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Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

Primary Purpose

Bronchopulmonary Dysplasia

Status

Recruiting

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

Human Umbilical Cord Derived-Mesenchymal Stem Cells

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia

Eligibility Criteria

3 Days - 51 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Subjects of postnatal age between 3 to 30 days.
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.
Subjects with birth weight between 501g to 1249 g.
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.
A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening.
A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment.
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:

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

Sites / Locations

National Chen-Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UMC119-01

Arm Description

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product

Outcomes

Primary Outcome Measures

The incidence and frequency of adverse events related to administration of UMC119-01.

• The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01.

Secondary Outcome Measures

The percentage of subjects who died from any cause during the study.

Changes of the oxygen saturation.

Changes from baseline of the oxygen saturation.

Changes of chest x-ray findings in participants before and after administration.

Changes from baseline to 3 months of chest x-ray findings in participants before and after administration.

Changes of inflammatory markers (pg/ml) before and after administration.

Changes from baseline of inflammatory markers (pg/ml) .

Comparison of the incidence and severity of preterm children's complications in participants before and after administration.

The number of days of intubation, or where ventilator or oxygen therapy.

Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).

Full Information

NCT ID

NCT03631420

First Posted

April 9, 2018

Last Updated

December 4, 2022

Sponsor

Meridigen Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03631420

Brief Title

Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 26, 2018 (Actual)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Meridigen Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UMC119-01

Arm Type

Experimental

Arm Description

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product

Intervention Type

Biological

Intervention Name(s)

Human Umbilical Cord Derived-Mesenchymal Stem Cells

Intervention Description

Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg

Primary Outcome Measure Information:

Title

The incidence and frequency of adverse events related to administration of UMC119-01.

Description

• The incidence and frequency of adverse events (AEs) and serious adverse events (SAEs), including their relationship to the administration of UMC119 01.

Time Frame

3 months from the day of administration

Secondary Outcome Measure Information:

Title

The percentage of subjects who died from any cause during the study.

Description

The percentage of subjects who died from any cause during the study.

Time Frame

3 months from the day of administration

Title

Changes of the oxygen saturation.

Description

Changes from baseline of the oxygen saturation.

Time Frame

3 months from the day of administration

Title

Changes of chest x-ray findings in participants before and after administration.

Description

Changes from baseline to 3 months of chest x-ray findings in participants before and after administration.

Time Frame

3 months from the day of administration

Title

Changes of inflammatory markers (pg/ml) before and after administration.

Description

Changes from baseline of inflammatory markers (pg/ml) .

Time Frame

3 days and 7 days after administration

Title

Comparison of the incidence and severity of preterm children's complications in participants before and after administration.

Description

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

Title

The number of days of intubation, or where ventilator or oxygen therapy.

Description

The number of days of intubation, or where ventilator or oxygen therapy.

Time Frame

3 months from the day of administration

Title

Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).

Description

Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA).

Time Frame

36 weeks postmenstrual age (PMA)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Days

Maximum Age & Unit of Time

51 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Neonatal infants who fulfil all of the following criteria will be enrolled: Subjects of postnatal age between 3 to 30 days. 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. Subjects with birth weight between 501g to 1249 g. 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. A subject who is intubated and receiving mechanical ventilation with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening. A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment. 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: Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, cardiovascular abnormality (except for patent ductus arteriosus, PDA). Have a known genetic syndrome. Have a condition that makes them ineligible for participation in this study, as determined by the investigator. Have C-reactive protein (CRP) >30 mg/L; or any infections including pneumonia, sepsis, or shock. Have pre-existing severe intraventricular hemorrhage (IVH) (grade ≥3). Have active pulmonary hemorrhage or air leak syndrome. 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). Are known to be infected with HIV or CMV. Are expected to have surgery within 24 hours prior to and/or after UMC119 01 instillation. Are expected to receive any other intratracheal treatments, including surfactant within 72 hours prior to and/or after UMC119 01 instillation. Are currently participating in any other interventional clinical trial.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Katherine Huang, MS

Phone

+886-2-26275175

Ext

19926

Katherine.Huang@meridigen.com

Facility Information:

Facility Name

National Chen-Kung University Hospital

City

Tainan City

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Katherine Huang, MS

Phone

+886-2-2627-5175

Ext

19926

Katherine.Huang@meridigen.com

First Name & Middle Initial & Last Name & Degree

Yuh-Jyh Lin, MD

First Name & Middle Initial & Last Name & Degree

Yung-Chieh Lin, MD

First Name & Middle Initial & Last Name & Degree

Yu-Shan Chang, MD

First Name & Middle Initial & Last Name & Degree

Yen-Ju Chen, MD

12. IPD Sharing Statement

Learn more about this trial

Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

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