure (PAOP) ≤18mmHg.

Who cannot join

  • Patients with severe allergic constitution;
  • Moderate to severe liver failure (children Pugh score > 12);
  • Patients with severe chronic respiratory diseases, PaCO2 > 50mmhg, and need home oxygen therapy;
  • Severe trauma occurred within 14 days before screening;
  • History of malignant tumor (patients with skin basal cell carcinoma in the past can be included);
  • They are undergoing hemodialysis or peritoneal dialysis;
Show all 21Show fewer
  • The patients who had deep venous thrombosis or pulmonary embolism within 90 days;
  • Acute myocardial infarction occurred within 30 days;
  • Neuromuscular diseases that result in impaired natural ventilation include, but are not limited to, C5 or higher spinal cord injury, amyotrophic lateral sclerosis, Guillain Barre syndrome, and myasthenia gravis;
  • Obesity (BMI > 28);
  • Lung transplantation;
  • Bone marrow transplantation;
  • Active immunosuppression is defined as receiving immunosuppressive drugs or having a medical condition associated with immunodeficiency. These included: 1) HIV (AIDS or CD4 < 200 cells / mm3); 2) chemotherapy within 6 weeks before randomization; 3) immunosuppressive therapy, including maintenance glucocorticoid therapy (> 40) Results: 1) short term systemic steroid therapy (intravenous or oral) for less than 1 week, topical steroid for skin diseases; 4) absolute neutrophil count < 500 / mm3;
  • Patients undergoing extracorporeal circulation support (ECMO) or high frequency oscillatory ventilation;
  • They were not willing to receive lung protective ventilation (minimum tidal volume 6ml / kg pbw) or liquid management treatment;
  • Have a history of epilepsy, need continuous anticonvulsant therapy, or have received anticonvulsant therapy in the past 3 years;
  • The estimated survival time was less than 30 days;
  • Hepatitis B, hepatitis C, AIDS, syphilis patients;
  • Women of childbearing age are pregnant, lactating or pregnant within one year;
  • Those who could not understand the study protocol;
  • According to the judgment of the researchers, there were other situations in which the patients were not suitable to participate in the study (for example, there were factors to reduce the follow-up compliance, and the patients did not receive relevant supportive treatment, etc.).

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Medical School of Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200025

Other trials in China

About this study

Official title: A Multiple, Randomized, Double-blinded, Controlled Clinical Study of Allogeneic Human Mesenchymal Stem Cell Exosomes (hMSC-Exos) Nebulized Inhalation in the Treatment of Acute Respiratory Distress Syndrome

To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

Read the detailed description

According to the 2012 Berlin diagnostic criteria, there are currently more than 3 million ARDS patients worldwide, accounting for about 10% of patients in the intensive care unit (ICU). In recent years, the incidence of ARDS has increased significantly, which has significantly increased the social and economic burden. The impact of ARDS can even be compared with tumors, AIDS or myocardial infarction. There are the basic clinical treatments, such as using various ventilation methods to improve hypoxia and choosing alternative therapies to improve renal insufficiency. Therefore, there is still a lack of specific treatment measures.

Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. Studies have confirmed that MSC-Exos can improve most of the pathological changes caused by lung infection, reduce pulmonary edema, reduce protein exudation, reduce alveolar inflammation, and clear bacterial infections. Thus, it brings new hope for the treatment of ARDS.

The purpose of this study is to evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

Being tested
low dose hMSC-Exos, medium dose hMSC-Exos, high dose hMSC-Exos, Dosage 1of hMSC-Exos, Dosage 2 of hMSC-Exos
Keywords
human mesenchymal stem cell exosomes
Medical subject headings
Respiratory Distress Syndrome

What participants receive

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

  • low dose hMSC-ExosBiological

    basic treatment and 7 times aerosol inhalation of hMSC-Exos (2.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

  • medium dose hMSC-ExosBiological

    basic treatment and 7 times aerosol inhalation of hMSC-Exos (8.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

  • high dose hMSC-ExosBiological

    basic treatment and 7 times aerosol inhalation of hMSC-Exos (16.0*10^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

  • Dosage 1of hMSC-ExosBiological

    basic treatment and 7 times aerosol inhalation of hMSC-Exos (a quarter of MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

  • Dosage 2 of hMSC-ExosBiological

    basic treatment and 7 times aerosol inhalation of hMSC-Exos (MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

  • No hMSC-derived exosomesBiological

    basic treatment and 7 times aerosol inhalation of normal saline (at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

Study groups in NCT04602104
Study groupRoleWhat they receive
Phase 1: hMSC-Exos low doseExperimentalhMSC-Exos low-dose group
Receives: Biological: low dose hMSC-Exos
Phase 1: hMSC-Exos medium doseExperimentalhMSC-Exos medium-dose group
Receives: Biological: medium dose hMSC-Exos
Phase 1: hMSC-Exos high doseExperimentalhMSC-Exos high-dose group
Receives: Biological: high dose hMSC-Exos
Phase 2: hMSC-Exos dosage 1Experimentalbasic treatment+hMSC-Exos (a quarter of MTD/day)
Receives: Biological: Dosage 1of hMSC-Exos
Phase 2: hMSC-Exos dosage 2Experimentalbasic treatment+hMSC-Exos (MTD/day)
Receives: Biological: Dosage 2 of hMSC-Exos
Phase 2: control groupPlacebo comparatorbasic treatment+normal saline
Receives: Biological: No hMSC-derived exosomes

What is being measured

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

  1. Incidence of adverse reaction

    Incidence of adverse reaction

    Measured: up to 14 days

  2. TTCI

    Time to Clinical improvement

    Measured: up to 28 days

  3. 28-day mortality

    28-day mortality

    Measured: up to 28 days

Secondary outcomes (5)

  1. Murray lung injury score

    The minimum value is 0 and the maximum are 16. Higher scores mean a worse outcome.

    Measured: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60

  2. PaO2/FiO2

    oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen

    Measured: baseline and Day 3, Day7, Day14, Day28, Day60

  3. SOFA score

    The minimum value is 0 and the maximum are 48. Higher scores mean a worse outcome.

    Measured: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60

  4. ApachⅡ score

    The minimum value is 0 and the maximum are 24. Higher scores mean a worse outcome.

    Measured: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60

  5. The number of days the survivor was in ICU

    The number of days the survivor was in ICU

    Measured: up to 60 days

Timeline

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

  1. First posted26 Oct 2020
  2. Study start30 Nov 2020
  3. Primary completion10 Nov 2022
  4. Study completion11 Jan 2023

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602104
Sponsor's protocol ID
MEXARDS
Status last verified
May 2024
First submitted
25 Aug 2020
Last updated
22 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to make individual participant data (IPD) available to other researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing low dose hMSC-Exos, medium dose hMSC-Exos and high dose hMSC-Exos in people with Acute Respiratory Distress Syndrome, 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 21 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 22 Jul 2024. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of adverse reaction (time frame: up to 14 days). The study lists 3 primary outcomes in all. 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 NCT04602104.

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 22 Jul 2024.

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