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Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Transplantation of mesenchymal stem cell
No Transplantation of Mesenchymal Stem Cell
Sponsored by
Children's Hospital of Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring human umbilical cord -derived mesenchymal stem cells, moderate and severe bronchopulmonary dysplasia

Eligibility Criteria

28 Days - 1 Year (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy
  2. The legal representative or the participant had signed consent.

Exclusion Criteria:

  • 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.

Sites / Locations

  • Children's Hospital of Chongqing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transplantation of Mesenchymal Stem Cell

No Transplantation of Mesenchymal Stem Cell

Arm Description

Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.

Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.

Outcomes

Primary Outcome Measures

the accumulative duration of oxygen therapy
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.

Secondary Outcome Measures

Changes of blood pressure in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. Blood pressure is measured by electronic sphygmomanometer .
Changes of heart rate in participants
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.

Full Information

First Posted
July 17, 2018
Last Updated
January 11, 2019
Sponsor
Children's Hospital of Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03601416
Brief Title
Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia
Official Title
Intravenous Human Umbilical-Cord-Derived Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasias in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2019 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Chongqing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 children with moderate and severe bronchopulmonary dysplasia.
Detailed Description
Bronchopulmonary dysplasia (BPD) is one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease. 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 bronchopulmonary dysplasia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
human umbilical cord -derived mesenchymal stem cells, moderate and severe bronchopulmonary dysplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transplantation of Mesenchymal Stem Cell
Arm Type
Experimental
Arm Description
Mesenchymal stem cell will be given to participants with moderate and severe bronchopulmonary dysplasia.
Arm Title
No Transplantation of Mesenchymal Stem Cell
Arm Type
Active Comparator
Arm Description
Mesenchymal stem cell will be not given to participants with moderate and severe bronchopulmonary dysplasia.
Intervention Type
Drug
Intervention Name(s)
Transplantation of mesenchymal stem cell
Intervention Description
Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion. Dose A - 1 million cells per kg Dose B - 5 million cells per kg
Intervention Type
Drug
Intervention Name(s)
No Transplantation of Mesenchymal Stem Cell
Intervention Description
Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
Primary Outcome Measure Information:
Title
the accumulative duration of oxygen therapy
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
Time Frame
from the time of diagnosis to the time of stopping oxygen therapy
Secondary Outcome Measure Information:
Title
Changes of blood pressure in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia. Blood pressure is measured by electronic sphygmomanometer .
Time Frame
24 hours after administration
Title
Changes of heart rate in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
Time Frame
24 hours after administration
Other Pre-specified Outcome Measures:
Title
Changes of respiratory rate in participants
Description
To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
Time Frame
24 hours after administration
Title
Changes of high-resolution chest CT in participants
Description
To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for moderate and severe bronchopulmonary dysplasia.
Time Frame
within 2 years after administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with moderate and severe bronchopulmonary dysplasia are not well treated by routine therapy The legal representative or the participant had signed consent. Exclusion Criteria: 1. Severe underlying diseases (e.g. systemic and hematological malignancies, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, III-IV grade pulmonary hypertension, Lung transplantation, current indications of acute surgery after lung transplantation) 2. Participants whose age is more than 1 year old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yunqiu Xia
Phone
023-63622066
Email
sunny_199001@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Zou
Phone
023-63622066
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhou Fu
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yunqiu Xia
Phone
13637719980
Email
sunny_199001@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28341525
Citation
Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.
Results Reference
background
PubMed Identifier
26928452
Citation
Laube M, Stolzing A, Thome UH, Fabian C. Therapeutic potential of mesenchymal stem cells for pulmonary complications associated with preterm birth. Int J Biochem Cell Biol. 2016 May;74:18-32. doi: 10.1016/j.biocel.2016.02.023. Epub 2016 Feb 27.
Results Reference
background
PubMed Identifier
22837858
Citation
Hansmann G, Fernandez-Gonzalez A, Aslam M, Vitali SH, Martin T, Mitsialis SA, Kourembanas S. Mesenchymal stem cell-mediated reversal of bronchopulmonary dysplasia and associated pulmonary hypertension. Pulm Circ. 2012 Apr-Jun;2(2):170-81. doi: 10.4103/2045-8932.97603.
Results Reference
background
PubMed Identifier
32005282
Citation
Wu X, Xia Y, Zhou O, Song Y, Zhang X, Tian D, Li Q, Shu C, Liu E, Yuan X, He L, Liu C, Li J, Liang X, Yang K, Fu Z, Zou L, Bao L, Dai J. Allogeneic human umbilical cord-derived mesenchymal stem cells for severe bronchopulmonary dysplasia in children: study protocol for a randomized controlled trial (MSC-BPD trial). Trials. 2020 Jan 31;21(1):125. doi: 10.1186/s13063-019-3935-x.
Results Reference
derived

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Human Mesenchymal Stem Cells For Moderate and Severe Bronchopulmonary Dysplasia

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