Stem Cells for Bronchopulmonary Dysplasia

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT03378063

Collaborator

Children's Hospital of Chongqing Medical University (Other), Chongqing Maternal and Child Health Hospital (Other)

100

Enrollment

Location

Arms

61.9

Anticipated Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bronchopulmonary Dysplasia	Drug: transplantation of mesenchymal stem cell Drug: no transplantation of mesenchymal stem cell	Early Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stem Cells for Bronchopulmonary Dysplasia: a Cohort Study

Actual Study Start Date :

Nov 1, 2017

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: transplantation of mesenchymal stem cell transplantation of mesenchymal stem cell will be given to the infants with BPD.	Drug: transplantation of mesenchymal stem cell allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
Active Comparator: no transplantation of mesenchymal stem cell transplantation of mesenchymal stem cell will be not given to the infants with BPD.	Drug: no transplantation of mesenchymal stem cell MSC transplantation will be not given to preterm infants

Arm

Intervention/Treatment

Experimental: transplantation of mesenchymal stem cell

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

Drug: transplantation of mesenchymal stem cell

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

Active Comparator: no transplantation of mesenchymal stem cell

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

Drug: no transplantation of mesenchymal stem cell

MSC transplantation will be not given to preterm infants

Outcome Measures

Primary Outcome Measures

death [within two years]
the infant is dead due to lung disease

Secondary Outcome Measures

Bayley Scales of Infant Development [30 months after birth]
scores of Bayley Scales of Infant Development at 2 months old and 2 years old

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosed with BPD

Exclusion Criteria:

parents' rejection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Pediatrics, Daping Hospital, Research Institute of Surgery, Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Children's Hospital of Chongqing Medical University
Chongqing Maternal and Child Health Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chen Long,MD, Principal Investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

ClinicalTrials.gov Identifier:

NCT03378063

Other Study ID Numbers:

stem cell for BPD

First Posted:

Dec 19, 2017

Last Update Posted:

Feb 16, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Bronchopulmonary Dysplasia

Study Results

No Results Posted as of Feb 16, 2021