Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS

Study Overview
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Brief Summary
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Evaluate the safety, tolerability, efficacy and pharmacodynamics&pharmacokinetic properties of CT303 in patients with ARDS.

Detailed Description
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This study is a multi-center, open-label, dose-escalation and dose-finding phase 1 clinical trial. The primary purpose is to evaluate the safety and tolerability of CT303 and the Secondary purpose is to evaluate the efficacy of CT303 in patients with ARDS. And the exploratory purpose is to evaluate pharmacodynamics properties pharmacokinetic properties of CT303 in patients with ARDS.

Official Title
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A Multi-center, Open-label Dose-escalation and Dose-finding Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With Acute Respiratory Distress Syndrome

Conditions
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Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Genetic: CT303


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 19 years old Patients who meet the ARDS criteria according to the Berline definition within 1 week of a known clinical insult or new or worsening respiratory symtoms Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules Respiratory failure not fully explained by cardiac failure or fluid overload oxygenation corresponding to mild, moderate, severe Patients requiring positive pressure ventilation using an endotracheal tube Patients or legal representative signed Informed consent form Exclusion Criteria: Greater than 96 hours since first meeting ARDS criteria Patients who was previously administered mesenchymal stem cell therapy products or other cell therapy products Patients with the following medical history or comorbid condition medical history Patients who had an organ transplant or bone-marrow transplantation Patients who had a pneumonectomy a maligant tumor within 5 years a deep vein thrombosis or pulmonary embolism with in 6 months a trauma within 7 days comorbid condition Patients with AST or ALT exceeding 5 times the upper limit of the normal range eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy severe chronic respiratory disease WHO functional assessment class III/IV pulmonary hypertension Severe cardiac insufficiency QTc > 480msec chronic underlying diseases viral hepatitis type B or type C, or positive HIV test Patients using extracorporeal life support devices or high-frequency oscillatory ventilation Moribund patients expected to die within 48 hours Patients who refuse or are likely to refuse life-sustaining treatment Fertile women or men who disagree a continence and a contraception Patients with a history of hypersensitivity reaction Patients participating in clinical trials within 4 weeks Patients determined by the investigator to be inappropriate to participate in this clinical trial

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>CT303 | Genetic: CT303<br>* Once a time, intravenous injection CT303 Starting Dose : 1.0*10^6 cells/kg CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Drug Reaction incidence rate | Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing. | Day 0 to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS