Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia

Brief Title

Human Mesenchymal Stem Cells For Bronchopulmonary Dysplasia

Official Title

Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia in Premature Infants

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 for moderate and severe 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 with moderate and severe BPD.
    

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

Number of participants with adverse reactions related to infusion after treatment

Secondary Outcome

 Changes of high-resolution chest CT in participants

Condition

Bronchopulmonary Dysplasia

Intervention

Transplantation of mesenchymal stem cell

Study Arms / Comparison Groups

 Transplantation of Mesenchymal Stem Cell

Description:  Mesenchymal stem cell will be given to preterm infants with BPD.

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

12

Start Date

June 28, 2018

Completion Date

June 30, 2022

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. The participants meet the diagnostic criteria for moderate and severe BPD established
             by the National Institutes of Child Health and Human Development (NICHD) workshop.

          2. The participants have abnormal respiratory manifestations.

          3. 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 - N/A

Accepts Healthy Volunteers

No

Contacts

Zhou Fu, 13637719980, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03558334

Organization ID

XYunqiu

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

May 2019