Brief Title
Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants
Official Title
The Safety and Feasibility of UMC119-01 Cell Therapy in Infants With Bronchopulmonary Dysplasia
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 with servere BPD.
Detailed Description
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for treatment of Bronchopulmonary dysplasia.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
The incidence and frequency of adverse events related to administration of UMC119-01.
Secondary Outcome
The percentage of subjects who died from any cause during the study.
Condition
Bronchopulmonary Dysplasia
Intervention
Human Umbilical Cord Derived-Mesenchymal Stem Cells
Study Arms / Comparison Groups
UMC119-01
Description: UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
9
Start Date
October 26, 2018
Completion Date
October 31, 2022
Primary Completion Date
October 31, 2020
Eligibility Criteria
Inclusion Criteria: Neonatal infants who fulfil all of the following criteria will be enrolled: 1. Are male and female infants born at a GA <29 weeks, with a birth weight ≤1250 g. 2. Have been diagnosed with severe BPD in accordance with National Institute of Child Health and Human Development (NICHD) criteria which require that at 36 weeks PMA there is need for 30% oxygen and/or positive pressure (positive-pressure ventilation or nasal continuous positive airway pressure). 3. On Day 1 (which will occur at, but not more than 12 weeks following, 36 weeks PMA), required oxygen for at least 28 days with no sign of weaning from the following respiratory support: FiO2 ≥30% and/or positive pressure (positive-pressure ventilation or nasal continuous positive airway pressure). 4. Have endotracheal tube in place as part of SoC for preterm infants with BPD at screening and on Day 1 and that they will have not been intubated for the purposes of this study. 5. 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, or cardiovascular abnormality (except for 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, within 1 week prior to enrolment of this study. 5. Have pre-existing severe IVH (grade ≥3). 6. Have active pulmonary hemorrhage or air leak syndrome within 1 week prior to enrolment into the study. 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 72 hours prior to and/or after UMC119 01 instillation. 10. Are expected to receive any other intratracheal treatments, including surfactant or nitric oxide within 72 hours prior to and/or after UMC119 01 instillation. 11. Are currently participating in any other interventional clinical trial.
Gender
All
Ages
36 Weeks - 48 Weeks
Accepts Healthy Volunteers
No
Contacts
, +886-2-26275175, [email protected]
Location Countries
Taiwan
Location Countries
Taiwan
Administrative Informations
NCT ID
NCT03631420
Organization ID
UMC119-01-001
Responsible Party
Sponsor
Study Sponsor
Meridigen Biotech Co., Ltd.
Study Sponsor
, ,
Verification Date
December 2019