Feasibility of allogeneic mesenchymal stem cells in pediatric hypoxic-ischemic encephalopathy: Phase I study

Table 1 Enrollment criteria

No.	Inclusion criteria
1	Age < 18
2	HIE radiologically confirmed at initial diagnosis and at study enrollment
3	The patients who does not have any chronic illness (cancer, kidney, heart/hepatic failure etc.) other than HIE. Adequate systemic organ function confirmed by normal ranged laboratory values
4	Life expectancy > 12 mo
5	No substiantial improvement despite of a treatment in neurological/functional status for the 3 mo before study enrollment
6	Severe disability defined as subject confined to a wheelchair/required to have home nursing care/needing assistance with activities of daily living
7	Expectation that the patient will receive standard post-treatment care and attend all visits
8	Signing in the written informed consent form for confirming to that know the treatment to be applied and to be willing by their parents/a surrogate
	Exclusion criteria
1	Presence of any other clinically significant medical/psychiatric condition, or laboratory abnormality, for which study participation would pose a safety risk in the judgment of the investigator/sponsor or history within the past year of drug/alcohol abuse
2	Recently diagnosed severe infection (meningitis, etc.)/development of liver, kidney/heart failure/sepsis or skin infection at the i.v. infusion site or positive for hepatitis B, C/HIV
3	History of uncontrolled seizure disorder
4	History of cerebral neoplasm, or cancer within the past 5 yr, with the exception of localized basal or squamous cell carcinoma
5	Having clinic symptoms that formation of white sphere number ≥ 15000/μL or platelet count ≤ 100.000/μL
6	Serum aspartate aminotransferase and serum alanine aminotransferase > 3× upper limit of normal/creatinine > 1.5× upper limit of normal
7	Participation in an another investigational stem cell study before treatment
8	The patient/parents decides to abandon the treatment or the patient death

HIE: Hypoxic-ischemic encephalopathy; HIV: Human immunodeficiency virus.