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

NCT04602104 | Completed Phase 1

• 1 other identifier: MEXARDS
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

human mesenchymal stem cell exosomes

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse reaction

  Incidence of adverse reaction

  up to 14 days

• TTCI

  Time to Clinical improvement

  up to 28 days

• 28-day mortality

  28-day mortality

  up to 28 days

Secondary Outcomes (5)

• Murray lung injury score

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

• PaO2/FiO2

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

• SOFA score

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

• ApachⅡ score

  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

  up to 60 days

Study Arms (6)

Phase 1: hMSC-Exos low dose

EXPERIMENTAL

hMSC-Exos low-dose group

Biological: low dose hMSC-Exos

Phase 1: hMSC-Exos medium dose

EXPERIMENTAL

hMSC-Exos medium-dose group

Biological: medium dose hMSC-Exos

Phase 1: hMSC-Exos high dose

EXPERIMENTAL

hMSC-Exos high-dose group

Biological: high dose hMSC-Exos

Phase 2: hMSC-Exos dosage 1

EXPERIMENTAL

basic treatment+hMSC-Exos (a quarter of MTD/day)

Biological: Dosage 1of hMSC-Exos

Phase 2: hMSC-Exos dosage 2

EXPERIMENTAL

basic treatment+hMSC-Exos (MTD/day)

Biological: Dosage 2 of hMSC-Exos

Phase 2: control group

PLACEBO COMPARATOR

basic treatment+normal saline

Biological: No hMSC-derived exosomes

Interventions

low dose hMSC-Exos BIOLOGICAL

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)

Phase 1: hMSC-Exos low dose

medium dose hMSC-Exos BIOLOGICAL

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)

Phase 1: hMSC-Exos medium dose

high dose hMSC-Exos BIOLOGICAL

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)

Phase 1: hMSC-Exos high dose

Dosage 1of hMSC-Exos BIOLOGICAL

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)

Phase 2: hMSC-Exos dosage 1

Dosage 2 of hMSC-Exos BIOLOGICAL

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)

Phase 2: hMSC-Exos dosage 2

No hMSC-derived exosomes BIOLOGICAL

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)

Phase 2: control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subjects themselves or their family members voluntarily participate in this study and sign the informed consent form;
• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: October 26, 2020
• Study Start: November 30, 2020
• Primary Completion: November 10, 2022
• Study Completion: January 11, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)