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

Primary Purpose

Bronchopulmonary Dysplasia

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Transplantation of hUC-MSCs

No transplantation of hUC-MSCs

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring high risk； Bronchopulmonary Dysplasia；hUC-MSCs

Eligibility Criteria

4 Days - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)
Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks)
Birth weight is between 500g and 1000g, inclusive
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
Written consent form signed by a legal representative or a parent.

Exclusion Criteria:

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.
The participants who have complex congenital heart disease.
The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment.
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.
The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc).
The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc).
The participants who have severe sepsis or shock.
The participants who is going to have surgery 72 hours before/after this study drug administration.
The participants who have surfactant administration within 24 hours before this study drug administration.
The participants who have severe intracranial hemorrhage ≥ grade 3 or 4.
The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment.
The participants who have the history of other clinical studies as a participant.
The participants who is considered inappropriate by the investigators.

Sites / Locations

Children's Hospital of Chongqing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Transplantation of hUC-MSCs

No transplantation of hUC-MSCs

Arm Description

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

Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs

Outcomes

Primary Outcome Measures

Number of participants with adverse reactions related to infusion after treatment

To evaluate the safety of hUC-MSCs for BPD.

Secondary Outcome Measures

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

To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD

Changes of high-resolution chest CT in participants

To evaluate the safety and efficacy of human umbilical cord -derived mesenchymal stem cells for BPDmesenchymal stem cells for BPD.

Changes of temperature in participants

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.mesenchymal stem cells for BPD.

Changes of blood pressure in participants

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer.

Changes of respiratory rate in participants

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

Changes of oxygen saturation in participants

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

Full Information

NCT ID

NCT03774537

First Posted

December 12, 2018

Last Updated

March 5, 2019

Sponsor

Children's Hospital of Chongqing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03774537

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2019 (Actual)

Primary Completion Date

December 1, 2020 (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

Studies a U.S. FDA-regulated Device Product

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchopulmonary Dysplasia

Keywords

high risk； Bronchopulmonary Dysplasia；hUC-MSCs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transplantation of hUC-MSCs

Arm Type

Experimental

Arm Description

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

Arm Title

No transplantation of hUC-MSCs

Arm Type

Other

Arm Description

Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs

Intervention Type

Drug

Intervention Name(s)

Transplantation of hUC-MSCs

Other Intervention Name(s)

Intravenous infusion of hUC-MSCs

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

No transplantation of hUC-MSCs

Other Intervention Name(s)

No intravenous infusion of hUC-MSCs

Intervention Description

Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs

Primary Outcome Measure Information:

Title

Number of participants with adverse reactions related to infusion after treatment

Description

To evaluate the safety of hUC-MSCs for BPD.

Time Frame

24 hours after administration

Secondary Outcome Measure Information:

Title

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

Description

To evaluate the efficacy of hUC-MSCs to prevent preterm infants at high risk of BPD from developing BPD

Time Frame

at the corrected gestational age of 36 weeks

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 BPDmesenchymal stem cells for BPD.

Time Frame

within 2 years after administration

Title

Changes of temperature in participants

Description

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.mesenchymal stem cells for BPD.

Time Frame

3 days after administration

Title

Changes of blood pressure in participants

Description

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD. Blood pressure is measured by electronic sphygmomanometer.

Time Frame

3 days after administration

Title

Changes of respiratory rate in participants

Description

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

Time Frame

3 days after administration

Title

Changes of oxygen saturation in participants

Description

To evaluate the safety of human umbilical cord -derived mesenchymal stem cells for BPD.

Time Frame

3 days after administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Days

Maximum Age & Unit of Time

14 Days

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: An infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth) Gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) < 28 weeks) Birth weight is between 500g and 1000g, inclusive 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 Written consent form signed by a legal representative or a parent. Exclusion Criteria: 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. The participants who have complex congenital heart disease. The participants who have severe pulmonary hypertension(cardiac ultrasound confirmed) at the time of assessment. 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. The participants who have severe chromosome anomalies :Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc). The participants who have severe congenital infection(Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc). The participants who have severe sepsis or shock. The participants who is going to have surgery 72 hours before/after this study drug administration. The participants who have surfactant administration within 24 hours before this study drug administration. The participants who have severe intracranial hemorrhage ≥ grade 3 or 4. The participants who have active pulmonary hemorrhage or active air leak syndrome at the time of assessment. The participants who have the history of other clinical studies as a participant. The participants who is considered inappropriate by the investigators.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yunqiu xia

Phone

13637719980

sunny_199001@foxmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lin Zou

Phone

18623121280

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

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunqiu Xia

Phone

13637719980

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

24508444

Citation

Chang YS, Ahn SY, Yoo HS, Sung SI, Choi SJ, Oh WI, Park WS. Mesenchymal stem cells for bronchopulmonary dysplasia: phase 1 dose-escalation clinical trial. J Pediatr. 2014 May;164(5):966-972.e6. doi: 10.1016/j.jpeds.2013.12.011. Epub 2014 Feb 6.

Results Reference

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PubMed Identifier

21336467

Citation

Hayes D Jr, Meadows JT Jr, Murphy BS, Feola DJ, Shook LA, Ballard HO. Pulmonary function outcomes in bronchopulmonary dysplasia through childhood and into adulthood: implications for primary care. Prim Care Respir J. 2011 Jun;20(2):128-33. doi: 10.4104/pcrj.2011.00002.

Results Reference

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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

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PubMed Identifier

25529339

Citation

Wilson JG, Liu KD, Zhuo H, Caballero L, McMillan M, Fang X, Cosgrove K, Vojnik R, Calfee CS, Lee JW, Rogers AJ, Levitt J, Wiener-Kronish J, Bajwa EK, Leavitt A, McKenna D, Thompson BT, Matthay MA. Mesenchymal stem (stromal) cells for treatment of ARDS: a phase 1 clinical trial. Lancet Respir Med. 2015 Jan;3(1):24-32. doi: 10.1016/S2213-2600(14)70291-7. Epub 2014 Dec 17.

Results Reference

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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

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PubMed Identifier

23212278

Citation

Pierro M, Ionescu L, Montemurro T, Vadivel A, Weissmann G, Oudit G, Emery D, Bodiga S, Eaton F, Peault B, Mosca F, Lazzari L, Thebaud B. Short-term, long-term and paracrine effect of human umbilical cord-derived stem cells in lung injury prevention and repair in experimental bronchopulmonary dysplasia. Thorax. 2013 May;68(5):475-84. doi: 10.1136/thoraxjnl-2012-202323. Epub 2012 Dec 4.

Results Reference

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PubMed Identifier

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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.

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PubMed Identifier

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Citation

Yeh TF, Chen CM, Wu SY, Husan Z, Li TC, Hsieh WS, Tsai CH, Lin HC. Intratracheal Administration of Budesonide/Surfactant to Prevent Bronchopulmonary Dysplasia. Am J Respir Crit Care Med. 2016 Jan 1;193(1):86-95. doi: 10.1164/rccm.201505-0861OC.

Results Reference

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

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