Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

China Medical University

Status and phase: Unknown; Phase 1

Conditions: No Severe Congenital Anomalies; no Severe IVH Neither Cystic PVL; Extremely Premature Infants; Severe BPD That Conventional Therapies Has Failed; Bronchopulmonary Dysplasia

Treatments: Biological: ucMSCs; Other: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01207869

DMR99-104

Details and patient eligibility

About

Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely premature infant with severe BPD to establish whether intratracheal instillation of umbilical cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.

Enrollment: 10 estimated patients

Sex: All

Ages: 1 week to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• severe BPD, defined by the National Institute of Child Health and Human Development workshop, who conventional therapies (including furosemide and theophylline, and HFO ventilation) has failed

Exclusion criteria

• severe congenital anomalies
• severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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10 participants in 2 patient groups, including a placebo group

Mesenchymal stem cells

Experimental group

Description:

the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Treatment:

Biological: ucMSCs

Control

Placebo Comparator group

Description:

Normal saline

Treatment:

Other: Normal saline