- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03631420
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
Status
Recruiting
Conditions
Intervention / Treatment
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
- Name: Joseph Chen
- Phone Number: 19905 +886-2-8978-7777
- Email: joseph.chen@meridigen.com
Study Contact Backup
- Name: Claire Liao, MS
- Phone Number: 19965 +886-2-8978-7777
- Email: Claire.Liao@meridigen.com
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:
- Joseph Chen
- Phone Number: 19905 +886-2-8978-7777
- Email: joseph.chen@meridigen.com
-
Contact:
- Claire Liao, MS
- Phone Number: 19965 +886-2-8978-7777
- Email: Claire.Liao@meridigen.com
-
-
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:
- 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.
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMC119-01-001
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
-
Centre Hospitalier Intercommunal CreteilNot yet recruitingControls Born at Term | Premature With Dysplasia Bronchopulmonary | Premature Without Dysplasia Bronchopulmonary
-
Adel MohamedHealth Sciences Centre, Winnipeg, Manitoba; Mount Sinai Hospital, CanadaCompletedBronchopulmonary Dysplasia (BPD)Canada
-
Children's Hospital of PhiladelphiaCompleted
-
Cynthia McEvoyUniversity of Florida; University of California, San Francisco; Thrasher Research... and other collaboratorsCompletedBronchopulmonary Dysplasia (BPD)United States
-
Medipost Co Ltd.RecruitingSevere Bronchopulmonary DysplasiaKorea, Republic of
-
PediatrixPhoenix Children's Hospital; Banner HealthActive, not recruitingBPD - Bronchopulmonary DysplasiaUnited States
-
Children's Hospital of Eastern OntarioThe Hospital for Sick Children; Hannover Medical School; MOUNT SINAI HOSPITAL; St... and other collaboratorsRecruitingLung Function | BPD - Bronchopulmonary DysplasiaCanada
-
Christoph HornikNational Heart, Lung, and Blood Institute (NHLBI); University of North Carolina...RecruitingBronchopulmonary Dysplasia of NewbornUnited States
-
University of FloridaCompletedPreterm Infant | Barotrauma | BPD - Bronchopulmonary DysplasiaUnited States
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedBronchopulmonary Dysplasia; Retinopathy of PrematurityItaly
Clinical Trials on Human Umbilical Cord Derived-Mesenchymal Stem Cells
-
Central South UniversityUnknown
-
Second Affiliated Hospital, School of Medicine,...Recruiting
-
Beijing 302 HospitalWuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, ChinaNot yet recruitingDecompensated CirrhosisChina
-
Beijing 302 HospitalVCANBIO Cell & Gene Engineering Corporation, LtdRecruitingDecompensated CirrhosisChina
-
Shanghai East HospitalRecruitingLung Injury | Ischemic Heart Disease | Non-cardiac SurgeryChina
-
Translational BiosciencesWithdrawnOsteoarthritis of the KneePanama
-
Samsung Medical CenterMedipost Co Ltd.Not yet recruitingAlzheimer's DiseaseKorea, Republic of
-
Institute of Hematology & Blood Diseases HospitalActive, not recruitingThrombocytopenia | Mesenchymal Stem CellsChina
-
Medipost Co Ltd.CompletedRespiratory Tract Infections | Premature Birth of Newborn | Bronchopulmonary DysplasiaKorea, Republic of
-
Medipost Co Ltd.Completed