Clinical trial NCT05238532: Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Acute Respiratory Distress Syndrome
Keywords: ARDS
Lead sponsor: GC Cell Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 19 years old
* Patients who meet the ARDS criteria according to the Berline definition

  1. within 1 week of a known clinical insult or new or worsening respiratory symtoms
  2. Bilateral opacities not fully explained by effusions, loar/lung collapse, or nodules
  3. Respiratory failure not fully explained by cardiac failure or fluid overload
  4. 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

  1. medical history

     1. Patients who had an organ transplant or bone-marrow transplantation
     2. Patients who had a pneumonectomy
     3. a maligant tumor within 5 years
     4. a deep vein thrombosis or pulmonary embolism with in 6 months
     5. a trauma within 7 days
  2. comorbid condition

     1. Patients with AST or ALT exceeding 5 times the upper limit of the normal range
     2. eGFR ≤ 29mL/min or Patients requiring continuous renal replacement therapy
     3. severe chronic respiratory disease
     4. WHO functional assessment class III/IV pulmonary hypertension
     5. Severe cardiac insufficiency
     6. QTc \> 480msec
     7. 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

Primary outcomes:
measure: Adverse Drug Reaction incidence rate
timeFrame: Day 0 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul national university hospital
city: Seoul
country: Korea, Republic of
facility: Seoul national university boramae medical center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Young-Jae Cho, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: