Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

December 1, 2023 updated by: Meridigen Biotech Co., Ltd.

The Safety and Feasibility of UMC119-01 Cell Therapy in Infants at High Risk for Bronchopulmonary Dysplasia

The clinical study with UMC119-01 is designed to investigate the safety in patients with bronchopulmonary dysplasia ("BPD"). This will be a dose escalation, open-label, single-center study in infants at high risk for BPD.

Study Overview

Detailed Description

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.

Study Type

Interventional

Enrollment (Estimated)

9

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Tainan City, Taiwan
        • Recruiting
        • National Chen-Kung University Hospital
        • Principal Investigator:
          • Yuh-Jyh Lin, MD
        • Sub-Investigator:
          • Yung-Chieh Lin, MD
        • Sub-Investigator:
          • Yu-Shan Chang, MD
        • Sub-Investigator:
          • Yen-Ju Chen, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 days to 1 month (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Neonatal infants who fulfil all of the following criteria will be enrolled:

  1. Subjects of postnatal age between 3 to 30 days.
  2. Are male and female infants born at GA between 23 weeks to 29 weeks. The postmenstrual age of subject received UMC119-01 should be no more than PMA36 weeks.
  3. Subjects with birth weight between 501g to 1249 g.
  4. Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on treatment visit (Day 0), and that they will have not been intubated for the purposes of this study.
  5. A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
  6. A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
  7. Written informed consent has been provided by the subject's parents, legal guardians, or a legal representative, who agree to comply with all of the study procedures, including those in the long-term safety surveillance period.

Exclusion Criteria:

Neonatal infants who meet any of the following criteria will be excluded:

  1. Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA).
  2. Have a known genetic syndrome.
  3. Have a condition that makes them ineligible for participation in this study, as determined by the investigator.
  4. Have C-reactive protein (CRP) >30 mg/L; or any infections including pneumonia, sepsis, or shock.
  5. Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3).
  6. Have active pulmonary hemorrhage or air leak syndrome.
  7. Have abnormal hepatic (AST, ALT >150 U/L or direct bilirubin >2 mg/dL or total bilirubin >15 mg/dL) or renal function (serum creatinine >1 mg/dL or oliguria).
  8. Are known to be infected with HIV or CMV.
  9. Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation.
  10. Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation.
  11. Are currently participating in any other interventional clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: UMC119-01
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product
Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence and frequency of adverse events related to administration of UMC119-01.
Time Frame: 3 months from the day of administration
• The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01.
3 months from the day of administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of subjects who died from any cause during the study.
Time Frame: 3 months from the day of administration
The percentage of subjects who died from any cause during the study.
3 months from the day of administration
Changes of the oxygen saturation.
Time Frame: 3 months from the day of administration
Changes from baseline of the oxygen saturation.
3 months from the day of administration
Changes of chest x-ray findings in participants before and after administration.
Time Frame: 3 months from the day of administration
Changes from baseline to 3 months of chest x-ray findings in participants before and after administration.
3 months from the day of administration
Changes of inflammatory markers (pg/ml) before and after administration.
Time Frame: 3 days and 7 days after administration
Changes from baseline of inflammatory markers (pg/ml) .
3 days and 7 days after administration
Comparison of the incidence and severity of preterm children's complications in participants before and after administration.
Time Frame: 3 months from the day of administration
Comparison of the incidence and severity of preterm children's complications in participants before and after administration.
3 months from the day of administration
The number of days of intubation, or where ventilator or oxygen therapy.
Time Frame: 3 months from the day of administration
The number of days of intubation, or where ventilator or oxygen therapy.
3 months from the day of administration
Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).
Time Frame: 36 weeks postmenstrual age (PMA)
Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).
36 weeks postmenstrual age (PMA)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 9, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Estimated)

December 4, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bronchopulmonary Dysplasia

Clinical Trials on Human Umbilical Cord Derived-Mesenchymal Stem Cells

3
Subscribe