Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open Label, Single-Center, Phase 1 Clinical Study to Evaluate the Safety and the Efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
Brief Summary: PNEUMOSTEM® is human umbilical cord blood derived mesenchymal stem cells and it is intended to treat premature infants with bronchopulmonary dysplasia. This study is to assess the safety and the efficacy of this study drug.


Options:
A: Inclusion Criteria:

* Mothers must have consented for cord blood collection at delivery
* cord blood must be available for extraction of stem cells.
* \>34 weeks gestation
* cord or neonatal pH\<7.0 or base deficit\>16 milliequivalents per liter (mEq/L) or history of acute perinatal event
* either a 10 minute Apgar \< 5 or continued need for ventilation.
* All infants must have signs of encephalopathy within 6 hours of age.

Exclusion Criteria:

* Inability to enroll by 14 days of age.
* Presence of known chromosomal anomaly.
* Presence of major congenital anomalies.
* Severe intrauterine growth restriction (weight \<1800g)
* Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.
* Parents refuse consent.
* Attending neonatologist refuses consent.
* Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.
B: Inclusion Criteria:

* Inborn infants at term gestation (38-42 weeks)
* Apgar score ≤ 3 at 5 minutes and/or delayed first breath beyond five minutes after birth
* Profound metabolic or mixed acidosis with serum bicarbonate \<12 mMol/L in initial arterial blood gas
* Evidence of encephalopathy such as stupor, coma, seizures, or hypotonia in the immediate neonatal period

Exclusion Criteria:

* Twin gestation
* Maternal diabetes
* Congenital malformations of the central nervous system
* Chromosomal abnormalities
* Chorioamnionitis and congenital infections
* Intrauterine growth restriction
C: Major Inclusion Criteria:

* Be ≥ 18 and \< 95 years of age.
* Provide written informed consent.
* Diagnosis of nonischemic dilated cardiomyopathy.
* Be a candidate for cardiac catheterization within 5 to 10 weeks of screening.
* Been treated with appropriate maximal medical therapy for heart failure.
* Ejection fraction below 40% and either a left ventricular end diastolic diameter (LVEDD) \> 5.9cm in male subjects, an LVEDD of \> 5.6cm in female subjects or left ventricular end diastolic volume index \> 125 mL/m2
* Be able to undergo an MRI or CT.

Major Exclusion Criteria:

* Baseline glomerular filtration rate equal or \< 45 ml/min/1.73m2.
* Be eligible for or require standard-of-care surgical or percutaneous intervention for the treatment of nonischemic dilated cardiomyopathy.
* Presence of a prosthetic aortic valve or heart constrictive device.
* Presence of a prosthetic mitral valve.
* Previous myocardial infarction (MI) as documented by a clinical history that will include an elevation of cardiac enzymes and/or ECG changes consistent with MI.
* Diagnosis of nonischemic dilated cardiomyopathy due to valvular dysfunction, mitral regurgitation, tachycardia, or myocarditis.
* Previous treatment for post-infarction left ventricular dysfunction including PCI and thrombolytic therapy.
* Documented presence of a known LV thrombus, aortic dissection, or aortic aneurysm.
* Documented presence of epicardial stenosis of 70% or greater in one or more major epicardial coronary arteries.
* Documented presence of aortic stenosis (aortic stenosis graded as 1.5cm2 or less).
* Documented presence of moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency graded as ≥+2).
* Evidence of a life-threatening arrhythmia in the absence of a defibrillator (nonsustained ventricular tachycardia ≥ 20 consecutive beats or complete second or third degree heart block in the absence of a functioning pacemaker) or QTc interval \> 550 ms on screening ECG.
* AICD firing in the past 30 days prior to the procedure
* Be eligible for or require coronary artery revascularization.
* Diabetic with poorly controlled blood glucose levels and/or evidence of proliferative retinopathy.
* Have a hematologic abnormality as evidenced by hematocrit \< 25%, white blood cell \< 2,500/ul or platelet values \< 100,000/ul without another explanation.
* Have liver dysfunction, as evidenced by enzymes (ALT and AST) greater than three times the ULN.
* Have a coagulopathy condition = (INR \> 1.3) not due to a reversible cause.
* Known, serious radiographic contrast allergy.
* Known allergies to penicillin or streptomycin.
* Organ transplant recipient.
* Have a history of organ or cell transplant rejection
* Clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
* Non-cardiac condition that limits lifespan to \< 1 year.
* On chronic therapy with immunosuppressant medication.
* Serum positive for HIV, hepatitis BsAg, or viremic hepatitis C.
* Female patient who is pregnant, nursing, or of child-bearing potential and not using effective birth control.
* Have a history of drug or alcohol abuse within the past 24 months.
* Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
D: Inclusion Criteria:

* Birth weight range: 500g\~1250g
* Fetal gestational age: 23 weeks to 29 weeks
* Premature infants who cannot do spontaneous breathing, which ventilation rate is less than 12 breaths per min of ventilation rate and 25% of oxygen demand
* Premature infants who does not improve the breathing or worse within 24 hours prior to enrollment of this study
* Written consent form signed by a legal representative or a parent

Exclusion Criteria:

* Cyanotic or acyanotic congenital heart diseases except patent ductus arteriosus
* Severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
* Severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
* Severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
* CRP \> 30 mg/dL; Severe sepsis or shock
* Premature infants who is going to or expected to have surgery 72 hours before/after this study drug administration
* Surfactant administration within 24 hours prior to this study drug administration
* Severe intracranial hemorrhage ≥ grade 3 or 4
* Premature infants who have active pulmonary hemorrhage or active air leak syndrome at the time point of screening
* History of other clinical studies as a participant
* Premature infants who are allergic to Gentamicin
* Premature infants who is considered inappropriate by the investigators

Answer: D