Back to resultsClinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Withdrawn
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT303
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ARDS
Eligibility Criteria
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
Sites / Locations
- Seoul national university hospital
- Seoul national university boramae medical center
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
CT303
Outcomes
Primary Outcome Measures
Adverse Drug Reaction incidence rate
Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05238532
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulties in recruiting Subjects
Study Start Date
January 26, 2022 (Actual)
Primary Completion Date
February 22, 2023 (Actual)
Study Completion Date
February 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GC Cell Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Arm Description
CT303
Intervention Type
Genetic
Intervention Name(s)
CT303
Intervention Description
Once a time, intravenous injection
CT303 Starting Dose : 1.0*10^6 cells/kg
CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg
Primary Outcome Measure Information:
Title
Adverse Drug Reaction incidence rate
Description
Evaluate safety through the incidence rate of adverse drug reactions corresponding to criteria for stopping the dose increasing.
Time Frame
Day 0 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Jae Cho, MD, MPH, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national university hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Seoul national university boramae medical center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seoul
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of CT303 in Patients With ARDS
We'll reach out to this number within 24 hrs