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

NCT05238532 | Withdrawn Phase 1

• 1 other identifier: CT303B101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

CT303

Genetic: CT303

Interventions

CT303 GENETIC

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

Single Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GC Cell Corporation: lead

Study Sites (3)

Seoul national university hospital

Seoul, 03080, South Korea

Location

Seoul national university boramae medical center

Seoul, 07061, South Korea

Location

Seoul National University Bundang Hospital

Seoul, 13620, South Korea

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Young-Jae Cho, MD, MPH, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 14, 2022
• Study Start: January 26, 2022
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-03

Locations

KR (3)