A Phase 1 interventional study of autologous umbilical cord blood (UCB) and standard care in Hypoxic-Ischemic Encephalopathy, Hypoxia Neonatal and Cerebral Ischemia of Newborn, sponsored by Mononuclear Therapeutics Ltd.. Status unknown at 1 site in Hong Kong. Open to participants aged Up to 48 Hours. Per ClinicalTrials.gov, last updated 2018-06-07.
Sponsored by Mononuclear Therapeutics Ltd. · Phase 1, Interventional, and Treatment
The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.
Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →This is the only study on the registry with Mononuclear Therapeutics Ltd. as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
autologous UCB transfusion
Biological: autologous umbilical cord blood (UCB)
standard care
Procedure: standard care
autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
standard care procedure to the newborn infants presence of HIE and/or anemia
HIE: Mortality
Mortality Rate of the HIE Subjects
Time frame: 6 months
Anemia: Change from Baseline Hematocrit
Change from Baseline Hematocrit of the Anemia Subjects
Time frame: 48 hours, 1 week, 3 months, 6 months
HIE: HINE
Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
Time frame: 6 months, 1 year and 2 years
HIE: HNNE
Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects
Time frame: -1 day, 3 months (before discharge)
HIE: GMDS
Griffiths Mental Development Scale (GMDS) of the HIE Subjects
Time frame: 6 months, 1 year and 2 years
HIE: CBCL
Child Behavior Checklist for Attention Deficit of the HIE Subjects
Time frame: 2 years
HIE: Q-CHAT
Quantitative Checklist for Autism in Toddlers of the HIE Subjects
Time frame: 2 years
Anemia: hemoglobin
Change from Baseline hemoglobin of the Anemia Subjects
Time frame: 48 hours, 1 week, 3 months and 6 months
Anemia: Oxygenation level
Change from Baseline SpO2 of the Anemia Subjects
Time frame: 48 hours, 1 week
Anemia: Oxidative Stress Level
Change of Baseline Isoprostane of the Anemia Subjects
Time frame: 48 hours, 1 week, 3 months, and 6 months
Anemia: Requirements of Packed Cell Transfusion
Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects
Time frame: 6 months
Incidence of Adverse Event
Safety outcomes are Incidence of Adverse Events
Time frame: 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2018 (actual). Primary completion is estimated for Jun 2020, 26 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Autologous cord blood