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
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.
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
July 31, 2025
Primary Completion Date
December 31, 2022
Eligibility Criteria
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.
Gender
All
Ages
3 Days - 51 Days
Accepts Healthy Volunteers
No
Contacts
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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
April 2021