Stem Cells for Bronchopulmonary Dysplasia

NCT ID: NCT03378063

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2022-12-30

Brief Summary

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Very preterm infants are at high risk to develop to bronchopulmonary dysplasia (BPD) for the lack of effective measures to prevent or ameliorate this common and serious disorder. BPD remains a major cause of mortality and lifelong morbidity in preterm infants

Detailed Description

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Several studies have shown that transplantation of mesenchymal stem cells (MSCs) in immunocompetent animals attenuates lung injury, such as impaired alveolarization, inflammatory response, increased apoptosis, and fibrosis. Human umbilical cord blood (hUCB) is considered a better source of MSCs because of their ready availability and greater proliferative capacity and less antigenicity than other cell types.

transplantation of hUCB-derived MSCs should be effective in treating BPD. The safety and efficacy of MSC transplantation for prevention of BPD has not been tested previously, however.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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transplantation of mesenchymal stem cell

transplantation of mesenchymal stem cell will be given to the infants with BPD.

Group Type EXPERIMENTAL

transplantation of mesenchymal stem cell

Intervention Type DRUG

allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants

no transplantation of mesenchymal stem cell

transplantation of mesenchymal stem cell will be not given to the infants with BPD.

Group Type ACTIVE_COMPARATOR

no transplantation of mesenchymal stem cell

Intervention Type DRUG

MSC transplantation will be not given to preterm infants

Interventions

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transplantation of mesenchymal stem cell

allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants

Intervention Type DRUG

no transplantation of mesenchymal stem cell

MSC transplantation will be not given to preterm infants

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosed with BPD

Exclusion Criteria

* parents' rejection
Minimum Eligible Age

1 Month

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role collaborator

Chongqing Maternal and Child Health Hospital

OTHER

Sponsor Role collaborator

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chen Long,MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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stem cell for BPD

Identifier Type: -

Identifier Source: org_study_id

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