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Mesenchymal Stem Cells for Prevention of Bronchopulmonary Dysplasia in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631420
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Meridigen Biotech Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Biological: Human Umbilical Cord Derived-Mesenchymal Stem Cells Phase 1

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.

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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, 2022
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UMC119-01
UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Changes of the oxygen saturation. [ Time Frame: 3 months from the day of administration ]
    Changes from baseline of the oxygen saturation.

  3. 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.

  4. 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) .

  5. 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.

  6. 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.

  7. 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:   up to 51 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Taiwan
National Chen-Kung University Hospital
Tainan City, Taiwan
Sponsors and Collaborators
Meridigen Biotech Co., Ltd.
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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: April 26, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases