Mesenchymal Stem Cells for The Treatment of Bronchopulmonary Dysplasia in Infants

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 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

NCT ID

NCT03631420

Organization ID

UMC119-01-001

Responsible Party

Sponsor

Study Sponsor

Meridigen Biotech Co., Ltd.

Study Sponsor

, , 

Verification Date

December 2019