Follow-Up Study of Mesenchymal Stem Cells for Bronchopulmonary Dysplasia

Chongqing Medical University

Status and phase: Unknown; Phase 1

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: transplantation of hUC-MSCs

Study type: Interventional

Funder types: Other

Identifiers

NCT03873506

yunqiu xia

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 1 month to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Mesenchymal Stem Cell

Experimental group

Description:

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

Treatment:

Drug: transplantation of hUC-MSCs