Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD) (IUMTB)

Fudan University

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Bronchopulmonary Dysplasia

Treatments: Drug: Human Umbilical Cord-derived Mesenchymal stem cell; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03645525

EKYYIUMTB

Details and patient eligibility

About

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Full description

Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Sex: All

Ages: 2 to 3 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
• Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age

Exclusion criteria

• Patients with severe congenital diseases
• Patients with IVH more than 3 grade
• Patients with severe sepsis
• Patients with active pulmonary hemorrhage

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups, including a placebo group

Mesenchymal stem cell

Experimental group

Description:

Human Umbilical Cord-derived Mesenchymal stem cell in the saline

Treatment:

Drug: Human Umbilical Cord-derived Mesenchymal stem cell

placebo

Placebo Comparator group

Description:

saline without mesenchymal stem cell

Treatment:

Drug: placebo