Clinical Trial: Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase I/II, Open-Label Dose Escalation Trial to Evaluate the Safety and Efficacy of Two Dose Levels of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary D

Brief Summary: PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.

Detailed Summary:
Sponsor: Medipost America Inc.

Current Primary Outcome: Number of participants with adverse reactions for 84 days after treatment [ Time Frame: 84 days ]

Original Primary Outcome:

  • Number of participants with adverse reactions for 84 days after treatment [ Time Frame: 84 days ]
  • Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]


Current Secondary Outcome:

  • Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]
  • Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]
  • Hospital Re-admission between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]
  • Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]


Original Secondary Outcome:

  • Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) [ Time Frame: 36 weeks PMA ]
  • Hospital Re-admission between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]
  • Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age [ Time Frame: Between 84 days after treatment and 20 months of corrected age ]


Information By: Medipost America Inc.

Dates:
Date Received: February 15, 2015
Date Started: March 2015
Date Completion: May 2018
Last Updated: January 18, 2017
Last Verified: September 2016