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

Acute Respiratory Distress Syndrome Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05238532
• Other study ID #: CT303B101
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 26, 2022
• Est. completion date: February 22, 2023

Study information

• Verified date: March 2023
• Source: GC Cell Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 22, 2023
• Est. primary completion date: February 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Genetic:
• CT303
Once a time, intravenous injection CT303 Starting Dose : 1.0*10^6 cells/kg CT303 Increasing Quantity Dose : 2.0*10^6 cells/kg

Locations

Country	Name	City	State
Korea, Republic of	Seoul national university boramae medical center	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Seoul
Korea, Republic of	Seoul national university hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
GC Cell Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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