Status:
WITHDRAWN
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
Lead Sponsor:
GC Cell Corporation
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
Evaluate the safety, tolerability, efficacy and pharmacodynamics\&pharmacokinetic properties of CT303 in patients with ARDS.
Detailed Description
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...
Eligibility Criteria
Inclusion
- ≥ 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
- 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
Key Trial Info
Start Date :
January 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05238532
Start Date
January 26 2022
End Date
February 22 2023
Last Update
April 4 2023
Active Locations (3)
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1
Seoul national university hospital
Seoul, South Korea, 03080
2
Seoul national university boramae medical center
Seoul, South Korea, 07061
3
Seoul National University Bundang Hospital
Seoul, South Korea, 13620