Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02381366
Other study ID # MD-BPD-US001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date March 2015
Est. completion date May 2018

Study information

Verified date August 2018
Source Medipost America Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 2018
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 14 Days
Eligibility Inclusion Criteria:

- A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)

- A subject whose gestational age is between 23 and 28 weeks (23 weeks = gestational age (GA) < 28 weeks)

- A subject whose birth weight is between 500g and 1000g, inclusive

- A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening

- A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment

- A subject whose parent/guardian can give a written informed consent

Exclusion Criteria:

- A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)

- A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly

- A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)

- A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)

- A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening

- A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration

- A subject who was administered surfactant within 24 hours before study drug administration

- A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage

- A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening

- A subject who is currently participating in any other interventional clinical trial

- A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells
Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells: Dose A: 10 million cells per kg / Dose B: 20 million cells per kg

Locations

Country Name City State
United States Rush University Medical Center Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
Medipost America Inc. Medipost Co Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with adverse reactions for 84 days after treatment 84 days
Secondary Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age Between 84 days after treatment and 20 months of corrected age
Secondary Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA) 36 weeks PMA
Secondary Hospital Re-admission between 84 days after treatment until 20 months of corrected age Between 84 days after treatment and 20 months of corrected age
Secondary Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age Between 84 days after treatment and 20 months of corrected age
See also
  Status Clinical Trial Phase
Terminated NCT04506619 - Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Completed NCT04936477 - Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants N/A
Recruiting NCT05285345 - Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
Completed NCT03649932 - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing Phase 1
Terminated NCT02524249 - Early Versus Late Caffeine for ELBW Newborns N/A
Completed NCT02249143 - Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants N/A
Active, not recruiting NCT01632475 - Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Completed NCT01460576 - Improving Prematurity-Related Respiratory Outcomes at Vanderbilt N/A
Unknown status NCT00254176 - Cysteine Supplementation in Critically Ill Neonates Phase 2/Phase 3
Completed NCT00419588 - Growth of Airways and Lung Tissues in Premature and Healthy Infants
Completed NCT00319956 - Trial II of Lung Protection With Azithromycin in the Preterm Infant Phase 2
Completed NCT00208039 - Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates N/A
Completed NCT00006401 - Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00006058 - Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns N/A
Completed NCT00005376 - Premature Birth and Its Sequelae in Women N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT00004805 - Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death N/A
Completed NCT05152316 - The Baby Lung Study
Recruiting NCT04821453 - NAVA vs. CMV Crossover in Severe BPD N/A