Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

NCT ID: NCT03873506

Last Updated: 2019-03-14

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-12-31

Brief Summary

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This is a follow-up study to investigate the long-term safety and efficacy of human umbilical cord -derived mesenchymal stem cells (hUC-MSCs), for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the PhaseⅠtrial (NCT03558334 ) will be followed-up until 48 months after the hUC-MSCs transplantation.

Detailed Description

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Subjects who completed the initial stage of the PhaseⅠclinical trial will be followed-up at 5 additional visits: 1, 3, 6, 12 and 24 months after the hUC-MSCs transplantation.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mesenchymal Stem Cell

A single intravenous transplantation of Mesenchymal Stem Cell (Dose A - 1 million cells per kg, Dose B - 5 million cells per kg)

Group Type EXPERIMENTAL

transplantation of hUC-MSCs

Intervention Type DRUG

Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.

Interventions

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transplantation of hUC-MSCs

Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.

Intervention Type DRUG

Other Intervention Names

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intravenous infusion of hUC-MSCs

Eligibility Criteria

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Inclusion Criteria

1. Subject who completed the safety and efficacy evaluations in hUC-MSCs PhaseⅠ clinical trial
2. Subject with a written consent form signed by a legal representative or a parent

Exclusion Criteria

1. Subject whose parent or legal representative does not agree to participate in the study
2. subject who is considered inappropriate to participate the study by the investigator
Minimum Eligible Age

1 Month

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xia Yunqiu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhou Fu

Role: STUDY_CHAIR

Children's Hospital of Chongqing Medical University

Locations

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Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunqiu Xia

Role: CONTACT

13637719980

Lin Zou

Role: CONTACT

18623121280

Facility Contacts

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Yunqiu Xia

Role: primary

13637719980

References

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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.

Reference Type BACKGROUND
PMID: 24508444 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28341525 (View on PubMed)

Other Identifiers

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yunqiu xia

Identifier Type: -

Identifier Source: org_study_id

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