Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants
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ClinicalTrials.gov Identifier: NCT03631420 |
Recruitment Status :
Recruiting
First Posted : August 15, 2018
Last Update Posted : December 7, 2022
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Condition or disease | Intervention/treatment | Phase |
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Bronchopulmonary Dysplasia | Biological: Human Umbilical Cord Derived-Mesenchymal Stem Cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 9 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | The Safety and Feasibility of UMC119-01 Cell Therapy in Infants at High Risk for Bronchopulmonary Dysplasia |
Actual Study Start Date : | October 26, 2018 |
Estimated Primary Completion Date : | December 31, 2025 |
Estimated Study Completion Date : | July 31, 2027 |

Arm | Intervention/treatment |
---|---|
Experimental: UMC119-01
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product
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Biological: Human Umbilical Cord Derived-Mesenchymal Stem Cells
Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg |
- 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.
- 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.
- Changes of the oxygen saturation. [ Time Frame: 3 months from the day of administration ]Changes from baseline of the oxygen saturation.
- 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.
- 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) .
- 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.
- 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.
- 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).

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Ages Eligible for Study: | 3 Days to 51 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631420
Contact: Katherine Huang, MS | +886-2-26275175 ext 19926 | Katherine.Huang@meridigen.com |
Taiwan | |
National Chen-Kung University Hospital | Recruiting |
Tainan City, Taiwan | |
Contact: Katherine Huang, MS +886-2-2627-5175 ext 19926 Katherine.Huang@meridigen.com | |
Principal Investigator: Yuh-Jyh Lin, MD | |
Sub-Investigator: Yung-Chieh Lin, MD | |
Sub-Investigator: Yu-Shan Chang, MD | |
Sub-Investigator: Yen-Ju Chen, MD |
Responsible Party: | Meridigen Biotech Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT03631420 |
Other Study ID Numbers: |
UMC119-01-001 |
First Posted: | August 15, 2018 Key Record Dates |
Last Update Posted: | December 7, 2022 |
Last Verified: | December 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bronchopulmonary Dysplasia Ventilator-Induced Lung Injury Lung Injury Lung Diseases |
Respiratory Tract Diseases Infant, Premature, Diseases Infant, Newborn, Diseases |