- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04602104
A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS
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
Study Overview
Status
Conditions
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)
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Jieming Qu, MD, PhD
- Phone Number: 86-21-64370045
- Email: jmqu0906@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital, Medical School of Shanghai Jiaotong University
-
Contact:
- Jieming Qu, MD, PhD
- Phone Number: 86-21-64370045
- Email: jmqu0906@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- 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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase 1: hMSC-Exos low dose
hMSC-Exos low-dose group
|
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)
|
Experimental: Phase 1: hMSC-Exos medium dose
hMSC-Exos medium-dose group
|
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)
|
Experimental: Phase 1: hMSC-Exos high dose
hMSC-Exos high-dose group
|
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)
|
Experimental: Phase 2: hMSC-Exos dosage 1
basic treatment+hMSC-Exos (a quarter of MTD/day)
|
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)
|
Experimental: Phase 2: hMSC-Exos dosage 2
basic treatment+hMSC-Exos (MTD/day)
|
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)
|
Placebo Comparator: Phase 2: control group
basic treatment+normal saline
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse reaction
Time Frame: up to 14 days
|
Incidence of adverse reaction
|
up to 14 days
|
TTCI
Time Frame: up to 28 days
|
Time to Clinical improvement
|
up to 28 days
|
28-day mortality
Time Frame: up to 28 days
|
28-day mortality
|
up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Murray lung injury score
Time Frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
The minimum value is 0 and the maximum are 16.
Higher scores mean a worse outcome.
|
baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
PaO2/FiO2
Time Frame: baseline and Day 3, Day7, Day14, Day28, Day60
|
oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen
|
baseline and Day 3, Day7, Day14, Day28, Day60
|
SOFA score
Time Frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
The minimum value is 0 and the maximum are 48.
Higher scores mean a worse outcome.
|
baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
ApachⅡ score
Time Frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
The minimum value is 0 and the maximum are 24.
Higher scores mean a worse outcome.
|
baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
|
The number of days the survivor was in ICU
Time Frame: up to 60 days
|
The number of days the survivor was in ICU
|
up to 60 days
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEXARDS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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