Phase I study on the safety and preliminary efficacy of allogeneic mesenchymal stem cells in hypoxic-ischemic encephalopathy

Table 1 Enrollment criteria

Inclusion criteria
Age ≥ 18
HIE ≥ 6 mo prior, radiologically confirmed at initial diagnosis and at study enrollment
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
Life expectancy > 12 mo
No substiantial improvement despite of a treatment in neurological/functional status for the 3 mo before study enrollment
Severe disability defined as subject confined to a wheelchair/required to have home nursing care/needing assistance with activities of daily living
Expectation that the patient will receive standard post-treatment care and attend all visits
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
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
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
History of uncontrolled seizure disorder
History of cerebral neoplasm, or cancer within the past 5 yr, with the exception of localized basal or squamous cell carcinoma
Having clinic symptoms that formation of white sphere number ≥ 15000/µL or platelet count ≤ 100.000/µL
Serum aspartate aminotransferase and serum alanine aminotransferase > 3 × upper limit of normal/creatinine > 1.5 × upper limit of normal
Pregnant/lactating/expectation to become pregnant during the study
Participation in an another investigational stem cell study before treatment
The patient/parents decides to abandon the treatment or the patient death

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