Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

Last updated: December 1, 2023
Sponsor: Meridigen Biotech Co., Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Lung Disease

Treatment

Human Umbilical Cord Derived-Mesenchymal Stem Cells

Clinical Study ID

NCT03631420
UMC119-01-001
  • Ages 3-51
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 postmenstrualage 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 atscreening and on treatment visit (Day 0), and that they will have not been intubatedfor the purposes of this study.
  5. A subject who is intubated and receiving mechanical ventilation with a fraction ofinspired 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 mechanicalventilation 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

Exclusion Criteria: Neonatal infants who meet any of the following criteria will be excluded:

  1. Have a major congenital abnormality, including neurological (including anencephaly andsimilar malformations), hepatic, renal, cardiovascular abnormality (except for patentductus arteriosus, PDA).
  2. Have a known genetic syndrome.
  3. Have a condition that makes them ineligible for participation in this study, asdetermined 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 totalbilirubin >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 01instillation.
  10. Are expected to receive any other intratracheal treatments, including surfactantwithin 72 hours prior to and/or after UMC119 01 instillation.
  11. Are currently participating in any other interventional clinical trial.

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: Human Umbilical Cord Derived-Mesenchymal Stem Cells
Phase: 1
Study Start date:
October 26, 2018
Estimated Completion Date:
July 31, 2027

Study Description

UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for prevention of Bronchopulmonary dysplasia.

Connect with a study center

  • National Chen-Kung University Hospital

    Tainan City,
    Taiwan

    Active - Recruiting

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