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Clinical Trials/NCT03645525
NCT03645525WithdrawnPhase 1

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

Children's Hospital of Fudan University3 sites in 1 countryStarted: December 1, 2019Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Withdrawn
Locations
3
Primary Endpoint
Oxygen requirement 3 days after transplantation

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
2 Weeks to 3 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Mesenchymal stem cell

Experimental

Human Umbilical Cord-derived Mesenchymal stem cell in the saline

Intervention: Human Umbilical Cord-derived Mesenchymal stem cell (Drug)

placebo

Placebo Comparator

saline without mesenchymal stem cell

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Oxygen requirement 3 days after transplantation

Time Frame: 3 days

Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ,which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %

Secondary Outcomes

  • Oxygen requirement 7 days after transplantation(7 days)
  • Duration of ventilator dependence(up to 36 weeks PMA)
  • Incidence of severe BPD(up to 36 weeks PMA)
  • Survival rate(up to 36 weeks PMA)
  • Temperature(3 days)
  • Heart rate(3 days)
  • Respiratory rate(3 days)
  • Duration of CPAP treatment(up to 36 weeks PMA)
  • Percentage of participants treated with steroids for weaning from ventilator(up to 36 weeks PMA)
  • Growth velocity (Z-score)(up to 36 weeks PMA)
  • bronohoalveolar lavage (BAL) cytokine level(7 days)
  • The severity of BPD in X-ray patterns(7 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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