Status:
NOT_YET_RECRUITING
Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells in Patients With Acute Respiratory Distress Syndrome
Lead Sponsor:
Asia Cell Therapeutics (Shanghai) Co., Ltd.
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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...
Detailed Description
Acute respiratory distress syndrome (ARDS) refers to various pathogenic factors that lead to excessive activation of the lung or even the whole body inflammatory response, which is manifested by the d...
Eligibility Criteria
Inclusion
- 18-75 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
- 100 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
Exclusion
- 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
- Any other condition that, in the judgement of the investigator, makes participation in this trial inappropriate, such as a condition in which the study is not in the subject's current best interest (e.g., detrimental to health)
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05983627
Start Date
August 30 2023
End Date
December 31 2026
Last Update
August 9 2023
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