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Mesenchymal Stem Cells for The Treatment 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03631420
Recruitment Status : Not yet recruiting
First Posted : August 15, 2018
Last Update Posted : August 15, 2018
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 with servere BPD. UMC119-01 is ex vivo cultured human umbilical cord tissue-derived mensenchymal stem cells product which is intended for treatment of Bronchopulmonary dysplasia.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Feasibility of UMC119-01 Cell Therapy in Infants With Bronchopulmonary Dysplasia
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UMC119-01 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 ]

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 ]
  2. Changes of the oxygen saturation. [ Time Frame: 3 months from the day of administration ]
  3. Changes of chest x-ray findings in participants before and after administration. [ Time Frame: 3 months from the day of administration ]
  4. Changes of inflammatory markers (pg/ml) before and after administration. [ Time Frame: 3 days and 7 days after administration ]
  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 ]
  6. The number of days of intubation, or where ventilator or oxygen therapy. [ Time Frame: 3 months from the day of administration ]


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Ages Eligible for Study:   36 Weeks to 38 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are male and female infants born at a GA ≤28 weeks, with a birth weight ≤1250 g.
  • 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).
  • On Day 1 (which will occur at, but not more than 14 days 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).
  • 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.
  • 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:

  • Have a major congenital abnormality, including neurological (including anencephaly and similar malformations), hepatic, renal, or cardiovascular abnormality (except for 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, within 1 week prior to enrolment of this study.
  • Have pre-existing severe IVH (grade ≥3).
  • Have active pulmonary hemorrhage or air leak syndrome within 1 week prior to enrolment into the study.
  • 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 72 hours prior to and/or after UMC119 01 instillation.
  • Are expected to receive any other intratracheal treatments, including surfactant or nitric oxide within 72 hours prior to and/or after UMC119 01 instillation.
  • 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


Contacts
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Contact: Jane Tsai, Ph. D. +886-2-26275175 ext 19922 Jane.Tsai@meridigen.com
Contact: Hugo Chang, MS +886-2-26275175 ext 19914 Hugo.Chang@meridigen.com

Locations
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Taiwan
National Chen-Kung University Hospital Not yet recruiting
Tainan City, Taiwan
Contact: Jane Tsai, Ph. D.    +886-2-26275175 ext 19922    Jane.Tsai@meridigen.com   
Principal Investigator: Yuh-Jyh Lin, MD         
Sponsors and Collaborators
Meridigen Biotech Co., Ltd.

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Responsible Party: Meridigen Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03631420     History of Changes
Other Study ID Numbers: UMC119-01-001
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018

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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