Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

Brief Title

Human Mesenchymal Stem Cells For Infants At High Risk For Bronchopulmonary Dysplasia

Official Title

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Premature Infants Ａt High Risk For Bronchopulmonary

Brief Summary

      This study is an open-label, single-center, dose escalation study to evaluate of safety and
      efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs) in premature
      infants at high risk for Bronchopulmonary Dysplasia（BPD）
    

Detailed Description

      BPD is a chronic lung disease that occur in premature infants receiving prolonged oxygen
      pulmonary and ventilator therapy. It remains a main complication of extreme prematurity and
      currently lacks efficient treatment.The mortality rate of one year after birth is still high
      and the quality of life is not optimistic.

      hUC-MSCs are widely used in clinic due to their low immunogenicity and convenient to get.
      Many animal study had shown that hUC-MSCs had therapeutic effects on a variety of animal
      models of lung disease.Furthermore,there are a large number of clinical trials of MSCs
      applied to various system diseases and the safety was verified.So, the main purpose of this
      study is to evaluate the safety and efficacy of hUC-MSCs in participants at high risk for BPD
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional

Primary Outcome

Number of participants with adverse reactions related to infusion after treatment

Secondary Outcome

 The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop.

Condition

Bronchopulmonary Dysplasia

Intervention

Transplantation of hUC-MSCs

Study Arms / Comparison Groups

 Transplantation of hUC-MSCs

Description:  Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

20

Start Date

March 1, 2019

Completion Date

December 31, 2021

Primary Completion Date

December 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and
             14 days after birth)

          2. Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28
             weeks)

          3. Birth weight is between 500g and 1000g, inclusive

          4. Being intubated and receiving mechanical ventilation within 5-14 days after birth,
             with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening

          5. Written consent form signed by a legal representative or a parent.

        Exclusion Criteria:

          1. Although mechanical ventilation or oxygen is required in participants, there are no
             signs of dyspnea or BPD-related changes in lung imaging, such as central apnea or
             diaphragm paralysis.

          2. The participants who have complex congenital heart disease.

          3. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed)
             at the time of assessment.

          4. The participants who have severe respiratory tract malformation: pierre-robin
             syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis,
             tracheo-esophageal fistula, pulmonary emphysema, pulmonary sequestration, congenital
             pulmonary dysplasia, congenital pulmonary cyst, congenital spasm, etc.

          5. The participants who have severe chromosome anomalies :Edward syndrome, Patau
             syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus,
             Encephalocele, etc).

          6. The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella,
             Syphilis, AIDS, etc).

          7. The participants who have severe sepsis or shock.

          8. The participants who is going to have surgery 72 hours before/after this study drug
             administration.

          9. The participants who have surfactant administration within 24 hours before this study
             drug administration.

         10. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.

         11. The participants who have active pulmonary hemorrhage or active air leak syndrome at
             the time of assessment.

         12. The participants who have the history of other clinical studies as a participant.

         13. The participants who is considered inappropriate by the investigators.
      

Gender

All

Ages

N/A - 14 Days

Accepts Healthy Volunteers

No

Contacts

Zhou Fu, 13637719980, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03774537

Organization ID

XiaYQ

Responsible Party

Principal Investigator

Study Sponsor

Children's Hospital of Chongqing Medical University

Study Sponsor

Zhou Fu, Study Chair, Children's Hospital of Chongqing Medical University

Verification Date

March 2019