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

March 5, 2019 updated by: Xia Yunqiu, Children's Hospital of Chongqing Medical University

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

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）

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Children's Hospital of Chongqing Medical University
        • Contact:
          • Yunqiu Xia
          • Phone Number: 13637719980

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 days to 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transplantation of hUC-MSCs
Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs.
Drug: Transplantation of hUC-MSCs
Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
Other Names:
  • Intravenous infusion of hUC-MSCs
Other: No transplantation of hUC-MSCs
Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
Drug: No transplantation of hUC-MSCs
Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
Other Names:
  • No intravenous infusion of hUC-MSCs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse reactions related to infusion after treatment
Time Frame: 24 hours after administration
To evaluate the safety of hUC-MSCs for BPD.
24 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of respiratory rate in participants
Time Frame: 3 days after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
3 days after administration
Changes of oxygen saturation in participants
Time Frame: 3 days after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.
3 days after administration
The incidence and severity of BPD defined by the National Institutes of Child Health and Human Development (NICHD) workshop.
Time Frame: at the corrected gestational age of 36 weeks
To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD
at the corrected gestational age of 36 weeks
Changes of high-resolution chest CT in participants
Time Frame: within 2 years after administration
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPDmesenchymal stem cells for BPD.
within 2 years after administration
Changes of temperature in participants
Time Frame: 3 days after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.mesenchymal stem cells for BPD.
3 days after administration
Changes of blood pressure in participants
Time Frame: 3 days after administration
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer.
3 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Chongqing Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 12, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (Actual)

December 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XiaYQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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