Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Respiratory Distress Syndrome

NCT05983627 | Not Yet Recruiting Phase 1

• 1 other identifier: QS-ARDS-S1
• Study Type: interventional
• Target: 9
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS), and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Mild to Moderate Acute Respiratory Distress Syndrome (ARDS). Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells. Each subject will receive three infusions.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Human Umbilical Cord Mesenchymal Stem Cells; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (3)

• Adverse Event (AE)

  Adverse events that occurred during the trials

  Day 1 to Day 28

• Serious Adverse Event (SAE)

  Serious adverse events that occurred during the trial

  Day 1 to Day 28

• Maximum Tolerated Dose (MTD)

  Maximum Tolerated Dose

  Day 1 to Day 28

Secondary Outcomes (7)

• Oxygenation index

  Day 1(Before infusion)、Day 2、Day 3、Day 4、Day 7、Day 14、Day 28

• Chest routine scan

  Baseline、Day 4、Day 14、Day 28

• Intubation rate

  Day 1 to Day 28

• Length of hospitalisation

  Day 1 to Day 28

• Time out of ICU

  Day 1 to Day 28

Other Outcomes (8)

• Interferon-γ (IFN-γ）

  Baseline (1h before infusion)、Day 2、Day 3、Day 7、Day 14、Day 28

• Interleukin-1β （IL-1β）

  Baseline (1h before infusion)、Day 2、Day 3、Day 7、Day 14、Day 28

• Interleukin-6 （IL-6）

  Baseline (1h before infusion)、Day 2、Day 3、Day 7、Day 14、Day 28

Study Arms (1)

Human Umbilical Cord Mesenchymal Stem Cells

EXPERIMENTAL

The trial was divided into three dose groups： Low-dose group: 1000000 cells/kg Medium-dose group: 2000000 cells/kg High-does group: 4000000 cells/kg

Biological: Human Umbilical Cord Mesenchymal Stem Cells

Interventions

Human Umbilical Cord Mesenchymal Stem Cells BIOLOGICAL

The stem cell infusion route is peripheral intravenous infusion. All subjects received experimental drugs and conventional treatment during the study period.

Human Umbilical Cord Mesenchymal Stem Cells

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old (including the threshold), male or female
• A definite diagnosis of mild to moderate acute respiratory distress syndrome (ARDS) (according to the ARDS Berlin definition and diagnostic criteria)
• ARDS onset ≤ 5 days
• mmHg \< PaO2/FiO2 ≤ 300 mmHg
• Bilateral pulmonary infiltrates on chest radiograph or chest CT
• Rule out other causes of pulmonary oedema, such as cardiogenic pulmonary oedema and pulmonary oedema due to fluid overload
• Have no plans to have children within 2 weeks before screening and 3 months after the end of the trial, and agree to use effective non-pharmacological contraception during the trial
• Patients voluntarily signed an informed consent form and were willing to co-operate with the trial process

You may not qualify if:

• Hypersensitivity to known components of the drug (the main component of this product is human umbilical cord mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin, compound electrolyte injection), the presence of a history of allergy to gentamicin or other history of severe allergy
• Patients requiring treatment for any malignancy within 2 years prior to administration (except non-melanoma skin cancer)
• Lung transplant patients
• Patients with malignant haematological diseases
• Persons who have had a cardiovascular event within 3 months prior to dosing (e.g., unstable angina, congestive heart failure, myocardial infarction within the last 12 months, haemodynamic instability or known left ventricular ejection fraction (LVEF) \<40% or clinically significant rhythm or conduction abnormalities)
• A history of deep vein thrombosis or pulmonary embolism during the Screening Period that, in the judgement of the Investigator, may be triggered or increase risk by receiving MSC transplantation therapy
• A breastfeeding female or a female with a positive blood pregnancy test result during the Screening Period
• History of immunodeficiency and/or autoimmune disease such as systemic lupus erythematosus (SLE), or other congenital immunodeficiency disease, idiopathic IgA deficiency. Laboratory tests at screening meet any of the following: Albuminous transaminase (AST) or albuminous transaminase (ALT) \> 5 x ULN (non-hepatic sources are excluded; Serum creatinine \> 1.5 x ULN or glomerular filtration rate \< 60 mL/min/1.74 m2; Activated partial thromboplastin time (APTT) \> 2.5 x ULN or prothrombin time; (PT) \> 2.5 x ULN (not receiving anticoagulation)
• Positive infectious diseases (HBsAg, HCV, HIV-1, syphilis, active tuberculosis)
• Currently receiving extracorporeal life support (ECLS) such as continuous haemodialysis (CRRT) and carbon dioxide removal (ECCO2R), or high frequency oscillatory ventilation (HFOV)
• Presence of any other irreversible condition or symptom for which the subject has an expected survival of \<3 months
• Combined WHO Class III or IV pulmonary hypertension
• Patients who refuse lung protective ventilation and fluid management
• Participation in other clinical trials or studies within 3 months prior to administration
• Persons with prior stem cell therapy

Sponsors & Collaborators

• Asia Cell Therapeutics (Shanghai) Co., Ltd.: lead

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jieming Qu

  SHANGHAI JIAOTONG UNIVERSITY SCHOOL OF MEDICINE RUIJIN HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenli Liu

CONTACT

+86 13402137712; liuwenli@xibaozhiliao.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 9, 2023
• Study Start: August 30, 2023
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2023

Record last verified: 2023-08